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INFLECTRA Safely and Effectively

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INFLECTRA Safely and Effectively HIGHLIGHTS OF PRESCRIBING INFORMATION 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Some adult patients who These highlights do not include all the information needed to use initially respond to treatment may benefit from increasing the dose to 10 INFLECTRA safely and effectively. See full prescribing information for mg/kg if they later lose their response. INFLECTRA. Pediatric Crohn’s Disease (2.2) 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. INFLECTRA (infliximab-dyyb) for Injection, for Intravenous Use Ulcerative Colitis (2.3) Initial U.S. Approval: 2016 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. INFLECTRA (infliximab-dyyb) is biosimilar* to REMICADE (infliximab) for Rheumatoid Arthritis (2.4) the indications listed. (1) In conjunction with methotrexate, 3 mg/kg at 0, 2 and 6 weeks, then every 8 WARNING: SERIOUS INFECTIONS and MALIGNANCY weeks. Some patients may benefit from increasing the dose up to 10 mg/kg or See full prescribing information for complete boxed warning treating as often as every 4 weeks. Ankylosing Spondylitis (2.5) Increased risk of serious infections leading to hospitalization or death, 5 mg/kg at 0, 2 and 6 weeks, then every 6 weeks. including tuberculosis (TB), bacterial sepsis, invasive fungal infections Psoriatic Arthritis (2.6) and Plaque Psoriasis (2.7) (such as histoplasmosis) and infections due to other opportunistic 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. pathogens. (5.1) Discontinue INFLECTRA if a patient develops a serious infection. (5.1) -----------------------DOSAGE FORMS AND STRENGTHS-----------------------­ For injection: 100 mg of lyophilized infliximab-dyyb in a 20 mL vial for Perform test for latent TB; if positive, start treatment for TB prior to intravenous infusion. (3) starting INFLECTRA. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. (5.1) --------------------------------CONTRAINDICATION---------------------------------­ Lymphoma and other malignancies, some fatal, have been reported in INFLECTRA doses >5 mg/kg in moderate to severe heart failure. (4) children and adolescent patients treated with tumor necrosis factor Previous severe hypersensitivity reaction to infliximab products, or known (TNF) blockers, including infliximab products. (5.2) hypersensitivity to inactive components of INFLECTRA or to any murine Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) proteins. (4) have been reported in patients treated with TNF blockers, including infliximab products. Almost all had received azathioprine or 6­ --------------------------WARNING AND PRECAUTIONS--------------------------­ mercaptopurine concomitantly with a TNF-blocker at or prior to • Serious infections – do not give INFLECTRA during an active infection. If an diagnosis. The majority of cases were reported in patients with Crohn’s infection develops, monitor carefully and stop INFLECTRA if infection disease or ulcerative colitis, most of whom were adolescent or young becomes serious. (5.1) adult males. (5.2) Invasive fungal infections – for patients who develop a systemic illness on INFLECTRA, consider empiric antifungal therapy for those who reside or ---------------------------INDICATIONS AND USAGE-------------------------------­ travel to regions where mycoses are endemic (5.1) TM INFLECTRA is a tumor necrosis factor (TNF) blocker indicated for: Malignancies – the incidence of malignancies including lymphoma was Crohn’s Disease (1.1): greater in TNF blocker treated patients than in controls. Due to the risk of reducing signs and symptoms and inducing and maintaining clinical remission HSTCL carefully assess the risk/benefit especially if the patient has Crohn’s in adult patients with moderately to severely active disease who have had an disease or ulcerative colitis, is male, and is receiving azathioprine or 6­ inadequate response to conventional therapy. mercaptopurine treatment. (5.2) reducing the number of draining enterocutaneous and rectovaginal fistulas and Hepatitis B virus (HBV) reactivation – test for HBV infection before starting maintaining fistula closure in adult patients with fistulizing disease. INFLECTRA. Monitor HBV carriers during and several months after therapy. Pediatric Crohn’s Disease (1.2): If reactivation occurs, stop INFLECTRA and begin anti-viral therapy. (5.3) reducing signs and symptoms and inducing and maintaining clinical remission Hepatotoxicity – rare severe hepatic reactions, some fatal or necessitating in pediatric patients with moderately to severely active disease who have had liver transplantation. Stop INFLECTRA in cases of