Fylnetra: A Cost-Effective Option to Boost White Blood Cells During Chemotherapy

Published on by Dr. Mark Alfonso, PharmD, BCMTMS

Every year, millions of people undergo chemotherapy to treat cancer. Although chemotherapy can be lifesaving, it comes with many side effects. One such side effect of chemotherapy is that it can lower the number of white blood cells in your body. White blood cells fight off foreign substances, such as viruses and bacteria. So, a decrease in the number of white blood cells can increase your risk of infections. 

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Fortunately, modern medicines can help manage this side effect and protect you from infections during your cancer treatment. One such medication is Fylnetra (pegfilgrastim-pbbk). You may be wondering what Fylnetra is, how it works, and what the side effects are. In this article, we’ll explore everything you need to know about Fylnetra.

What Is Fylnetra?

Fylnetra (pegfilgrastim-pbbk) is a prescription medicine used to prevent infections in patients receiving chemotherapy that may lower their white blood cell (neutrophil) counts. It is a biosimilar to Neulasta (pegfilgrastim). This means that there is no meaningful clinical difference between Fylnetra and Neulasta, but the price of Fylnetra is less. 

Amneal Pharmaceuticals LLC developed Fylnetra, and the FDA first approved it on May 26, 2022 [1]. It belongs to a class of drugs called colony-stimulating factors (CSF). CSFs help stimulate your bone marrow to produce more white blood cells (neutrophils), which play a crucial role in fighting infections. 

By helping your body make more white blood cells, Fylnetra reduces the risk of infections that often come with certain chemotherapy treatments. You can receive this drug as a subcutaneous injection (an injection under the skin).

What Is It Used To Treat?

Fylnetra (pegfilgrastim-pbbk) is an FDA-approved medication used for the following two purposes [2]:

Prevention of infection in cancer patients receiving myelosuppressive chemotherapy who have a significant risk of febrile neutropenia: Fylnetra can reduce the risk of infection in patients with non-myeloid cancers who are receiving myelosuppressive chemotherapy (cancer treatments that can significantly lower white blood cell counts). By boosting white blood cell production, Fylnetra helps protect the body against infections during chemotherapy.

Improvement of survival in patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome (ARS): This is a condition caused by acute exposure to myelosuppressive doses of radiation, which damages the bone marrow and reduces your ability to produce blood cells and fight infection. Fylnetra can increase survival in these patients by stimulating the bone marrow, helping patients rebuild their white blood cell levels.

How Does Fylnetra Work?

Chemotherapy targets rapidly dividing cells to destroy cancer cells. However, in the process, chemotherapy can also harm healthy cells, including those in the bone marrow, where blood cells are produced. This damage can lead to a drop in neutrophils (a type of white blood cell). When neutrophil levels are too low, you are more prone to infections.

Fylnetra contains pegfilgrastim. It is a man-made version of a natural protein in the body called granulocyte colony-stimulating factor (G-CSF). Fylnetra works by stimulating the bone marrow to make more neutrophils [2]. 

Unlike some similar medications (e.g., filgrastim), Fylnetra stays in your body for a longer time. Because of this, you need to take it only once per chemotherapy cycle.

Fylnetra Side Effects

Smiling cancer patient sitting and resting at home

Like any other medication, Fylnetra can also cause some side effects. Some of these side effects are mild and temporary, while others are severe and require immediate medical attention. Here are some of the side effects of this medication [2][3]:

Common Side Effects

Here are some common side effects of Fylnetra:

  • Bone pain
  • Pain in arms or legs
  • Back pain
  • Fatigue

These side effects are usually mild and go away within a few days. However, if these symptoms persist or worsen, consult your doctor.

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Serious Side Effects

In rare cases, Fylnetra can cause some serious side effects. If you encounter any of these severe side effects, contact your doctor immediately. Here are some of those serious side effects:

Fatal Splenic Rupture: Fylnetra can cause your spleen to become large, which can rupture and cause death. Symptoms of an enlarged spleen include pain in the left upper abdomen or shoulder tip.

Serious Allergic Reactions: You may experience symptoms like rashes, swelling, shortness of breath, or dizziness after injection. Discontinue permanently if you experience allergic reactions.

Acute Respiratory Distress Syndrome (ARDS): This serious lung condition can cause shortness of breath, fever, and fast breathing.

Fatal Sickle Cell Crises: In patients with sickle cell disease, Fylnetra can cause a severe sickle cell crisis (a painful episode). Discontinue use if a sickle cell crisis occurs.

Aortitis (Inflammation of the Aorta): Symptoms include fever, fatigue, and pain in the chest, back, or abdomen.

Kidney Problems: Fylnetra can damage your kidneys. Symptoms include dark urine, swelling in your face or legs, and little to no urination.

Capillary Leak Syndrome (CLS): This condition occurs when fluid and proteins leak out of your small blood vessels (capillaries) into surrounding tissues. This leads to low blood pressure, low levels of albumin in your blood, swelling, fatigue, shortness of breath, and diarrhea.

Please note that this is not a complete list of all possible side effects. Always consult your doctor if you experience any unusual symptoms.

Dosing and Administration

Fylnetra is available as a single-dose prefilled syringe, which is given subcutaneously (under the skin). Before using, inspect the syringe, and if you see any discoloration or particulates, discard it. The usual recommended dosage is given below [2]:

For patients with cancer receiving myelosuppressive chemotherapy: The recommended dose is 6 mg, administered subcutaneously (under the skin) once per chemotherapy cycle. Do not administer Fylnetra within 14 days before or 24 hours after receiving cytotoxic chemotherapy.

For patients acutely exposed to myelosuppressive doses of radiation: These patients will receive two 6 mg doses one week apart. The first dose is given as soon as possible after suspected or confirmed radiation exposure, and the second dose is given one week later.

Fylnetra Cost

The price of Fylnetra is approximately $2,450 per syringe [4]. However, the actual cost will depend on your insurance plan, location, and the pharmacy you visit. You can apply for the Amneal Patient Assistance Program [5]. If you are eligible, you can receive free medication for up to a year.

FAQs

1. Can I use Fylnetra during pregnancy or breastfeeding?

There is still not enough data available to establish if usage during pregnancy is safe or not [2]. Therefore, you should only use Fylnetra during pregnancy or breastfeeding if your doctor thinks that the benefits outweigh the risks.

2. Is it safe for children?

Yes. The use of Fylnetra is safe and approved for pediatric patients. Scientific studies have shown no significant differences in safety between adults and children.

3. How is Fylnetra different from Neulasta?

Fylnetra is a biosimilar to Neulasta. This means that it is highly similar, but not identical, to the active ingredient in Neulasta (pegfilgrastim) and both provide the same clinical benefits and safety profile. However, it is generally less expensive.

2026 Medicare Open Enrollment Guide: What We’re Seeing & What Patients Need to Know

Published on by David Mogote

Insights from AmeriPharma Specialty’s Billing and Insurance Coverage Support Team

If you’re on a specialty medication like IVIG, TPN, oncology, or biologics, the 2026 open enrollment period is one of the most important windows of the year to review your insurance plan.

At AmeriPharma Specialty Care, our team supports thousands of patients across Medicare, Marketplace, and commercial insurance plans. Each year, we help patients avoid coverage gaps, uncover assistance opportunities, and resolve issues that could have been prevented with earlier planning.

This guide shares the top questions we hear, the most common mistakes we see, and what you need to know to protect your access to treatment in 2026.

We guide. You decide.
AmeriPharma helps you understand how your therapy is covered and where to look for financial assistance. AmeriPharma is not an insurance agent, and we do not recommend specific plans.

Key Open Enrollment Dates (for 2026 Coverage)

  • Medicare (AEP):
     Oct 15 – Dec 7, 2025
    Changes take effect Jan 1, 2026
  • ACA Marketplace Plans:
     Nov 1, 2025 – Jan 15, 2026
    Enroll by Dec 15 for Jan 1 coverage; Dec 16–Jan 15 for Feb 1
  • Employer Plans:
     Dates vary, but most are in October–December

How to Compare Plans for Specialty Therapies

1. Ask These Three Questions First

Every year, we speak to patients who chose plans based on monthly premiums — only to discover that their medication isn’t covered, or they’re locked into a pharmacy that can’t meet their needs.

Before selecting any plan, we recommend confirming these three things:

  • Is my medication on your formulary? What tier is it?
  • Do I have to use a specific specialty pharmacy? If yes, can I request an exception?
  • For Medicare Advantage plans: Does my provider work with the specified plan?

These three answers affect access, cost, and whether your prescriber and preferred specialty pharmacy can support you. Too often, patients skip this step—only to discover later that their plan won’t allow them to use their preferred pharmacy, or that starting treatment will be delayed while a new pharmacy is arranged.

2. Look at the Whole Cost — Not Just the Premium

Each year during open enrollment, we see patients choose plans with the lowest monthly premium, thinking they’re saving money — only to be surprised by higher out-of-pocket costs, pharmacy restrictions, or treatment delays once the year begins.

The reality is: A low premium doesn’t always mean a low total cost—especially if you’re on a specialty therapy.

