Remicade (infliximab)
REMICADE (infliximab) – a biologic anti-inflammatory agent that binds specifically to TNF-alpha and blocks its interaction with the p75 cell surface TNF receptor. TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Elevated levels of TNF are found in the synovial fluid of patients with RA, JIA, PsA, and AS and play an important role in both the pathologic inflammation and the joint destruction that are hallmarks of these diseases.
FDA approved uses:
1. Chrohn’s disease
2. Pediatric Chrohn’s disease
3. Ulcerative colitis (UC)
4. Pediatric ulcerative colitis
5. Rheumatoid arthritis (RA) in combination with methotrexate (MTX)
6. Ankylosing spondylitis
7. Psoriatic arthritis (PA)
8. Plaque psoriasis
Available dosage forms:
100 mg of lyophilized infliximab in a 20 mL vial for intravenous infusion.
Usual dosage: REMICADE is administered by intravenous infusion over a period of not less than 2 hours. Crohn’s Disease – 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Some adult patients who initially respond to treatment may benefit from increasing the dose to 10 mg/kg if they later lose their response. Pediatric Crohn’s Disease – 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Ulcerative Colitis – 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Pediatric Ulcerative Colitis – 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Rheumatoid Arthritis – In conjunction with methotrexate, 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Some patients may benefit from increasing the dose up to 10 mg/kg or treating as often as every 4 weeks. Ankylosing Spondylitis – 5 mg/kg at 0, 2 and 6 weeks, then every 6 weeks. Psoriatic Arthritis (2.7) and Plaque Psoriasis-mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
Contraindications: The use of Remicade in contraindicated in sepsis.
Special Warnings: SERIOUS INFECTIONS – 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 REMICADE if a patient develops a serious infection or sepsis during treatment. Perform test for latent TB; if positive, start treatment for TB prior to starting REMICADE. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. MALIGNANCY: Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including REMICADE. Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers including REMICADE.
Adverse reactions (side effects) of these medications: The most common side effects of Remicade include infections (e.g. upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain. Other adverse reactions reported in clinical trial data include Nausea, diarrhea, dyspepsia, sinusitis, pharnyigitis, coughing, bronchitis, rash, pruritis, fatigue, pain, fever, moniliasis, arthralgia, urinary tract infection, and hypertension.
Common drug interactions: Abatacept and anakinra increase the likelihood of serious infections when used with infliximab. The use of abatacept and anakinra in patients on Remicade is not recommended. The formation of CYP450 enzymes may be suppressed by increased levels of cytokines (e.g., TNFα, IL-1, IL-6, IL-10, IFN) during chronic inflammation. Therefore, it is expected that for a molecule that antagonizes cytokine activity, such as infliximab, the formation of CYP450 enzymes could be normalized. Upon initiation or discontinuation of REMICADE in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as needed. The use of tocilizumab in combination with biological DMARDs such as TNF antagonists, including REMICADE, should be avoided because of the possibility of increased immunosuppression and increased risk of infection.
Special instructions for patients: Do not use abatacept or anakinra while being treated with Remicade. Tell your doctor about any medications you are taking, including over the counter and herbals. Tell your doctors about all of your medical conditions, including heart failure, multiple sclerosis, Guillian-Barre syndrome, phototherapy treatment, active infections and TB, as Remicade should not be used in certain conditions. You should report any signs of new or worsening medical conditions to your doctors , such as central nervous system demyelinating disorders, heart failure or autoimmune disorders, such as lupus-like syndrome or autoimmune hepatitis. Seek immediate medical attention for symptoms of severe allergic reactions.
Full prescribing information may be found at the manufacturer‘s official website Remicade.com or at the U.S. Food and Drug Administration’s website at Remicade Info at Drugs@FDA
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