Copaxone [Glatiramer Acetate]
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Immunomodulator The drug used in multiple sclerosis
Relapsing-remitting multiple sclerosis.
1 ml of Glatiramer acetate - 40 mg
Excipients: mannitol - 40 mg, water d / and - up to 1 ml.
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Dosage and Administration
Introduce n / a in the form of injections of 40 mg (1 filled with a solution of the drug syringe for injection) 3 times a week, the minimum interval between injections is 48 hours.
The drug is not intended for intravenous or intramuscular injection.
Currently, data on the duration of treatment is not available. The decision on the appointment of a long course of treatment should be made by the attending physician in each case.
Patients are recommended to undergo training on self-injection technology. The first injection (as well as 30 minutes after it) should be supervised by a qualified specialist. To reduce the risk of irritation or pain in the injection area, it is necessary to change the area for injection each time.
The drug is not recommended for use in children and adolescents under the age of 18 years, since clinical studies in patients of these age groups have not been conducted.
The efficacy and safety of the drug in elderly patients have not been studied.
The efficacy and safety of the drug in patients with renal insufficiency have not been studied.
Each syringe with the drug Copaxone® 40 is intended for single use only.
Most of the safety data on the use of Copaxone® 40 have been accumulated on the basis of using Copaxone®-Teva 20 mg / ml in the form of daily injections. This section presents data accumulated during 4 placebo-controlled clinical studies on the use of Copaxone®-Teva as a sc injection in a dose of 20 mg / ml 1 time per day and 1 placebo-controlled study of the use of Copaxone® 40 in the form of s / c injections in a dose of 40 mg / ml 3 times a week.
Copaxone®-Teva 20 mg / ml (with daily use)
Most often during clinical studies of the drug Copaxone®-Teva, reactions at the injection site were observed. A placebo-controlled study showed that the proportion of patients reporting these adverse events was at least 1% 70% for Copaxone®-Teva and 37% for placebo. Redness, pain, induration, itching, swelling, inflammation, and hypersensitivity were most commonly observed.
A reaction associated with at least one or more symptoms (vasodilation, chest pain, shortness of breath, rapid heartbeat, or tachycardia) that occurs a few minutes after the injection is called an immediate post-injection reaction. At least 1 of the symptoms of this reaction was observed at least 1 time in 31% of patients receiving Copaxone®-Teva, compared with 13% of patients with placebo.
All adverse reactions most frequently observed in patients who received Copaxone®-Teva compared with the placebo group are presented below. These data were obtained during 4 double-blind, placebo-controlled trials involving 512 patients who received Copaxone®-Teva daily, and 509 patients who received placebo for 36 months. In 3 studies, 269 patients were diagnosed with relapsing-remitting multiple sclerosis who received Copaxone®-Teva daily for 35 months and 271 patients from the placebo group. The fourth study involved 243 patients (the Copaxone®-Teva group) with the first clinical episode of the disease, who had a high risk of developing clinically confirmed multiple sclerosis, and 238 patients receiving placebo. The duration of the study was 36 months.
Determination of the frequency of adverse reactions: very often (≥1 / 10); often (≥1 / 100, but <1/10); infrequently (≥1 / 1000, but <1/100); rarely (≥1 / 10,000, but <1/1000).
Infections and invasions: very often - infections, flu; often - bronchitis, gastroenteritis, otitis media, infections caused by herpes simplex, rhinitis, periodontal abscess, vaginal candidiasis *; infrequently - abscess, inflammation of the subcutaneous fat, furunculosis, pyelonephritis, infections caused by Herpes zoster.
Neoplasms, including polyps and cysts: often - benign skin neoplasms, neoplasms; infrequently - skin cancer.
On the part of the hematopoietic and lymphatic systems: often - lymphadenopathy *, infrequently - leukocytosis, leukopenia, splenomegaly, thrombocytopenia, changes in the morphology of lymphocytes.
On the part of the immune system: often - hypersensitivity reactions.
On the part of the endocrine system: infrequently - goiter, hyperthyroidism.
On the part of the metabolism: often - anorexia, weight gain *; infrequently - alcohol intolerance, gout, hyperlipidemia, hypernatremia, a decrease in serum ferritin concentration.
Mental disorder: very often - anxiety *, depression; often - nervousness; infrequently - unusual dreams, psychosis, euphoria, hallucinations, aggressiveness, mania, personality disorders, suicidal attempts.
