IVIG for Birdshot Retinochoroidopathy (BSRC)

Published on by Dr. Christine Leduc, PharmD

Birdshot retinochoroidopathy (BRSC), also known by other terms like birdshot uveitis, birdshot chorioretinopathy, or HLA-A29 uveitis, is a rare and potentially sight-threatening disease that affects both eyes and can lead to permanent vision loss if not treated early. 

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Since there is no cure for BSRC, corticosteroids or immunosuppressive drugs are used as standard treatments to manage the condition in affected individuals. However, some patients experience serious side effects from these medications and seek alternative treatments like intravenous immunoglobulin (IVIG) infusions. 

IVIG therapy has proven effective in treating the symptoms of BSRC in many patients, especially those who don’t respond well to the standard treatment (i.e., corticosteroids or immunosuppressive drugs). 

Read further to learn how IVIG can help patients with birdshot chorioretinopathy, how this therapy works, and what you can expect during treatment with IVIG.

Birdshot Retinochoroidopathy: Brief Overview

Birdshot retinochoroidopathy is a chronic (long-term) eye disease caused by an abnormal attack on the immune system. It is also known as a T-cell-mediated autoimmune disorder. T-cells trigger an immune response against the retina and choroid, two important components of your eyes that are responsible for vision. 

Research has demonstrated that T-cell activation is strongly associated with the human leukocyte antigen (HLA) A29 allele, and more than 95% of BSRC patients carry this gene variant. 

The HLA-A29 activates the cytotoxic T-cells, which then target and attack the retinal and choroidal tissues, leading to progressive inflammation and damage. As a result, patients with birdshot retinochoroidopathy experience visual disturbances like blurred vision, floaters (small moving spots in the vision field), and peripheral vision loss over time. 

In short, genetics, along with the immune system, are responsible for the onset of this disease. Also, birdshot retinochoroidopathy is a chronic disease; therefore, affected individuals require long-term treatment to slow the disease progression and preserve vision.  

IVIG Therapy and Birdshot Retinochoroidopathy: Clinical Evidence

A case report published in the journal “Ocular Immunology and Inflammation” highlighted the positive effects of intravenous immunoglobulin (IVIG) in treating birdshot uveitis. The study found that patients who did not respond to standard treatments, such as immunosuppressive drugs or steroids, experienced significant improvements in their vision after receiving IVIG therapy. The treatment regimen consisted of IVIG administered at a dose of 1.6 g/kg every 4 weeks for 6 months, followed by infusions of 1.2 to 1.6 g/kg at 6 to 8-week intervals.

Similarly, another case report of 18 patients with active birdshot retinochoroidopathy showed that, after IVIG infusions, 53% showed significant improvement in vision, while 29% remained stable. Additionally, eye inflammation was reduced in 81% of patients, and macular swelling (edema) improved in 65% of cases.

This, and several other small case studies, reported that IVIG could be a safe and potentially effective treatment for birdshot uveitis when standard treatments are refractory. However, large-scale clinical trials are limited regarding the long-term use of IVIG therapy in birdshot retinochoroidopathy patients. 

How Does IVIG Work in Patients With Birdshot Retinochoroidopathy?

The exact mechanism of IVIG therapy in managing this autoimmune condition is unclear. However, several case studies have reported that IVIG has multiple modes of action that may help slow vision loss and reduce inflammation and flare-ups in patients with BSRC.

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IVIG and Mechanisms of Action

Arm of patient receiving IVIG

IVIG therapy delivers immunoglobulin (antibodies) derived from the pooled plasma of thousands of healthy donors. These antibodies regulate the immune system, either by maintaining the IgG levels in patients with immunodeficiency or calming down the overactive immune system in patients with autoimmune conditions. 

In the case of birdshot retinochoroidopathy, which is also an autoimmune condition, IVIG helps suppress the overactive immune system to prevent the immune cells from further damaging the retinal tissues. In these patients, IVIG may work in several ways:

1. It Modulates the T Cell Activity 

IVIG suppresses the overactive T cells and reduces the immune response against retinal and choroidal tissues. In short, IVIG prevents further damage. 

2. It Blocks the Activity of Autoantibodies

The antibodies provided during the IVIG treatment neutralize the effect of harmful autoantibodies and prevent them from attacking retinal tissues.

3. It Reduces Intraocular Inflammation

IVIG has anti-inflammatory effects, which help to reduce intraocular inflammation (inflammation occurs inside the eye) by decreasing the inflammatory signals (IL-17 and IFN-γ) and promoting the release of anti-inflammatory cytokines (molecules that reduce inflammation). This also potentially reduces the need for treatment with steroids and other immunosuppressants.

4. It Enhances the Function of Regulatory T Cells 

Normally, the regulatory T cells (also called Tregs) suppress the excessive immune responses. However, in the case of BSRC, these cells do not work properly and contribute to uncontrolled T-cell activity and chronic inflammation. 

IVIG therapy enhances the activity of regulatory T cells, which help prevent autoimmune attacks and inflammation.

Benefits of IVIG for Patients With Birdshot Retinochoroidopathy

Unlike standard treatments of birdshot retinochoroidopathy, IVIG offers several benefits to patients, such as:

  1. It is generally well-tolerated and has fewer side effects than steroids and immunosuppressive drugs (such as methotrexate, mycophenolate mofetil, or anti-TNF agents) that can cause weight gain, osteoporosis, diabetes, or liver and kidney toxicity. 
  2. It has long-lasting effects (given every 3 – 4 weeks) compared to traditional BSRC medications that are typically required daily.
  3. It is more effective, especially in patients who do not respond to conventional therapies. 
  4. It reduces intraocular inflammation and prevents further vision loss by suppressing the overactive immune response. 

Note: Individual responses to IVIG therapy may vary significantly. While some patients can experience rapid improvement within weeks, others may require longer treatment durations to achieve optimal results.

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What Can You Expect During IVIG Treatment?

During IVIG treatment, your healthcare provider will administer the medication through an intravenous (IV) infusion. The infusion process typically takes 2 –  6 hours to complete and is repeated every 3 – 4 weeks, depending on your response. 

You may experience some mild side effects like headache, fatigue, fever, or nausea during or after the IVIG infusions. Talk to your doctor if you suffer from any of these symptoms. 

Takeaway

Birdshot retinochoroidopathy is a rare but chronic eye disease that requires long-term management to prevent vision loss. Although conventional treatments like corticosteroids and immunosuppressants remain the standard of care, IVIG therapy can be used as an alternative treatment for patients with treatment-resistant diseases or those who cannot tolerate standard therapies. 

If you or your loved one is interested in IVIG, you should discuss the risks, benefits, and accessibility with your ophthalmologist and immunologist before switching to IVIG.

GLASSIA: Usage, Dosage, Adverse Effects, and Precautionary Measures

Published on by Dr. Robert Hakim, PharmD

If you’ve been diagnosed with emphysema (a lung disease) or are experiencing symptoms similar to emphysema due to alpha-1 antitrypsin deficiency (AATD), your healthcare provider may prescribe a medication called GLASSIA.

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GLASSIA, also known by its generic name, alpha-1 proteinase inhibitor (Alpha 1-PI), was approved by the FDA on July 1, 2010, for AATD. This medication replaces the missing Alpha 1-PI in adults with AATD and helps prevent further lung damage.

Read on to learn important details about this drug, such as its usage, dosage, working mechanisms, associated side effects, warnings, and precautionary measures.

What is GLASSIA Used for​?

GLASSIA infusions are FDA-approved for chronic augmentation and maintenance therapy in adults who have emphysema due to severe hereditary deficiency of alpha-1 proteinase inhibitors.

Note: Alpha-1 proteinase inhibitor (Alpha 1-PI) and alpha-1 antitrypsin (AAT) are both terms that refer to the same protein.

Composition and Mechanism of Action

GLASSIA is made from human plasma (the liquid part of the blood), which contains alpha-1 proteinase inhibitor protein.

Normally, alpha 1-PI or ATT protein protects the lungs by stopping the activity of an enzyme (a protein) called neutrophil elastase, which kills bacteria in the lungs.

However, in people with AAT deficiency, elastase doesn’t stop working and eventually damages the lungs. This typically leads to emphysema, which causes symptoms like shortness of breath, wheezing, and a chronic cough.

Mechanism of Action

GLASSIA treatments work by raising the alpha-1 PI levels in the bloodstream. This helps lower inflammation and prevent further damage to lung tissue, thereby slowing the progression of lung disease.

