Kopakson -Teva - instructions for use, doses, side effects, contraindications

Active substanceGlatiramer acetateGlatiramer acetate

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Dosage form: & nbsphypodermic solution

Composition:

In 1 ml of solution contains:

active substance: Glatiramer acetate 20.0 mg;

Excipients: mannitol (mannitol) 40.0 mg, water for injection q.s. up to 1 ml.

Description:

Lightly opalescent solution from colorless to light yellow color.

Pharmacotherapeutic group:Immunomodulating agent

ATX: & nbsp

L.03.A.X.13 Glatiramer acetate

Pharmacodynamics:

Copaxone®-Teva (glatiramer acetate) is an acetic acid salt of a mixture of synthetic polypeptides formed by 4 natural amino acids: L-glutamic acid, L-alanine, L-tyrosine and Llysine, and has a chemical structure similar to the main myelin protein.

Glatiramer acetate changes the course of the pathological process in the demyelinating disease of the central nervous system (CNS) - multiple sclerosis, which refers to autoimmune diseases that change the ratio of T-suppressors in the body. Glatiramer acetate performs immunomodulatory action at the injection site. Its therapeutic effect is mediated through the systemic spread of activated T-suppressors. Glatiramer acetate has a specific mechanism of action, which is based on the ability to competitively replace the myelin antigens - the main protein myelin, myelin oligodendrocyte glycoprotein and proteolipid protein in places of binding with molecules of the main histocompatibility complex of class 2 located on antigen-presenting cells. The consequence of competitive displacement is two reactions: stimulation antigen-specific suppressor T-lymphocytes (Th2type) and inhibition of antigen-specific effector T-lymphocytes (Th1-type). Activated T-suppressor lymphocytes enter the systemic circulation and penetrate the central nervous system. Getting in the site of inflammation in the central nervous system, these T-lymphocytes are reactivated with myelin antigens, which leads to the production of anti-inflammatory cytokines (IL-4, IL-6, IL-10, etc.). These cytokines reduce local inflammation by suppressing the local inflammatory T cell response, which leads to the accumulation of specific anti-inflammatory cells Th2type and inhibition of the proinflammatory system Th1 - cells.

Besides, glatiramer acetate stimulates the synthesis of the neurotrophic factor Th2- cells and protects brain structures from damage (neuroprotective effect). Glatiramer acetate does not have a generalized effect on the main links of normal immune reactions of the body, which fundamentally distinguishes it from nonspecific immunomodulators, including interferon-beta preparations. The resulting antibodies to glatiramer acetate in long-term use do not have a neutralizing effect, which reduces the clinical effect of the drug.

Pharmacokinetics:

Due to the peculiarities of the chemical structure of glatiramer acetate, which is a mixture of polypeptides formed by natural amino acids, as well as a low therapeutic dose, the pharmacokinetics data are only indicative. Based on them, as well as on experimental data, it is believed that after a subcutaneous injection glatiramer acetate quickly hydrolyzed at the injection site. Hydrolysis products, as well as a small part of unchanged glatiramer acetate, can enter the lymphatic system and partially reach the vascular bed.The determined concentration of glatiramer acetate or its metabolites is not correlated with the therapeutic effect.

Indications:

Clinically isolated syndrome (the only clinical episode of demyelination that suggests multiple sclerosis) with the severity of the inflammatory process, requiring the use of intravenous glucocorticosteroids (to slow the transition to clinically significant multiple sclerosis).
Recurrent-remitting multiple sclerosis (to reduce the frequency of exacerbations, slow the development of disabling complications).

Contraindications:

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

Carefully:

Predisposition to the development of allergic reactions, cardiovascular diseases, impaired renal function.

Pregnancy and lactation:

Data on the use of glatiramer acetate during pregnancy are not available, the possible risk of such use during pregnancy is not established. Copaxone®-Teva is contraindicated during pregnancy.

During treatment with Copaxone-Teva, reliable contraceptive methods should be used.

It is not known whether glatiramer acetate with breast milk, therefore, if you need to use during lactation, you should evaluate the expected benefit of therapy for the mother and the potential risk to the child.

Dosing and Administration:

In the form of subcutaneous injections of 20 mg of Copaxone®-Teva (one syringe filled with injection for injection) once a day, preferably at the same time of day. Treatment is long. The decision to discontinue therapy should be made by the attending physician.

