Glatsetat (Solution) Instructions for Use

Marketing Authorization Holder

Pharmasintez, JSC (Russia)

ATC Code

L03AX13 (Glatiramer acetate)

Active Substance

Glatiramer acetate (USAN)

Dosage Forms

	Glatsetat	Solution for subcutaneous administration 20 mg/ml: syringes 1 ml 1, 28 or 30 pcs.
		Solution for subcutaneous administration 40 mg/ml: syringes 1 ml 1, 6, 12 or 14 pcs.

Dosage Form, Packaging, and Composition

Solution for subcutaneous administration – a slightly opalescent solution from colorless to light yellow.

Excipients: mannitol – 40 mg, water for injections – up to 1 ml.

1 ml – single-dose syringes (1) – cardboard packs (1).
1 ml – single-dose syringes (1) – cardboard packs (28) – cardboard boxes.
1 ml – single-dose syringes (1) – cardboard packs (30) – cardboard boxes.
1 ml – single-dose syringes (5) – contour blisters (6) – cardboard packs.
1 ml – single-dose syringes (7) – contour blisters (4) – cardboard packs.

Solution for subcutaneous administration – a slightly opalescent solution from colorless to light yellow.

Excipients: mannitol – 40 mg, water for injections – up to 1 ml.

1 ml – single-dose syringes (1) – cardboard packs (1).
1 ml – single-dose syringes (1) – cardboard packs (6) – cardboard boxes.
1 ml – single-dose syringes (1) – cardboard packs (12) – cardboard boxes.
1 ml – single-dose syringes (3) – contour blisters (4) – cardboard packs.
1 ml – single-dose syringes (7) – contour blisters (2) – cardboard packs.

Clinical-Pharmacological Group

Drug used for diseases of the nervous system

Pharmacotherapeutic Group

Immunomodulatory agent

Pharmacological Action

Immunomodulator. It is a mixture of synthetic polypeptides formed by amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine. Copolymers from these amino acids have structural similarity to the myelin basic protein, the main component of the myelin sheaths that are destroyed in multiple sclerosis. It modifies the immune response and affects immunocompetent cells.

It competes with myelin protein, as well as myelin oligodendrocyte glycoprotein and proteolipid protein for binding to class II major histocompatibility complex molecules on the surface of antigen-presenting cells.

It stimulates the formation of antigen-specific T-lymphocytes. It blocks myelin-specific autoimmune reactions that cause the destruction of the myelin sheath of nerve fibers (demyelination) in multiple sclerosis. In the treatment of patients with relapsing-remitting multiple sclerosis, it reduces the frequency of exacerbations and slows the rate of progression of irreversible neurological disorders.

Pharmacokinetics

After subcutaneous administration, a significant portion of glatiramer acetate is hydrolyzed locally. Some of the active substance enters the lymphatic system and a small amount enters the systemic circulation unchanged.

Indications

Relapsing-remitting multiple sclerosis.

ICD codes

Dosage Regimen

Administer the 20 mg/mL formulation subcutaneously once daily.

Administer the 40 mg/mL formulation subcutaneously three times per week. Maintain at least 48 hours between injections; do not administer on consecutive days.

Inject the entire contents of the single-dose syringe (1 mL). Adhere to a consistent time of day for administration.

Rotate injection sites with each administration. Use the thigh, abdomen, upper arm, or buttock. Avoid injecting into areas with redness, tenderness, bruising, or scarring.

Treatment is long-term. Do not discontinue therapy without consulting your physician.

Initiate treatment under the guidance of a healthcare professional experienced in managing multiple sclerosis.

Inspect the solution visually for particulate matter and discoloration prior to administration. Use only if the solution is clear, colorless to light yellow, and essentially free of particles.

Allow the syringe to reach room temperature for 20 minutes before injection. Do not warm using any other heat source.

Adverse Reactions

From the nervous system: asthenia, migraine, anxiety, loss of consciousness, tremor.

From the cardiovascular system: facial flushing, sensation of heaviness and pain in the chest, palpitations, arrhythmia, vasodilation, increased blood pressure.

From the digestive system: decreased appetite, nausea, vomiting, diarrhea, difficulty swallowing, candidiasis.

From the sensory organs: vertigo, nystagmus, visual impairment.

From the respiratory system: dyspnea, difficulty breathing, acute respiratory viral infection, laryngospasm, bronchitis, hyperventilation.

From the reproductive system: dysmenorrhea, decreased potency.

From the urinary system: peripheral edema, hematuria, abnormal Papanicolaou test results.

Allergic reactions: urticaria, angioedema.

Local reactions: hyperemia, edema, skin itching, pain at the injection site.

Other: arthralgia, lymphadenopathy, back pain, increased sweating, flu-like syndrome.

Contraindications

Pregnancy, breastfeeding period, children and adolescents under 18 years of age, hypersensitivity to glatiramer acetate.

Use in Pregnancy and Lactation

Adequate and well-controlled studies of the safety of glatiramer acetate during pregnancy have not been conducted.

It is unknown whether Glatiramer acetate is excreted in breast milk, so if it is necessary to use during lactation, breastfeeding should be discontinued.

In experimental studies, no mutagenic effects of glatiramer acetate or its negative impact on the reproductive system, embryonic development, or the birth process were identified.

Use in Renal Impairment

Use with caution in patients with impaired renal function.

Pediatric Use

Contraindication: children and adolescents under 18 years of age.

Geriatric Use

The efficacy and safety of use in elderly patients have not been studied.

Special Precautions

The maximum therapeutic effect is achieved when treatment is started at an early stage of the disease.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.