Monograph Details
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Gastrointestinal Tract
> Colorectal disorders
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CIMZIA |
| Manufacturer |
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UCB Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Tumor necrosis factor blocker. |
| Generic Name |
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Certolizumab pegol 200mg/vial; pwd for SC inj after reconstitution; preservative-free. |
| Indications |
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In moderately to severely active Crohn's disease: to reduce signs and symptoms and to maintain clinical response in adult patients with inadequate response to conventional therapy. |
| Children |
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Not recommended. |
| Adults |
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Give by SC inj in abdomen or thigh. 400mg (two 200mg inj) on day 1, then at weeks 2 and 4; maintenance 400mg every 4 weeks. |
| Precautions |
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Active infections: not recommended. Chronic or history of recurring infections. Conditions that predispose to infection. Test for tuberculosis, treat TB first. Monitor closely for new infections, discontinue if serious infection develops. History of TB or histoplasmosis exposure. Immunosuppressed. Hepatitis B infection; discontinue if reactivation occurs. Malignancies. CNS demyelinating disorders. Hematological abnormalities. CHF. Discontinue if lupus-like syndrome or serious hypersensitivity reaction occurs. Pregnancy (Cat.B). Nursing mothers: not recommended. |
| Interactions |
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Concurrent anakinra, live vaccines or other TNF blockers: not recommended. Immunosuppressants increase risk of infection. May interfere with coagulation tests (eg, aPTT). |
| Adverse Reactions |
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Upper respiratory infections, UTI, arthralgia, other infections; rare: TB, HBV reactivation, hypersensitivity reactions, malignancies, antibody formation. |
| How Supplied |
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Kit—1 (2 single-dose vials w. syringes, needles, supplies) |
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