Note: GLASSIA is not a cure for AAT deficiency; it only helps to manage this complex condition and slow down or prevent further lung damage.

GLASSIA Dosing and Administration

GLASSIA is a liquid medication that is administered through intravenous (IV) infusions once a week. It’s available as a single-dose vial containing approximately 1 gram (1,000 mg) of functional Alpha-1 PI in 50 ml of ready-to-use solution.

The recommended dosage of this medication is 60 mg/kg of body weight, which is infused at a rate of 0.2 ml per kg per minute. GLASSIA infusions take approximately 15 minutes.

The dosage of GLASSIA is based on your body weight; your dose may change if you lose or gain weight.

GLASSIA: Side Effects

The most common side effects are headaches and upper respiratory tract infections. Other possible side effects of GLASSIA include:

  • Cough
  • Fatigue
  • Nausea
  • Dizziness
  • Sinus infection
  • Chest discomfort
  • Shortness of breath
  • Increased liver enzymes

Serious side effects observed during clinical trials include:

  • Worsening or flare-up of chronic obstructive pulmonary disease (COPD)

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Get medical help immediately if you notice signs of an allergic reaction to GLASSIA. Common signs include:

  • Itching
  • Hives and rash
  • Chest discomfort
  • Fainting or dizziness
  • Swelling in the mouth or throat
  • Trouble breathing and wheezing

Your healthcare provider may prescribe epinephrine or provide other supportive care for certain severe allergic reactions.

Contraindications and Warnings

A doctor administering IV infusions to a patient

GLASSIA is contraindicated in patients who have:

Furthermore, you may get an infection from GLASSIA. Although this medication is made from human blood and undergoes a rigorous testing and screening process, there is still a chance that it might contain infectious agents such as:

Precautionary Measures

Before opting for GLASSIA, tell your healthcare provider if you are/have:

  • Pregnant or plan to become pregnant because it is not known whether GLASSIA treatments can cause harm to an unborn baby.
  • Breastfeeding or plan to breastfeed, since there is no information available on how GLASSIA infusions may affect breastfed infants or milk production.
  • Taking any over-the-counter medications, supplements, or herbal products.
  • Any health problem like liver disease, chronic obstructive pulmonary disease (COPD), or other breathing problems.

Estimated Cost of GLASSIA

One single-use vial of GLASSIA (for intravenous use) typically costs around $10. However, the cost could differ depending on your pharmacy.

Alternatives to GLASSIA

Your healthcare provider might prescribe other medications in place of GLASSIA. Some possible alternatives are Aralast, Aralast NP, Zemaira, and Prolastin. Talk to your healthcare provider about which medication is best for you.

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Managing alpha-1 antitrypsin deficiency with GLASSIA infusions can help slow lung damage and improve quality of life.

If your healthcare provider has recommended GLASSIA treatment for your condition, AmeriPharma® Specialty Pharmacy is here to support you every step of the way.

Our URAC-accredited specialty pharmacy offers at-home GLASSIA therapy with full-service coordination, copay assistance, and 24/7/365 support. Book a call today to speak to a patient navigator and start receiving specialty care at home.

Frequently Asked Questions (FAQs)

Can GLASSIA infusions cure AATD?

No, it does not cure AATD; it only helps slow the progression of lung disease by increasing the levels of alpha-1 antitrypsin protein (AAT) in the blood and lungs. There currently isn’t a cure for AATD.

How long do I need to take GLASSIA?

AATD is a lifelong condition, so treatment with GLASSIA is ongoing. Your healthcare provider will likely have you continue taking the medication as long as it’s helping your condition and you’re not having any significant side effects.

Talk to your healthcare provider if you have questions or concerns about your treatment.

Can I receive this medication at home?

Yes, many patients receive GLASSIA medication at home after proper training or with the help of a nurse. However, your healthcare provider will likely have you receive the first few doses in a clinic or infusion center.

GLASSIA comes in a ready-to-administer formulation, so you don’t need to mix anything before infusion.

Is GLASSIA treatment the same as other AAT therapies?

GLASSIA is similar to other Alpha 1-PI therapies like Prolastin-C, Aralast NP, and Zemaira. Still, it is unique because it is a ready-to-use liquid rather than a powder that requires mixing.

What should I do if I miss a dose?

If you miss a dose, contact your healthcare provider for further instructions. Do not double the next dose to make up for the missed one.

Is this medication FDA-approved?

Yes, GLASSIA is an FDA-approved medication. The 1-gram vial size was approved by the FDA in 2010, and the new larger vial sizes (4 and 5 grams) will be available beginning July 2025.

Is GLASSIA a biologic?

Yes, GLASSIA (Alpha1-Proteinase Inhibitor [Human]) is a biologic, meaning it’s derived from human blood plasma.

What is the maximum infusion rate?

The maximum recommended infusion rate for GLASSIA is 0.2 ml/kg/min. Your infusion should only take approximately 15 minutes at the recommended dose and maximum infusion rate.

A Complete Overview of Abrilada

Published on by Dr. Mark Alfonso, PharmD, BCMTMS

If you are suffering from chronic autoimmune conditions like arthritis, plaque psoriasis, or Crohn’s disease, drugs like Abrilada can help.

In this article, we will explore everything you need to know about this drug, including its dosing, side effects, cost, and much more.

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What Is Abrilada?

Abrilada (adalimumab-afzb) is an FDA-approved prescription medicine, available in a pre-filled pen, used to treat certain autoimmune conditions.

On November 18, 2019, the FDA approved it as a biosimilar to another drug called Humira. Later, on October 5, 2023, the FDA designated Abrilada as interchangeable with Humira [1].

This means that there is no significant difference between Abrilada injections and Humira. You can choose to take Abrilada instead of Humira if you prefer.

Abrilada can treat certain kinds of arthritis, plaque psoriasis, ulcerative colitis, Crohn’s disease, uveitis, and hidradenitis suppurativa. It belongs to a group of drugs called TNF inhibitors, and it works by blocking the action of a protein called TNF (tumor necrosis factor), which causes inflammation.

What Is Abrilada Used To Treat?

Abrilada can treat the following conditions [2][3]:

Crohn’s Disease

Crohn’s disease is a lifelong condition that causes inflammation in your digestive tract. Doctors use the drug to treat moderate to severe Crohn’s disease in adults and children aged 6 years or older.

Ulcerative Colitis

Ulcerative colitis is a long-term disease in which your colon and rectum become inflamed. It causes symptoms like diarrhea, stomach pain, and rectal pain.

Doctors use Abrilada to treat adults with ulcerative colitis. However, it is not known if Abrilada is an effective medication in patients who have stopped responding to anti-TNF drugs or cannot tolerate them.

Plaque Psoriasis

Plaque psoriasis is a skin condition that manifests as raised, inflamed, scaly patches on the body.

Doctors can use Abrilada injections to treat adults with moderate to severe plaque psoriasis. You can take this medication if you are ready for systemic therapy or phototherapy and your doctor thinks that other systemic therapies are less appropriate.

Hidradenitis Suppurativa

This is a painful, long-term skin condition. It causes skin abscesses and scarring. Doctors can use Abrilada to treat adults with moderate to severe hidradenitis suppurativa.

Uveitis

Uveitis refers to inflammation inside your eye that causes pain, blurry vision, and redness. Doctors use Abrilada injections in adult patients to treat uveitis that is not caused by an infection.

Abrilada can treat three kinds of uveitis:

  • Intermediate (inflammation in the middle part of the eye)
  • Posterior (inflammation in the back of the eye)
  • Panuveitis (inflammation in all parts of the eye)

This drug can also reduce the signs and symptoms of the following conditions.

Rheumatoid Arthritis

Doctors can use Abrilada to reduce the signs and symptoms of moderate to severe rheumatoid arthritis in adult patients. You can use it alone, with methotrexate, or certain other medicines.

Abrilada injections can protect your bones and joints from further damage and improve your capacity to carry out day-to-day life.

Juvenile Idiopathic Arthritis

Doctors can use the drug to reduce the signs and symptoms of moderate to severe juvenile idiopathic arthritis in patients 2 years of age or older.

Psoriatic Arthritis

Abrilada can reduce the signs and symptoms of psoriatic arthritis in adult patients. It may protect your bones from further damage and improve your ability to carry out daily tasks.

Ankylosing Spondylitis

Abrilada can reduce the signs and symptoms of ankylosing spondylitis in adult patients.

How Does Abrilada Work?

Normally, your immune system defends you from diseases by attacking various viruses and bacteria.

