What Is Inflectra (Infliximab-dyyb)?

Inflectra is an FDA-approved prescription drug used to treat several autoimmune disorders. People with autoimmune diseases have dysregulated immune systems that cause the immune cells to attack healthy tissues in the body. 

 

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What Is Inflectra?

Inflectra is a biological product in a category of medicines called tumor necrosis factor (TNF) blockers or anti-TNF agents. Biological products, also known as biologics, are made using living cells. 

Inflectra contains the active molecule infliximab-dyyb, a biosimilar to infliximab (brand name: Remicade). This means that Inflectra is almost identical to Remicade in terms of safety, purity, and potency. Other biosimilars to Remicade include:

• Renflexis (infliximab-abda)
• Avsola (infliximab-axxq)

The 4-letter suffix following the non-proprietary name of the drug (infliximab in this case) is unique to a biological product. It helps healthcare professionals distinguish between different branded versions of a biologic.

 

How Is Inflectra Supplied and Used?

Inflectra comes as a powder for intravenous infusion (IV) in a single-dose vial. Each vial contains 100 mg of infliximab-dyyb; no other strengths are currently available. 

Before administering the drug, your doctor or nurse will make a solution by mixing the powder with sterile water. Then, they will administer the solution by intravenous infusion over a period of at least 2 hours (1 hour if previously tolerated). Infusion should begin within 3 hours after dilution. 

 

How Does Inflectra Work?

Inflectra blocks the action of a pro-inflammatory protein called tumor necrosis factor-alpha (TNF-ɑ). TNF-α plays a determining role in the pathogenesis of several chronic inflammatory diseases, such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, psoriasis, psoriatic arthritis, ankyloting spondylitis, Wegener granulomatosis, and sarcoidosis. By blocking its action, Inflectra relieves a wide range of symptoms associated with these diseases.

 

What Is Inflectra Used to Treat?

Adults

The FDA has approved Inflectra to treat the following autoimmune disorders in adults:

• Crohn’s disease (CD). CD is a chronic disease that causes inflammation and irritation in the digestive tract, especially the small intestine and upper part of the large intestine. Inflectra reduces signs and symptoms and helps maintain a symptom-free state. 
• Ulcerative colitis (UC). UC causes inflammation and irritation only in the large intestine.  Inflectra reduces signs and symptoms and helps maintain a symptom-free state. 
• Rheumatoid arthritis (RA). People with RA have joint pain, swelling, and stiffness.  Inflectra reduces signs and symptoms, delays joint damage, and helps improve joint function.  
• Ankylosing spondylitis. Ankylosing spondylitis (a form of arthritis) affects the spine.  Inflectra reduces signs and symptoms. 
• Psoriatic arthritis. Psoriatic arthritis can occur in some people with psoriasis (long-lasting patches on the skin). Inflectra reduces signs and symptoms, delays joint damage, and helps improve joint function. 
• Plaque psoriasis. Plaque psoriasis is a skin disease that causes scaly and painful skin patches (plaques). Inflectra improves symptoms in adults with chronic severe plaque psoriasis. 

Children

The FDA has approved Inflectra to treat Crohn’s disease and ulcerative colitis in children 6 years and older. 

 

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What Are the Side Effects of Inflectra in Adults?

Inflectra side effects can be mild or severe. However, in rare cases, they can be fatal. 

For instance, Inflectra has been associated with a higher risk of certain cancers and potentially life-threatening infections in some users. 

Mild Side Effects

• Headache
• Respiratory infections, such as sinusitis (inflamed sinuses), pharyngitis (sore throat), and  bronchitis (swollen airways)
• Urinary tract infection
• Cough
• Stomach pain
• Indigestion
• Rashes and itchy skin

Most of these issues typically resolve within a few days to weeks. If they worsen or persist, consult your doctor or pharmacist.

Severe Side Effects

Call your doctor immediately if you experience serious side effects. Moreover, call 911 if you think your symptoms are life-threatening. Severe side effects with their symptoms are listed below:

Hepatitis (Liver Inflammation) or Liver Failure

• Pain on the upper right side of the stomach
• Dark brown urine
• Exhaustion
• Fever
• Jaundice (yellowish skin and eyes)

New or Worsening Heart Failure

• Shortness of breath
• Swelling of ankles or feet
• Sudden weight gain

Heart Attack, Ischemia (Decreased Blood Flow to the Heart), or Irregular Heartbeat

These problems may occur within 24 hours after starting the infusion. 