What To Ask When Comparing Plans

To get the full picture, ask the plan to help you estimate your total yearly cost, including:

  • Monthly premium — what you pay each month
  • Annual deductible — what you must pay before coverage begins
  • Copays or coinsurance — for your specific medication
  • Out-of-pocket maximum — the most you’ll pay in a year before the plan pays 100% (For Medicare Part D: $2,100 in 2026)

These numbers vary significantly between plans—and even small differences can add up quickly when you’re managing high-cost medications.

What We See Go Wrong

  • Patients thinking they must use their plan’s preferred specialty pharmacy: This is one of the most common misconceptions. When patients enroll in a new plan, they often receive letters stating they must use the plan’s preferred specialty pharmacy. Many assume this is mandatory and may even request to cancel their service with the existing specialty pharmacy — believing their plan “requires” it. In reality, this is rarely the case. Patients usually have the right to choose their specialty pharmacy and should feel empowered to speak up about who they want to provide their care.
  • 50/50 coinsurance with no max: You pay half the drug cost indefinitely, with no cap on your spending.
  • High deductibles: You may owe thousands up front before coverage begins.
  • Mandated or excluded pharmacies: You could be forced to switch pharmacies or lose access entirely.
  • Delays from insurance approvals or site-of-care rules: Added steps can delay or block time-sensitive treatments.

When a Higher Premium Makes Sense

Sometimes, paying more per month gives you:

  • Better cost-sharing (like 80/20 instead of 50/50)
  • Lower coinsurance for infusions or injectables
  • Access to your preferred specialty pharmacy
  • Faster approvals with fewer administrative hurdles

Key Takeaway

Don’t shop by premium alone. Look at your total annual costs for your therapy and choose a plan that supports your therapy during Medicare open enrollment, minimizes delays, and keeps your out-of-pocket costs predictable.

3. Understand Plan Types

Some plans may restrict where you can get your treatment or how it’s billed:

Plan TypeWhat to Know
HMOLow flexibility. You must stay in-network. Often hard for specialty meds.
EPOSimilar to HMOs. Strict networks, no out-of-network options.
PPOMore flexible. May allow out-of-network care and pharmacy exceptions.
Medicare Advantage (Part C)One card for A, B & D, but may limit access to preferred pharmacies or sites of care.
Original Medicare + Medigap + Part DOften best for specialty therapies. Medigap covers the 20% coinsurance under Part B but does not cover any out-of-pocket expenses under Part D.

4. Confirm How Your Therapy Is Billed

Ask the plan whether your medication is billed under:

  • Pharmacy Benefit (e.g., Part D or commercial pharmacy):
    Covers most self-administered drugs or some specialty meds. OON options are sometimes available.
  • Medical Benefit (e.g., Part B or commercial medical):
    Applies to many infused therapies like IVIG, TPN, and oncology treatments. Coverage rules vary and may require strict network use or prior authorization.

Understanding how your therapy is billed can help avoid surprises with network status, authorizations, and costs.

Medicare: What’s New in 2026

Medicare Part D: Out-of-Pocket Cap

In 2025, Medicare introduced a new rule that limits how much you pay out-of-pocket for covered Part D prescription drugs in a calendar year.

For 2026, that out-of-pocket cap is $2,100. Once you’ve paid that amount—through deductibles, coinsurance, or copays—your Part D plan will cover 100% of covered drugs for the rest of the year.[insert language about how last year was $2000]

This limit applies only to Part D medications (not Part B infusions) and helps patients on high-cost therapies predict their maximum drug costs.

💡 Why this matters: If you’re on a high-cost specialty drug, this cap helps limit how much you’ll spend—and gives you a clearer idea of your worst-case scenario.

What to Know About the Monthly Payment Plan (Smoothing)

The Medicare Prescription Payment Plan—also called payment smoothing—was introduced in 2025. It allows Medicare Part D enrollees to spread their prescription drug costs across monthly payments, rather than paying large amounts all at once at the pharmacy.

In 2026, the out-of-pocket limit for covered Part D medications is $2,100. This plan doesn’t reduce that amount—it just spreads it out over time. While this may seem like a helpful budgeting tool, it’s important to understand what you’re agreeing to:

If you enroll, you’re still responsible for the full $2,100 out-of-pocket cap for 2026 — even if you qualify for financial assistance later.

In some cases, patients will sign up for smoothing and later become eligible for manufacturer copay programs or foundation grants—but because they were already committed to the full payment schedule, those assistance options could no longer be used.

Before enrolling, it’s a good idea to speak with an AmeriPharma Financial Assistance specialist who can walk you through how smoothing might affect your total cost. Depending on your situation, it may not be the best option.  Smoothing might sound helpful, but depending on your diagnosis, income, and medication, it could limit your access to assistance programs—and end up costing more.

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We’re here to help you avoid treatment delays, explore financial assistance, and make confident insurance choices for 2026.

Navigating Medicaid

Medicaid rules vary by state. In most states, Medicaid does not cover out-of-network pharmacies—even for specialty drugs. However:

  • Medi-Cal (California Medicaid) may cover medications under the pharmacy benefit, which allows more flexibility.
  • Other states: Coverage is often limited or not accepted by our pharmacy. Contact us to check eligibility.

Medicare Tips for Specialty Patients

  • Original Medicare + Medigap + Part D
     Often the smoothest experience for specialty care. Medigap helps cover what Parts A & B don’t, and Part D handles outpatient prescriptions.
  • Medicare Advantage (Part C)
     These plans bundle A, B & D under a private insurer. They may require stricter prior authorization, mandate specific pharmacies, or limit your site of care.
  • Medi-Medi (Medicare + Medicaid)
     This setup can work well if Medicaid is truly secondary, but coverage rules and allowed amounts vary by state.

Navigating Employer & Marketplace Plans

If you’re reviewing a plan from your employer or the ACA Marketplace:

  • Start with the formulary: Is your drug covered? What tier? Any PA or quantity limits?
  • Ask about pharmacy mandates: Some plans require you to use a specific specialty pharmacy.
  • Watch out for:
    • 50/50 coinsurance with no cap
    • High deductibles (makes first fills expensive)

💡 Tip: Even if a plan is out-of-network, we may still be able to help—especially if your medication is under the pharmacy benefit. About 98% of patients in this situation are still covered when processed through pharmacy billing.

Financial Assistance: How We Can Help

  • External help first: We explore manufacturer copay programs and disease-specific foundations.
  • Internal help next: If external help isn’t available, we’ll check our internal support options.
  • What matters most:
    • Household income
    • Diagnosis
    • Medication prescribed
    • Insurance benefit type (Part B vs Part D)

Please avoid enrolling in Medicare Part D payment plans (smoothing) before talking to us—it can block access to some assistance programs.

Quick Checklist Before You Choose a Plan

Confirm your medication, strength, and site of care

Ask: Is it covered? What tier? Any limits or prior auth?

Ask: Do I have to use a specific pharmacy?

Confirm if it’s billed under pharmacy or medical benefit

Estimate total cost: premium + deductible + coinsurance

Know your annual cap ($2,100 for Part D)

Start prior auth early to avoid treatment gaps

Ask about manufacturer or foundation assistance

Call us before signing up for Part D payment plans

      Speak with an Insurance Coverage Specialist

      We’re here to help you review your coverage, check your benefits, and find out what assistance may be available. We’ll also help you prepare for insurance approvals so you don’t miss a dose when January 1 rolls around — especially if you’re making changes during Medicare Open Enrollment.

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      IVIG for Parvovirus B19-Induced Pure Red Cell Aplasia: Benefits, Success Rates, and Treatment Insights

      Published on by Dr. Samantha Kaeberlein, PharmD

      IVIG for parvovirus B19-induced pure red cell aplasia is often considered the first-line treatment, especially in individuals with weakened immune systems. Learn about the benefits of IVIG, mechanism of action, and limitations of use. 

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      A Quick Overview

      Pure red cell aplasia is a rare condition. It occurs when cells that eventually turn into red blood cells become depleted or absent in the bone marrow. As a result, the bone marrow fails to produce sufficient healthy red blood cells, leading to severe anemia. Symptoms can include:

      • Shortness of breath 
      • Weakness 
      • Dizziness
      • Fatigue

      Parvovirus B19-induced pure red cell aplasia occurs when severe anemia develops following infection with parvovirus B19. 

      In otherwise healthy individuals, anemia is transient and often self-limiting. However, anemia can last longer and may cause life-threatening complications in immunocompromised individuals such as those with HIV/AIDS or transplant recipients. 

      What Are the Benefits of IVIG for Parvovirus B19-Induced Pure Red Cell Aplasia?

      IVIG is often considered the primary treatment for parvovirus B19-induced pure red cell aplasia in individuals with weakened immune systems [1,2].

      Several case reports suggest IVIG for parvovirus B19-induced pure red cell aplasia may cure or correct anemia within weeks.

      For example, in a 2022 study, researchers from Norway reported a case of a 39-year-old man who had successfully received a pancreas from a donor. The person was receiving immunosuppressive drugs to prevent the rejection of the transplanted organ. 

      Several months after the transplant, the person was diagnosed with parvovirus B19-induced pure red cell aplasia. Following the diagnosis, the person received 30 g (0.4 g/kg/day) IVIG for 6 consecutive days. At the end of the IVIG therapy, hemoglobin levels gradually increased to a satisfactory level [3]. 

