HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use TYSABRI safely and effectively. See full prescribing information for TYSABRI
TYSABRI (natalizumab) injection for intravenous use
Initial U.S. Approval: 2004
WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY
See full prescribing information for complete boxed warning
TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability (5.1)
Monitor patients, and withhold TYSABRI immediately at the first sign or symptom suggestive of PML (4, 5.1)
TYSABRI is available only through a special restricted distribution program called the TOUCH® Prescribing Program and must be administered only to patients enrolled in this program (5.1, 5.2)
RECENT MAJOR CHANGES
Warnings and Precautions
Progressive Multifocal Leukoencephalopathy (5.1) 11/2009
INDICATIONS AND USAGE
TYSABRI is an integrin receptor antagonist indicated for treatment of:
Multiple Sclerosis (MS) (1.1)
As monotherapy for the treatment of patients with relapsing forms of multiple sclerosis to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations. TYSABRI is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate MS therapy.
Crohn's Disease (CD) (1.2)
Inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn's disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate conventional CD therapies and inhibitors of TNF-α.
Important Limitations:
In CD, TYSABRI should not be used in combination with immunosuppressants or inhibitors of TNF-α.
DOSAGE AND ADMINISTRATION
300 mg infused intravenously over approximately one hour, every four weeks. Do not give as an intravenous push or bolus (2.1, 2.2).
TYSABRI solution must be administered within 8 hours of preparation (2.3).
Observe patients during the infusion and for one hour after the infusion is complete (2.4).
In CD, discontinue in patients that have not experienced therapeutic benefit by 12 weeks of induction therapy, and in patients that cannot discontinue chronic concomitant steroids within six months of starting therapy (2.2).
DOSAGE FORMS AND STRENGTHS
Solution [300 mg per 15 mL vial] for dilution prior to infusion (3).
CONTRAINDICATIONS
Patients who have or have had PML (4).
Patients who have had a hypersensitivity reaction to TYSABRI (4).
WARNINGS AND PRECAUTIONS< |
