INDICATIONS AND USAGE
Multiple Sclerosis (MS)
TYSABRI 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 beyond two years are unknown.
Because TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability, TYSABRI is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate multiple sclerosis therapy [see Boxed Warning, Warnings and Precautions (5.1) ].
Safety and efficacy in patients with chronic progressive multiple sclerosis have not been studied.
Crohn's Disease (CD)
TYSABRI is indicated for 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. TYSABRI should not be used in combination with immunosuppressants (e.g., 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate) or inhibitors of TNF-α [see Boxed Warning, Warnings and Precautions (5.1) ].
DOSAGE AND ADMINISTRATION
Multiple Sclerosis (MS)
Only prescribers registered in the MS TOUCH™ Prescribing Program may prescribe TYSABRI for multiple sclerosis [see Boxed Warning, Warnings and Precautions (5.2) ]. The recommended dose of TYSABRI for multiple sclerosis is 300 mg intravenous infusion over one hour every four weeks.
Crohn's Disease (CD)
Only prescribers registered in the CD TOUCH™ Prescribing Program may prescribe TYSABRI for Crohn's disease [see Boxed Warning, Warnings and Precautions (5.1) ].
The recommended dose of TYSABRI for Crohn's disease is 300 mg intravenous infusion over one hour every four weeks. TYSABRI should not be used with concomitant immunosuppressants (e.g., 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate) or concomitant inhibitors of TNF-α. Aminosalicylates may be continued during treatment with TYSABRI.
If the patient with Crohn's disease has not experienced therapeutic benefit by 12 weeks of induction therapy, discontinue TYSABRI. For patients with Crohn's disease that start TYSABRI while on chronic oral corticosteroids, commence steroid tapering as soon as a therapeutic benefit of TYSABRI has occurred; if the patient with Crohn's disease cannot be tapered off of oral corticosteroids within six months of starting TYSABRI, discontinue TYSABRI. Other than the initial six-month taper, prescribers should consider discontinuing TYSABRI for patients who require additional steroid use that exceeds three months in a calendar year to control their Crohn's disease.
- Use aseptic technique when preparing TYSABRI solution for intravenous infusion. Each vial is intended for single use only.
- TYSABRI is a colorless, clear to slightly opalescent concentrate. Inspect the TYSABRI vial for particulate material and discoloration 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.
- To prepare the solution, withdraw 15 mL of TYSABRI 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 solution.
- Gently invert the TYSABRI solution to mix completely. Do not shake. Inspect the solution visually for particulate material prior to administration.
- The final dosage solution has a concentration of 2.6 mg/mL.
- Following dilution, infuse TYSABRI solution immediately, or refrigerate solution at 2 to 8°C, and use within 8 hours. If stored at 2 to 8°C, allow the solution to warm to room temperature prior to infusion. DO NOT FREEZE.
- Infuse TYSABRI 300 mg in 100 mL 0.9% Sodium Chloride Injection, USP, over approximately one hour (infusion rate approximately 5 mg per minute). Do not administer TYSABRI as an intravenous push or bolus injection. After the infusion is complete, flush with 0.9% Sodium Chloride Injection, USP.
- Observe patients during the infusion and for one 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 and Precautions (5.3) ].
- 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.
DOSAGE FORMS AND STRENGTHS
TYSABRI is a concentrated solution that must be diluted prior to intravenous infusion. TYSABRI injection is supplied as 300 mg natalizumab in 15 mL (20 mg/mL) in a sterile, single-use vial free of preservatives.
HOW SUPPLIED/STORAGE AND HANDLING
NDC 59075-730-15, TYSABRI injection is supplied as 300 mg natalizumab in 15 mL in a sterile, single-use vial free of preservatives. Each package contains a single-use vial. TYSABRI is a colorless and clear to slightly opalescent solution for dilution prior to intravenous infusion.
TYSABRI is available only through registered infusion centers participating in the TOUCH™ Prescribing Program. To locate these infusion centers, contact Biogen Idec at 1-800-456-2255.
TYSABRI single-use vials must be refrigerated between 2 to 8°C (36° to 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 diluted TYSABRI solution for infusion at 2 to 8°C (36° to 46°F). TYSABRI solution for infusion must be administered within 8 hours of preparation.