Infliximab

REMICADE is a tumor necrosis factor (TNF) blocker indicated for: Crohn's Disease : reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. ( 1.1 ) reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease. …

• Prior to treatment, ensure appropriate personnel and medication are available to treat reactions (e.g., hypersensitivity) that occur during infusion and shortly after infusion
• REMICADE is administered by intravenous infusion for at least 2 hours with an in-line filter 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
• Pediatric Crohn's Disease (≥ 6 years old) : 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 (≥ 6 years old) : 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 every 8 weeks 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 and Plaque Psoriasis : 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks
• Dosage in Adult Crohn's Disease The recommended dosage of REMICADE is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter
• For the treatment of adults with moderately to severely active CD or fistulizing CD. …

For injection: 100 mg of infliximab as a white lyophilized powder in a single-dose vial for reconstitution and dilution. For injection: 100 mg of infliximab as a lyophilized powder in a single-dose vial for reconstitution and dilution. ( 2.11 , 3 )

• The safety and effectiveness of REMICADE have been established
• In pediatric patients 6 to 17 years of age for induction and maintenance treatment of CD and UC [ see Dosage and Administration and Adverse Reactions ]
• However, the safety and effectiveness of REMICADE
• In pediatric patients

Of the total number of REMICADE-treated patients in RA and Ps clinical studies, 256 (9.6%) were 65 years old and over, while 17 (0.6%) were 75 years old and over. In these trials, no overall differences in safety or effectiveness were observed between geriatric patients (patients ≥ 65 years old) and younger adult patients (patients 18 to 65 years old). …

• Advise the patient or their caregiver to read the FDA-approved patient labeling (Medication Guide)
• Patients or their caregivers should be advised of the potential benefits and risks of REMICADE
• Healthcare providers should instruct their patients or their caregivers to read the Medication Guide before starting REMICADE therapy and to reread it each time they receive an infusion
• Infections Inform patients that REMICADE increases the risk for developing serious infections. …

• The use of REMICADE at doses >5 mg/kg is contraindicated in patients with moderate or severe heart failure [see Warnings and Precautions and Adverse Reactions ]
• REMICADE is contraindicated in patients with a previous severe hypersensitivity reaction to infliximab or any of the inactive ingredients of REMICADE or any murine proteins [severe hypersensitivity reactions have included anaphylaxis, hypotension, and serum sickness] [see Warnings and Precautions and Adverse Reactions …

Other Biological Products – increased risk of serious infections. ( 7.1 ) 7.1 Other Biological Products The combination of REMICADE with other biological products used to treat the same conditions as REMICADE is not recommended [see Warnings and Precautions (5.10) ] . An increased risk of serious infections was seen in clinical studies of other TNF blockers used in combination with anakinra or abatacept, with no added clinical benefit. Because of the nature of the adverse reactions seen with these combinations with TNF blocker therapy, similar toxicities may also result from the combination of anakinra or abatacept with other TNF blockers. …

Serious infections – do not give REMICADE during an active infection. If an infection develops, monitor carefully and stop REMICADE if infection becomes serious. ( 5.1 ) Invasive fungal infections – for patients who develop a systemic illness on REMICADE, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic ( 5.1 ) Malignancies – the incidence of malignancies, including invasive cervical cancer and lymphoma, was greater in REMICADE-treated patients than in controls. …

Most common adverse reactions (>10%) – infections (e.g. upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …

8.1 Pregnancy Risk Summary Available observational studies in pregnant women exposed to REMICADE showed no increased risk of major malformations among live births as compared to those exposed to non-biologics. However, findings on other birth and maternal outcomes were not consistent across studies of different study design and conduct (see Data ) . …

Single doses up to 20 mg/kg have been administered without any direct toxic effect. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects [see Warnings and Precautions (5) ] and appropriate symptomatic treatment instituted immediately.

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

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.