Generic Name and Formulations:
Natalizumab 300mg/15mL; soln; for IV infusion after dilution; preservative-free.

Company:
Biogen
Indications for TYSABRI:
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.

Adult:
≥18yrs: Give by IV infusion over 1hr; monitor during and for 1hr 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 months of starting therapy. May continue with aminosalicylates.

Children:
<18yrs: not recommended.

Pharmacological Class:
Immunomodulator (integrin receptor antagonist).

Contraindications:
Progressive multifocal leukoencephalopathy (PML).

Warnings/Precautions:
Increased risk of PML with longer treatment duration (>2yrs), prior treatment with immunosuppressants, and/or presence of anti-JCV antibodies. Monitor for signs/symptoms of PML; withhold if develops. Test patients for anti-JCV antibody status prior to or during treatment if status unknown; patients with negative status should be retested periodically. Reeva luate periodically (at 3 months and 6 months post-infusion, every 6 months thereafter, and for at least 6 months after discontinuation). MS: obtain MRI scan prior to initiating therapy. Monitor for signs/symptoms of meningitis and herpes encephalitis; discontinue and treat if occurs. Discontinue if jaundice or liver injury occurs. Immunosuppression. Monitor for infections. Vaccinations. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:
Concomitant other immunosuppressants or TNF-α inhibitors: not recommended.

Adverse Reactions:
Headache, fatigue, arthralgia, infections, depression, pain in extremity, abdominal discomfort, diarrhea NOS, nausea, fatigue, rash; immune reconstitution syndrome (monitor), hypersensitivity reactions (discontinue if occurs; do not restart), hepatotoxicity, inj site reactions, antibody formation (if persistent, may substantially reduce efficacy), changes in blood cell counts.

Note:
This product is only available through the TOUCH prescribing program. For more information call (800) 456-2255.

REMS:
YES

How Supplied:
Single-use vial (300mg)—1