"Oct. 5, 2011 -- People with multiple sclerosis (MS) may soon have a second needle-free option to control their disease.
Last year, the FDA approved the first disease-modifying pill, a drug called Gilenya, to treat MS.
- Patient Information:
Details with Side Effects
Immediate Post-Injection Reaction
Approximately 16% of patients exposed to COPAXONE (glatiramer acetate) in the 5 placebo-controlled trials compared to 4% of those on placebo experienced a constellation of symptoms immediately after injection that included at least two of the following: flushing, chest pain, palpitations, anxiety, dyspnea, constriction of the throat, and urticaria. The symptoms were generally transient and self-limited and did not require treatment. 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. During the postmarketing period, 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.
Approximately 13% of COPAXONE (glatiramer acetate) patients in the 5 placebo-controlled studies compared to 6% of placebo patients experienced at least one episode of what was described as 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 of COPAXONE (glatiramer acetate) was not always known. The pain was transient (usually lasting only a few minutes), 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.
Lipoatrophy and Skin Necrosis
At injection sites, localized lipoatrophy and, rarely, injection site skin necrosis have been reported during the postmarketing experience. 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 daily.
Potential Effects on Immune Response
Because COPAXONE (glatiramer acetate) can modify immune response, it may interfere with immune functions. For example, treatment with COPAXONE (glatiramer acetate) 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 (glatiramer acetate) does this, but there has not been a systematic evaluation of this risk. Because COPAXONE (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 COPAXONE (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 COPAXONE may result in untoward effects.
Glatiramer acetate-reactive antibodies are formed in most 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 RRMS patients given COPAXONE (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.
Patient Counseling Information
[See FDA-Approved Patient Labeling]
Instruct patients that if they are pregnant or plan to become pregnant while taking COPAXONE (glatiramer acetate) they should inform their physician.
Immediate Post-Injection Reaction
Advise patients that COPAXONE (glatiramer acetate) may cause various symptoms after injection, include flushing, chest pain, palpitations, anxiety, dyspnea, constriction of the throat, and urticaria. These symptoms are generally transient and self-limited and do not require specific treatment. Inform patients that these symptoms may occur early or may have their onset several months after the initiation of treatment. A patient may experience one or several episodes of these symptoms.
Advise patients that they may experience transient chest pain either as part of the Immediate Post-Injection Reaction or in isolation. Inform patients that the pain should be transient (usually only lasting a few minutes). Some patients may experience more than one such episode, usually beginning at least one month after the initiation of treatment. Patient should be advised to seek medical attention if they experience chest pain of unusual duration or intensity.
Lipoatrophy and Skin Necrosis at Injection Site
Advise patients that localized lipoatrophy, and rarely, injection site necrosis may occur at injections sites. Instruct patients to follow proper injection technique and to rotate injection areas and sites on a daily basis.
Instructions for Use
Instruct patients to read the COPAXONE (glatiramer acetate) Patient Information leaflet carefully. Caution patients to use aseptic technique. The first injection should be performed under the supervision of a health care professional. Instruct patients to rotate injection areas and sites on a daily basis. Caution patients against the reuse of needles or syringes. Instruct patients in safe disposal procedures.
Advise patients that the recommended storage condition for COPAXONE (glatiramer acetate) is refrigeration (36-46°F /2-8°C), although COPAXONE (glatiramer acetate) can be stored at room temperature (59-86°F /15-30°C) for up to one month. COPAXONE (glatiramer acetate) should not be exposed to higher temperatures or intense light.
Carcinogenesis, Mutagenesis, Impairment of Fertility
In a 2-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 of 20 mg/day on a mg/m2 basis). No increase in systemic neoplasms was observed. In males receiving the 60-mg/kg/day dose, 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 2-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 neoplasms was observed.
Glatiramer acetate was not mutagenic in in vitro (Ames test, mouse lymphoma tk) assays. Glatiramer acetate was clastogenic in two separate in vitro chromosomal aberration assays in cultured human lymphocytes but not clastogenic in an in vivo mouse bone marrow micronucleus assay.
When glatiramer acetate was administered by subcutaneous injection prior to and during mating (males and females) and throughout gestation and lactation (females) at doses up to 36 mg/kg/day (18 times the human therapeutic dose on a mg/m2 basis) no adverse effects were observed on reproductive or developmental parameters.
Use In Specific Populations
Pregnancy Category B.
Administration of glatiramer acetate by subcutaneous injection to pregnant rats and rabbits resulted in no adverse effects on offspring development. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, COPAXONE (glatiramer acetate) should be used during pregnancy only if clearly needed.
In rats or rabbits receiving glatiramer acetate by subcutaneous injection during the period of organogenesis, no adverse effects on embryo-fetal development were observed at doses up to 37.5 mg/kg/day (18 and 36 times, respectively, the therapeutic human dose of 20 mg/day on a mg/m2 basis). In rats receiving 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.
Labor and Delivery
The effects of COPAXONE (glatiramer acetate) on labor and delivery in pregnant women are unknown.
It is not known if glatiramer acetate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when COPAXONE (glatiramer acetate) is administered to a nursing woman.
The safety and effectiveness of COPAXONE (glatiramer acetate) have not been established in patients under 18 years of age.
COPAXONE (glatiramer acetate) has not been studied 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.
Last reviewed on RxList: 4/15/2009
This monograph has been modified to include the generic and brand name in many instances.
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