Monograph Details
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Gastrointestinal Tract
> Colorectal disorders
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TYSABRI |
| Manufacturer |
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Biogen Idec, Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Immunomodulator (integrin receptor antagonist). |
| Generic Name |
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Natalizumab 300mg/15mL; soln; for IV infusion after dilution; preservative-free. |
| Indications |
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In moderately-to-severely active Crohn's disease: to induce and maintain clinical response and remission in adult patients with evidence of inflammation who have had inadequate response to or are intolerant to conventional therapy and TNF-α inhibitors. |
| Children |
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<18yrs: not recommended. |
| Adults |
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≥18yrs: Give by IV infusion over 1 hour; monitor during and for 1 hour post-infusion. 300mg every 4 weeks. Discontinue after 12 weeks of induction therapy if no therapeutic response, or if unable to taper off chronic concomitant steroids within 6 mos of starting therapy. May continue with aminosalicylates. |
| Contraindications |
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Progressive multifocal leukoencephalopathy (PML). |
| Precautions |
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Renal or hepatic insufficiency. Monitor for signs and symptoms of progressive multifocal leukoencephalopathy; discontinue if occurs. Reevaluate periodically (at 3months and 6months post-infusion, then every 6months thereafter). Immunosuppression. Vaccinations. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended. |
| Interactions |
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Concomitant other immunosuppressants or TNF-α inhibitors: not recommended. |
| Adverse Reactions |
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Infections, allergic reactions (discontinue if occurs; do not restart), hepatotoxicity (monitor and discontinue if occurs), nausea, cholelithiasis, urticaria, headache, fatigue, arthralgia, inj site reactions; antibody formation (if persistent, may substantially reduce efficacy); changes in blood cell counts; intestinal obstruction or stenosis, abdominal adhesions. |
| Extra Text |
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Note: This product is only available through the TOUCH prescribing program. For more information call (800) 456-2255. |
| How Supplied |
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Single-use vial (300mg)—1 |
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