From the nervous system: very often - headache; often - taste perversion, hypertonicity of muscles, migraine, speech disorders, fainting, tremor *; infrequently - carpal tunnel syndrome, cognitive disorders, convulsions, dysography, dyslexia, dystonia, impaired motor functions, myoclonus, neuritis, neuromuscular blockade, nystagmus, paralysis, paralysis of the peroneal nerve, stupor, visual field defect.
On the part of the organ of vision: often - diplopia, visual impairment *; infrequently - cataract, corneal damage, dry sclera and cornea, hemorrhage in the eye, eyelid ptosis, mydriasis, optic nerve atrophy.
On the part of the organ of hearing and balance: often - a hearing loss.
Since the cardiovascular system: very often - vasodilation *; often - palpitations *, tachycardia *; infrequently - extrasystole, sinus bradycardia, paroxysmal tachycardia, varicose veins.
On the part of the respiratory system: very often - shortness of breath *; often - cough, seasonal rhinitis; infrequently - apnea, feeling of suffocation, nosebleeds, hyperventilation, laryngospasm, pulmonary disorders.
On the part of the digestive system: very often - nausea *; often - anorectal disorders, constipation, caries, dyspepsia, dysphagia, fecal incontinence, vomiting *; infrequently - colitis, enterocolitis, colon polyposis, belching, esophageal peptic ulcer, periodontitis, rectal bleeding, enlarged salivary glands.
On the part of the liver and biliary tract: often deviation of liver function tests; infrequently - cholelithiasis, hepatomegaly.
From the skin and subcutaneous fat: very often - skin rash *; often - ecchymosis, hyperhidrosis, itchy skin, skin diseases *, urticaria; infrequently - angioedema, contact dermatitis, erythema nodosum, skin nodules.
On the part of the musculoskeletal system: very often - arthralgia, back pain *; often - neck pain; infrequently - arthritis, bursitis, pain in the side, muscular atrophy, osteoarthritis.
On the part of the urinary system: often - the imperative urge, pollakiuria, urinary retention; infrequently - hematuria, nephrolithiasis, diseases of the urinary tract, deviations from laboratory norms of urine analysis.
Reproductive system: infrequently - spontaneous abortion, breast engorgement, erectile dysfunction, pelvic organ prolapse, priapism, prostate disease, deviation of laboratory parameters in cervical smears, testicular dysfunction, vaginal bleeding, vulvovaginal disorders.
Other: very often - asthenia, chest pain *, reactions at the injection site * and **, pain *; often - chills *, face *, atrophy at the injection site ***, local reactions *, peripheral edema, edema, fever; infrequently - hypothermia, immediate post-injection reaction, inflammation, cyst, hangover, mucosal diseases, post-vaccination syndrome, necrosis at the injection site.
* The probability of occurrence of such cases in patients taking Copaxone®-Teva is more than 2% (> 2/100) compared with the placebo group.An undesirable reaction without the “*” sign indicates a difference less than or equal to 2%.
** Reactions at the injection site (various types) - include any adverse events that occur at the injection site, with the exception of atrophy and necrosis, which are listed separately.
*** Refers to localized lipoatrophy at the injection site.
In the fourth clinical study, mentioned above, an open phase of the study followed the placebo-controlled phase, which lasted 5 years. During this study, no changes were detected in the previously established safety profile of Copaxone®-Teva.
In patients with multiple sclerosis who received Copaxone®-Teva when conducting uncontrolled clinical trials, as well as during post-marketing use, rare cases (≥1 / 10,000, but <1/1000) of anaphylactoid reactions were recorded.
Copaxone® 40 at a dose of 40 mg / ml (when applied 3 times a week)
During a double-blind, placebo-controlled study that lasted 12 months, the safety of Copaxone® 40 was evaluated in 943 patients with a diagnosis of relapsing-remitting multiple sclerosis compared with the placebo group, which included 461 patients.
In general, in patients who took Copaxone® 40 3 times a week, unwanted reactions at the injection site coincided with those observed with daily administration of Copaxone®-Teva 20 mg / ml.
In particular, the reactions at the injection site (RMI) and immediate post-injection reactions (NPIR) with the administration of the drug Copaxone® 40 3 times a week were less common than with daily injections of the drug Copaxone®-Teva (35.5% compared to 70% for PMI and 7.8% compared with 31% for NPIR, respectively).