However, in the case of autoimmune diseases, your immune system mistakenly attacks your own cells and organs. This causes symptoms of inflammation in your body. A protein called TNF (tumor necrosis factor) causes inflammation in autoimmune disorders.

Abrilada injections work by blocking the activity of TNF, which helps reduce pain and inflammation in autoimmune disorders.

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Side Effects

Like any other medicine, Abrilada can also have some side effects. Here are some common and severe side effects [3]:

Common Side Effects

Common side effects of Abrilada medication include:

  • Rash
  • Headache
  • Sinus infection
  • Pain, redness, swelling, or itching at the injection site

Severe Side Effects

Serious adverse side effects of the drug include:

Severe Infections: This medication can increase your chances of having severe infections, including tuberculosis (TB) and infections caused by viruses, fungi, or bacteria. During your treatment, your doctor will regularly monitor you for the signs and symptoms of TB.

Cancer: Abrilada may increase your chances of getting lymphoma or other types of cancer.

Hepatitis B Infection: If you are a carrier of the hepatitis B virus, this drug may make the virus become active again. Symptoms include tiredness, dark urine, vomiting, muscle aches, skin or eyes that look yellow, fever, and chills.

Heart Problems: Abrilada injections can cause heart failure or make existing heart problems worse. Symptoms include shortness of breath, sudden weight gain, and swelling of your feet or ankles.

Liver Problems: Abrilada can cause liver problems. Symptoms include fatigue, loss of appetite, vomiting, yellowing of the skin or eyes, and abdominal pain.

Nervous System Problems: In rare cases, the drug can cause nervous system diseases like multiple sclerosis (MS) and optic neuritis. Symptoms include weakness in your arms and legs, dizziness, numbness or tingling, and vision problems.

Please note that this is not a complete list of all possible side effects. Contact your doctor immediately if you encounter any severe side effects of Abrilada.

Dosing

The dosage of Abrilada depends on several factors, including your age, condition, and medical history. Your doctor will determine the right dosage for you based on your situation.

You will receive Abrilada by injection under your skin. Below are the usual recommended dosages of Abrilada medication [2].

Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis

The usual recommended adult dose is 40 mg every other week. If you do not take methotrexate, you can increase the dosage to 40 mg every week or 80 mg every other week.

Crohn’s Disease, Ulcerative Colitis, Hidradenitis Suppurativa

The usual recommended dose for adults is 160 mg on Day 1. After that, patients will receive 80 mg on Day 15 and 40 mg every other week starting on Day 29.

Juvenile Idiopathic Arthritis

Children aged 2 years or older can take Abrilada. Children weighing 10 kg to less than 15 kg can have 10 mg every other week.

Those weighing 15 kg to less than 30 kg can have 20 mg every other week. Children weighing 30 kg or more can have 40 mg every other week.

Plaque Psoriasis, Uveitis

Adults will have an initial dose of 80 mg. Then, they will receive 40 mg every other week starting one week after the initial dose.

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Abrilada Cost

An Abrilada single-dose 40 mg/0.8 ml prefilled pen costs about $1,470 [4]. However, the actual cost of treatment will depend on your insurance coverage, location, treatment plan, and the pharmacy you visit.

FAQs

1. Can I use Abrilada instead of Humira?

Yes. Abrilada is an interchangeable biosimilar to Humira. This means that there is no meaningful difference between Abrilada injections and Humira in terms of safety, effectiveness, and mechanism of action. So, you can use this medication instead of Humira if you want.

2. Can I take Abrilada if I have an infection?

No. You should not use this medication if you have an active infection unless your doctor says it is okay. Abrilada can lower your immune system’s ability to fight foreign pathogens like viruses and bacteria. So, it can increase your risk of getting infections, including tuberculosis.

3. How long do I need to take Abrilada?

Abrilada is a medication that’s mainly used in the long term to treat chronic autoimmune diseases. Your doctor will choose the length of your therapy based on your response to the treatment and any side effects you may have.

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Eloctate: Things To Know About This Long-Acting Medicine for Hemophilia A

Published on by Dr. Robert Hakim, PharmD
  • Eloctate is a long-acting recombinant factor VIII therapy used to treat hemophilia A in both children and adults.
  • It works by replacing the missing factor VIII protein, which is essential for proper blood clotting.
  • Eloctate is administered intravenously, and the dosage is determined by a healthcare provider based on factors like body weight and bleeding severity.
  • Common side effects include joint/muscle pain, tiredness, headache, and rash, and there is a risk of developing inhibitors (antibodies) that can reduce the medication’s effectiveness.

Sanofi’s Eloctate is a long-acting antihemophilic factor (recombinant) used to treat hemophilia A in children and adults. It was approved by the FDA in June 2014. In this article, you will learn about its mechanism of action, dosage, side effects, cost, and more.

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What Is Eloctate Used For?

Eloctate is a brand-name prescription product. It contains the active ingredient, recombinant clotting factor VIII, also called the recombinant antihemophilic factor. Eloctate belongs to a medication class called antihemophilic factors.

A healthcare provider may prescribe Eloctate for children and adults with hemophilia A to:

In people with hemophilia A, blood doesn’t clot properly, as they have a coagulation factor VIII deficiency. Factor VIII deficiency increases the risk of unexplained bleeding or, in severe cases, potentially fatal internal bleeding.

Eloctate shouldn’t be used to treat another similar bleeding disorder called von Willebrand disease.

Eloctate Mechanism of Action

Eloctate injection contains a protein, which is made using recombinant DNA technology. This protein in Eloctate replaces the missing Factor 8 in children and adults with hemophilia A.

Eloctate Dosing

This medication comes as a sterile white to off-white powder for reconstitution for intravenous (IV) injection in single-dose vials.

The following strengths are available in the U.S.:

  • 250 IU
  • 500 IU
  • 750 IU
  • 1,000 IU
  • 1,500 IU
  • 2,000 IU
  • 3,000 IU
  • 4,000 IU
  • 5,000 IU
  • 6,000 IU

Before administering Eloctate for hemophilia, your healthcare provider will use a specific formula to determine the dose. Then, they will prepare the medication by following the instructions in the package insert.

The dose and duration of Eloctate treatment depend on:

  • Body weight
  • Severity of factor VIII deficiency
  • Desired factor VIII level
  • Location and extent of bleeding

A healthcare provider may adjust the dose for children younger than 6 years old. For individuals 6 years or older, dose adjustment isn’t usually necessary.

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Eloctate Factor VIII Therapy Dosing for Control of Bleeding Episodes

Minor and moderate bleeding: 20 – 30 IU/kg IV to achieve factor VIII level of 40% – 60% of normal. Repeat every 24 – 48 hours until bleeding is resolved.

Major bleeding: 40 – 50 IU/kg IV to achieve factor VIII level of 80% – 100% of normal. Repeat Eloctate treatment every 12 – 24 hours until bleeding is resolved.

Eloctate Factor VIII Therapy Dosing for Preventing Bleeding During Surgery

Minor surgery: 25 – 40 IU/kg IV to achieve factor VIII level of 50% – 80% of normal. A repeat dose every 24 hours may be necessary for at least one day until healing is achieved.

Major surgery: 40 – 60 IU/kg IV before surgery to achieve a factor VIII level of 80% – 120% of normal. Repeat a dose of 40 – 50 IU/kg IV after 8 – 24 hours, then every 24 hours until the wound heals. Continue Eloctate treatment for at least one week.

Eloctate Factor VIII Therapy Dosing for Routine Prevention of Bleeding Episodes

  • The recommended starting dose of Eloctate injections is 50 IU/kg IV every 4 days. The dosage may be adjusted depending on your response, with a dosing range of 25 – 65 IU/kg at 3 – 5 day intervals.
  • For children younger than 6 years old diagnosed with hemophilia A, the recommended starting dose of Eloctate is 50 IU/kg IV twice weekly. The dosage may be adjusted depending on the response, with a dosing range of 25 – 65 IU/kg at 3 – 5 day intervals.

Eloctate Side Effects

A child holding his head in pain

Side effects of Eloctate can be mild or severe.

The most common side effects in previously treated individuals can include:

  • Joint or muscle pain
  • Tiredness
  • Headache
  • Rash

The most common side effects in previously untreated individuals can include:

  • Inhibitor (antibody) production
  • Rash
  • Blood clots at the infusion site

Use During Pregnancy and Lactation

There are no human or animal studies about Eloctate use during pregnancy. It is unknown if this medication can harm an unborn baby or affect the ability to have a baby. Tell your healthcare provider if you’re pregnant or plan to get pregnant.