Each syringe with Copaxone®-Teva is for single use only.

Recommendations for patients on the use of the drug

1. Make sure that you have everything you need for injection: a disposable syringe filled with Copaxone®-Teva solution, a container for used syringes, a cotton swab moistened with alcohol.

2. Before injection, remove the disposable syringe from the contoured cell package, removing the protective paper strip.

3. Soak the syringe with the solution at room temperature for at least 20 minutes.

4.Before you apply Copaxone®-Teva, wash your hands thoroughly with soap and water.

5. Inspect the solution carefully in a syringe. In the presence of suspended particles or changes in the color of the solution, it should not be used.

6. Choose a place for injection. Possible areas for injection are indicated in Fig. 1: arms, hips, buttocks, abdomen (about 5 cm around the navel). Do not inject into painful areas, discolored, reddened areas of skin or areas with seals and nodules. Choosing a new place, you can reduce discomfort and pain during the injection. Within each injection zone, there is enough room for several injections. It is recommended to draw up a scheme of injection sites and have it with you. For injections on the buttocks and hands, you will need the help of another person.

7. Remove the protective cap from the needle.

8. Pre-treating the injection site with a cotton wool soaked in alcohol solution, slightly gather the skin into the fold with the thumb and forefinger (Fig. 2).

9. With the syringe needle perpendicular to the injection site (Figure 3), puncture the skin and, evenly pressing the syringe onto the plunger, insert its contents into the injection site.

10.Remove the needle by moving the syringe perpendicular to the injection site.

11. Place the syringe in a container for used syringes.

If you forgot to inject Copaxone®-Teva, inject immediately as soon as you remember it. Do not administer a double dose of the drug. Use the next syringe with Copaxone®-Teva only after 24 hours.

Side effects:

Copaxone®-Teva is safe and well tolerated by patients. In some cases, the following adverse reactions may occur.

From the side of the blood and lymphatic system: lymphadenopathy, leukocytosis, leukopenia, splenomegaly, thrombocytopenia, changes in lymphocyte structure.

From the immune system: hypersensitivity reaction, anaphylactoid reaction, angioedema.

From the endocrine system: hyperthyroidism.

From the side of metabolism: anorexia, weight gain, alcohol intolerance, gout, hyperlipidemia, hypernatremia, decreased ferritin concentration in serum.

From the nervous system: headache, anxiety, depression, euphoria, nervousness, pathological dreams, psychosis, hallucinations, hostility, mania,personality disorder, suicidal behavior, taste distortion, migraine, syncope, tunnel syndrome, cognitive disorders, tremor, convulsions, dysgraphia, dyslexia, motor function disorders, myoclonus, neuritis, neuromuscular blockade, paralysis, including peroneal nerve, stupor.

From the side of the organ of vision: diplopia, visual field defect, eye movement disorder, cataract, corneal damage, dryness of sclera and cornea, subconjunctival hemorrhage, age of ptosis, mydriasis, nystagmus, optic nerve atrophy, visual impairment.

From the side of the organ of hearing and balance: headache, hearing loss.

From the cardiovascular system: heart palpitations, tachycardia, extrasystole, sinus bradycardia, paroxysmal tachycardia, increased blood pressure, varicose veins.

From the respiratory system: cough, shortness of breath, seasonal rhinitis, apnea, hyperventilation of the lungs, laryngospasm.

From the digestive system: nausea, vomiting, edema of the tongue, constipation, caries, odontogenic periostitis, salivary gland enlargement, dyspepsia, dysphagia, belching, esophageal ulcer, colitis, enterocolitis, polyposis of the large intestine,anorectal disorders, rectal bleeding.

From the liver and bile ducts: cholelithiasis, hepatomegaly. From the skin and subcutaneous tissues: ecchymosis, hyperhidrosis, skin rash, itching, urticaria, contact dermatitis, erythema nodosum, cutaneous nodules.

From the side of the musculoskeletal system and connective tissue: arthralgia, pain in the cervical spine, back pain, arthritis, bursitis, pain in the side, muscle atrophy, osteoarthritis.

From the urinary system: imperative urge to urinate, pollakiuria, urine retention, hematuria, nephrolithiasis.