      Nonetheless, relapses occurred at 4 and 8 months after IVIG therapy. On both occasions, IVIG was administered with promising results. 

      Another 2022 review analyzed data of eight kidney and two heart transplant patients and 86 studies to determine the use of IVIG and recurrence rate. All cases in the study had parvovirus B19-induced pure red cell aplasia and were solid organ recipients. 

      The researcher found that [4]:

      • About 91% of cases received IVIG
      • About 54% received IVIG and immunosuppression reduction
      • 6.5% of cases showed reduced immunosuppression without IVIG
      • Recurrence rate was 17.5%

      They also noted that reducing the use of immunosuppressive medicines may help resolve anemia in individuals with parvovirus. 

      In a 2024 study, two kidney transplant recipients with relapsing parvovirus B19-induced pure red cell aplasia were treated with 0.4g/kg/day of IVIG and a reduced amount of immunosuppressive medication. Although they relapsed around the same time frame as other patients, they responded to treatment earlier, showing some success for this dosing regimen [5].

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      What’s the Success Rate of IVIG for Parvovirus B19-Induced Pure Red Cell Aplasia?

      Patient receiving IVIG treatment at home
      • Viral load
      • Type of organ transplant 
      • Underlying health conditions of the patient
      • Type and dosage of immunosuppressive agent taken by the patient 

      Success rate may vary depending on several factors, including:

      According to a review published in Clinical Infectious Diseases, 93% of study participants achieved satisfactory hemoglobin levels after the first IVIG therapy. Unfortunately, relapse occurred in about 40% of participants after about 130 days [6]. 

      IVIG for Parvovirus B19-Induced Pure Red Cell Aplasia: How Does IVIG Work?

      Individuals with weakened immune systems do not have enough proteins (antibodies) against parvovirus B19. IVIG contains significant amounts of these antibodies, which neutralize parvovirus B19 and help correct anemia. 

      Nonetheless, relapses can occur when there are insufficient virus-neutralizing antibodies, which is common with IVIG treatment discontinuation. 

      Yet, IVIG remains the treatment of choice, given that no specific antiviral drug against parvovirus exists, and case reports suggest most patients respond to IVIG.  

      Limitations of IVIG

      Despite widespread use, IVIG for parvovirus B19-induced pure red cell aplasia faces several challenges, such as:

      • A lack of optimal dosage and duration of IVIG therapy from large, controlled trials 
      • IVIG may not be necessary for all HIV patients who have parvovirus B19-induced pure red cell aplasia [7]
      • IVIG treatment does not always eradicate parvovirus B19, and relapses may occur (requiring repeated IVIG administration)
      • A lack of cost-benefit comparison between low- and high-dose IVIG
      • IVIG availability and rising costs, especially with repeated administration

      What To Expect During IVIG

      You will receive IVIG as a slow infusion into your veins (intravenous) at an infusion center or at home. Though IVIG is generally safe and well-tolerated, you may experience side effects, typically during the first 60 minutes of infusion, such as:

      • Shortness of breath
      • Wheezing
      • Chest tightness
      • Coughing
      • Headache
      • Nausea
      • Vomiting 
      • Fever Rash 
      • Back pain 

      To minimize the risk of such reactions, your healthcare provider may give you fluids and IVIG premedications. 

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      Frequently Asked Questions

      How does IVIG work for parvovirus B19-induced pure red cell aplasia?

      IVIG works for parvovirus B19-induced pure red cell aplasia by providing virus-neutralizing antibodies to the patient. There has also been evidence to suggest IVIG therapy can promote antibody formation in affected patients [8].

      What is the treatment for parvovirus B19?

      Standard parvovirus B19 infections are generally mild and self-limiting. Complete recovery occurs in most individuals who are otherwise healthy. Treatment may involve medications to relieve fever, itching, and joint pain and swelling. 

      How do you treat aplastic anemia due to parvovirus?

      The most preferred treatment for parvovirus-associated severe aplastic anemia is bone marrow transplantation. 

      How does parvovirus B19 cause pure red cell aplasia?

      Parvovirus B19 specifically targets and destroys cells that would otherwise mature into red blood cells. Consequently, the bone marrow is unable to produce mature red blood cells, leading to a dramatic drop in hemoglobin levels. 

      What drugs cause pure red cell aplasia?

      The three drugs most commonly associated with pure red cell aplasia are:

      • Phenytoin (anticonvulsant)
      • Azathioprine (immunosuppressive agent)
      • Isoniazid (antibiotic to treat tuberculosis)

      Free Drug Programs for Hemophilia: What Happens After the Trial Ends?

      Published on by AmeriPharma Pharmacy Staff

      Many patients with hemophilia who are new to treatment or want to explore alternatives and voluntarily participate in manufacturer-subsidized free drug programs. These programs, which are limited in supply, can be particularly appealing since they provide free access to hemophilia medications for a limited time. 

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      These programs can be a great opportunity to try the latest treatments without financial risk. But what happens when the free supply runs out?

      Many patients struggle to continue the long-term treatment process after the program ends, so it’s important to understand how they work, what to expect during and after participation, and how to plan ahead so your care remains uninterrupted once the program concludes.

      Read on to learn how free drug programs work, what challenges you may face afterward, and what options you can choose to maintain long-term, sustainable support for uninterrupted hemophilia treatment.

      What is a Manufacturer-Subsidized Free Drug Program?

      A free drug program is a temporary, short-term program offered by several pharmaceutical manufacturers that allows patients to try a specific medication free of cost for a limited period. 

      Hemophilia patients typically benefit from free drug programs, as they may involve factor replacement therapies or other specialty drugs such as new bypassing agents or longer-acting clotting factor concentrates, which are essential for managing bleeding episodes. 

      With this type of program, you can assess how well the medication works and decide if it’s the right option for you to use long-term.

      Note: A manufacturer-subsidized free drug program is not the same as a clinical trial.

      • In a clinical trial, patients participate in a formal research study to test a new medication’s safety and effectiveness under FDA oversight.
      • In a manufacturer-subsidized free drug program, the medication is already approved and prescribed — the manufacturer simply provides it at no cost for a short time to help patients start treatment or transition therapies.

      How a Free Drug Program Typically Works for Hemophilia Patients

      Before applying, it’s helpful to know that eligibility criteria can vary depending on the manufacturer and drug type. Factors such as your diagnosis, age, treatment history, insurance status, and previous exposure to certain therapies may determine whether you qualify. Hemophilia patients usually undergo the following process to enroll in a free drug program: 

      • Eligibility Check 

      Your physician will apply through the drug manufacturer’s support program after confirming your diagnosis and factor deficiency severity (hemophilia A or B, with/without inhibitors). 

      • Enrollment Process

      You may be asked about an additional requirement, such as your insurance coverage, income status, or prior treatment history. For instance, Novoeight® Trial Prescription Program (Novo Nordisk) offers six free doses to new patients with commercial insurance.

      Most programs are designed to let patients “test” the drug before committing to a long-term plan.

      You can find information about free drug programs from several sources:

      • Your hematologist or treatment center who can contact manufacturer representatives directly.
      • Manufacturer websites, which usually list their patient support and access programs.
      • Patient advocacy groups, such as the National Hemophilia Foundation (NHF) or the Hemophilia Federation of America (HFA), which maintains updated program directories.
      • Medication Supply

      Once you receive an approval, the manufacturers directly ship the medication, like factor replacement therapy or non-factor products (e.g., Emicizumab/Hemlibra) to you or your treatment center at no cost for a limited period. Your medication supply may last from a few weeks to a few months, at no direct cost, depending on the program. 

      • Monitoring

      During the program, a healthcare provider tracks your response to the medication, such as bleeding frequency, factor levels, side effects, and overall health improvements. 

      This follow-up process helps both the patient and the healthcare provider to determine whether the prescribed drug is appropriate and safe for long-term use.

      • Safety and Patient Rights

      Before starting, your healthcare provider should explain the medication’s purpose, possible side effects, and what to expect. You can discontinue participation in the program at any time without losing access to your doctor or future support programs. Report any unusual side effects or bleeding events immediately to your care team.

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      What Happens After the Program Ends?

      Doctor's appointment to discuss hemophilia free drug programs

      After the program ends, you may transition to regular therapy or a more affordable alternative if your insurance does not approve the coverage. Below are some of the common issues hemophilia patients usually face after the program ends:

      • Loss of Coverage and Delays in Treatment

      Sometimes, insurance coverage may not automatically approve the medication, especially if prior authorization is required. This often led to gaps in treatment access while the coverage is being sorted. 

      Even short delays can raise the risk of bleeding episodes and complications for people with hemophilia.

      • Confusion About Next Steps

      Many patients think their medication will continue on its own, but they end up finding that they must deal with paperwork, insurance approvals, or alternative assistance programs. This causes anxiety and stress, especially for parents of children with hemophilia.

      • Financial Concerns

      Hemophilia medication is very expensive. Specialty medications, for example, can be expensive, and continuing the treatment without assistance programs might be difficult for some patients. 

      Hence, it is important for patients to always plan to avoid these issues after the program ends.

