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1 HIGHLIGHTS of PRESCRIBING INFORMATION These Highlights Do Not Include All the Information Needed to Use REMICADE® Safely

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1 HIGHLIGHTS of PRESCRIBING INFORMATION These Highlights Do Not Include All the Information Needed to Use REMICADE® Safely HIGHLIGHTS OF PRESCRIBING INFORMATION REMICADE® (infliximab) These highlights do not include all the information needed to use REMICADE® safely and effectively. See full prescribing information for REMICADE. • Pediatric Crohn’s Disease (≥ 6 years old): 5 mg/kg at 0, 2 and 6 weeks, then REMICADE (infliximab) for injection, for intravenous use every 8 weeks. (2.2) Initial U.S. Approval: 1998 • Ulcerative Colitis: 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. (2.3) • Pediatric Ulcerative Colitis (≥ 6 years old): 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. (2.4) WARNING: SERIOUS INFECTIONS and MALIGNANCY • Rheumatoid Arthritis: In conjunction with methotrexate, 3 mg/kg at 0, 2 and See full prescribing information for complete boxed warning. 6 weeks, then every 8 weeks. Some patients may benefit from increasing the • Increased risk of serious infections leading to hospitalization or death, dose up to 10 mg/kg every 8 weeks or treating as often as every 4 weeks. (2.5) including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such • Ankylosing Spondylitis: 5 mg/kg at 0, 2 and 6 weeks, then every 6 weeks. (2.6) as histoplasmosis) and infections due to other opportunistic pathogens. (5.1) • Psoriatic Arthritis and Plaque Psoriasis: 5 mg/kg at 0, 2 and 6 weeks, then every • Discontinue REMICADE if a patient develops a serious infection. 8 weeks. (2.7, 2.8) • 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 --------------------------- DOSAGE FORMS AND STRENGTHS --------------------------- initial latent TB test is negative. (5.1) For injection: 100 mg of infliximab as a lyophilized powder in a single-dose vial for • Lymphoma and other malignancies, some fatal, have been reported in reconstitution and dilution. (2.11, 3) children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including REMICADE. (5.2) ----------------------------------- CONTRAINDICATIONS ----------------------------------- • Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have • REMICADE doses >5 mg/kg in moderate or severe heart failure. (4) been reported in patients treated with TNF blockers including REMICADE. • Previous severe hypersensitivity reaction to infliximab or any inactive Almost all had received azathioprine or 6-mercaptopurine concomitantly ingredients of REMICADE or to any murine proteins. (4) with a TNF blocker at or prior to diagnosis. The majority of REMICADE cases were reported in patients with Crohn’s disease or ulcerative colitis, -----------------------------WARNINGS AND PRECAUTIONS ----------------------------- most of whom were adolescent or young adult males. (5.2) • Serious infections – do not give REMICADE during an active infection. If an infection develops, monitor carefully and stop REMICADE if infection becomes -------------------------------- RECENT MAJOR CHANGES -------------------------------- serious. (5.1) Warnings and Precautions: Vaccinations and Use of Live Vaccines/ • Invasive fungal infections – for patients who develop a systemic illness on Therapeutic Infectious Agents (5.13) 5/2020 REMICADE, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic (5.1) Dosage and Administration (2.11) 5/2020 • Malignancies – the incidence of malignancies, including invasive cervical Contraindications (4) 5/2020 cancer and lymphoma, was greater in REMICADE treated patients than in Warnings and Precautions: Heart Failure (5.5) 5/2020 controls. Due to the risk of HSTCL carefully assess the risk/benefit especially if the patient has Crohn’s disease or ulcerative colitis, is male, and is receiving -------------------------------- INDICATIONS AND USAGE -------------------------------- azathioprine or 6-mercaptopurine treatment. (5.2) REMICADE is a tumor necrosis factor (TNF) blocker indicated for: • Hepatitis B virus reactivation – test for HBV infection before starting • Crohn’s Disease: REMICADE. Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop REMICADE and begin anti-viral therapy. (5.3) ° reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who • Hepatotoxicity – severe hepatic reactions, some fatal or necessitating liver have had an inadequate response to conventional therapy. (1.1) transplantation. Stop REMICADE in cases of jaundice and/or marked liver enzyme elevations. (5.4) ° reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease. (1.1) • Heart failure – new onset or worsening symptoms may occur. (4, 5.5) • Pediatric Crohn’s Disease: reducing signs and symptoms and inducing and • Cytopenias – advise patients to seek immediate medical attention if signs and maintaining clinical remission in pediatric patients 6 years of age and older symptoms develop, and consider stopping REMICADE. (5.6) with moderately to severely active disease who have had an inadequate • Hypersensitivity – serious infusion reactions including anaphylaxis or serum response to conventional therapy. (1.2) sickness-like reactions may occur. (5.7) • Ulcerative Colitis: reducing signs and symptoms, inducing and maintaining • Cardiovascular and Cerebrovascular Reactions – Cerebrovascular accidents, clinical remission and mucosal healing, and eliminating corticosteroid use in myocardial infarctions (some fatal), and arrhythmias have been reported during adult patients with moderately to severely active disease who have had an and within 24 hours of initiation of REMICADE infusion. Monitor patients during inadequate response to conventional therapy. (1.3) REMICADE infusion and if serious reaction occurs, discontinue infusion. (5.8) • Pediatric Ulcerative Colitis: reducing signs and symptoms and inducing and • Demyelinating disease – exacerbation or new onset may occur. (5.9) maintaining clinical remission in pediatric patients 6 years of age and older • Lupus-like syndrome – stop REMICADE if syndrome develops. (5.12) with moderately to severely active disease who have had an inadequate • Vaccinations and Use of Live Vaccines/Therapeutic Infectious Agents – Prior response to conventional therapy. (1.4) to initiating REMICADE bring pediatric and adult patients up to date with all • Rheumatoid Arthritis in combination with methotrexate: reducing signs and vaccinations. Live vaccines or therapeutic infectious agents should not be symptoms, inhibiting the progression of structural damage, and improving given with REMICADE. At least a six month waiting period following birth is physical function in adult patients with moderately to severely active disease. (1.5) recommended before the administration of live vaccines to infants exposed • Ankylosing Spondylitis: reducing signs and symptoms in adult patients with in utero to infliximab (5.13). active disease. (1.6) ----------------------------------- ADVERSE REACTIONS ----------------------------------- • Psoriatic Arthritis: reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in adult Most common adverse reactions (>10%) – infections (e.g. upper respiratory, patients. (1.7) sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal • Plaque Psoriasis: treatment of adult patients with chronic severe (i.e., extensive pain. (6.1) and/or disabling) plaque psoriasis who are candidates for systemic therapy To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at and when other systemic therapies are medically less appropriate. (1.8) 1-800-JANSSEN (1-800-526-7736) or FDA at 1-800-FDA-1088 or www.fda.gov/ medwatch. -----------------------------DOSAGE AND ADMINISTRATION----------------------------- • Prior to treatment, ensure appropriate personnel and medication are available ----------------------------------- DRUG INTERACTIONS ----------------------------------- to treat reactions (e.g., hypersensitivity) that occur during infusion and shortly Other Biological Products– increased risk of serious infections (7.1) after infusion (2.11) • REMICADE is administered by intravenous infusion for at least 2 hours with an See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. in-line filter (2.11) Revised: 5/2020 • 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 every 8 weeks if they later lose their response. (2.1) 1 REMICADE® (infliximab) REMICADE® (infliximab) FULL PRESCRIBING INFORMATION: CONTENTS* 6 ADVERSE REACTIONS WARNING: SERIOUS INFECTIONS AND MALIGNANCY 6.1 Clinical Trials Experience 1 INDICATIONS AND USAGE 6.2 Immunogenicity 1.1 Crohn’s Disease 6.3 Postmarketing Experience 1.2 Pediatric Crohn’s Disease 7 DRUG INTERACTIONS 1.3 Ulcerative Colitis 7.1 Other Biological Products 1.4 Pediatric Ulcerative Colitis 7.2 Methotrexate and Other Concomitant Medications 1.5 Rheumatoid Arthritis 7.3 Immunosuppressants 1.6 Ankylosing Spondylitis 7.4 Cytochrome P450 Substrates 1.7 Psoriatic Arthritis 7.5 Live Vaccines/Therapeutic Infectious Agents 1.8 Plaque Psoriasis 8 USE IN SPECIFIC POPULATIONS 2 DOSAGE AND ADMINISTRATION 8.1 Pregnancy 2.1 Dosage in Adult Crohn’s Disease 8.2 Lactation 2.2 Dosage in Pediatric Crohn’s Disease 8.4 Pediatric Use 2.3 Dosage in Adult Ulcerative
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