Aksoglatiran^® FS (Solution) Instructions for Use

Marketing Authorization Holder

Pharmental Group, LLC (Russia)

Manufactured By

Nativa, LLC (Russia)

Or

Pharmstandard-UfaVITA OJSC (Russia)

ATC Code

L03AX13 (Glatiramer acetate)

Active Substance

Glatiramer acetate (USAN)

Dosage Form

Aksoglatiran® FS

Solution for subcutaneous administration 20 mg: syringes 28 or 30 pcs.

Dosage Form, Packaging, and Composition

Solution for s.c. administration colorless or with a slight yellowish tint, transparent or slightly opalescent.

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

1 ml – single-use glass syringes (1) – blister packs (1) – cardboard packs (28) – cardboard packs (consumer package).
1 ml – single-use glass syringes (1) – blister packs (1) – cardboard packs (30) – cardboard packs (consumer package).

Clinical-Pharmacological Group

Immunomodulator. A drug used for multiple sclerosis

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 of 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 progression of irreversible neurological impairment.

Pharmacokinetics

After s.c. 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 subcutaneously at a dose of 20 mg once daily.

Inject at the same time each day to maintain consistent drug levels.

Rotate injection sites with each administration; suitable areas include the abdomen, thighs, buttocks, and upper arms.

Avoid areas where the skin is tender, bruised, red, or hardened.

Ensure the solution is colorless to slightly yellowish and clear or slightly opalescent before use; do not use if discolored or containing particulate matter.

Treatment is long-term and requires continuous administration for therapeutic effect.

The maximum therapeutic benefit is achieved when initiated during the early stages of relapsing-remitting multiple sclerosis.

Adhere strictly to the prescribed schedule; do not alter the dose or frequency without consulting a physician.

Adverse Reactions

Nervous system disorders: asthenia, migraine, anxiety, loss of consciousness, tremor.

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

Digestive system disorders: decreased appetite, nausea, vomiting, diarrhea, difficulty swallowing, candidiasis.

Sensory organ disorders: vertigo, nystagmus, visual impairment.

Respiratory system disorders: dyspnea, difficulty breathing, acute respiratory viral infection, laryngospasm, bronchitis, hyperventilation.

Reproductive system disorders: dysmenorrhea, decreased potency.

Urinary system disorders: peripheral edema, hematuria, abnormal Papanicolaou test results.

Allergic reactions: urticaria, angioedema.

Local reactions: hyperemia, swelling, 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 on the safety of glatiramer acetate during pregnancy have not been conducted.

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

Experimental studies have not revealed mutagenic effects of glatiramer acetate or its negative impact on the reproductive system, embryonic development, or the process of childbirth.

Use in Renal Impairment

Use with caution in patients with renal impairment.

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 25°C (77°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.