• Home
  • A-B index
  • Pharmacological Index
  • Drug Classes
  • Active Ingredients
  • Companies
  • News
  • Copaxone
    / Teva

    Active Ingredient
    Glatiramer Acetate 20 mg/ml, 40 mg/ml

    Status in Israel

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Pre-filled Syringe (solution for injection)

    3 X 40 mg

    partial basket chart 53950 9751

    Pre-filled Syringe (solution for injection)

    28 x 20 mg

    partial basket chart 21055 3925

    Related information


    Copaxone 20 mg/ml Prefilled Syringe: The recommended dose is 20 mg/day injected subcutaneously. Copaxone should be administered at the same time every day.
    Copaxone 40 mg/ml Prefilled Syringe: The recommended dosage in adults is 40 mg (one pre-filled syringe), administered as a subcutaneous injection three times a week. At the present time, it is not known for how long the patient should be treated. A decision concerning long term treatment should be made on an individual basis by the treating physician.


    Reduction of frequency of relapses in relapse-remittent multiple sclerosis. For the treatment of patients who have experienced a well defined first clinical episode and are determined to be at high risk of developing clinically definite multiple sclerosis (CDMS). These patients should have MRI findings which are compatible with the diagnosis of multiple sclerosis.


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

    Special Precautions

    NOTE: The only recommended route of administration of Copaxone injection is by the subcutaneous route. Copaxone should not be administered by the intravenous route.
    General: Patients should be instructed about self-injection techniques to assure the safe administration of Copaxone. Based on current data, no special caution is required in patients engaged in activities requiring mental alertness such as driving a car or operating machinery.
    No evidence or experience suggests that abuse or dependence occurs with Copaxone therapy; however, the risk of dependence has not been systematically evaluated.
    Considerations Involving the Use of a Product Capable of Modifying Immune Response: Because glatiramer acetate can modify immune response, consideration must be given to the possibility that it could interfere with useful immune function. 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 defenses against infections and tumor surveillance. There is no evidence that it does so, 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. Although there is no evidence that this occurs in humans, systematic surveillance for these effects have not been undertaken. Studies in both the rat and monkey, however, have suggested that immune complexes are deposited in the renal glomeruli. Furthermore, in a controlled trial of 125 patients with relapsing-remitting multiple sclerosis (RRMS) given glatiramer acetate, 20 mg subcutaneously every day for 2 years, serum IgG levels reached approximately 3 times baseline values in 80% of patients within 3 to 6 months of initiation of treatment. These values returned to about 50% greater than baseline during the remainder of treatment. 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. Anaphylaxis can be associated with the administration of almost any foreign substance. Based on the protein nature of glatiramer acetate, the risk of anaphylaxis cannot be excluded. Of the approximately 900 patients treated in premarketing trials, none experienced anaphylactic shock. Data collected during premarketing development do not suggest the necessity for routine laboratory monitoring.
    For full details see prescribing information.