      • How to Prepare Before the Program Ends

      To avoid interruptions, start planning 2–3 weeks before your supply ends:

      • Confirm your medication’s end date and remaining doses.
      • Ask your provider whether you’ll continue the same medication or switch.
      • Contact your insurance company early for prior authorization or coverage review.
      • Collect all documents (prescriptions, income info, insurance cards) for patient assistance applications.
      • Coordinate with a specialty pharmacy experienced in hemophilia care or your care manager for transition planning.

      Available Options for Continued Treatment

      There are several ways to maintain access to your medication:

      • Manufacturer Assistance Programs

      The first option is copay or patient assistance programs. Several pharmaceutical companies provide these programs that lower the out-of-pocket costs or provide medication at no cost to eligible patients.

      • Bridge Programs: Some manufacturers offer short-term coverage (“bridge supply”) while you wait for insurance approval.
      • Foundation Grants: Independent charitable organizations may provide grants for copays, travel, or treatment-related costs.
      • Insurance Coverage

      Before the program ends, you should work with your healthcare provider and insurance company to secure insurance approvals for ongoing therapy. Early submission of the documentation can prevent treatment interruptions.

      If coverage is denied, you have the right to file an appeal. Your doctor or specialty pharmacy can help you prepare the necessary documentation.

      • Specialty Pharmacies

      Specialty pharmacies, like AmeriPharma Specialty Care, can coordinate between patients, providers, and insurance to ensure the smooth continuation of therapy. They offer services including medication delivery, education on proper usage, and assistance with financial programs.

      Speak to a Specialist

      About Copay Assistance
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      Why Choose AmeriPharma® Specialty Care?

      At AmeriPharma Specialty Care, we help hemophilia patients move from temporary programs to long-term, uninterrupted care. 

      Here’s how we make it easier:

      • Copay Assistance: We help patients access programs that can lower or even eliminate out-of-pocket costs. Some patients can continue on the same medication with a $0 copay.
      • Smooth Coordination: We work with your doctor and insurance to handle approvals and delivery, so your medication arrives on time.
      • Ongoing Support: We provide guidance on how to use your medication, store it properly, and manage any side effects.
      • 24/7 Specialized Care: When it comes to hemophilia, timing matters. Bleeding episodes, travel situations, or unexpected supply needs can happen at any hour. Our specialty pharmacy is available 24/7 and experienced in handling real-world scenarios unique to hemophilia patients.

      If you or a loved one is currently participating in a free drug program, don’t wait until it ends to plan your next steps. Contact our copay assistance experts who can help you reduce your out-of-pocket costs and will guide you through the entire process, from choosing the right copay assistance programs to applying for them and receiving lower-cost treatments.

      Ojjaara: A New Oral Therapy to Treat Rare Blood Cancer

      Published on by Dr. Robert Hakim, PharmD

      Ojjaara is an oral prescription medicine used to treat certain forms of myelofibrosis (a type of bone marrow cancer) in adults with anemia. 

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      Ojjaara Introduction and Uses

      Ojjaara is a brand-name product. It contains the active ingredient momelotinib, which belongs to the Janus kinase (JAK) inhibitor drug class. No generic versions of this medication are currently available. 

      Ojjaara is not chemotherapy, but rather a targeted therapy that lowers the activity of the immune system for cancer treatment. 

      In 2023, the US FDA approved this medication to treat certain forms of myelofibrosis in adults with anemia. Myelofibrosis is a rare cancer that causes scar tissue to form in the bone marrow. As a result, the bone marrow fails to produce enough healthy blood cells, resulting in:

      • Shortness of breath and tiredness
      • Easy bruising or bleeding 
      • Recurrent infections 

      Your liver or spleen may also become enlarged. 

      Ojjaara Mechanism of Action 

      Ojjaara is a janus kinase (JAK) inhibitor. Cells inside the bone marrow contain proteins (JAK) that become overactive when you have myelofibrosis. Ojjaara blocks the action of these proteins. In addition, Ojjaara blocks another protein in the liver cells, leading to an increased level of healthy red blood cells. 

      Ojjaara Dosage

      A senior woman taking a tablet of Ojjaara

      Ojjaara comes as 100 mg, 150 mg, and 200 mg tablets that are taken by mouth. 

      The recommended dosage is 200 mg orally once daily. Your healthcare provider may prescribe a lower dose, 150 mg orally once daily, if you have severe liver problems.   

      Before and during treatment with this medication, your healthcare provider will monitor your blood counts and liver function. Moreover, you will be asked to take tests to see if you have active hepatitis B before starting this medication. 

      Treatment with Ojjaara is long-term and will likely continue as long as it is safe and effective for you. However, if you experience severe side effects or the medication stops working, your healthcare provider may ask you to stop it temporarily or permanently. 

      Ojjaara Side Effects

      Common side effects

      • Low platelet count
      • Bleeding
      • Bacterial infection
      • Tiredness
      • Dizziness
      • Diarrhea
      • Nausea
      • Pain in the back, leg, or arm 
      • Rash 
      • Itching 
      • Blurry vision 

      Talk to your healthcare provider or pharmacist if any side effect worsens or don’t get better with time. 

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      Severe side effects

      Call your healthcare provider immediately or seek emergency care if you have signs and symptoms of:

      • Infections, such as fever, chills, cough, difficulty breathing, diarrhea, vomiting, pain, or a burning sensation when passing urine
      • Low platelet counts, such as unexplained bleeding or bruising, or tarry stools
      • Liver problems, such as yellow skin or eyes, or pain in the upper right region of your stomach 
      • Severe skin reactions, such as flu-like symptoms, severe rashes, skin peeling, blistering of the lips, eyes, or mouth

      Heart attack or stroke

      Though not specifically reported in people taking Ojjaara, heart attack and stroke have been reported in individuals taking a different JAK inhibitor. The risk may be higher among current or past smokers. Seek emergency care if you experience any signs or symptoms of a heart attack or stroke, such as: 

      • Discomfort in your chest
      • Severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
      • Pain or discomfort in your arms, back, neck, jaw, or stomach
      • Shortness of breath with or without chest discomfort
      • Nausea or vomiting
      • Lightheadedness
      • Weakness in one part or on one side of your body
      • Slurred speech

      Blood clots

      Blood clots in the arms or legs (deep vein thrombosis or DVT) or in the arteries or lungs (pulmonary embolism or PE) have occurred in people taking JAK inhibitors like Ojjaara. Go to the emergency room immediately if you are experiencing:

      • Swelling, pain, or tenderness in one or both legs
      • Sudden, unexplained chest pain
      • Difficulty breathing

      New cancers

      Taking JAK inhibitors may increase the risk of getting new cancers. The risk may be higher among current or past smokers. Talk to your healthcare provider about the risk of new cancers while taking this medication. 

      Use in Pregnancy 

      Animal studies suggest this medication may harm your unborn baby. Avoid getting pregnant during treatment and for seven days after the final dose. Inform your healthcare provider immediately if you become pregnant during treatment. 

      Use in Lactation

      Animal studies suggest Ojjaara can get into breastmilk, which can be passed on to your baby. Avoid breastfeeding during treatment and for 7 days after the final dose. 

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      Before Taking Ojjaara

      Before taking your first dose, inform your healthcare provider if you:

      • Have an infection
      • Have or have had hepatitis B
      • Have or have had liver issues
      • Have had a heart attack, or have had other heart problems, or a stroke
      • Have or have had a blood clot
      • Smoke or were a smoker in the past
      • Have or have had any other cancers
      • Are pregnant or plan to become pregnant

      Missed Dose and Overdose

      Skip the missed dose and continue your recommended dosing schedule. Never take a double dose to make up for the missed one. 

      If you think you have overdosed on Ojjaara, contact the Poison Help line (1-800-222-1222) or seek medical help by going to an emergency room immediately. 

      Proper Use, Storage, and Disposal

      • Before using this medication, read the instructions on the prescription label carefully. Take your doses exactly as directed. 
      • If you have any questions, talk to your doctor or pharmacist. 
      • Swallow the entire tablet; avoid crushing, chewing, or breaking it. 
      • You may take this medication with or without food.
      • Never stop taking this or any medicine without talking to your healthcare provider.
      • Store this medication at temperatures between 20°C and 25°C (68°F and 77°F). Storage between 15°C and 30°C (59°F and 86°F) may be allowed for a brief period.
      • Store Ojjaara in the original bottle, which contains a desiccant packet that protects the tablets from moisture. Never discard desiccant.
      • Replace the cap tightly each time after you take the recommended tablets.
      • Dispose of unused or expired medicines following the local requirements. Click HERE to learn how to dispose of unneeded or expired drugs. 

      Ojjaara Cost

      Cost can vary depending on your insurance plan, location, and pharmacy. Ask your insurance provider if your plan covers this medication or if you need prior authorization. 

      GSK (GlaxoSmithKline), the manufacturer of Ojjaara, may provide reimbursement support and financial assistance if you are eligible. 
      Contact us if you are interested in exploring financial and copay assistance for Ojjaara.

      IVIG for Isoimmune Hemolytic Disease of the Newborn (HDN)

      Published on by Dr. Mark Alfonso, PharmD, BCMTMS

      Healthcare providers sometimes recommend IVIG treatment when first-line treatment, like phototherapy, is insufficient for newborns with isoimmune hemolytic disease (HDN). 

