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What is this medication?

Antirheumatic, Disease Modifying;
 Gastrointestinal Agent; Immunosuppressant Agent; Monoclonal Antibody; Tumor Necrosis Factor (TNF) Blocking Agent

REMICADE and biosimilars INFLECTRA, RENFLEXIS, and AVSOLA (Infliximab) are tumor necrosis factor (TNF) blockers indicated for treatment of ankylosing spondylitis, crohn's disease, ulcerative colitis, plaque psoriasis, juvenile idiopathic arthritis, rheumatoid arthritis, psoriatic arthritis.

Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens.  Discontinue Infliximab if a patient develops a serious infection.  Perform test for latent TB; if positive, start treatment for TB prior to starting Infliximab. Monitor all patients for active TB during treatment, even if the initial latent TB test is negative. Lymphoma and other malignancies have been reported with tumor necrosis factor (TNF) blockers.

What is a biosimilar biologic drug?

Manufacturers have found cost-efficient ways to recreate the molecules used in the original or “reference” biologic drug.  Biosimilars are highly “similar” to a reference biological drug despite differing in their chemical composition.  

The FDA approval of biosimilar drugs is based on a totality of evidence which is used by regulators in the approval of reference and biological drugs.  The FDA uses the same approach in evaluating biosimilars to confirm that there are no clinically meaningful differences in safety and efficacy between the reference biologic drug and the biosimilar.  The rigorous standard for authorization means that you can have confidence knowing that the quality, safety, and efficacy of a biosimilar is the same as any other biologic drug.

REMICADE is a biologic
INFLECTRA is a biosimilar to REMICADE (Infliximab)
RENFLEXIS is a biosimilar to REMICADE (Infliximab)
AVSOLA is a biosimilar to REMICADE (Infliximab)

What is the difference between the brands?

INFLECTRA, RENFLEXIS, and AVSOLA are tumor necrosis factor (TNF) blockers that are biosimilar to REMICADE (Infliximab).  According to the FDA, a biosimilar is shown to have no clinically meaningful differences in terms of safety and effectiveness from the reference product -- in this case Remicade. Only minor differences in clinically inactive components are allowable in biosimilar products.

How does this medication work? 

REMICADE/INFLECTRA/ RENFLEXIS/AVSOLA (Infliximab) neutralizes the biological activity of TNF by binding with high affinity to the soluble and transmembrane forms of TNF and inhibits binding of TNF with its receptors. Infliximab does not neutralize TNF (lymphotoxin-), a related cytokine that utilizes the same receptors as TNF. Biological activities attributed to TNF include induction of proinflammatory cytokines such as interleukins (IL) 1 and 6, enhancement of leukocyte migration by increasing endothelial layer permeability and expression of adhesion molecules by endothelial cells and leukocytes, activation of neutrophil and eosinophil functional activity, induction of acute phase reactants and other liver proteins, as well as tissue degrading enzymes produced by synoviocytes and/or chondrocytes.

How should I take this medication? 

IV: Administer 5mg/kg by intravenous infusion at 0, 2, and 6 weeks, then every 8 weeks. 

How to Take: Administer by intravenous infusion over a period of not less than 2 hours.

What should I watch for while using this medication? 

Before starting REMICADE/INFLECTRA/RENFLEXIS/AVSOLA (Infliximab), make sure your physician is aware of any allergies or medications you currently take.  Do not use Infliximab if you have an active infection.  Test for hepatitis B virus reactivation prior to starting Infliximab, and monitor HBV carriers during and several months after therapy.  If reactivation occurs, stop Infliximab and begin antiviral therapy.  Infliximab has been associated with malignancies including lymphoma.  Serious infusion reactions including anaphylaxis or serum sickness-like reactions may occur and need to be treated appropriately.  Live vaccines or therapeutic infectious agents should not be given with Infliximab.

What if I miss a dose?

If you miss an appointment for an injection, call your doctor’s office or clinic right away to reschedule. Your doctor can also help readjust your infusion schedule for future doses, if necessary.

How should I store this medication?

Store unopened vials in a refrigerator at 2°C to 8°C (36°F to 46°F). If needed, unopened vials may be stored at room temperatures up to a maximum of 30ºC (86°F) for a single period of up to 6 months but not exceeding the original expiration date.

What are the possible side effects of using this medication?

Headache, abdominal pain, nausea, anemia, elevated liver enzymes, antibody development, increased ANA titer and antibody development, local injection site pain and irritation, respiratory tract infection, sinusitis, cough, and pharyngitis.

Note this is not a complete list of side effects for REMICADE/INFLECTRA/ RENFLEXIS/AVSOLA (Infliximab), only common ones.