Recommended Dose

COPAXONE is for subcutaneous use only using the prefilled syringe or an optional injection device [see Dosage and Administration (2.2)]. Do not administer intravenously. The dosing schedule depends on the product strength that is selected. The recommended doses are:

• COPAXONE 20 mg per mL: administer once per day

  or

• COPAXONE 40 mg per mL: administer three times per week and at least 48 hours apart

COPAXONE 20 mg per mL and COPAXONE 40 mg per mL are not interchangeable.

Instructions for Use

Remove one blister-packaged prefilled syringe from the refrigerated carton. Let the prefilled syringe stand at room temperature for 20 minutes to allow the solution to warm to room temperature. Visually inspect the syringe for particulate matter and discoloration prior to administration. The solution in the syringe should appear clear, colorless to slightly yellow. If particulate matter or discoloration is observed, discard the syringe.

Areas for subcutaneous self-injection include arms, abdomen, hips, and thighs. The prefilled syringe is for single use only. Discard unused portions.

If using an optional autoinjector for administration, ensure the device is compatible for use with TEVA’s COPAXONE [see How Supplied/Storage and Handling (16)]. Refer to the autoinjector labeling to determine which device to use with COPAXONE and for information regarding instructions for use. Using an autoinjector that is not compatible for use with TEVA’s COPAXONE may increase the risk for medication errors, such as dose omission or administration of a partial dose.