Copaxone 40,40 mg/ml 1 ml syringes 12 pcs

Special Instructions

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 those occurring immediately after injection of the drug Copaxone 40. Most of these symptoms are short-lived, resolving spontaneously without consequences.

If serious adverse reactions develop, immediately discontinue therapy and contact the attending physician or call an ambulance. The decision to use symptomatic therapy is up to the physician.

There is no evidence that certain groups of patients are at greater risk of such reactions. However, patients with cardiovascular disease should be monitored by a physician for the duration of treatment.

A few cases of seizures and/or anaphylactoid or allergic reactions have been identified. Serious hypersensitivity reactions (bronchospasm, anaphylactic reaction or urticaria) may also occur rarely.

In case of severe reactions it is necessary to prescribe appropriate treatment and discontinue the drug.

Antibodies to glatiramer acetate were detected in the serum of patients. After a treatment course of 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 data 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 conclusive evidence that deposition of immune complexes affects glomerular filtration.

If the patient is unable to store the Copaxone 40 syringes in the refrigerator, storage at 15-25 °C is acceptable, but not more than one month.

If the syringes with the drug have not been used within a month, and the contour cell pack has not been opened, these syringes should be further stored in a refrigerator (2-8 °С).
Effect on the ability to drive vehicles and mechanisms:

Studies on the effect on the ability to drive vehicles and mechanisms have not been conducted.

Contraindications

• Hypersensitivity to glatiramer acetate or mannitol;
• children under 18 years of age (effectiveness and safety not studied):
• pregnancy.

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Side effects

The majority of data on the safety of Copaxone 40 were accumulated based on the use of Copaxone-Teva 20 mg/mL as daily injections.

This section presents the data accumulated during 4 placebo-controlled clinical trials of Copaxone-Teva as a p/v injection in a dose of 20 mg/ml once daily and 1 placebo-controlled trial of Copaxone 40 as a p/v injection in a dose of 40 mg/ml 3 times weekly.

Copaxone-Teva 20 mg/ml (used daily)

The most frequent reactions during clinical trials of the drug Copaxone-Teva were observed at the injection site.

The placebo-controlled studies showed that the proportion of patients who reported these adverse events at least once was 70% for Copaxone-Teva and 37% for placebo. The most frequently observed adverse events were redness. pain. Thickening, itching, swelling, inflammation, and hypersensitivity.

A reaction associated with at least one or more symptoms (vasodilation, chest pain, shortness of breath, palpitations, or tachycardia) that occurs a few minutes after injection is called an immediate post-injection reaction.

At least one of the symptoms of this reaction was observed at least once in 31% of patients treated with Copaxone-Teva, compared with 13% of placebo patients.

All adverse reactions most frequently observed in patients receiving Copaxone-Teva compared to the placebo group are shown below.

These data were obtained from four registration, double-blind, placebo-controlled studies involving 512 patients who received Copaxone-Teva daily and 509 patients who received placebo for 36 months.

The three studies included 269 patients diagnosed with relapsing-remitting multiple sclerosis who received Copaxone-Teva daily for 35 months and 271 patients in the placebo group.

The fourth study included 243 patients (the Copaxone-Teva group) with first clinical disease withdrawal who were at high risk of developing clinically confirmed multiple sclerosis and 238 patients who received placebo. The study duration was 36 months.

The incidence of adverse reactions was classified as follows: very common (≥1/10); common (≥1/100, but < 1/10): infrequent (≥1/1000, but < 1/100): rare (≥1/10000, but < 1/11000).

Infections and invasions: very common – infections, influenza; common – bronchitis, gastroenteritis, otitis media, Herpes simplex, rhinitis, periodontal abscess, vaginal candidiasis*; infrequent – abscess, inflammation of subcutaneous fatty tissue, furunculosis, pyelonephritis, Herpes zoster.

New growths including polyps and cysts: often – benign skin growths, neoplasms: infrequent – skin cancer.

Hematopoietic and lymphatic system disorders: frequent – lymphadenopathy*; infrequent – leukocytosis, leukopenia, splenomegaly, thrombocytopenia, changes in lymphocyte morphology.

Immune system disorders: often – hypersensitivity reactions.

Endocrine system disorders: infrequent – goiter, hyperthyroidism.

Metabolism and nutrition: frequently – anorexia, weight gain*; infrequently – alcohol intolerance, gout, hyperlipidemia, hypernatriemia, decreased concentration of ferritin in serum.

Psychiatric disorders: very common – anxiety*, depression; common – nervousness; infrequent – unusual dreams, psychosis, euphoria, hallucinations, aggressiveness, mania, personality disorders, suicide attempts.

Nervous system disorders: very common – headache; common – perversion of taste, muscle hypertonicity, migraine, speech disorders, syncope, tremor*; infrequent – carpal tunnel syndrome, cognitive disorders, seizures, dysgraphia, dyslexia, dystonia, motor function disorders, myoclonus, neuritis, neuromuscular blockade, nystagmus, paralysis, peroneal nerve paralysis, stupor, visual field defect.

VIVIVIVI: often – diplopia, visual impairment*; infrequent – cataract, corneal damage, dry sclera and cornea, ocular hemorrhage, ptosis of eyelids, mydriasis, optic atrophy.

Hearing and balance disorders: often – hearing impairment.