It is unknown if Eloctate factor 8 therapy passes into breast milk, harms the breastfed infant, or affects milk production. Tell your healthcare provider if you are breastfeeding.

Important Eloctate Warnings and Precautions

Allergic reactions

Eloctate injections may cause allergic reactions, which can be fatal. Seek emergency medical care if you experience:

  • Hives
  • Breathing difficulty
  • Swelling in the face or throat

Inhibitor (Antibody) Production

In some cases, your body can make proteins called “inhibitors” or antibodies, which can stop this medication from working well.

If your immune system makes inhibitors, you will need special treatment to help control bleeding episodes. Talk to your healthcare provider to learn more about inhibitors and tests to measure your inhibitor level.

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Before Taking Eloctate

Before you receive your first dose of Eloctate for hemophilia A, inform your provider if you:

  • Are allergic to this product, any product component, or any other medications
  • Have heart disease
  • Have diseases of the blood vessels

Eloctate Cost

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

Sanofi Corporation, the manufacturer of Eloctate, offers three financial assistance programs to help you access treatment:

  • Free Trial Plus Program: With this program, you may be able to get your first 30-day supply within 24 – 48 hours with a valid prescription from your prescriber.
  • Copay Program: Contact a Sanofi professional at 1-855-MyELOCTATE (1-855-693-5628) for more information.
  • Factor Access Program: This program can help you access Eloctate factor VIII therapy even if your insurance is interrupted.

Click HERE to learn more about the programs mentioned above. Contact us to explore other financial assistance programs for Eloctate injections.

Eloctate Storage and Handling

Before preparing the solution

  • Store in the original package to prevent exposure to sunlight.
  • Maintain storage temperature between 2°C and 8°C (36°F and 46°F). Avoid freezing.
  • You may store the Eloctate hemophilia medication at room temperature (maximum temperature 30°C or 86°F) for up to 6 months in a row. The expiration date should be printed on the label.
  • If you store this medication at room temperature, record the date when it was removed from refrigeration.
  • Once at room temperature, avoid returning the product to the refrigerator.
  • Never use Eloctate beyond the expiration date printed on the vial or 6 months after storage at room temperature.

After preparing the solution

  • You may store the solution at room temperature (maximum temperature 30°C or 86°F) for up to 3 hours. Avoid exposure to direct sunlight.
  • Discard the solution if not used within 3 hours after reconstitution.
  • Never use a solution that is cloudy or has particulate matter.
  • Throw away any unused product.

Adynovate vs. Eloctate

According to a 2019 study, both products have almost identical properties. So, switching from Adynovate to Eloctate factor 8 therapy or vice versa doesn’t typically require changing the prophylaxis regimen [1].

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At AmeriPharma® Specialty Pharmacy, we know that living with hemophilia A can be overwhelming. But you don’t have to navigate the complexities of treatment on your own.

Our URAC and ACHC-accredited specialty pharmacy is available 24/7 to provide personalized support, from handling insurance approvals to guidance through copy assistance programs, to make it easier for those with complex health conditions to receive the necessary treatments they need.

Contact us now to learn how we can support you on your hemophilia treatment journey.

FEIBA: Everything You Need to Know About Its Use

Published on by Dr. Mark Alfonso, PharmD, BCMTMS
  • FEIBA is a medication used for patients with hemophilia A or B who have developed inhibitors (antibodies) against their standard clotting factor treatments.
  • It works by bypassing the action of these inhibitors to promote blood clotting and control or prevent bleeding episodes.
  • FEIBA is administered intravenously, and the dosage is customized based on the patient’s condition and the severity of bleeding.
  • While effective, FEIBA is an expensive medication and can have side effects, including a risk of serious thromboembolic events.

FEIBA (or factor 8 inhibitor bypass activity) is used in patients who have hemophilia A or B and have developed inhibitors (antibodies) against the clotting factor medications (i.e., factor VIII or IX).

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Hemophilia, a genetic disorder, is treated with clotting factor medications that help control bleeding episodes in patients. However, in some cases, the patient’s bodies start to produce antibodies (inhibitors) against these drugs, neutralize their effects, and make them less effective in preventing bleeding episodes.

FEIBA, a medication also known by its generic name “anti-inhibitor coagulant complex,” works by bypassing the activity of these inhibitors and promoting blood clotting in patients with clotting factor inhibitors.

If your doctor has prescribed you FEIBA, this guide will help you learn important details about this drug. Here, you’ll learn about FEIBA’s usage, dosage, working mechanisms, associated side effects, warnings, and precautionary measures.

What is FEIBA Used for?

The FDA has approved FEIBA infusions to be used in the following conditions in patients with hemophilia A or B with inhibitors:

However, it is not indicated to treat bleeding episodes in patients who do not have inhibitors against factors VIII or IX.

Composition and Mode of Action

FEIBA is a plasma-derived product and consists of multiple activated and non-activated clotting factors, including factors II, VII, IX, and X. It promotes blood clotting even in the presence of inhibitors (antibodies) in hemophilia A or hemophilia B patients.

Patients with hemophilia A can develop antibodies against clotting factor VIII, while hemophilia B patients can develop antibodies against clotting factor IX. These antibodies (inhibitors) neutralize the effects of factor VIII or IX drugs, making them less effective in controlling or preventing bleeds.

FEIBA bypasses the activity of these inhibitors and makes sure that the blood clots properly. It is important to know that this hemophilia medication does not cure your condition but only helps to control bleeding episodes.

FEIBA Dosing and Administration

FEIBA is a medication that comes in the form of lyophilized powder in single-dose vials containing concentrations of 500, 1,000, or 2,500 units per vial.

FEIBA is administered intravenously, and the drug’s dosage is tailored based on the patient’s clinical condition and the severity of the bleeding episodes.

1. Control and Prevention of Bleeding Episodes

Patients with minor to moderate bleeds may receive a dose of 50 – 100 units/kg FEIBA infusions, which is repeated every 6 – 12 hours until bleeding is resolved.

In cases of major bleeds (i.e., severe hemorrhage), the dose of FEIBA is increased to 100 units/kg with intervals adjusted based on clinical response.

2. Surgical Prophylaxis

Patients undergoing surgical procedures receive 50 – 100 units/kg of the FEIBA medication immediately before surgery. Furthermore, additional doses may be given after the surgery, every 6 – 12 hours, until the bleeding is resolved and the damaged area is healed.

3. Routine Prophylaxis

In routine prophylaxis, a dose of 85 units/kg is administered every other day. The dose and frequency are adjusted according to the extent of bleeding and the patient’s clinical conditions.

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FEIBA Administration Process

After receiving the appropriate instruction from a qualified healthcare professional, FEIBA can be administered by a caregiver or the patients themselves. Here are some useful tips you should follow when administering the FEIBA drug safely.

  • Follow an aseptic technique to reduce the risk of IV site-related infections.
  • The medication should be reconstituted with the provided diluent and administered as an intravenous infusion.
  • Reconstituted products should be used immediately or stored at room temperature and used within 3 hours.
  • The FEIBA infusion rate should not exceed 2 units per kilogram per minute to minimize the risk of adverse reactions.
  • Patients should be monitored closely during and after administration for any signs of adverse reactions.
  • Do not combine FEIBA with other medications.

Side Effects of FEIBA

A child lying down with a parent’s hand on his forehead

All medicines can have side effects. Some side effects are minor and temporary, while some could be severe and require immediate medical attention. Some common side effects reported by >5% of people during prophylaxis trials include:

The serious side effects seen with this drug include hypersensitivity reactions and thromboembolic events, such as stroke, pulmonary embolism, and deep vein thrombosis.

Always consult your doctor or hemophilia treatment center if you experience any side effects after taking FEIBA.

Warning

FEIBA can cause thromboembolic events following doses above 200 units per kg per day and in patients with thrombotic risk factors. Monitoring patients receiving FEIBA infusions for signs and symptoms of thromboembolic events is important.

Contraindications

Patients who have or had a history of anaphylactic or severe hypersensitivity reactions to its components should not take this drug.

FEIBA is also contraindicated in patients suffering from a blood clotting condition called disseminated intravascular coagulation (DIC) and acute thrombosis or embolism.

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Drug Interactions

Some drugs may interfere with FEIBA and how it works. If you are taking any other medications like antifibrinolytic agents, such as tranexamic acid and aminocaproic acid, during your treatment with FEIBA, it can increase your risk of thrombotic events.

