Monograph Details
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Musculoskeletal Disorders
> Arthritis/rheumatic 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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To reduce signs/symptoms, inhibit progression of structural damage, and improve physical function in psoriatic arthritis and with methotrexate in moderately to severely active rheumatoid arthritis (RA). To reduce signs/symptoms of active ankylosing spondylitis. |
| Children |
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Not recommended. |
| Adults |
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Give by IV infusion over at least 2 hours. RA: 3mg/kg at weeks 0, 2, 6, then every 8 weeks. May increase to 10mg/kg or give every 4 weeks. Ankylosing spondylitis: 5mg/kg at weeks 0, 2, 6, then every 6 weeks. Psoriatic arthritis: 5mg/kg at weeks 0, 2, 6, then every 8 weeks. All: 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. 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. |
| How Supplied |
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Single-use vials—1 |
| Additional Resources |
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• Related Prescribing Note |
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