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      Isoimmune hemolytic disease of the newborn is a potentially life-threatening condition that develops when there is a blood group incompatibility between the mother and her newborn. This incompatibility causes rapid destruction of the baby’s red blood cells (hemolysis), resulting in jaundice soon after birth. 

      Phototherapy is the first-line treatment. When it fails to manage isoimmune HDN in severe cases, blood exchange transfusion (BET) is considered as a second-line treatment. However, BET treatment carries significant risks for newborns, and to avoid this, IVIG therapy is often considered as an adjunct therapy. 

      In fact, research has shown that IVIG therapy is safe and effective for patients with isoimmune HDN, as it reduces the need for more invasive and risky procedures like BET. Read on to learn what isoimmune hemolytic disease of the newborn (HDN) is and how IVIG can help newborns.  

      Isoimmune Hemolytic Disease of the Newborn (HDN): Overview

      Isoimmune hemolytic disease of the newborn (HDN) is an immune-mediated condition in newborns. This condition typically occurs when the mother and baby have different blood types (A, B, AB, or O) and Rh factors (positive or negative).  

      In most cases, HDN is triggered by an Rh factor incompatibility. Rh factor is a protein (D antigen) present on the red blood cells (RBCs). 

      When a mother with Rh-negative (no Rh protein) blood has a baby with Rh-positive blood type (inherited from the father), the mother’s immune system sees the baby’s red cells as “foreign” and produces antibodies against them. 

      These antibodies cross the placenta during pregnancy and attack the baby’s Rh-positive red cells. As the antibodies destroy the red cells, the baby gets sick. This is called erythroblastosis fetalis during pregnancy. Once the baby is born, it’s referred to as isoimmune hemolytic disease of the newborn (HDN).

      Soon after birth, newborns show symptoms of anemia and jaundice, like yellowing of skin/eyes due to high bilirubin (a yellow substance that is released during the destruction of RBCs). 

      Since the newborn’s liver is still immature and cannot process and clear excess bilirubin quickly, it starts to build up in the baby’s bloodstream, causing symptoms of anemia and jaundice. 

      Common Symptoms of Isoimmune HDN

      The symptoms of isoimmune hemolytic disease of the newborn (HDN) may differ among infants. Some common symptoms that your newborn may show after birth include:

      • Pale skin and jaundice (yellowing of skin, eyes, and umbilical cord) due to anemia
      • Enlarged liver and spleen
      • Lethargy
      • Rapid heart rate
      • Hydrops fetalis (severe swelling of the entire body)
      • Kernicterus (brain damage due to high buildup of bilirubin in the blood)

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      IVIG and Isoimmune Hemolytic Disease of the Newborn (HDN)

      A mother holding her newborn baby

      The American Academy of Pediatrics (AAP) 2022 Clinical Practice Guideline recommends that IVIG should only be used in selective, severe cases of isoimmune HDN, especially when:

      • Total serum bilirubin (TSB) continues to rise despite using intensive phototherapy. 
      • Bilirubin levels (2 – 3 mg/dl) are close to the point where blood exchange transfusion would be needed.
      • Blood exchange transfusion is either risky for the baby or is not available.

      Observational and review papers report that adding IVIG to intensive phototherapy in antibody-mediated HDN (Rh or significant ABO) can slow bilirubin rise and may lessen the need for exchange transfusion in selected infants. 

      Similarly, previous randomized controlled trials showed that IVIG is effective in treating neonates with hemolytic jaundice and significantly reduces the need for exchange transfusions. Likewise, in a case series of 11 newborns with isoimmune hemolytic disease (HDN), when treated with 3 – 4 IVIG doses, the bilirubin levels fell below blood exchange transfusion thresholds in all cases.

      Furthermore, a 2023 retrospective cohort study also reported the potential benefits of IVIG in reducing the need for exchange transfusion in isoimmune HDN. But the overall high-quality evidence is vague. 

      The current guidelines advise using IVIG only in selective cases of isoimmune HDN. For instance, an international panel suggested that IVIG should not be used routinely to treat Rh- or ABO-mediated HDN, but should only be considered when blood exchange transfusion cannot be readily performed.

      How IVIG Works in Isoimmune Hemolytic Disease of the Newborn 

      The exact working mechanism of IVIG in isoimmune HDN is unclear, but research studies demonstrate that IVIG blocks macrophages (a type of immune cell involved in the destruction of the baby’s RBCs). 

      Newborns with isoimmune hemolytic disease have red blood cells coated with the mother’s antibodies. The baby’s immune cells (i.e., macrophages) recognize and destroy these antibody-coated RBCs, resulting in low RBCs (anemia) and high bilirubin levels (jaundice) in babies. 

      IVIG works by interfering with this process. The antibodies provided by IVIG treatment bind to receptor sites on macrophages and prevent them from attacking the baby’s antibody-coated RBCs. 

      By doing this, IVIG slows down the breakdown of the baby’s RBCs, reduces bilirubin levels, and lowers the risk of serious complications. 

      Recommended Dosage of IVIG for Isoimmune Hemolytic Disease of the Newborn 

      According to the AAP 2022 Clinical Practice Guideline and the Canadian Pediatric Society, the recommended dose of IVIG for isoimmune HDN is 0.5 – 1 g/kg given over 2 hours when the total serum levels of bilirubin increase despite intensive phototherapy or if levels are 2 – 3 mg/dl above the exchange level. 

      A second dose of IVIG can be given 12 hours later if needed. 

      Reported Adverse Effects of IVIG

      IVIG treatment is generally well-tolerated. But in newborns, the stakes are high and safety matters a lot. Some earlier studies reported that IVIG may increase the risk of necrotizing enterocolitis (NEC). 

      Other potential adverse effects reported in neonatal case series are thrombosis, anaphylaxis, fluid shifts, and hypoglycemia. 

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      Key Takeaway

      Most babies with isoimmune hemolytic disease (HDN) improve with phototherapy alone. IVIG is considered only in selected and severe cases of isoimmune hemolytic disease of the newborn when phototherapy is not sufficient and blood exchange transfusion poses higher risks.

      Imfinzi: Uses, Dosage, Side Effects, Mode of Action and More

      Published on by Dr. Christine Leduc, PharmD

      Imfinzi (pronounced im-FIN-zee) is a type of immunotherapy drug used in cancer treatment and administered as an intravenous infusion. This medicine does not directly kill the cancer cells, but helps your immune system find and attack them. 

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      Imfinzi (durvalumab) was first approved by the FDA in 2017 for treating locally advanced or metastatic bladder cancer. Since then, it has received approval for treating additional, various types of cancers in adults.  

      While Imfinzi improves survival rates, it also carries adverse effects. Read on to understand its usage, recommended dosage, side effects, mechanism of action, and more. 

      Important Safety Information

      Since Imfinzi helps the immune system fight cancer, it can also cause your immune system to attack healthy tissues or organs, potentially affecting their function. This can lead to severe or even life-threatening problems and may result in death. These problems can happen at any time during treatment or even after it has ended.

      Imfinzi: Uses or Indications

      Imfinzi is prescribed when the cancer is advanced, has spread, cannot be entirely removed by surgery, or has returned after previous treatment. It is indicated to treat patients with the following types of cancers: 

      • Small cell lung cancer (SCLC)
      • Non-small cell lung cancer (NSCLC)
      • Biliary tract cancer (BTC), which includes cancer of the bile ducts and gallbladder
      • Hepatocellular carcinoma (HCC)
      • Muscle-invasive bladder cancer (MIBC)
      • Endometrial cancer (dMMR)

      Imfinzi can be used alone (as a monotherapy) or combined with other immunotherapies (e.g., Imjudo) or chemotherapy, depending on the type of cancer being treated. 

      Mechanism of Action (MOA)

      Your immune system can recognize and attack the harmful cells, including cancerous ones. However, some cancer cells develop genetic changes and produce a protein called PD-L1 (Programmed Death-Ligand 1). 

      This protein (PD-L1) is also present on the surface of healthy cells, which usually acts as a safety signal to prevent the immune system from attacking them. Cancer cells, on the other hand, also start to produce a lot of PD-L1, which allows them to hide from the immune system and keep multiplying. 

      Durvalumab, the active ingredient in Imfinzi, is a PD-L1-blocking antibody and belongs to the class of immune checkpoint inhibitors. Durvalumab works by blocking the PD-L1 protein, which helps the immune cells, especially T-cells, to find, recognize, and attack cancer cells. 

      Dosage Form and Administration

      Patient receiving an infusion at home

      Imfinzi is available as a liquid solution in single-dose vials. Each vial contains 50 mg/ml of Imfinzi solution. The single-dose vials come in two sizes: 

      • 120 mg/2.4 ml
      • 500 mg/10 ml

      The medication is administered as an IV infusion by a healthcare professional. With IV infusions, the drug is slowly injected into a vein over a certain period of time. Imfinzi infusion typically takes 1 hour to complete.

      Recommended Dosage for Cancer Patients

      The dosage of Imfinzi (Durvalumab) depends on the type of cancer being treated, the patient’s body weight (kg), and whether this medication is given alone or combined with other therapies. 

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      The following are the recommended dosages of Imfinzi for adult patients with certain types of cancers. 