Similarly, taking other coagulation factors and medications can affect the efficacy of FEIBA. Therefore, it is recommended to always discuss your medication profile with your doctor before getting a prescription.

Precautionary Measures

Always consult your healthcare provider before taking the drug if you are/have:

  • Pregnant or plan to become pregnant
  • Breastfeeding or plan to breastfeed
  • Allergic to any of the FEIBA components
  • Taking any over-the-counter medications, prescription medications like emicizumab, supplements, or herbal products
  • Any medical problems

FEIBA: Estimated Cost

FEIBA is very expensive. The medication’s cost may vary depending on your location, insurance, and the pharmacy you visit.

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AmeriPharma® Specialty’s patient care advocates are available 24/7 to help you with all your healthcare needs. Contact us today and let our team guide you every step of the way.

IVIG for Autoimmune Mucocutaneous Blistering Diseases

Published on by Dr. Saba Rassouli, PharmD

Research has shown that IVIG is a promising treatment option for patients with autoimmune mucocutaneous blistering diseases (AMBDs), a group of conditions that cause painful blisters, sores, and sometimes scarring on the skin or mucous membranes. 

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Previously, standard therapies like corticosteroids and immunosuppressive agents were used to treat autoimmune mucocutaneous blistering diseases. However, these therapies failed to give satisfactory results due to the serious side effects or opportunistic infections they caused when used long-term.

IVIG therapy has resolved these concerns and emerged as a safer and more effective alternative treatment with fewer and more manageable side effects. 

To understand how IVIG can help you, let’s first briefly review what exactly causes autoimmune mucocutaneous blistering diseases. 

Autoimmune Mucocutaneous Blistering Diseases: A Brief Overview

Autoimmune mucocutaneous blistering diseases are a rare and potentially fatal group of skin conditions that occur due to immune attacks. In this condition, the immune system that protects you from pathogens starts an immune response against your healthy cells. 

In autoimmune blistering diseases, the immune system mistakenly identifies the proteins that hold (glue) the skin and mucous membrane together as foreign material and initiates an immune response against them. The autoantibodies produced during this response attack these proteins and cause blisters and erosions on the skin, mouth, eyes, throat, and other mucosal surfaces.

Categories of Autoimmune Blistering Diseases 

The following are the skin conditions or diseases that fall into the category of AMBDs: 

1. Pemphigus Vulgaris

This is a potentially fatal mucocutaneous autoimmune disease that causes painful blisters and erosions on the skin and mucous membranes, particularly in the mouth.

2. Bullous Pemphigoid

This condition typically affects older adults and causes large, tense blisters on the skin, often preceded by itching and redness.

3. Mucous Membrane Pemphigoid (MMP)

Also known as cicatricial pemphigoid, this condition primarily affects mucous membranes of the mouth, nose, genitals, and eyes. Scarring due to sores in the eyes can lead to blindness in some patients. 

4. Pemphigus Foliaceus

This mild skin condition causes superficial blisters that often start on the face and scalp.

5. Paraneoplastic Pemphigus

This skin condition is a rare and severe form and is often associated with underlying diseases like lymphoma or leukemia. 

6. Dermatitis Herpetiformis

Although primarily associated with celiac disease, this condition involves the formation of intensely itchy blisters and small raised spots (papules), typically appearing symmetrically on areas such as the elbows, knees, buttocks, back, or scalp. These skin issues are caused by the deposition of immunoglobulin A (IgA) antibodies in the skin.

Autoimmune blistering diseases are debilitating and can cause pain, difficulty in eating, and even blindness if not properly treated. 

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IVIG and Autoimmune Mucocutaneous Blistering Diseases

Nurse setting up IVIG at home

IVIG therapy can help patients with autoimmune mucocutaneous blistering diseases by modulating their overactive immune systems. During this therapy, antibodies (prepared from the donated blood plasma) are administered intravenously into the patient’s body. 

Though the exact therapeutic effect of IVIG in AMBDs is not clear yet, research reports that it works in several ways:

It Neutralizes the Effects of Autoantibodies

IVIG provides a wide array of antibodies that neutralize the effects of autoantibodies produced by the immune system. These antibodies bind to harmful autoantibodies, prevent them from attacking healthy cells, and reduce disease severity. 

It Modulates Immune Response

IVIG has immunomodulatory effects, which means it has the ability to regulate the immune system. IVIG modulates the immune response by suppressing the production of autoantibodies and promoting the expansion of regulatory T cells to keep the immune system in check.

It Reduces Inflammation

IVIG is known for its anti-inflammatory effects that down-regulate the production of cytokines (a signaling protein that drives inflammation). The reduction in inflammation helps to alleviate the swelling, redness, and pain associated with blisters. 

It Block Fc Receptors

IVIG inhibits the overt immune response by blocking the Fc receptors on the surface of immune cells such as T, B and dendritic cells. 

Fc receptors on immune cells typically help identify and eliminate harmful substances. However, in autoimmune blistering diseases, these receptors mistakenly target the body’s own skin and mucous membranes, treating them as threats. Intravenous immunoglobulin (IVIG) therapy can mitigate this by blocking Fc receptors, preventing such misguided attacks. 

Benefits of IVIG Over Conventional Therapies for Autoimmune Mucocutaneous Blistering Diseases

IVIG offers several benefits to patients over conventional therapies. For example:

1. It Is a Safe Alternative With Fewer Side Effects

Compared to conventional therapies, IVIG is generally well-tolerated and causes no or fewer side effects, which are often mild and easily manageable. 

A study published in PNAS followed 21 patients with pemphigus vulgaris (PV) over 20 years, all treated with IVIG as their sole therapy. The results showed that 57% of the patients remained relapse-free for two decades, while 29% experienced brief relapses triggered by stress or COVID-19 infection/vaccination but recovered quickly with additional IVIG treatment. Moreover, no severe side effects from IVIG were reported. 

The findings suggest that IVIG may help restore the immune system’s balance and offer hope for long-term remission. It also provides valuable insights into how autoimmune blistering diseases like PV can be managed.

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2. It Is More Effective Than Conventional Treatments

IVIG is more effective than corticosteroids and immunosuppressive agents. For example, a case report of a 78-year-old woman with AMBDs showed that one week of treatment with IVIG significantly improved her symptoms; blisters and lesions healed faster, and no new lesions appeared. 

3. It Improves Quality of Life

IVIG not only clears clinical symptoms over time but also reduces the need for other medications. It also improved the quality of life, with many reported being able to perform daily activities more comfortably after taking IVIG treatment. 

IVIG is typically recommended as an alternative treatment to patients with autoimmune mucocutaneous blistering diseases when:

  1. Standard therapies like corticosteroids or immunosuppressive agents are refractory or contraindicated.
  2. Patients fail to respond to standard therapy or show relapses under standard treatment.
  3. Patients suffer from severe side effects from other medications.
  4. The patient’s condition is rapidly progressing.

In short, IVIG can be a safe and effective treatment for patients with autoimmune blistering diseases, and those who do not get promising results from conventional therapies can explore IVIG treatment regimens with their healthcare provider.

Myths About IG Therapy: Debunking Common Misconceptions

Published on by Dr. Christine Leduc, PharmD

Immunoglobulin (IG) therapy is a standard treatment for immune deficiencies, autoimmune disorders, and certain rheumatologic conditions. However, various myths and misconceptions surround its use.

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For example, you may have heard that you can stop IG therapy if you feel better or that IG therapy is the only cure for your condition. 

Patients with limited knowledge about immunoglobulin (IG) therapy — such as its mechanism, the importance of ongoing treatment, and variations in care among providers — are more susceptible to believing myths and misconceptions.

In this article, we will debunk eight common misconceptions about IG therapy so that you can make more informed decisions about your health.

Eight Common Misconceptions About IG Therapy

Myth 1: You Can Discontinue IG Therapy When You Feel Better

One of the most common misconceptions among patients is that they can discontinue IG therapy once they feel better and healthy. This is not true. 

In reality, feeling better or noticing improvements in symptoms after receiving IG infusions indicates that therapy is working well for patients. It does not imply that the underlying condition has been cured and that the patient no longer needs therapy. 

For example, a patient with primary immune deficiency (PI) disorder, who has a weaker immune system as their body does not produce essential antibodies, requires regular IG infusions to restore their immune function to a normal level so it can fight infections.

IG therapy can become a life-long treatment for these patients, and early discontinuation can leave their body more vulnerable to severe, recurrent, life-threatening infections. 

Myth 2: IG Therapy is Expensive and Unaffordable

IG therapy can be expensive for some patients who need it for the long term. This makes many patients discontinue IG therapy without realizing its long-term benefits to their health.