Cardiovascular system: very common: vasodilation*; common: palpitations*, tachycardia*; infrequent: extrasystole, sinus bradycardia, paroxysmal tachycardia, varicose veins.

Respiratory system: very common – shortness of breath*; common – cough, seasonal rhinitis; infrequent – apnea, choking sensation, nasal bleeding, hyperventilation of lungs, laryngospasm, pulmonary disorders.

Gastrointestinal tract: very common – nausea*; common – anorectal disorders, constipation, caries, dyspepsia, dysphagia, incontinence, vomiting*; infrequent – colitis, enterocolitis, colon polyposis, belching, esophageal ulcer, periodontitis, rectal bleeding, increased salivary glands.

Hepatic and biliary tract disorders: frequently – abnormal liver function tests; infrequently – biliary stone disease, hepatomegaly.

Skin and subcutaneous fat: very common – skin rash*; common – ecchymosis, hyperhidrosis, pruritus, skin disorders*, urticaria; infrequent – angioedema, contact dermatitis, erythema nodosum, skin nodules.

Muscular system and connective tissue: very common – arthralgia, back pain*; common – neck pain; infrequent – arthritis, bursitis, pain in the side, muscular atrophy, osteoarthritis.

Recreational and urinary system disorders: frequently – imperative urges, pollakiuria. urinary retention; infrequently – hematuria, nephrolithiasis. urinary tract disorders, deviations from laboratory norms of urine analysis.

Pregnancy, postpartum and perinatal conditions: infrequent – spontaneous abortion.

Gender and mammary gland disorders: infrequent – breast engorgement, erectile dysfunction, pelvic organ prolapse, priapism, prostate disorders, abnormal laboratory values in cervical smears, testicular function disorders, vaginal bleeding, vulvovaginal disorders.

Others: very common – asthenia, chest pain*, injection site reactions* ^and **, pain*; common – chills*, facial edema*, injection site atrophy***, local reactions*, peripheral edema, swelling, fever; infrequent – hypothermia, immediate post-injection reaction, inflammation, cysts, hangover syndrome, mucous membrane diseases, postvaccination 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 to the placebo group. An adverse reaction without an “*” indicates a difference less than or equal to 2%.

** “Injection site reactions” (various types) includes any adverse events occurring at the injection site, except atrophy and necrosis, which are listed separately.

*** Refers to localized lipoatrophy at the injection site.

In the fourth clinical trial above, the placebo-controlled phase was followed by an “open-label” phase study that lasted 5 years. During this study, there were no changes in the previously established safety profile of Copaxone-Teva.

Rare (≥1/10,000 but < 1/1000) cases of anaphylactoid reactions have been reported in patients with multiple sclerosis who received Copaxone-Teva in uncontrolled clinical trials as well as during post-marketing use.

Copaxone 40 at a dose of 40 mg/ml (administered three times weekly)

The Choice double-blind, placebo-controlled study, which lasted 12 months, evaluated the safety of Copaxone 40 in 943 patients diagnosed with relapsing-remitting multiple sclerosis compared to a placebo group that included 461 patients.

In general, in patients who received Copaxone 40 three times a week, adverse reactions at the injection site were the same as those seen with daily administration of Copaxone-Teva 20 mg/mL.

In particular, injection site reactions (ISRs) and immediate post-injection reactions (IPIRs) were observed less frequently with Copaxone 40 three times a week than with daily injections of Copaxone-Teva (35.5% compared to 70% for ISRs and 7.8% compared to 31% for IPIRs, respectively).

In 36% of patients treated with Copaxone-40 compared to 5% of patients treated with placebo, RMI was observed. NSAIDs were observed in 8% of patients treated with Copaxone 40 compared to 2% of patients treated with placebo.

A few specific adverse reactions were noted:

• In patients with multiple sclerosis receiving Copaxone-Teva 20 mg/mL pr], uncontrolled clinical trials, and post-marketing experience with use, anaphylactic reactions were observed in rare cases (≥1/10,000 but < 1/1000). In patients taking Copaxone 40. Such cases were 0.3% (infrequent: ≥1/1000 but < 1/100);

• no cases of injection site necrosis were detected:

• in 2.1% of patients treated with Copaxone 40 (frequently: ≥1/100, but < 1/10). had cases of reddening of the skin and pain in the extremities, which were not detected with Copaxone-Teva 20 mg/mL:

• one patient (0.1%). receiving Copaxone-Teva 40 (infrequent: ≥1/1000 but < 1/100). drug-induced liver injury and toxic hepatitis were observed, which were also rare in patients with multiple sclerosis receiving Copaxone-Teva 20 mg/mL during the post-marketing follow-up period.

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Overdose

There have been several reports of overdose (up to 300 mg of glatiramer acetate). No adverse reactions other than those listed in the side effect section have been observed.

In case of overdose, close observation, symptomatic and supportive treatment is indicated.

Pregnancy use

There are no data on the use of the drug Copaxone 40 during pregnancy. the possible risk of use during pregnancy has not been established.

The conducted animal studies are insufficient to establish the effect of the drug on pregnancy, embryo/fetal development, childbirth and postnatal development. The drug Copaxone 40 is contraindicated during pregnancy. During treatment it is necessary to use reliable contraception methods.

It is unknown whether glatiramer acetate is excreted with breast milk, therefore if it is necessary to use the drug Copaxone 40 during lactation, the expected benefits of therapy for mother and the potential risk for the child should be assessed.