      1. Imfinzi Dosage for Non-Small Cell Lung Cancer (NSCLC)

      The dosage of Imfinzi is prescribed based on whether the NSCLC is unresectable (cannot be removed surgically) or metastatic (spread to other parts of the body). Imfinzi is administered with other cancer treatments with varying dosages and frequencies. 

      However, the dose typically prescribed for non-small cell lung cancer is an infusion of 10 mg/kg every 2 weeks or 1,500 mg every 4 weeks (if you weigh ≥ 30 kg). If you weigh < 30 kg, a dose of 10 mg/kg will be given every 2 weeks. 

      2. Imfinzi Dosage for Small Cell Lung Cancer (SCLC)

      To treat limited-stage SCLC, you will receive Imfinzi as a single agent once every 4 weeks.

      • If your weight is ≥ 30 kg, a 1,500 mg dose is administered.
      • If your weight is < 30 kg, you’ll receive 20 mg/kg.

      For extensive-stage SCLC, you’ll receive your first dose of Imfinzi with chemotherapy for cycles 1 through 4, then as a single agent (Imfinzi alone). 

      • If your weight is ≥ 30 kg, an infusion of 1,500 mg/kg is administered once every 3 weeks. After cycles 1 through 4, you’ll receive 1,500 mg of Imfinzi alone every 4 weeks.
      • If your weight is < 30 kg, a dose of 20 mg/kg is given. After cycles 1 through 4, you’ll receive 10 mg/kg once every 2 weeks.

      3. Imfinzi Dosage for Biliary Tract Cancer (BTC)

      For biliary tract cancer, Imfinzi is given with chemotherapy once every 3 weeks for up to 8 cycles. After finishing chemotherapy, you’ll receive a dose of Imfinzi as a standalone treatment every 4 weeks.

      • If you weigh ≥ 30 kg, an infusion of 1,500 mg/kg is given, while an infusion of 20 mg/kg is given if you weigh < 30 kg.

      4. Imfinzi Dosage for Hepatocellular Carcinoma

      To treat unresectable hepatocellular carcinoma (HCC), a type of liver cancer that cannot be surgically removed, you’ll receive the first dose of Imfinzi in combination with immunotherapy (tremelimumab). 

      After immunotherapy, it is administered as a single agent once every 4 weeks. An infusion of 1,500 mg/kg will be given if the weight is ≥ 30 kg, and 20 mg/kg in cases of < 30 kg. 

      5. Imfinzi Dosage for Endometrial Cancer (dMMR)

      To treat advanced or recurrent endometrial cancer, you’ll receive an Imfinzi dose combined with other cancer medicines every 3 weeks for six treatment cycles, then Imfinzi alone. 

      • If you weigh ≥ 30 kg, you’ll receive a dose of 1,120 mg/ kg once every 3 weeks for six cycles. After that, your dosage will be changed to 1,500 mg Imfinzi once every 4 weeks as a stand-alone treatment.
      • If you weigh < 30 kg, you’ll receive a dose of 15 mg/kg once every 3 weeks for six cycles. After that, your dosage will be changed to 20 mg/kg Imfinzi once every 4 weeks as a stand-alone treatment. 

      For more information about your specific dosage, talk with your doctor.

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      Side Effects

      You may experience some of the common side effects during treatment with Imfinzi. Note that these side effects can vary depending on the type of cancer you have and other cancer medicines you may be using.  

      If you’re taking Imfinzi alone, you may experience the following effects: 

      • Cough
      • Diarrhea or constipation
      • Rash
      • Joint Pain
      • Fever
      • Abdominal (stomach) pain
      • Infection in the nose and throat
      • Itching
      • Hypothyroidism 
      • Anemia (low hemoglobin level)
      • Nausea or vomiting
      • Shortness of breath
      • Hair loss
      • Low appetite
      • Lung inflammation (pneumonitis)
      • Low magnesium, elevated liver enzymes (AST/ALT)

      Though less common, Imfinzi can also cause serious effects like: 

      • Severe allergic reactions, which include fever, swollen lymph nodes, swelling in the face, lips, tongue, or throat, itching, skin rash, and breathing problems 
      • Infusion-site reactions such as fever or chills, flushing, shortness of breath, itching or skin rash, dizziness, or fainting
      • Immune system reactions, which include:
        • Pneumonitis (inflamed lungs)
        • Colitis (inflamed intestine)
        • Hepatitis (inflamed liver)
        • Inflamed nerves
        • Inflamed muscles or joints
        • Heart or blood vessel inflammation
        • Inflamed eye (Uveitis)
        • Inflamed brain (encephalitis)
        • Inflamed kidney (nephritis)
        • Inflammation in the hormonal glands

      Tell your healthcare provider right away if you have any of these signs or symptoms, even if you are no longer taking this medicine.

      Information to Tell Your Doctor Before Taking Imfinzi

      Tell your doctor if you have/are:

      • Autoimmune disorders like Crohn’s disease, ulcerative colitis, or lupus
      • Received an organ transplant 
      • Received radiation treatment for your chest area
      • Received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
      • Received radiation treatment to the chest area
      • A condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
      • Pregnant or plan to become pregnant, as Imfinzi can harm your unborn baby
      • Are breastfeeding or plan to breastfeed. It is not known if Imfinzi passes into your breast milk. (Do not breastfeed during treatment and for 3 months after the last dose of Imfinzi).
      • Taking any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements.

      Small Fiber Neuropathy Symptoms and How to Detect Them

      Published on by Dr. Saba Rassouli, PharmD
      • Small fiber neuropathy symptoms include burning, stabbing pain, tingling, numbness, and hypersensitivity, often starting in the feet and legs before moving upward.
      • Autonomic SFN symptoms such as dizziness, dry eyes/mouth, abnormal skin color, and blood pressure issues indicate nerve involvement beyond sensation.
      • Symptoms can progress from mild early signs to severe pain.
      • Early recognition of symptoms is crucial for timely treatment.

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      Small fiber neuropathy (SFN) is a nerve condition with distinct symptoms that can be challenging to recognize. These symptoms often emerge gradually and vary from person to person.

      However, understanding them is crucial for diagnosing the disease early and managing it effectively. Today, we will examine the various symptoms of SFN to help you understand what to watch for with this disease.

      Understanding Small Fiber Neuropathy

      The neuropathy of small fibers is a type of peripheral neuropathy. Peripheral neuropathies are conditions that influence the peripheral nervous system, which consists of the nerves located outside of the brain and the spinal cord. 

      The small nerve fibers of the peripheral nervous system are affected by the condition known as small fiber neuropathy, which can present with different symptoms in each patient.

      When Does Small Fiber Neuropathy Occur?

      Small fiber neuropathy occurs when small myelinated (Aδ) nerve fibers and small unmyelinated C fibers are damaged. 

      These fibers are involved in sensory functions that play a role in pain and temperature. They are also involved in involuntary processes in the body. 

      Frequently, small fiber neuropathy occurs idiopathically (where the cause is unknown). However, patients with many underlying ailments can suffer from small fiber neuropathy as well.

      A person holding his tingling foot

      Common Small Fiber Neuropathy Symptoms

      Symptoms of this condition vary from patient to patient. External stimuli can trigger certain sensory symptoms. Some individuals may experience foot pain when wearing socks or when touching bedsheets.

      Here is a closer look at the most common symptoms that will be alleviated with proper SFN treatments.

      Pain

      According to studies, a common clinical feature of SFN includes patients who report experiencing electric shock-like pain. 

      These sudden, sharp bursts of pain are usually localized. However, they can spread and radiate, especially in affected areas like the feet or legs.

      These symptoms of small fiber neuropathy are caused by the damage to the nerves responsible for transmitting pain signals, which leads to abnormal nerve firing and heightened pain perception.

      Paresthesia

      Paresthesia is the prickling, burning, or tingling sensation some may feel when diagnosed with SFN. Patients describe it as a persistent or intermittent tingling feeling in the hands or feet that is similar to pins and needles.

      This sensation results from nerve fibers transmitting abnormal signals or becoming hyperactive due to nerve damage. The affected fibers fail to process sensory information correctly and cause the brain to interpret normal stimuli as abnormal sensations.

      Loss of Sensation

      Some of the most common small fiber neuropathy symptoms include reduced distal temperature and vibration sensitivity in certain people, as well as reduced distal pinprick sensitivity. 

      Individuals may notice that they cannot feel temperature changes or vibrations clearly, especially in their lower legs and feet. 

      These SFN symptoms occur because the small nerve fibers responsible for the sensations are impaired. Hence, the brain’s ability to interpret sensory signals accurately is diminished. 

      As a result, affected areas may feel disconnected, and the patient will have a higher risk of incurring unnoticed injuries and burns.

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      Numbness in the Limbs

      Patients may experience a feeling of heaviness or complete numbness. These small fiber neuropathy symptoms typically start in the lower extremities, like the lower stomach, legs, or feet, before progressing upward.

      This numbness is another result of nerve damage disrupting normal sensory pathways. The sensation can be distressing and reduce the patient’s awareness of pain and injury.

      Hypersensitivity

      On the other end of the spectrum, the opposite of losing sensations may happen. Some individuals may find that even mild touches or slight temperature changes provoke intense burning or stinging sensations.