In reality, insurance and financial assistance programs often cover IG therapy expenses for patients with qualifying conditions. Moreover, patients can also switch to home-based IG therapy, which not only reduces hospital costs but also minimizes the frequency of serious infections and improves patients’ overall health. In short, the long-term benefits of IG therapy far outweigh the costs.

Therefore, it is recommended that the patient always consult with the healthcare provider and insurance company to explore coverage options and financial support programs before discontinuing therapy. 

Myth 3: All Healthcare Providers Are the Same and Offer the Same Quality of Care

Many patients believe that all healthcare providers are the same and provide the same quality of care. But this is not the case. 

Variations exist in the level of expertise, administration techniques, monitoring, and support services among providers. For example, some healthcare providers specializing in certain autoimmune disorders have in-depth knowledge about managing IG therapy and its associated side effects and offer more personalized care plans to patients.

On the other hand, general healthcare providers don’t have that much expertise in certain conditions and may not provide the same quality of care. Therefore, you should research and choose healthcare providers that align with your specific needs. 

For instance, you should look at whether a healthcare provider has:

  • Specialization in managing your condition or disease
  • Expertise in IG therapy and administration
  • A strong reputation for patient care
  • Experienced medical staff
  • Robust support services and monitoring

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Myth 4: Long-Term IG Patients Don’t Need Monitoring If They Have No History of Adverse Reactions

Man in bed receiving Ig therapy

This is a myth. Even long-term IG patients who have not experienced any adverse reaction during the course of their treatment still need monitoring to some degree by a healthcare professional or experienced nurse during infusions. 

Patients may experience hypersensitivity or other unexpected reactions even after tolerating IG therapy well. This could happen due to several reasons, such as changes in infusion rates, batch-to-batch variability of IG products, or even underlying health conditions that can impact how a patient responds to IG. 

Therefore, it is recommended that you receive IG infusions under the supervision of a competent healthcare clinician or trained nurses. 

Myth 5: IG Products are Interchangeable

IG products are NOT interchangeable. Though all products contain similar amounts of IgG antibodies, they differ in composition. For instance, the concentration of IgA and IgM, stabilizers, additives, sodium content, osmolarity, and levels of impurities may vary among different brands of IG products. 

Because of the difference in every IG product composition, IG products cannot be mixed or used interchangeably. In some cases, patients switch from one IG product brand to another. However, this only happens after the approval of the healthcare provider. 

Myth 6: IG Therapy is a Cure for Immune Deficiencies and Disorders

IG therapy is not a cure but a treatment for immunodeficiencies and autoimmune disorders. Its purpose is to manage these immune conditions. 

For example, in patients who lack essential antibodies, IG therapy supplements the patient’s body with deficient antibodies to maintain their immune function and prevent infections. On the other hand, in patients with autoimmune disorders, IG therapy helps manage the disease symptoms and prevents flare-ups. 

In short, both immune deficiency and autoimmune disorder patients require regular IG treatment since it does not address the root cause. 

Myth 7: You Don’t Need a Follow-Up with the Doctor if You’re on Home IG Therapy

This is not true. Patients receiving IG therapy in the comfort of their homes should follow up with their doctors routinely. Appointments with healthcare providers can help them track progress or improvements in a patient’s condition and schedule the next doses accordingly. 

In addition to this, the patient can also discuss their concerns or side effects with the healthcare provider during a follow-up.  

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Myth 8: IG Therapy Becomes Ineffective Over Time

Many people believe that IG therapy becomes ineffective over time as the body builds tolerance against it. In reality, this is not true. 

IG therapy remains effective as long as it is needed. However, individual responses may vary, and dosage or administration method adjustments may be required over time based on clinical evaluations.

Conclusion

Understanding the realities of IG therapy is crucial for patients relying on this life-saving treatment. By debunking common myths and misconceptions, individuals can make informed decisions about their healthcare and ensure they receive the best possible care.

If you’d like to learn more about IVIG, check out our IVIG Patient Resource Hub.

Questions To Ask Before Switching Your IG Provider: A Checklist for Patients

Published on by Dr. Samantha Kaeberlein, PharmD

If your healthcare provider suggests you switch to another IG provider or infusion center for immunoglobulin (IG) therapy, you must know what questions to ask before transitioning. 

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If you do not discuss everything before the transition, switching can affect not only your treatment and health outcomes but also your overall quality of life. This article will guide you through what questions to ask based on the reason for switching so you can make an informed decision about your health. 

Read on to explore the checklist of questions to ask your IG provider when they discuss switching with you. 

What Questions Should I Ask Regarding Switching? 

We have organized checklists based on the common reasons for transitioning to a new pharmacy, infusion center, or IG provider, which include (but are not limited to): 

  • Advanced medical treatment
  • Changes in insurance coverage
  • Medication availability
  • Treatment preferences (Infusion center or home IG infusion)
  • IG provider expertise

Understanding the specific reason for the transition can help you have more informed discussions with your healthcare provider about your health and financial concerns.

1. Advanced Medical Treatment

If the transition is because of advanced medical treatment, you can inquire about the changes in your current treatment plan. For example:

  • Will I be switched to a different brand or formulation of IG? If so, how does the new product compare to my current one in terms of efficacy, safety, and administration method (e.g., subcutaneous vs. intravenous)?
  • Will my dosing schedule or infusion duration change?
  • Will I have side effects, and how will these be monitored?

2. Changes in Insurance Coverage

Financial consideration is often a key factor in switching providers or infusion centers. If this is the reason in your case, you should ask the following questions: 

  • Does my insurance cover the new provider or infusion center, or will I need prior authorization?
  • Are there any hidden fees or additional costs?
  • Will my out-of-pocket costs (copays, deductibles, or coinsurance) change?
  • Does the new provider, infusion center, or pharmacy offer financial assistance programs or payment plans?
  • If I am part of a patient assistance program, will I still qualify under the new provider?
  • How are billing and claims handled, and will I need to submit any paperwork myself?

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3. Switching to a New Pharmacy Because of Medication Unavailability 

If your IG provider or current pharmacy has a shortage of certain IG products (including the one you take) and suggests a new pharmacy, you should ask the following questions:

  • How does the new pharmacy handle medication shortages and backorders?
  • What is the process for ordering, refilling, and delivering my medication?
  • How far in advance do I need to request refills?
  • Does the provider offer emergency medication supply if shipment is delayed?
  • Will I receive the same brand of IG medication consistently, or is there a risk of switching due to availability?
Patient at home receiving IVIG infusion with help from a nurse

Patients who live far from the infusion center often ask their IG provider for recommendations on nearby infusion centers where they can conveniently receive regular treatments. If this is your case, you should inquire how and where you’ll receive the IG infusions. 

  • Where is the new infusion center located, and can I travel there conveniently?
  • What is the setup like at the new infusion center? (Private rooms, comfortable seating, amenities?)
  • Are home infusion services an option if I prefer to receive treatment at home? If so, will I receive adequate training and support?
  • Are there options for flexible scheduling at the new location?
  • Are they accredited by reputable organizations (e.g., ACHC, URAC)?

If your IG provider recommends you switch to a more experienced IG provider specializing in your condition, then you should ask the following questions:

  • What is the provider’s track record with patients like me, and how many patients have they served with my condition?
  • Can I try the new provider before fully committing?
  • What is the provider’s background, and how long have they been in this role?
  • What safety measures and protocols are in place to ensure the highest quality care?
  • How does the new provider handle emergencies or complications?

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Other Questions to Ask

Support Services and Patient Education

If you want to know about the support services of the new IG provider, you can ask the following questions:

  • Does the new provider offer 24/7 patient support or nursing assistance for urgent concerns?
  • Does the new provider offer patient education resources on IG therapy?
  • Are there resources for financial assistance, travel reimbursement, or medication delivery?
  • What measures are in place to help me transition smoothly to the new provider?

What Questions Should I Ask If I’m Not Satisfied with the New Provider? 

Most patients worry about switching as they think this would impact their health since they don’t know the expertise of the new provider. If you have concerns about what steps to take if you are not satisfied with the new provider, then make sure to ask these questions:

  • Can I return to my current provider if needed?
  • Are there other providers I can consider if this one isn’t a good fit?
  • What is the process for switching providers again?

How Will the Switching Process Be Managed? 

