Monograph Details
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Gastrointestinal Tract
> Colorectal disorders
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REMICADE |
| Manufacturer |
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Centocor, Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Tumor necrosis factor-α blocker. |
| Generic Name |
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Infliximab 100mg/vial; pwd for IV infusion after reconstitution and dilution; preservative-free. |
| Indications |
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In moderately-to-severely active Crohn's disease: to reduce signs/symptoms and to induce and maintain clinical remission in adult and pediatric patients with inadequate response to conventional therapy. In fistulizing Crohn's disease: to reduce number of draining enterocutaneous and rectovaginal fistula(s); and maintain fistula closure in adults. In moderately-to-severely active ulcerative colitis: to reduce signs/symptoms, to induce and maintain clinical remission and mucosal healing, and to eliminate corticosteroid use in patients with inadequate response to conventional therapy. |
| Children |
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Give by IV infusion over at least 2 hours. Active Crohn's disease:<6yrs: not recommended. ≥6yrs: 5mg/kg at weeks 0, 2, 6, then once every 8 weeks. |
| Adults |
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Give by IV infusion over at least 2 hours. Crohn's disease: 5mg/kg at weeks 0, 2, 6, then once every 8 weeks; if relapse, may increase to 10mg/kg; discontinue if no response by week 14. Ulcerative colitis: 5mg/kg at weeks 0, 2, 6, then once every 8 weeks. Both: max 5mg/kg in CHF. |
| Contraindications |
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Moderate or severe CHF. Clinically important, active infection. Concurrent live vaccines. Allergy to murine proteins. Concurrent anakinra: not recommended. |
| Precautions |
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Chronic or history of recurring infections or hematological abnormalities. Conditions that predispose to infection. Monitor closely if new infection, reactivation of hepatitis B virus (HBV), or blood dyscrasias develop; discontinue if serious infection, sepsis, HBV reactivation, or hematological abnormality develops. Discontinue if lupus-like syndrome with antibody formation, serious hypersensitivity reactions, or jaundice with liver enzymes ≥5xULN occurs. Mild CHF; discontinue if CHF occurs or worsens. CNS demyelinating or seizure disorders; discontinue if significant CNS effects occur. Malignancies. Test for tuberculosis; treat TB first. Children: complete vaccinations before starting therapy (see literature). Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended. |
| Adverse Reactions |
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Infection, infusion reactions, headache, GI upset, fatigue, cough, fever, pain, dizziness, rash, pruritus, CHF, antibody formation; rare: malignancies (eg, lymphoma), optic neuritis, seizures, lupus-like syndrome, blood dyscrasias, hepatotoxicity; also children: blood in stool, bone fracture, respiratory tract allergic reaction. |
| How Supplied |
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Single-use vials—1 |
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