• Chest discomfort or pain
• Arm pain
• Stomach pain
• Shortness of breath
• Anxiety
• Lightheadedness
• Dizziness
• Fainting
• Sweating
• Nausea and vomiting
• Irregular heartbeat
• Feelings of a pounding heart

Blood Problems

• Persistent fever
• Easy bruising or bleeding
• Pale skin
• Hematologic toxicities

Problems Affecting the Brain, Spinal Cord, and Nerves

• Vision changes
• Seizures
• Tingling or numbness that can affect any part of the body
• Rare cases of optic neuritis and demyelinating disease in patients with preexisting or recent-onset CNS demyelinating disorders

Lupus-like Syndrome

• Persistent chest pain or discomfort
• Shortness of breath
• Joint pain
• Rash on your cheeks or arms, which often gets worse in the sun

Infliximab treatment has also been associated with active tuberculosis (may be disseminated or extrapulmonary) or reactivation of latent infections.

 

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Infusion-related Reactions

Infusion-related reactions can occur during or within 60 minutes after an infusion. They may also be delayed by days or weeks (concurrent immunomodulators such as thiopurine and methotrexate may reduce the risk of immediate infusion reactions). 

Infusion-related reactions include:

• Shortness of breath
• Flushing
• Headache
• Rash
• Chest pain
• Seizures
• Low blood pressure
• Temporary vision loss

Allergic Reactions

Seek immediate medical help if you experience the following:

• Chest pain
• Hives
• Shortness of breath
• High or low blood pressure
• Fever
• Chills

 

Inflectra Side Effects on Children

Children and adults who take Inflectra for ulcerative colitis experience similar side effects. Nonetheless, differences exist when the drug is used to treat people with Crohn’s disease. 

Clinical trials show that the following side effects are more common in children:

• Anemia (low red blood cell levels)
• Leukopenia (low white blood cell levels)
• Flushing
• Viral infection
• Neutropenia (low levels of specific immune cells)
• Bone fracture
• Bacterial infection
• Allergies affecting the child’s respiratory tract

 

Inflectra Dosage

Your doctor will prescribe Inflectra doses based on your:

• Diagnosis
• Body weight 
• Response to treatment
• Other health conditions

Furthermore, they may decide to discontinue treatment if no response is observed. Before and during therapy, they will test you for tuberculosis (TB) and hepatitis B. 

The recommended Inflectra doses are as follows:

Adult Dosage

• Crohn’s disease: 5 mg/kg body weight at 0, 2, and 6 weeks, then every 8 weeks. If the dose is effective initially but no longer effective after a while, it may be increased to 10 mg/kg every 8 weeks. 
• Ulcerative colitis: 5 mg/kg at 0, 2, and 6 weeks, then every 8 weeks.
• Rheumatoid arthritis: With methotrexate, 3 mg/kg at 0, 2, and 6 weeks, then every 8 weeks. The dose may be increased to 10 mg/kg every 4 or 8 weeks.
• Ankylosing spondylitis: 5 mg/kg at 0, 2, and 6 weeks, then every 6 weeks.
• Psoriatic arthritis and plaque psoriasis: 5 mg/kg at 0, 2, and 6 weeks, then every 8 weeks.

 

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Child Dosage (6 Years and Older) 

Crohn’s disease and ulcerative colitis: 5 mg/kg at 0, 2, and 6 weeks, then every 8 weeks.

 

Use in Pregnancy and Lactation

Those who are pregnant or planning to get pregnant should ask their doctor about the potential risks and benefits of Inflectra treatment. 

Limited data suggest that using Inflectra during pregnancy is unlikely to cause problems with fetal development. 

Nonetheless, an infant born to a mother who used infliximab during pregnancy may be more prone to infections. Therefore, such infants should not get vaccinated with live vaccines (e.g., rotavirus vaccine) until they reach the age of 6 months. 

Breast milk contains low levels of infliximab. However, infliximab is degraded in the digestive tract, so it is unlikely that infliximab in breast milk can affect an infant’s immunity or development. 

 

How Much Does Inflectra Cost?

The amount you pay for Inflectra treatment can vary, depending on your insurance plan, geographical location, and pharmacy. Contact your insurance provider to find out if your plan covers Inflectra or if you need prior authorization. 

Pfizer, the maker of Inflectra, provides assistance of up to $20,000 per calendar year to commercially insured patients. Both Medicare and Medicaid cover Inflectra. Contact us below to learn more about financial assistance for Inflectra.