      This hypersensitivity to temperature and touch occurs because nerves become overly responsive or misfire due to nerve fiber damage. They amplify normal stimuli into painful and uncomfortable sensations.

      These small fiber neuropathy symptoms often worsen at night and disrupt the patient’s sleep. They can also make routine activities like bathing or dressing challenging.

      Stocking-Glove Pain

      One of the SFN symptoms that patients with diabetes experience is a stocking-glove symmetric pain. 

      This pattern of pain starts in the feet and gradually moves up the legs and then the hands. It results from nerve fiber damage that affects large areas symmetrically, mainly in the distal limbs.

      However, not all patients experience symmetrical pain. In some cases, SFN can also manifest in an asymmetrical pattern affecting that patient’s scalp, proximal limbs, and face as well. 

      A woman experiencing dizziness

      Autonomic Small Fiber Neuropathy Symptoms

      In some instances, small fiber neuropathy interferes with autonomic functions. The body’s autonomic functions include the regulation of digestion, blood pressure, and urinary function.

      When autonomic nerve fibers are damaged, the following SFN symptoms may manifest.

      Constipation

      Some patients may have difficulty passing stool or experience abdominal discomfort and bloating. 

      These problems occur because nerve damage impairs the autonomic signals controlling bowel movements and slows down intestinal motility. Following a balanced diet and nutrition plan may help patients manage this symptom.

      Infrequent or Excessive Sweating

      Patients might notice sweating that is either absent in some areas or excessive in others. The most common places where these small fiber neuropathy symptoms manifest include the palms, soles, and forehead.

      This imbalance results from nerve damage disrupting the sweat glands’ regulation, impacting the body’s temperature control, causing either hyperhidrosis (excess sweating) or anhidrosis (lack of sweating).

      Dizziness

      Many people living with small fiber neuropathy experience dizziness when standing up quickly. This lightheadedness happens because damaged nerves impair blood pressure regulation and cause orthostatic hypotension. 

      The body struggles to adjust blood flow rapidly. This struggle leads to dizziness and sometimes even fainting.

      Dry Eyes and Mouth

      Other symptoms of SFN include dry eyes and mouth. Patients may notice a gritty sensation in their eyes or a sticky feeling in their mouths. 

      These small fiber neuropathy symptoms are nerve damage that affects tear and saliva production. Reduced stimulation of these glands lowers secretions, causing discomfort in the eyes and difficulty swallowing or even speaking.

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      Skin Discoloration

      Some may observe abnormal skin color changes. They may notice paleness or flushing in areas like the face, hands, and feet. 

      This discoloration occurs due to nerve damage disrupting blood vessel constriction and dilation. When blood flows unevenly throughout the body, skin discoloration becomes noticeable.

      Extremely Low Blood Pressure

      As we mentioned before, some may feel dizzy, weak, or faint, especially when standing up. This weakness is due to severe drops in blood pressure. 

      Extremely low blood pressure is one of the small fiber neuropathy symptoms that occurs due to the body’s impaired ability to constrict blood vessels swiftly. 

      This defect causes blood pressure to fall dangerously low and reduces blood flow to the brain, risking fainting or falling.

      Irregular or Rapid Heartbeat

      Some may experience sensations of pounding, racing, or irregular heartbeats. These SFN symptoms are another result of nerve damage affecting heart rate regulation and constricting blood flow. 

      It can cause the heart to beat too fast, too slow, or irregularly, which can lead to chest discomfort or fatigue.

      Bladder Control Issues

      Many patients experience bladder control issues, such as urgency, leakage, or difficulty starting urination, that may resolve after receiving treatment for neuropathy.

      These small fiber neuropathy symptoms present due to the impaired signal transmission between the brain and the bladder. The bladder loses its ability to store or empty urine properly, leading to incontinence or retention issues.

      Sexual Dysfunction

      Some might experience problems related to sexual performance, such as:

      • Reduced sensation
      • Decreased lubrication
      • Difficulty achieving an erection
      • Difficulty maintaining an erection

      These problems occur because the damage affects the nerves responsible for sexual arousal and response. Hence, they interfere with the blood flow and nerve signals for normal sexual function.

      SFN Symptoms Progression

      The early symptoms of the disease are usually mild, but over time, symptoms progress and worsen. Small fiber neuropathy typically begins at the feet and progresses upward. 

      As mentioned earlier, this distribution is known as “stocking-and-glove.” In the later stages of this condition, the hands may be affected.

      Foot and hand pain is the most common early sign of small fiber neuropathy. However, this condition can also impair the body’s ability to feel localized pain and detect temperature. As the disease progresses, people may experience symptoms in their knees, legs, and arms.

      How Severe Are the Symptoms?

      Small fiber neuropathy symptoms can range from mild to severe. People frequently experience mild symptoms that may go unnoticed in the early stages. Typically, symptoms worsen over time and spread to other areas of the body.

      These symptoms frequently begin in the feet and move upwards. They could become worse over time. The severity of symptoms increases throughout the day. Patients usually experience the worst pain during the night.

      Take the Next Step in Managing Your SFN Symptoms

      Understanding the symptoms of small fiber neuropathy can help you manage your condition more effectively. Early recognition of these symptoms can lead to receiving timely treatment and living a higher quality of life.

      If you need help managing your condition, AmeriPharma® Specialty Pharmacy is here for you. Our ACHC-accredited specialty pharmacy offers hard-to-find medications and at-home IVIG treatment for small fiber neuropathy patients in over 40 U.S. states and territories.

      Contact us today to get started with our full-service coordination, copay assistance, and 24/7/365 support.

      TPN Central Line Care and Infection Prevention: A Patient’s Guide

      Published on by Neil Marshall, DACM, BSN, LAc, RN, CRNI, NCCAOM®

      If you or your loved one is receiving home infusion therapy like total parenteral nutrition (TPN), following strict hand hygiene and proper care steps is the best way to protect yourself from infections. 

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      Although TPN is a life-saving treatment for individuals who cannot ingest food orally or enterally, it also carries a significant risk when a central venous access device (CVAD) or central line is used. This device not only provides direct access for delivering essential nutrition to your body, but it also creates a direct pathway for germs to enter your bloodstream.

      Central-line-associated bloodstream infections, or CLABSIs, are one of the common and severe complications that cause thousands of deaths in the United States every year. Fortunately, most of the CLABSI cases are preventable if careful daily practices are followed. 

      This article is designed to give both new and current TPN patients a practical, step-by-step guide to central line care. By following these practices, you can keep your line safe, reduce complications, and ensure that your treatment is effective.

      What Is a Central Venous Access Device (CVAD)?

      A central venous access device (CVAD) or central venous catheter (CVC), often described by healthcare professionals as a “central line,” is a thin, flexible tube that is placed into a large vein, typically in the chest, neck, or arm. 

      Unlike short, temporary IV catheters, which are inserted in the hand, arm, or foot for venous access, central lines access a major vein and can remain in place for months or even years. 

      A central line serves as a long-term access point for:

      • Delivering TPN (nutrition through the vein)
      • Giving medications or fluids
      • Drawing blood samples
      • Receiving blood transfusions

      Types of Central Venous Access Devices (CVAD) or Central Lines

      There are four general categories of CVADs, which include:

      1. PICC lines (peripherally inserted central catheters): Inserted through a vein in the arm.
      2. Tunneled catheters (Hickman, Broviac): Surgically placed under the skin, often in the chest.
      3. Non-tunneled catheters: Typically for short-term use and are placed directly into a large vein.
      4. Implanted ports (port-a-cath): Small device placed under the skin, accessed with a special needle. This type is not visible like other catheters and does not require as much daily care as a PICC line or tunneled catheter might. 

      Why Proper Central Line Care Matters

      Consistent, careful central line care helps you:

      • Prevent infections that can be life-threatening
      • Keep your line working properly, so nutrition and medication flow smoothly
      • Avoid complications, like clots, leaks, or accidental dislodgement
      • Extend the life of your CVADs
      • Stay out of the hospital and continue your treatment safely at home

      However, without proper care, the line may become infected, blocked, or even dislodged, and your risk of developing CLABSI may also increase. 

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      Central Line-Associated Bloodstream Infection (CLABSI) Basics

      Central Line-Associated Bloodstream Infection (CLABSI) is a severe infection. It occurs when bacteria or other germs, like fungi or viruses, enter the bloodstream through your central line. 

      Why It Matters

      1. Infections can spread quickly and increase the risk of mortality by 2.27-fold.
      2. Infections can add up to 3 extra weeks to a hospital stay.
      3. Infections can delay your TPN treatment and cause serious setbacks for your health.

      Warning Signs of CLABSI

      People with CLABSI may experience:

      • Fever and chills
      • Redness, swelling, pain, or drainage around the insertion site
      • A sluggish or blocked line
      • Confusion, dizziness, or feeling faint

      If you notice any of these, call your healthcare provider right away. In an emergency, dial 911.

      6 Essential Daily Steps for Central Line Care and Preventing Infection

      Person washing hands with soap and water

      1. Practice Strict Hand Hygiene 

      • Always wash your hands with soap and water for at least 20 seconds before and after touching your line.
      • If soap and water are unavailable, use alcohol-based hand sanitizer.