If you’re ready to switch, then ask about the process and timeline, like:

  • What steps are involved in transferring my care to the new provider?
  • How long will the transition take, and will there be any treatment interruptions?
  • Who will oversee the transition, and how will I be kept informed?
  • How will my existing medical records be transferred to a new provider?
  • If I am unsatisfied with the new provider, what are my options for switching back or finding another provider?
  • Are there any administrative forms or approvals required to complete the transition?

Key Takeaway

For individuals who rely on lifelong immunoglobulin therapy, transitioning to a new provider or infusion center can be a source of anxiety and discomfort. However, if you know which questions to ask, you can gain the information you need to make an informed decision about your health.

IVIG for Enteroviral Meningoencephalitis: Is This Therapy Effective? 

Published on by Dr. Mark Alfonso, PharmD, BCMTMS

Limited evidence supports the use of IVIG for enteroviral meningoencephalitis. However, considering that no standard treatment exists, IVIG may be an option, particularly in those with weakened immune systems. 

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A Quick Overview of Enteroviral Meningoencephalitis

Enteroviral meningoencephalitis is a rare but potentially fatal condition. It occurs when certain types of non-polio enteroviruses cause swelling of both the brain and its coverings (meninges). 

Enteroviruses comprise many different types of viruses that usually cause mild infection. However, in people with compromised immune systems, infants, and children, they can cause severe symptoms. 

Examples of enteroviruses are coxsackieviruses, echoviruses, polioviruses, and the hepatitis A virus. These viruses can spread from one person to another via direct contact with viruses shed from the digestive tract or upper airway. 

Symptoms of enteroviral meningoencephalitis can include:

  • Fever
  • Headache
  • Vomiting
  • Neck stiffness
  • Seizures
  • Rashes
  • Sudden, uncontrollable muscle contraction
  • Changes of consciousness
  • Coma

Though anyone can get enteroviral meningoencephalitis, newborns and people with weakened immune systems are at the highest risk. Symptoms in newborns can include:

  • Fever
  • Poor feeding
  • Irritability
  • Lethargy
  • Jaundice (yellow discoloration of the skin and eyes)

How Effective Is IVIG For Enteroviral Meningoencephalitis?

Results can vary widely. 

Several case reports suggest IVIG can result in the complete resolution of symptoms. However, in some cases, IVIG is ineffective, followed by disease progression or even death.

Factors that may contribute to the outcome of IVIG for enteroviral meningoencephalitis include [1]:

  • Delays in diagnosis 
  • Differences in the amount of enteroviral antibodies (proteins) among IVIG preparations

Nonetheless, some researchers recommend high-dose IVIG as the first-line therapy for enteroviral meningoencephalitis [2].

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IVIG For Enteroviral Meningoencephalitis: Recent Success Stories

In a 2023 case report, German researchers reported a case of full recovery in a 38-year-old male with long-term enterovirus meningoencephalitis. The patient had taken the cancer medication rituximab 4 years earlier, which the researchers believe could be one of the causes of enterovirus meningoencephalitis. 

The patient received 2g/kg body weight of IVIG in the beginning. After a few days of IVIG therapy, the symptoms improved, and the patient was able to walk. 

Later, the IVIG dose was reduced to 0.5g/kg body weight every 6 weeks. After 3 months, his physical and cognitive symptoms improved drastically. A full recovery was observed at follow-up 11 months after starting IVIG [3].

A similar success story was observed by American researchers in a 2021 study. This case involved a 37-year-old female who had enteroviral meningoencephalitis as a complication of rituximab therapy for rheumatoid arthritis [4].

At the time of admission, she had a fever, headache, confusion, and tremor. Diagnostic tests found her positive for enterovirus. She received IVIG 0.4g/kg daily for 5 days, and her symptoms (agitation, confusion, tremors, gait abnormalities, and headaches) improved significantly. 

Complete resolution of symptoms occurred over the next 12 months. 

Likewise, in a 2019 case report, a 46-year-old female with enteroviral meningoencephalitis taking rituximab for psoriatic arthritis was treated with IVIG 0.4g/kg/day for 5 days. After IVIG therapy, her symptoms improved, and she was discharged from the hospital. 

However, complete resolution of symptoms was not observed at the time of discharge [5].

Earlier Success Stories

IVIG patient receiving treatment for enteroviral meningoencephalitis

In a 1981 case report published in the New England Journal of Medicine, investigators reported a 32-year-old man with a weakened immune system who fully recovered from echovirus-induced meningoencephalitis with high-dose modified IVIG [6].

In 1987, researchers at the Duke University Medical Center analyzed data of over 40 patients with chronic enteroviral meningoencephalitis. Most patients in this review had some form of immunodeficiency. 

According to researchers, IVIG can be considered an empirical treatment for chronic enteroviral meningoencephalitis [7]. Empirical treatment is the practice of using medication based on experience instead of precise knowledge of the causative factor or nature of a disease.

The Challenges of Using IVIG for Enteroviral Meningoencephalitis

Despite promising results in several case reports, the definitive benefits of IVIG for enteroviral meningoencephalitis have yet to be demonstrated in large trials. 

Unfortunately, there have been reports of symptom worsening and death following treatment of enteroviral meningoencephalitis with IVIG. 

For instance, a 2016 review analyzed 10 cases of rituximab-associated meningoencephalitis. Of the 10 patients, five received IVIG. Two patients who received IVIG died [8].

While death cannot be directly attributed to IVIG therapy, available evidence suggests that IVIG may not be a lifesaver in many cases. 

Other factors that limit IVIG use for enteroviral meningoencephalitis include:

  • A lack of large, controlled human trials
  • Insufficient knowledge about the effective dosage range
  • Duration of therapy
  • A lack of the precise mechanism of action of IVIG

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Frequently Asked Questions

1. Is IVIG used for enterovirus encephalitis?

IVIG may be considered for enterovirus encephalitis in patients with weakened immune systems. According to a 2021 review, a high-dose approach (2 g/kg) may be more beneficial [9].

2. How do you treat enteroviral encephalitis?

Specific treatment is unavailable currently. Nonetheless, specific antiviral medications and IVIG may help improve treatment outcomes in individuals with enteroviral encephalitis.

3. What is the first-line treatment for encephalitis?

Most neurologists recommend oral or intravenous (IV) corticosteroids for initial therapy. IVIG or plasma exchange are potentially effective treatment options, especially when other treatments don’t work. 

4. How do you diagnose meningoencephalitis?

The primary diagnostic test for meningoencephalitis is CSF analysis. CSF analysis examines your cerebrospinal fluid (the fluid in and around the brain and spinal cord) to help diagnose diseases of the brain and spinal cord. 

5. What is the drug of choice for meningoencephalitis?

Depending on the cause and severity, your provider may prescribe medications, such as antiviral drugs, antiseizure drugs, or corticosteroids. 

6. What is IVIG used for in neurology?

IVIG is used in neurology to treat many conditions, including:

7. Encephalitis vs. meningoencephalitis: What’s the difference?

Encephalitis is inflammation (swelling) of the brain. Meningoencephalitis is simultaneous inflammation of the brain and its coverings.

A Guide to the Most Effective CIDP Disease Treatment Options

Published on by Dr. Saba Rassouli, PharmD

Chronic inflammatory demyelinating polyneuropathy (CIDP) is not just a complicated medical term; it is a rare disease that can cause sensory loss and severely impact mobility.

Although there is currently no known cure, early diagnosis and treatment of CIDP disease can help manage symptoms and prevent irreversible nerve damage.

In this guide, we will explore the various CIDP treatment options available to help you enjoy a higher quality of life with this debilitating disease.

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Understanding CIDP

CIDP is a neurological autoimmune disorder that occurs when the body’s immune system mistakenly attacks the myelin, the protective sheath surrounding peripheral nerves.

This attack disrupts the communication between the nerves and the brain, leading to symptoms that can significantly impact mobility and daily life. Symptoms of CIDP may include:

  • Loss of sensation
  • Reduced reflexes
  • Pain or discomfort
  • Weakness in the limbs
  • Numbness and tingling
  • Difficulty walking or standing

Early recognition of these signs is vital for managing symptoms with appropriate CIDP treatments and preserving nerve function. Without timely treatment of the disease, CIDP can lead to more severe complications such as paralysis.

Difficulty in Diagnosing CIDP

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CIDP is extremely rare, with approximately five to seven out of every 100,000 people diagnosed with the disease.

CIDP is often confused with Guillain-Barre syndrome (GBS) because of the similarity of symptoms. Both are autoimmune diseases that affect the myelin (an insulating layer or sheath that forms around nerves).