From the genitals and mammary glands: amenorrhea, mammary gland enlargement, erectile dysfunction, prolapse of pelvic organs, deviation of laboratory parameters in smears from the cervical canal, violation of the menstrual cycle, vulvovaginal disorders.

Infections: otitis media, bronchitis, gastroenteritis, exacerbation of diseases caused by N. simplex, rhinitis, vaginal candidiasis, inflammation of subcutaneous fat, furunculosis, pyelonephritis, herpes zoster.

Other: reactions immediately after injection *, asthenia, fatigue, chills,fever, nasal bleeding, peripheral edema, a hangover state.

* Reactions immediately after injection

Local reactions: pain, redness, swelling, abscess, hematoma, lipoatrophy, skin necrosis.

Systemic reactions: "tides" of blood, chest pain, palpitation, anxiety, shortness of breath, difficulty swallowing, urticaria. These symptoms are temporary and limited and do not require special intervention; they can also begin several months after the initiation of therapy, the patient may experience a symptom occasionally.

Overdose:

Data on the overdose of Copaxone®-Teva is not available. In case of an overdose, careful observation and symptomatic treatment are indicated.

Interaction:

The interaction between glatiramer acetate and other drugs has not been adequately studied. No drug interaction was found, including simultaneous use of glatiramer acetate with drugs that are used for the treatment of multiple sclerosis, including with glucocorticosteroids (for combined use for up to 28 days).Very rarely the frequency of local reactions can increase.

Special instructions:

At the beginning of treatment Copakson®-Teva requires control of a neurologist and a doctor who has experience in treating multiple sclerosis

Patients should be informed of the possibility of adverse reactions, including those immediately following the injection of Copaxone®-Teva. Most of these symptoms are brief, spontaneously resolved without consequences. If serious adverse reactions develop, stop treatment immediately and consult your doctor or call for emergency medical attention. The decision to use symptomatic therapy is taken by a doctor.

Pain in the chest that occurs immediately after injection (see section "Side effect"), as a rule, is transient, lasts several minutes, has no connection with other symptoms, passes by itself without any clinical consequences. The mechanism of development of this symptom is unclear.

With long-term use (for several months) of Copaxone®-Teva at the injection site, lipoatrophy may develop and in some cases - necrosis of the skin.In order to prevent the development of these local reactions, it is necessary to recommend the patient strictly follow the sequence of injection sites according to a scheme in which a mandatory daily change in the site for injection should be provided. Patients with impaired renal function or cardiovascular disease should be under the supervision of a physician.

Due to the fact that Copakson®-Teva is an immunomodulating drug and is used in the treatment of autoimmune disease-multiple sclerosis, its application may be accompanied by changes in the functions of the immune system, and therefore the condition of the patient's immune system should be periodically monitored.

If the patient is unable to store syringes with Copaxone®-Teva in the refrigerator, storage at a temperature of 15-25 ° C, but not more than one month, is allowed. If the syringe with the drug has not been used for a month, and the contour pack has not been opened, these syringes should be stored in the refrigerator (2-8 ° C).

Effect on the ability to drive transp. cf. and fur:

Based on the available data, there is no need for special precautions for persons driving a vehicle or complex equipment.

Form release / dosage:

A solution for subcutaneous administration of 20 mg / ml.

Packaging:

1 ml of the drug solution in a disposable syringe made of colorless glass type I (Hebrew Pharm.) With a plastic piston and rubber sealant of the piston, with a fixed needle protected by a double cap consisting of an inner rubber and outer hard plastic parts.

For 5 syringes in a contour squeeze box made of PVC; 6 contour packs with instructions for use in a cardboard box.

For 7 syringes in a planar cell box made of PVC; on 4 contour cellular packs together with the instruction on application in a cardboard pack.

In the case of secondary packaging in the territory of the Russian Federation

4 contour packs with instructions for use in a pack of cardboard for consumer packaging subgroups chrome or chromium-ersatz according to GOST 7933-89 or imported, approved for use in the Russian Federation.

Storage conditions:

In the dark place at a temperature of 2 to 8 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-000384

Date of registration:24.03.2010 / 08.08.2017

Expiration Date:Unlimited

The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel

Manufacturer: & nbsp