      2. Protect Your Line From Water

      • Never submerge your line in water (avoid baths, hot tubs, or swimming).
      • Cover your line with a waterproof dressing before showering.
      • Keep your supplies in a clean, designated space at home.

      3. Check the Site Daily

      Look for early warning signs:

      • Redness, swelling, warmth, or pain around the site
      • Drainage or leaking fluid
      • Fever or chills

      Report changes promptly to your healthcare provider.

      4. Flush Your Line Properly

      Flushing keeps the catheter open and prevents sluggish or clogged lines.

      • Use the technique your nurse taught you, with sterile saline or heparin as instructed.
      • Scrub the hub for at least 15 seconds with an alcohol wipe before each flush.
      • Always use a new syringe for each flush.
      • Flush at the times prescribed (often once daily or before and after each use).
      • Use a slow push-pause method; never force a flush.

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      5. Change the Dressing on Schedule

      The dressing protects the insertion site from infection.

      • Your nurse will change your dressing every 7 days, or sooner if it becomes loose, wet, dirty, or bloody.
      • The infusion pharmacy will provide special dressing change kits for the nurse to use. 
      • If your dressing falls off, place clean gauze over the site, tape it in place, and call your healthcare provider right away.

      6. Follow Safe Tubing Practices

      • Always disinfect the IV hub by scrubbing with an alcohol wipe for at least 15 seconds and letting it air-dry before connecting anything.
      • Use new tubing with each new TPN or hydration bag.
      • Protect tubing connections from water and dirt.

      Activity and Lifestyle Guidelines

      Living with a central line requires some adjustments, but you can still enjoy life safely.

      • Avoid heavy lifting or activities that could pull on your line.
      • Wear loose clothing to prevent irritation or tugging.
      • Never use scissors near your line, as accidental cuts can damage the catheter.
      • Do not touch the catheter tip; it must stay sterile.
      • Keep emergency contact information handy at all times.

      When To Call Your Healthcare Provider

      Seek immediate help if you experience:

      • Fever (100.4°F / 38°C or higher)
      • Redness, swelling, pain, or discharge at the site
      • Difficulty flushing or infusing TPN
      • A cracked, leaking, or dislodged line
      • Sudden dizziness, shortness of breath, or chest pain

      It’s always better to ask than risk complications. Keep your care team’s number, emergency contacts, and after-hours information handy at all times.

      Preventing Complications Beyond Infection

      Though infection prevention is the main priority, central line care also involves avoiding mechanical problems like:

      • Clotting: Inadequate flushing can cause clots inside the line.
      • Breakage or leakage: Rough handling or use of sharp objects nearby may damage the catheter.
      • Dislodgment: Accidental pulling or tugging can move the line out of place.

      If any of these occur, stop using the line and contact your care team right away.

      IVIG for CAR-T Therapy-Related Hypogammaglobulinemia: Uses, Benefits, Dosage, and More

      Published on by Dr. Samantha Kaeberlein, PharmD

      Clinicians often recommend IVIG for CAR-T therapy-related hypogammaglobulinemia to reduce infection risk and improve survival. However, these recommendations are slim and based on expert opinion and clinical trial results. 

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      A Quick Overview of CAR-T Therapy

      CAR-T therapy is an acronym for chimeric antigen receptor (CAR)-T cell therapy. A form of immunotherapy, CAR-T cell therapy is currently used to treat certain blood cancers. Immunotherapy for cancer enhances your immune system’s ability to identify and destroy cancer cells. 

      As the name suggests, CAR-T cell therapy uses the patient’s own T cells. T cells or T lymphocytes are a type of white blood cell that primarily destroy bacteria, viruses, and cancer cells. 

      CAR-T cell therapy involves the following steps:

      1. T cells are collected from a patient’s blood and sent to the lab. 
      2. In the lab, these cells are genetically modified to create special proteins called chimeric antigen receptors (CARs) on the cell surface. 
      3. The modified cells — CAR-T cells — are grown to millions in the lab. 
      4. Lastly, when there are enough of the modified cells, they are administered to the patient in a single infusion. Once in the patient’s bloodstream, these cells identify and kill cancer cells. 

      The entire process, from collection to reinfusion, takes about 4 weeks. 

      Examples of FDA-approved CAR-T cell therapy include:

      • Yescarta
      • Kymriah
      • Tecartus
      • Carvykti
      • Abecma
      • Breyanzi

      What Is CAR-T Therapy-Related Hypogammaglobulinemia?

      Hypogammaglobulinemia is when immunoglobulin G (IgG) levels drop too low, increasing a person’s risk of getting potentially life-threatening bacterial, viral, or fungal infections. 

      CAR-T therapy-related hypogammaglobulinemia is common and expected during or after CAR-T therapy. It can occur a few weeks after infusion and last months or even years. Studies show that children are more likely than adults to get CAR-T therapy-related hypogammaglobulinemia [1].

      The definitions of CAR-T therapy-related hypogammaglobulinemia can vary. Nevertheless, hypogammaglobulinemia is typically confirmed if the serum IgG levels fall below 400 mg/dl. Hypogammaglobulinemia may be classified as [2]:

      • Mild (IgG < 650 mg/dL)
      • Moderate (IgG < 400 mg/dL)
      • Severe (IgG < 200 mg/dL)

      Several factors determine the occurrence, severity, and duration of hypogammaglobulinemia and infections. These include:

      • Product type
      • Age of the patient
      • IgG levels before starting CAR-T therapy
      • Use of chemotherapy during the CAR-T cell manufacturing period (the period between T cell collection and reinfusion of modified T cells)
      • Type of cancer being treated

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      Understanding the Mechanism of CAR-T Therapy-Related Hypogammaglobulinemia

      CAR-T therapy works by identifying and attacking cancer cells. It does so by identifying a specific protein on the surface of the B cells, which produce infection-fighting molecules called antibodies or immunoglobulins. 

      Sometimes, CAR-T cells fail to differentiate cancerous B cells from healthy B cells. Consequently, they destroy both cancerous and normal B cells, leading to a low level of immunoglobulins. 

      When To Use IVIG for CAR-T Therapy-Related Hypogammaglobulinemia

      Patient receiving IVIG for CAR-T therapy-related hypogammaglobulinemia at home

      IVIG is often used after CAR-T therapy to reduce infection risk and manage hypogammaglobulinemia. However, this practice lacks standardization. 

      Most experts agree that IVIG for CAR-T therapy-related hypogammaglobulinemia should be considered for patients with [1]:

      • IgG ≤ 400 mg/dl within the first 90 days after starting treatment, especially if they get serious or recurrent bacterial infections. After 90 days, IVIG may be stopped if the patient has no infection. 
      • IgG between 400 and 600 mg/dl who are having recurrent or serious infections. 
      • IgG > 600 mg/dl, but are experiencing recurrent or serious infections, and blood tests show extremely low levels of specific antibodies.

      IVIG for CAR-T Therapy-Related Hypogammaglobulinemia in Children

      IVIG treatment should be considered for children with IgG below 400 mg/dl.

      The usual dosage of IVIG for children of all ages is 0.5 g/kg monthly until the IgG level reaches the value considered normal for the child’s age. IVIG therapy should be started 30 days after CAR T-cell infusion. 

      For those with IgG between 400 and 600 mg/dl, IVIG therapy should be considered every 3 to 4 weeks to maintain appropriate immunoglobulin levels.

      For children younger than 10 years, IVIG therapy should be considered if the IgG level is equal to or less than 800 mg/dl [1].

      Some health experts recommend IVIG every 3 to 4 weeks, as it may be superior to using IVIG as needed. 

      IVIG for CAR-T Therapy-Related Hypogammaglobulinemia: What Are the Benefits?

      IVIG has been associated with a myriad of benefits in patients receiving CAR-T cell therapy, such as [3]:

      • A lower rate of infections
      • Improvement in ongoing infections

      IVIG may also be used to treat potentially fatal neurotoxicity associated with CAR-T therapy [4].

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      Frequently Asked Questions

      1. Does IVIG treat hypogammaglobulinemia?

      Yes, IVIG treats hypogammaglobulinemia by replacing antibodies obtained from donors. That way, IVIG helps prevent infections in individuals who have developed hypogammaglobulinemia secondary to a cancer treatment called CAR-T therapy. 

      2. Is CAR-T better than chemo?

      CAR-T cell therapy was superior to chemotherapy in improving survival and was associated with a higher rate of remission among patients with treatment-resistant acute lymphoblastic leukemia. This is according to a 2018 comparative study published in the Annals of Hematology [5].

      3. What are the long-term side effects of CAR-T cell therapy?

      The long-term side effects of CAR-T cell therapy can include:

      • Low levels of red blood cells, white blood cells, or platelets in the blood
      • Late infections
      • Hypogammaglobulinemia 
      • Neurocognitive deficits (impaired memory, attention, or thinking)

      4. What is the death rate among patients receiving CAR-T cell therapy?

      According to a 2024 study published in Nature, CAR-T therapy-related side effects were responsible for about 11% of total nonrelapse deaths [6].

      5. What is B-cell aplasia?

      B-cell aplasia is when the blood levels of B cells (a type of white blood cell) drop too low. It happens when CAR-T cells mistakenly attack and kill healthy B cells in the body.