Copaxone

COPAXONE- glatiramer acetate injection, solution
Teva Neuroscience, Inc.

1 INDICATIONS AND USAGE

COPAXONE is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

2 DOSAGE AND ADMINISTRATION

2.1 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.

2.2 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.

3 DOSAGE FORMS AND STRENGTHS

  • Injection: 20 mg per mL in a single-dose, prefilled syringe with a white plunger. For subcutaneous use only.
  • Injection: 40 mg per mL in a single-dose, prefilled syringe with a blue plunger. For subcutaneous use only.

4 CONTRAINDICATIONS

COPAXONE is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol.

5 WARNINGS AND PRECAUTIONS

5.1 Immediate Post-Injection Reaction

Approximately 16% of patients exposed to COPAXONE 20 mg per mL in the 5 placebo-controlled trials compared to 4% of those on placebo, and approximately 2% of patients exposed to COPAXONE 40 mg per mL in a placebo-controlled trial compared to none on placebo, experienced a constellation of symptoms that may occur immediately (within seconds to minutes, with the majority of symptoms observed within 1 hour) after injection and included at least two of the following: flushing, chest pain, palpitations, tachycardia, anxiety, dyspnea, constriction of the throat, and urticaria. In general, these symptoms have their onset several months after the initiation of treatment, although they may occur earlier, and a given patient may experience one or several episodes of these symptoms. Whether or not any of these symptoms actually represent a specific syndrome is uncertain. Typically, the symptoms were transient and self-limited and did not require treatment; however, there have been reports of patients with similar symptoms who received emergency medical care. Whether an immunologic or nonimmunologic mechanism mediates these episodes, or whether several similar episodes seen in a given patient have identical mechanisms, is unknown.

5.2 Chest Pain

Approximately 13% of COPAXONE 20 mg per mL patients in the 5 placebo-controlled studies compared to 6% of placebo patients, and approximately 2% of patients exposed to COPAXONE 40 mg per mL in a placebo-controlled trial compared to 1% of placebo patients, experienced at least one episode of transient chest pain. While some of these episodes occurred in the context of the Immediate Post-Injection Reaction described above, many did not. The temporal relationship of this chest pain to an injection was not always known. The pain was usually transient, often unassociated with other symptoms, and appeared to have no clinical sequelae. Some patients experienced more than one such episode, and episodes usually began at least 1 month after the initiation of treatment. The pathogenesis of this symptom is unknown.

5.3 Lipoatrophy and Skin Necrosis

At injection sites, localized lipoatrophy and, rarely, injection site skin necrosis may occur. Lipoatrophy occurred in approximately 2% of patients exposed to COPAXONE 20 mg per mL in the 5 placebo-controlled trials compared to none on placebo, and 0.5% of patients exposed to COPAXONE 40 mg per mL in a single placebo-controlled trial and none on placebo. Skin necrosis has only been observed in the postmarketing setting. Lipoatrophy may occur at various times after treatment onset (sometimes after several months) and is thought to be permanent. There is no known therapy for lipoatrophy. To assist in possibly minimizing these events, the patient should be advised to follow proper injection technique and to rotate injection sites with each injection.

5.4 Potential Effects on Immune Response

Because COPAXONE can modify immune response, it may interfere with immune functions. For example, treatment with COPAXONE may interfere with the recognition of foreign antigens in a way that would undermine the body’s tumor surveillance and its defenses against infection. There is no evidence that COPAXONE does this, but there has not been a systematic evaluation of this risk. Because COPAXONE is an antigenic material, it is possible that its use may lead to the induction of host responses that are untoward, but systematic surveillance for these effects has not been undertaken.

Although COPAXONE is intended to minimize the autoimmune response to myelin, there is the possibility that continued alteration of cellular immunity due to chronic treatment with COPAXONE may result in untoward effects.

Glatiramer acetate-reactive antibodies are formed in most patients receiving glatiramer acetate. Studies in both the rat and monkey have suggested that immune complexes are deposited in the renal glomeruli. Furthermore, in a controlled trial of 125 RRMS patients given COPAXONE 20 mg per mL, subcutaneously every day for 2 years, serum IgG levels reached at least 3 times baseline values in 80% of patients by 3 months of initiation of treatment. By 12 months of treatment, however, 30% of patients still had IgG levels at least 3 times baseline values, and 90% had levels above baseline by 12 months. The antibodies are exclusively of the IgG subtype and predominantly of the IgG-1 subtype. No IgE type antibodies could be detected in any of the 94 sera tested; nevertheless, anaphylaxis can be associated with the administration of most any foreign substance, and therefore, this risk cannot be excluded.

5.5 Hepatic Injury

Cases of hepatic injury, some severe, including liver failure and hepatitis with jaundice, have been reported with COPAXONE. Hepatic injury has occurred from days to years after initiating treatment with COPAXONE. If signs or symptoms of liver dysfunction occur, consider discontinuation of COPAXONE.

6 ADVERSE REACTIONS

The following serious adverse reactions are described elsewhere in the labeling:

  • Immediate Post-Injection Reaction [see Warnings and Precautions (5.1)]
  • Chest Pain [see Warnings and Precautions (5.2)]
  • Lipoatrophy and Skin Necrosis [see Warnings and Precautions (5.3)]
  • Potential Effects on Immune Response [see Warnings and Precautions (5.4)]
  • Hepatic Injury [see Warnings and Precautions (5.5)]

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