TYSABRI^Ò is indicated 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. The safety and efficacy of TYSABRI^Ò beyond two years are unknown.

Because TYSABRI^Ò increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability (see BOXED WARNING and WARNINGS, Progressive Multifocal Leukoencephalopathy), TYSABRI^Ò is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternate multiple sclerosis therapies.

Safety and efficacy in patients with chronic progressive multiple sclerosis have not been studied.

Only prescribers registered in the TOUCHÒ Prescribing Program may prescribe TYSABRI^Ò (see BOXED WARNING).

The recommended dose of TYSABRI^Ò is 300 mg IV infusion every four weeks. Dilute TYSABRI^Ò concentrate 300 mg/15 mL in 100 mL 0.9% Sodium Chloride Injection, USP, and infuse over approximately one hour. Do not administer TYSABRI^Ò as an IV push or bolus injection (see Preparation Instructions) .

Observe patients during the infusion and for 1 hour after the infusion is complete. Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity-type reaction (see WARNINGS, Hypersensitivity).

Use aseptic technique when preparing TYSABRI^Ò solution for IV infusion. Each vial is intended for single use only.

TYSABRI^Ò is a colorless, clear to slightly opalescent concentrate. Inspect the TYSABRI^Ò vial for particulate material prior to dilution and administration. If visible particulates are observed and/or the liquid in the vial is discolored, the vial must not be used. Do not use TYSABRI^Ò beyond the expiration date stamped on the carton or vial.

To prepare the solution, withdraw 15 mL of TYSABRI^Ò concentrate from the vial using a sterile needle and syringe. Inject the concentrate into 100 mL 0.9% Sodium Chloride Injection, USP. No other IV diluents may be used to prepare the TYSABRI^Ò solution.

Gently invert the TYSABRI^Ò solution to mix completely. Do not shake. Inspect the solution visually for particulate material prior to administration.

Following dilution, infuse TYSABRI^Ò solution immediately, or refrigerate solution at 2-8° C, and use within 8 hours. If stored at 2-8° C, allow the solution to warm to room temperature prior to infusion. DO NOT FREEZE.

Infuse TYSABRI^Ò 300 mg in 100 mL 0.9% Sodium Chloride Injection, USP over approximately one hour. After the infusion is complete, flush with 0.9% Sodium Chloride Injection, USP.

Use of filtration devices during administration has not been evaluated. Other medications should not be injected into infusion set side ports or mixed with TYSABRI^Ò.

TYSABRI^Ò concentrate is supplied as 300 mg natalizumab in a sterile, single-use vial free of preservatives. Each package contains a single-use vial. NDC 59075-730-15

TYSABRI^Ò is available only through registered infusion centers participating in the TOUCHÒ Prescribing Program. To locate these infusion centers, contact Biogen Idec at 1-800-456-2255.

TYSABRI^Ò single-use vials must be refrigerated between 2-8°C (36°-46°F). Do not use beyond the expiration date stamped on the carton and vial label. DO NOT SHAKE OR FREEZE. Protect from light.

If not used immediately, store the TYSABRI^Ò solution for infusion at 2-8°C (36°-46°F). TYSABRI^Ò solution for infusion must be administered within 8 hours of preparation.

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