In 36% of patients when using the drug Copaxone® 40 compared with 5% of patients while receiving a placebo, RMI was observed. In 8% of patients treated with Copaxone® 40 compared with 2% of patients taking placebo, NPIR was detected. However, several specific adverse reactions were noted:
- in patients with multiple sclerosis who received the drug Copaxone®-Teva 20 mg / ml when conducting uncontrolled clinical studies, as well as the results of post-marketing experience in rare cases (≥1 / 10,000, but <1/1000), an anaphylactic reaction was observed. In patients taking the drug Copaxone® 40, such cases were 0.3% - rarely (≥1 / 1000, but <1/100);
- no cases of necrosis at the injection site have been identified;
- in 2.1% of patients receiving the drug Copaxone® 40, often (≥1 / 100, but <1/10) there were cases of redness of the skin and pain in the extremities that were not detected when using the drug Copaxone®-Teva 20 mg / ml;
- in 1 patient (0.1%) who received the drug Copaxone® 40, infrequently (> 1/1000, but <1/100), drug-induced liver damage and toxic hepatitis were observed, which were also rarely seen in patients with multiple sclerosis who took Copaxone®-Teva 20 mg / ml during post-marketing follow-up.
- hypersensitivity to Glatiramer acetate or mannitol;
- children's and teenage age till 18 years (efficiency and safety are not studied).
With care: predisposition to the development of allergic reactions, cardiovascular diseases, impaired renal function.
The interaction between the drug Copaxone® 40 and other drugs have not been separately evaluated. No data on the interaction with interferon beta.
An increase in cases of reactions at the injection site with simultaneous administration of the drug Copaxone® 40 with corticosteroids.
In an in vitro study, it was suggested that Glatiramer acetate has a high degree of binding to plasma proteins and is not displaced from its association with plasma protein alone, as well as phenytoin or carbamazepine.However, since the drug Copaxone® 40 has a potential effect on protein-binding substances, it is necessary to control its simultaneous use with other medications.
Pregnancy and Lactation
The drug Copaxone® 40 is contraindicated in pregnancy. During treatment, you must use reliable methods of contraception.
There is no data on the use of Copaxone® 40 during pregnancy, the possible risk of use during pregnancy has not been established.
Studies on animals are insufficient to establish the effect of the drug on pregnancy, embryo / fetus development, childbirth, and postnatal development.
It is not known whether Glatiramer acetate is excreted in breast milk, so if you need to use Copaxone® 40 during lactation, you should evaluate the expected benefit of therapy for the mother and the potential risk to the baby.
Initiation of treatment with Copaxone® 40 should be carried out under the supervision of a neurologist and a physician experienced in the treatment of multiple sclerosis. The drug is not indicated for the treatment of primary or secondary progressive multiple sclerosis.
Patients should be informed about the possibility of adverse reactions, including arising directly after an injection of the drug Kopakson® 40.
Most of these symptoms are short-lived, spontaneously resolved without consequences. With the development of serious adverse reactions should immediately discontinue therapy and contact your doctor or call an ambulance. The decision on the use of symptomatic therapy is taken by the doctor.
There is no evidence that certain groups of patients are more at risk of such reactions. However, patients with cardiovascular diseases should be supervised by a physician throughout the entire treatment period.
Several cases of seizures and / or anaphylactoid or allergic reactions have been identified. Severe hypersensitivity reactions (bronchospasm, anaphylactic reaction or urticaria) can also be rarely encountered. In case of severe reactions, it is necessary to prescribe the appropriate treatment and stop taking the drug.
Antibodies to Glatiramer acetate were detected in the serum of patients. After a course of treatment with an average duration of 3-4 months, their maximum concentration was recorded, which subsequently decreased and stabilized at a level just above the baseline.
There is no evidence that antibodies to Glatiramer acetate have a neutralizing effect or affect the clinical efficacy of the drug.
In patients with renal insufficiency, renal function should be monitored, although there is no convincing evidence that the deposition of immune complexes has an effect on glomerular filtration.
If the patient does not have the ability to store syringes with the drug Copaxone® 40 in the refrigerator, then storage is allowed at a temperature of 15-25 ° C, but not more than 1 month. If during the month syringes with the drug were not used, and the blister cell packaging was not opened, these syringes should be further stored in a refrigerator (from 2 ° to 8 ° C).
Influence on ability to drive motor transport and control mechanisms
Studies on the impact on the ability to drive vehicles and mechanisms was not conducted.
Symptoms: There have been several reports of overdose (up to 300 mg of Glatiramer acetate). No adverse reactions other than those listed above were observed.
Treatment: in case of overdose, careful observation, symptomatic and supportive therapy is indicated.
- Brand name: Copaxone-Teva
- Active ingredient: Glatiramer Acetate
- Dosage form: Solution for s / c injection from colorless to light yellow, slightly opalescent.
- Manufacturer: Teva
- Country of Origin: Israel