REMICADE 100 mg/10mL
INFLIXIMAB · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Janssen Biotech, Inc.
REMICADE is a injection, powder, lyophilized, for solution containing infliximab at 100 mg/10mL, taken intravenous. Manufactured by Janssen Biotech, Inc..
Key Facts
- Brand Name
- REMICADE
- Generic Name
- INFLIXIMAB
- NDC Code (Product)
57894-030- Manufacturer
- Janssen Biotech, Inc.
- Strength
- 100 mg/10mL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA103772
- Drug Class
- Tumor Necrosis Factor Blocker [EPC]
- Marketing Start
- 08/24/1998
Recall History
Baptist Health Medical Towers Pharmacy and Infusion Services
Lack of Sterility Assurance
Infusion Options, Inc.
Lack of Assurance of Sterility
Walgreens Infusion Services
Lack of Assurance of Sterility
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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. ( 1.1 ) Pediatric Crohn's Disease : reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active disease who have had an inadequate response to conventional therapy. ( 1.2 ) Ulcerative Colitis : reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. ( 1.3 ) Pediatric Ulcerative Colitis : reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely acti…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Prior to treatment, ensure appropriate personnel and medication are available to treat reactions (e.g., hypersensitivity) that occur during infusion and shortly after infusion. ( 2.11 ) REMICADE is administered by intravenous infusion for at least 2 hours with an in-line filter ( 2.11 ) 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 ) Pediatric Crohn's Disease (≥ 6 years old) : 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. ( 2.2 ) 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 ) 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. ( 2.5 ) Ankylosing Spondylitis : 5 mg/kg at 0, 2 and 6 weeks, then every 6 weeks. ( 2.6 ) Psoriatic Arthritis and Plaque Psoriasis : 5 mg/kg at 0, 2…
Contraindications
4 CONTRAINDICATIONS The use of REMICADE at doses >5 mg/kg is contraindicated in patients with moderate or severe heart failure [see Warnings and Precautions (5.5) and Adverse Reactions (6.1) ] . 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 (5.7) and Adverse Reactions (6.1) ]. REMICADE doses >5 mg/kg in moderate or severe heart failure. ( 4 ) Previous severe hypersensitivity reaction to infliximab or any inactive ingredients of REMICADE or to any murine proteins. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS 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. Therefore, the combination of REMICADE and anakinra or abatacept is not recommended [see Warnings and Precautions (5.10) ] . The concomitant use of tocilizumab with biological DMARDs such as TNF antagonists, including REMICADE, should be avoided because of the possibility of increased immunosuppression and increased risk of infection. 7.2 Methotrexate and Other Concomitant Medications Specific drug interaction studies, including interactions with methotrexate (MTX), have not been conducted. The majority of patients in RA or CD…
Adverse Reactions
6 ADVERSE REACTIONS 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. Adverse Reactions in Adults The data described herein reflect exposure to REMICADE in 4779 adult patients (1304 patients with RA, 1106 patients with CD, 202 with AS, 293 with PsA, 484 with UC, 1373 with Ps, and 17 patients with other conditions), including 2625 patients exposed beyond 30 weeks and 374 exposed beyond 1 year. [For information on adverse reactions in pediatric patients see Adverse Reactions (6.1) ]. One of the most-common reasons for discontinuation of treatment was infusion-related reactions (e.g., dyspnea, flushing, headache and rash). Infusion-Related Rea…
Frequently Asked Questions
What is REMICADE used for?
REMICADE contains INFLIXIMAB. It is a injection, powder, lyophilized, for solution taken intravenous. Consult your doctor for specific uses.
Is REMICADE a controlled substance?
REMICADE is not classified as a controlled substance by the DEA.
What is the generic name for REMICADE?
The generic name for REMICADE is INFLIXIMAB. There are 6 other brand versions of INFLIXIMAB.
What is the NDC code for REMICADE 100 mg/10mL?
The NDC (National Drug Code) for REMICADE 100 mg/10mL is 57894-030, listed by Janssen Biotech, Inc..