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Copaxone (Glatiramer Acetate) - Warnings and Precautions

 
 



WARNINGS

The only recommended route of administration of COPAXONE® Injection is the subcutaneous route. COPAXONE® Injection should not be administered by the intravenous route.

PRECAUTIONS

General

Patients should be instructed in self-injection techniques to assure the safe administration of COPAXONE® Injection (see  PRECAUTIONS: Information for Patients and the COPAXONE®  INJECTION PATIENT INFORMATION Leaflet). Current data indicate that no special caution is required for patients operating an automobile or using complex machinery.

Considerations Regarding the Use of a Product Capable of Modifying Immune Responses

Because glatiramer acetate can modify immune response, it could possibly interfere with useful immune functions. For example, treatment with glatiramer acetate might, in theory, 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 glatiramer acetate does this, but there has as yet been no systematic evaluation of this risk. Because glatiramer acetate 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 glatiramer acetate is intended to minimize the autoimmune response to myelin, there is the possibility that continued alteration of cellular immunity due to chronic treatment with glatiramer acetate might result in untoward effects.

Glatiramer acetate-reactive antibodies are formed in practically all patients exposed to daily treatment with the recommended dose. 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 RR MS patients given glatiramer acetate, 20 mg, 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 lgG subtype-and predominantly of the lgG-1 subtype. No lgE 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.

Information for Patients

To assure safe and effective use of COPAXONE® Injection, the following information and instructions should be given to patients:

  1. Inform your physician if you are pregnant, if you are planning to have a child, or if you become pregnant while taking this medication.
  2. Inform your physician if you are nursing.
  3. Do not change the dose or dosing schedule without consulting your physician.
  4. Do not stop taking the drug without consulting your physician.

Patients should be instructed in the use of aseptic techniques when administering COPAXONE® Injection. Appropriate instructions for the self-injection of COPAXONE® Injection should be given, including a careful review of the COPAXONE®  INJECTION PATIENT INFORMATION Leaflet. The first injection should be performed under the supervision of an appropriately qualified health care professional. Patient understanding and use of aseptic self-injection techniques and procedures should be periodically reevaluated. Patients should be cautioned against the reuse of needles or syringes and instructed in safe disposal procedures. They should use a puncture-resistant container for disposal of used needles and syringes. Patients should be instructed on the safe disposal of full containers according to local laws.

Awareness of Adverse Reactions: Physicians are advised to counsel patients about adverse reactions associated with the use of COPAXONE® Injection (see ADVERSE REACTIONS section). In addition, patients should be advised to read the COPAXONE® INJECTION PATIENT INFORMATION  Leaflet and resolve any questions regarding it prior to beginning COPAXONE® Injection therapy.

Laboratory Tests

Data collected during premarketing development do not suggest the need for routine laboratory monitoring.

Drug Interactions

Interactions between COPAXONE® Injection and other drugs have not been fully evaluated. Results from existing clinical trials do not suggest any significant interactions of COPAXONE® Injection with therapies commonly used in MS patients, including the concurrent use of corticosteroids for up to 28 days. COPAXONE® Injection has not been formally evaluated in combination with Interferon beta.

Drug/Laboratory Test Interactions

None are known.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

In a two-year carcinogenicity study, mice were administered up to 60 mg/kg/day glatiramer acetate by subcutaneous injection (up to 15 times the human therapeutic dose on a mg/m2 basis). No increase in systemic neoplasms was observed. In males of the high dose group (60 mg/kg/day), but not in females, there was an increased incidence of fibrosarcomas at the injection sites. These sarcomas were associated with skin damage precipitated by repetitive injections of an irritant over a limited skin area.

In a two-year carcinogenicity study, rats were administered up to 30 mg/kg/day glatiramer acetate by subcutaneous injection (up to 15 times the human therapeutic dose on a mg/m2 basis). No increase in systemic neoplasms was observed.

Mutagenesis

Glatiramer acetate was not mutagenic in four strains of Salmonella typhimurium and two strains of Escherichia coli (Ames test) or in the in vitro mouse lymphoma assay in L5178Y cells. Glatiramer acetate was clastogenic in two separate in vitro chromosomal aberration assays in cultured human lymphocytes; it was not clastogenic in an in vivo mouse bone marrow micronucleus assay.

Impairment of Fertility

In a multigeneration reproduction and fertility study in rats, glatiramer acetate at subcutaneous doses of up to 36 mg/kg (18 times the human therapeutic dose on a mg/m2 basis) had no adverse effects on reproductive parameters.

Pregnancy

Pregnancy Category B. No adverse effects on embryofetal development occurred in reproduction studies in rats and rabbits receiving subcutaneous doses of up to 37.5 mg/kg of glatiramer acetate during the period of organogenesis (18 and 36 times the therapeutic human dose on a mg/m2 basis, respectively). In a prenatal and postnatal study in which rats received subcutaneous glatiramer acetate at doses of up to 36 mg/kg from day 15 of pregnancy throughout lactation, no significant effects on delivery or on offspring growth and development were observed.

There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, glatiramer acetate should be used during pregnancy only if clearly needed.

Labor and Delivery

In a prenatal and postnatal study, in which rats received subcutaneous glatiramer acetate at doses of up to 36 mg/kg from day 15 of pregnancy throughout lactation, no significant effects on delivery were observed. The relevance of these findings to humans is unknown.

Nursing Mothers

It is not known whether glatiramer acetate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when COPAXONE® is administered to a nursing woman.

Pediatric Use

The safety and efficacy of COPAXONE® Injection have not been established in individuals under 18 years of age.

Use in the Elderly

COPAXONE® Injection has not been studied specifically in elderly patients.

Use in Patients with Impaired Renal Function

The pharmacokinetics of glatiramer acetate in patients with impaired renal function have not been determined.

Page last updated: 2008-03-27

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