Description Of Product
Infliximab, Remicade/Biosimilars (Renflexis/Inflectra/Avsola)
Description: Antirheumatic; Disease Modifying Agent; Gastrointestinal agent; Immunosuppressant; Monoclonal Antibody
“ALERT: US Boxed Warning
Serious infections: Patients treated with infliximab are at an increased risk of developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants, such as methotrexate or corticosteroids.
Discontinue infliximab if a patient develops a serious infection or sepsis.
Reported infections include the following:
Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before infliximab use and during therapy. Treatment for latent infection should be initiated prior to infliximab use.
Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric antifungal therapy should be considered in patients at risk of invasive fungal infections who develop severe systemic illness.
Bacterial, viral, and other infections caused by opportunistic pathogens, including Legionella and Listeria.
The risks and benefits of treatment with infliximab should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with infliximab, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
Malignancy: Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab. Post marketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including infliximab. These cases have had a very aggressive disease course and have been fatal. Almost all patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF-blocker at or prior to diagnosis. The majority of reported infliximab cases have occurred in patients with Crohn disease or ulcerative colitis, and most were in adolescent and young adult males.”
CSA NA – FDA Approved – REMS (N) – Can Ship
How Does It Work
Infliximab, Remicade/Biosimilars (Renflexis/Inflectra/Avsola) is a chimeric monoclonal antibody that binds to free and transmembrane forms of tumor necrosis factor alpha (TNFα), thereby interfering with endogenous TNFα activity that results in a reduction in proinflammatory mediators (i.e. interleukins), leukocyte migration, neutrophils and eosinophils
Indications For Use
Officially indicated for ankylosing spondylitis, Crohn disease, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis depending on which product is being used.
Development of an autoimmune disorder
Cardiovascular and cerebrovascular reactions following an infusion
Development of hematologic disorders, hepatic reactions, reactivation of Hepatitis B
Hypersensitivity or infusion reaction
Increased risk for serious infections
Use with caution in patients with pre-existing or recent onset CNS demyelinating disorders and heart failure
Intravenous infusion should be performed under the direct supervision of licensed medical professionals.
Pharmacist Tips On Using
How to Take Infliximab, Remicade/Biosimilars (Renflexis/Inflectra/Avsola): Intravenous administration of Remicade/Infliximab should be done under the direct supervision of a medical professional. Infliximab, Remicade/Biosimilars (Renflexis/Inflectra/Avsola) is generally administered at an infusion clinic.
The most common side effects reported in using Remicade/Infliximab include:
Central Nervous System: Headache (18%)
Gastrointestinal: Abdominal pain (Crohn disease: 26%; rheumatoid arthritis: 12%), nausea (21%)
Hematologic & Oncologic: Anemia (children and adolescents with Crohn disease: 11%; adults: <1%)
Hepatic: Increased serum alanine aminotransferase (<3 x ULN: 17% to 51%; ≥3 x ULN: 2% to 10%; ≥5x ULN: 1% to 4%)
Immunologic: Antibody development (10% to 52%), increased ANA titer (~50%), antibody development (double-stranded DNA, ~20%)
Infection: Infection (children and adolescents: 38% to 74%; other indications: 27% to 59%; adults with Crohn disease: 50%), serious infection (children and adolescents: 12% to 60%; adults: 5%), abscess (Crohn disease patients with fistulizing disease: 15%)
Respiratory: Upper respiratory tract infection (rheumatoid arthritis: 32%; children and adolescents with ulcerative colitis: 12%), sinusitis (14%), cough (12%), pharyngitis (8% to 12%)Miscellaneous: Infusion related reaction (≤18%; severe: <1%)
Frequently Asked Questions
What is a biosimilar drug?
A biosimilar is a biological product that is very similar to a reference biologic and for which there are no clinically meaningful differences in terms of safety, purity, and potency. These molecules are so large, complex, and difficult to make that slight variations in lab technique from one manufacturer to another result in minor molecular differences thereby preventing them from being considered a generic. They are not completely interchangeable and therefore more supporting evidence must be provided by the manufacturer in order to be approved by the FDA/Health Canada.
Why are biosimilars more affordable than their brand counterparts?
Biosimilars are considerably more affordable than their brand name counterparts because of the lower cost in manufacturing and entering the marketplace because of minimal investment in research and development.
Is there a biosimilar for infliximab?
Renflexis (infliximab-abda) and Inflectra (infliximab-dyyb) are approved as biosimilars to Remicade (infliximab). In Canada, Remsima is also approved as a biosimilar to Remicade (infliximab)