jaundice and/or marked an inadequate response to conventional therapy. liver enzyme elevations. (5.4) Ulcerative Colitis (1.3): Heart failure –new onset or worsening symptoms may occur. (4, 5.5) reducing signs and symptoms, inducing and maintaining clinical remission Cytopenias – advise patients to seek immediate medical attention if signs and and mucosal healing, and eliminating corticosteroid use in adult patients with symptoms develop, and consider stopping INFLECTRA. (5.6) moderately to severely active disease who have had an inadequate response to Hypersensitivity – serious infusion reactions including anaphylaxis or serum conventional therapy. sickness-like reactions may occur. (5.7) Rheumatoid Arthritis (1.4) in combination with methotrexate: Demyelinating disease –exacerbation or new onset may occur. (5.8) reducing signs and symptoms, inhibiting the progression of structural damage, Lupus-like syndrome – stop INFLECTRA if syndrome develops. (5.13) and improving physical function in patients with moderately to severely active Live vaccines or therapeutic infectious agents – should not be given with disease. INFLECTRA. Bring pediatric patients up to date with all vaccinations prior to Ankylosing Spondylitis (1.5): initiating INFLECTRA. At least a six month waiting period following birth is reducing signs and symptoms in patients with active disease. recommended before the administration of live vaccines to infants exposed in Psoriatic Arthritis (1.6): utero to infliximab products (5.14) reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function. -------------------------------ADVERSE REACTIONS---------------------------------­ Plaque Psoriasis (1.7): Most common adverse reactions (>10%) – infections (e.g. upper respiratory, treatment of adult patients with chronic severe (i.e., extensive and /or sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal disabling) plaque psoriasis who are candidates for systemic therapy and when pain. (6.1) other systemic therapies are medically less appropriate. To report SUSPECTED ADVERSE REACTIONS, contact -------------------------DOSAGE AND ADMINISTRATION------------------------­ CELLTRION, Inc. at 1-800-383-7504 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. INFLECTRA is administered by intravenous infusion over a period of not less than 2 hours. (2.10) Crohn’s Disease (2.1) 1 of 56 Reference ID: 3912620 See 17 for PATIENT COUNSELING INFORMATION and MEDICATION ------------------------USE IN SPECIFIC POPULATIONS--------------------------­ GUIDE. Pediatric Use –INFLECTRA has not been studied in children with Crohn’s disease or ulcerative colitis <6 years of age. (8.4) * Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, -------------------------------DRUG INTERACTIONS---------------------------------­ known as a reference product, and that there are no clinically meaningful Use with anakinra or abatacept– increased risk of serious infections (7.1) differences between the biosimilar product and the reference product. Revised: 04/2016 2 of 56 Reference ID: 3912620 FULL PRESCRIBING INFORMATION: CONTENTS* 5.14 Live Vaccines/Therapeutic Infectious Agents WARNING: SERIOUS INFECTIONS AND MALIGNANCY 6 ADVERSE REACTIONS 1 INDICATIONS AND USAGE 6.1 Clinical Trials Experience 1.1 Crohn’s Disease 6.2 Postmarketing Experience 1.2 Pediatric Crohn’s Disease 7 DRUG INTERACTIONS 1.3 Ulcerative Colitis 7.1 Use with Anakinra or Abatacept 1.4 Rheumatoid Arthritis 7.2 Use with Tocilizumab 1.5 Ankylosing Spondylitis 7.3 Use with Other Biological Therapeutics 1.6 Psoriatic Arthritis 7.4 Methotrexate (MTX) and Other Concomitant 1.7 Plaque Psoriasis Medications 2 DOSAGE AND ADMINISTRATION 7.5 Immunosuppressants 2.1 Crohn’s Disease 7.6 Cytochrome P450 Substrates 2.2 Pediatric Crohn’s Disease 7.7 Live Vaccines/Therapeutic Infectious Agents 2.3 Ulcerative Colitis 8 USE IN SPECIFIC POPULATIONS 2.4 Rheumatoid Arthritis 8.1 Pregnancy 2.5 Ankylosing Spondylitis 8.3 Nursing Mothers 2.6 Psoriatic Arthritis 8.4 Pediatric Use 2.7 Plaque Psoriasis 8.5 Geriatric Use 2.8 Monitoring to Assess Safety 10 OVERDOSAGE 2.9 Administration Instructions Regarding Infusion Reactions 11 DESCRIPTION 2.10 General Considerations and Instructions for Preparation and 12 CLINICAL PHARMACOLOGY Administration 12.1 Mechanism of Action 3 DOSAGE FORMS AND STRENGTHS 12.2 Pharmacodynamics 4 CONTRAINDICATIONS 12.3 Pharmacokinetics 5 WARNINGS AND PRECAUTIONS 13 NONCLINICAL TOXICOLOGY 5.1 Serious Infections 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5.2 Malignancies 14 CLINICAL STUDIES 5.3 Hepatitis B Virus Reactivation 14.1 Crohn’s Disease 5.4 Hepatotoxicity 14.2 Pediatric Crohn’s Disease 5.5 Patients with Heart Failure 14.3 Ulcerative Colitis 5.6
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