However, a significant difference is that GBS symptoms progress rapidly and can reach the most severe state in less than 4 weeks without appropriate treatments, while CIDP symptoms take longer to manifest.

Testing for CIDP

Since CIDP is a chronic disease, it is not diagnosed until symptoms persist and worsen over 8 weeks or longer.

To diagnose the disease and recommend the most suitable treatment for CIDP, doctors will review your medical history and may conduct the following tests:

  • Blood tests: These tests measure levels of specific markers in your blood to identify inflammation or rule out other conditions that may mimic CIDP.
  • Nerve biopsy: A small sample of nerve tissue is taken to examine for damage to the myelin sheath.
  • Lumbar puncture (spinal tap): Doctors extract cerebrospinal fluid to look for elevated protein levels and CIDP-associated inflammatory markers.
  • Magnetic Resonance Imaging (MRI): MRI scans provide detailed images of the spine and brain, helping doctors identify any abnormalities in the nervous system.
  • Nerve conduction studies and electromyography: These tests evaluate the electrical activity in nerves and muscles to assess the damage and the severity of the disease.

Early diagnosis and treatment of CIDP disease can prevent nerve damage and are crucial for successful recovery.

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CIDP Treatment Options

Since CIDP is an autoimmune disease, the prescribed treatments often work to suppress the immune response that is causing the attack on the myelin.

Here is a look at different CIDP treatments available to patients.

Corticosteroids

Corticosteroids are a class of anti-inflammatory medications widely used to manage autoimmune conditions like CIDP. A typical regimen involves oral prednisone or prednisolone. These drugs suppress the immune system and reduce the inflammatory response that damages the myelin.

Corticosteroid treatments for CIDP disease can lead to substantial improvements in muscle strength and reduced symptoms of weakness and sensory loss. A study involving 125 patients found that 60% of participants responded positively to corticosteroids and 61% maintained remission during a 55-month follow-up.

These findings indicate that corticosteroids are reliable first-line treatments for CIDP. In the long term, they can help maintain functional mobility and prevent further degeneration of nerve function.

Intravenous Immune Globulin (IVIG)

Intravenous Immune Globulin (IVIG) involves the infusion of antibodies derived from healthy donors into the bloodstream of individuals with CIDP disease. This treatment works by modulating the immune system and reducing inflammation.

Clinical trials indicate that around 90% of patients benefit from IVIG therapy, showing notable improvements in disability scores and muscle strength. Furthermore, 87% of patients remained relapse-free for an additional 24 weeks, demonstrating the long-term advantages of this treatment.

In addition to alleviating symptoms, IVIG improves patients’ overall quality of life. Many have reported significant improvements in physical functioning and social engagement. These findings highlight the potential of IVIG as a viable treatment option for CIDP.

Plasmapheresis

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Plasmapheresis, or plasma exchange, is another treatment for CIDP disease. It involves removing the plasma containing harmful antibodies from blood circulation. This process aims to reduce the autoimmune attacks on the nervous system.

Clinical benefits of plasmapheresis treatments for CIDP include significant short-term improvements in disability and nerve conduction velocities. Studies have shown that approximately 66% of patients experience notable improvements in symptoms following treatment.

In a trial involving 36 participants, those who underwent plasmapheresis demonstrated a mean improvement of 31 points on the Neuropathy Impairment Score after 4 weeks. This result indicates that plasmapheresis can effectively alleviate symptoms and improve overall function.

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Subcutaneous Immunoglobulin (SCIG)

Subcutaneous Immunoglobulin (SCIG) treatment for CIDP disease is administered by injecting immunoglobulin into the fatty tissue beneath the skin.

This method allows for the gradual absorption of antibodies into the bloodstream. It also provides a continuous supply of antibodies to help modulate the immune response. Recent studies have shown that SCIG is as effective as IVIG while having fewer systemic side effects.

A comprehensive meta-analysis of over 1,400 CIDP patients revealed that SCIG significantly improved muscle strength and sensory function while reducing relapse rates. Only 14% of patients experienced a relapse.

These findings highlight the role of SCIG as one of the valuable treatment options for CIDP.

Autologous Hematopoietic Stem Cell Transplantation (HSCT)

Autologous hematopoietic stem cell transplantation (HSCT) is another treatment for CIDP disease. It involves collecting a patient’s stem cells and reintroducing them after high-dose immunosuppressive therapy.

This procedure aims to reset the immune system and halt the autoimmune processes contributing to CIDP. HSCT is typically considered for patients with severe CIDP who have not responded to other treatments.

80% of patients undergoing HSCT achieve long-term remission. Studies indicate significant improvements in muscle strength, quality of life, and nerve conduction velocities post-transplant. These findings suggest that HSCT can be a transformative option for patients with treatment-resistant CIDP.

Monoclonal Antibodies

Monoclonal antibodies like Rituximab (Rituxan) are sometimes used in patients who do not respond to first-line treatments for CIDP disease. These targeted therapies bind to the proteins on the surface of B cells, which play a crucial role in autoimmune responses seen in CIDP.

By destroying B cells, they reduce the production of harmful antibodies that attack the myelin sheath surrounding nerves. This targeted approach can help mitigate the immune system’s attack on the peripheral nerves.

Reviews show that around 75% of those who received Rituximab experienced notable improvements in their symptoms, including enhanced strength and reduced disability scores. These patients previously had limited responses to standard treatment options for CIDP.

Physical Therapy

Doctors may also recommend physical therapy treatment for CIDP patients to alleviate the functional symptoms of the disease.

Physical therapists employ various techniques, including strength training, balance exercises, and gait training, to help patients regain lost motor functions and improve balance and coordination. The goal is to enable patients to maintain independence in daily activities.

Studies show that after a 12-week physical therapy program, 80% of CIDP patients demonstrated significant improvements in their functional abilities. Many noted an enhanced ability to perform activities of daily living, such as walking and climbing stairs, without assistance.

These findings underscore the importance of incorporating physical therapy into the comprehensive treatment plan for CIDP.

New CIDP Treatments

In 2024, the FDA approved three new drugs for the treatment of CIDP disease. These drugs are:

  • HYQVIA (used for maintenance therapy): HYQVIA is a subcutaneous infusion that combines immune globulin with recombinant human hyaluronidase. This formulation helps enhance absorption, making it easier for patients to receive treatment at home.
  • GAMMAGARD LIQUID: GAMMAGARD LIQUID is a 10% immunoglobulin solution derived from human plasma. It replenishes antibodies in individuals with primary immunodeficiency and offers an effective treatment option for CIDP.
  • Vyvgart Hytrulo (used by adults): Vyvgart Hytrulo is a subcutaneous injection of efgartigimod alfa and hyaluronidase. It works by blocking harmful IgG antibodies involved in CIDP. Vyvgart enhances patient convenience with an easy administration route.

The approval of these drugs offers additional treatments for those who suffer from CIDP disease.

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Life Expectancy and Quality of Life

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CIDP is not fatal. Various treatment options are available to help manage the disease. Even though patients have a life expectancy comparable to those without the disease, their quality of life can be significantly affected.

The longer the disease remains untreated, the greater the risk of permanent nerve damage, which can severely impair sensory and motor functions. If severe nerve damage sets in, patients may require assistance with daily living activities due to a lack of mobility.

Even with an accurate diagnosis and appropriate treatment, some patients with CIDP disease may still experience symptoms such as fatigue, pain, or sensory disturbances.

Supportive Strategies

Fortunately, in addition to different CIDP treatments, there are other things you can do on your own to make living with this condition easier, such as:

  • Getting plenty of sleep to help manage fatigue
  • Avoiding overexertion and taking frequent rests between activities
  • Using assistive devices such as canes and walkers to help with mobility
  • Making home modifications like installing raised toilet seats or grab bars
  • Engaging in light exercise (after consulting your health professional first)
  • Maintaining a healthy, balanced diet to get proper nutrients for promoting nerve health

These simple tips can help you manage CIDP disease while simultaneously receiving medical treatment and physical therapy.

Get Started with CIDP Treatments at AmeriPharma® Specialty Pharmacy

The sooner you identify CIDP and begin treatment, the higher the chance you can reverse symptoms and prevent further nerve damage.

If you are diagnosed with CIDP and require treatment to manage the disease, AmeriPharma® Specialty Pharmacy can help. Our ACHC-accredited specialty pharmacy provides hard-to-find medications and at-home treatments for CIDP patients.

We service 40+ U.S. states and territories with full-service coordination, copay assistance, and 24/7/365 support. Book a call today to talk to a specialist and learn more about our CIDP treatment options.