    Side Effects

    During premarketing clinical trials, approximately 850 patients with MS and 50 patients in clinical pharmacology trials received at least one dose of glatiramer acetate. In controlled clinical trials, the most commonly observed adverse experiences associated with the use of glatiramer acetate and not seen at an equivalent frequency among placebo-treated patients were: injection site reactions, vasodilation, chest pain, asthenia, infection, pain, nausea, arthralgia, anxiety, and hypertonia. Approximately 8% of the 893 subjects receiving glatiramer acetate discontinued treatment due to an adverse event. The adverse events most commonly associated with discontinuation were: injection site reactions (6.5%), vasodilation, unintended pregnancy, depression, dyspnea, urticaria, tachycardia, dizziness, and tremor.
    Immediate Post-Injection Reaction: Approximately 10% of patients with MS exposed to glatiramer acetate in premarketing studies experienced a constellation of symptoms immediately after injection that could include flushing, chest pain, palpitations, anxiety, dyspnea, constriction of the throat and urticaria. In clinical trials, the symptoms were generally transient and self-limited and did not require specific treatment. In general, these symptoms have their onset several months after the initiation of treatment, although they may occur earlier in the course of treatment, and a given patient may experience one or several episodes of these symptoms. Whether or not any of these symptoms actually represents a specific syndrome is uncertain. During the postmarketing period, there have been reports of patients with similar symptoms who received emergency medical care.  Whether these episodes are mediated by an immunologic or non-immunologic mechanism, or whether several similar episodes seen in a given patient have identical mechanisms is unknown.
    Chest Pain: Approximately 26% of glatiramer acetate patients in the multicenter controlled trial (compared to 10% 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 the chest pain to an injection of glatiramer acetate was not always known, although the pain was transient (usually lasting only a few minutes) often unassociated with other symptoms and appeared to have no important clinical sequelae. ECG monitoring was not performed during any of these episodes. Some patients experienced more than one such episode, and episodes usually began at least 1 month after the initiation of treatment. The pathogenesis of the symptom is unknown.
    Incidence of Adverse Reactions in Controlled Clinical Trials: The following table lists treatment emergent signs and symptoms that occurred in at least 2% of patients with MS treated with glatiramer acetate in placebo controlled trials and that were numerically more common in patients treated with glatiramer acetate than in placebo-treated patients. These trials include the two controlled trials in relapsing- remitting multiple sclerosis patients and a controlled trial in patients with chronic progressive multiple sclerosis. Adverse events were usually mild in intensity. The prescriber should be aware that these figures cannot be used to predict the frequency of adverse experiences in the course of usual medical practice where patient characteristics and other factors may differ from those prevailing during clinical studies. Similarly, the cited frequencies cannot be directly compared with figures obtained from other clinical investigations involving different treatments, uses, or investigators. An inspection of these frequencies, however, does provide the prescriber with one basis to estimate the relative contribution of drug and non-drug factors to the adverse events incidences in the population studied.
    Body as a Whole: Headache, injection site ecchymosis, accidental injury, abdominal pain, allergic rhinitis, neck rigidity and malaise.
    Digestive System: Dyspepsia, constipation, dysphagia, fecal incontinence, flatulence, nausea and vomiting, gastritis, gingivitis, periodontal abscess, and dry mouth.
    Musculoskeletal: Myasthenia and myalgia.
    Nervous System: Dizziness, hypesthesia, paresthesia, insomnia, depression, dysesthesia, incoordination, somnolence, abnormal gait, amnesia, emotional liability, Lhermitte’s sign, abnormal thinking, twitching, euphoria, and sleep disorder.
    Respiratory System: Pharyngitis, sinusitis, increased cough, and laryngitis.
    Skin and Appendages: Acne, alopecia, and nail disorder.
    Special Senses: Abnormal vision, diplopia, amblyopia, eye pain, conjunctivitis, tinnitus, taste perversion and deafness.
    Urogenital System Frequent: Amenorrhea, hematuria, impotence, menorrhagia, suspicious papanicolaou smear, urinary frequency and vaginal hemorrhage. Infrequent: Vaginitis, flank pain (kidney), abortion, breast engorgement, breast enlargement. carcinoma in situ cervix, fibrocystic breast, kidney calculus, nocturia, ovarian cyst, priapism, prostatectomy, pyelonephritis, abnormal sexual function and urethritis.
    Adverse Reactions in the Clinical Trial in Subjects with a Single Clinical Event Suggestive of MS: The safety profile of Copaxone in the study of subjects with a first clinical episode suggestive of MS is consistent with the known safety profile of Copaxone as demonstrated in RRMS patients during prior clinical trials and post-marketing surveillance. The safety issues with the greatest impact on drug tolerability continue to be injection site reactions, immediate post-injection reactions, hypersensitivity reactions including anaphylactic reactions, and skin and subcutaneous disorders.
    For full details see prescribing information.

    Drug interactions

    SInteractions between Copaxone and other drugs have not been fully evaluated. Results from existing clinical trials do not suggest any significant interactions with therapies commonly used in MS patients. An increased incidence of injection site reactions has been seen in Copaxone patients receiving concurrent administration of corticosteroids. Copaxone has not been formally evaluated in combination with interferon-beta. However, 10 patients who switched from therapy with interferon-beta to Copaxone have not reported any serious and unexpected adverse events thought to be related to treatment. In vitro work suggests that glatiramer acetate in blood is highly bound to plasma proteins but that it is not displaced by, and does not itself displace, phenytoin or carbamazepine. Nevertheless, as Copaxone has, theoretically, the potential to affect the distribution of protein-bound substances, concomitant use of such medicinal products should be monitored carefully.
    For full details see prescribing information.

    Pregnancy and Lactation

    Teratogenicity: No adverse effects on embryofetal development occurred in reproduction studies in rats and rabbits receiving subcutaneous doses up to 37.5 mg/kg of glatiramer acetate during the period of organogenesis (18 and 36 times the human dose of 20 mg on a mg/m2 basis, respectively). In a prenatal and postnatal study, in which rats received subcutaneous glatiramer acetate at doses 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. Effect on
    Fertility and Reproduction: In a multi-generation reproduction and fertility study in rats, glatiramer acetate at subcutaneous doses up to 36 mg/kg (18 times the recommended human daily dose of 20 mg on a mg/m2 basis) had no adverse effects on reproductive parameters.
    Pregnancy: There are no adequate and well-controlled studies in pregnant women. The potential risk for humans is unknown. Therefore, Copaxone should not be used during pregnancy.
    Breastfeeding: 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 mother.


    There are 13 reports to date of overdose with Copaxone which were confirmed by health care professionals. Most cases concern 2 or 3 injections given on the same day. The largest dose of Copaxone that has been administered is 280 mg on a single occasion. No adverse reactions occurred and the patient continued treatment. In clinical trials, daily doses of up to 30 mg glatiramer acetate for up to 24 months were not associated with adverse reactions other than those mentioned in Section 8. In case of overdose, patients should be monitored and the appropriate symptomatic and supportive therapy instituted.

    Teva Pharmaceutical Industries Ltd, Israel