Affinoleukin^® (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

L03AX (Other immunostimulants)

Dosage Forms

	Affinoleukin®	Lyophilisate for the preparation of a solution for subcutaneous administration 0.5 units: amp. 10 pcs.
		Lyophilisate for the preparation of a solution for subcutaneous administration 1 unit: amp. 10 pcs.
		Lyophilisate for the preparation of a solution for subcutaneous administration 2 units: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilisate for the preparation of a solution for subcutaneous administration

A complex of proteins with a molecular weight of 5-8 kDa, isolated by differential extraction and ultrafiltration from 500 million leukocytes of the blood of healthy donors, individually tested for the absence of hepatitis B surface antigen, hepatitis C, and antibodies to HIV-1 and HIV-2.

Excipients: glycine – 5.4 mg.

Does not contain preservatives or antibiotics.

Ampoules (10) – cardboard packs.

Clinical-Pharmacological Group

Immunomodulator

Pharmacotherapeutic Group

MIBP-cytokine

Pharmacological Action

An immunomodulator used for immunotherapy in cases of cellular immune deficiency.

Affinoleukin^® contains antigen-specific cytokines of T-cell origin. In cases of cellular immune deficiency, its administration restores lost and enhances suppressed cell-mediated immunoreactivity to antigens of widespread infectious pathogens, such as herpes simplex virus and hepatitis B virus, staphylococci, streptococci, Mycobacterium tuberculosis, Corynebacteria, and yeast-like fungi.

Indications

As an additional component of complex pharmacotherapy for exacerbations (in cases of their protracted course or the addition of a secondary infection)

• Severe and moderate forms of atopic dermatitis and psoriasis;
• Deep forms of recurrent ophthalmoherpes.

ICD codes

Dosage Regimen

Prescribed for adults and children over 2 years of age (data on use in younger children are not available).

The contents of the ampoule are dissolved immediately before use in 1 ml of isotonic (0.9%) sodium chloride solution. The drug should dissolve within no more than 15 seconds, forming a colorless transparent solution without insoluble particles.

Affinoleukin^® is administered subcutaneously once a day, 1-3 times a week; the first injection is 0.5 units, and in the absence of adverse reactions, the administered dose is increased by 0.5 units to 1 or 2 units depending on the patient’s age.

A single dose for children should not exceed 1 unit; for adolescents and adults – 2 units.

The course dose for children is typically 10 units; for adolescents and adults – 20 units.

If positive dynamics of the process are not achieved by the end of the course, it is advisable to continue the course for children up to 15 units, for adults — up to 30 units.

Upon achieving remission, for the prevention of exacerbations, it is recommended to administer 1 unit 1-2 times a month.

Preventive administration of the drug should not be started during remission in patients who have not previously received the drug to relieve an exacerbation. In case of relapse, the course of injections is repeated.

Adverse Reactions

Local and general reactions: in rare cases, when using the drug Affinoleukin^®, mild pain and paresthesia at the moment of injection, slight skin hyperemia at the injection site, and subfebrile temperature may occur.

In patients with atopic dermatitis and psoriasis, a slight, short-term increase in individual symptoms of dermatitis, hyperemia, and itching is possible; these reactions cannot serve as a reason for discontinuing the drug, as they usually do not occur with subsequent injections.

Contraindications

• Hypersensitivity to glycine.

Use in Pregnancy and Lactation

There are no data on the use of the drug Affinoleukin^® during pregnancy and lactation.

Pediatric Use

Prescribed to children over 2 years of age. Data on use in younger children are not available.

Special Precautions

Affinoleukin^® can be administered simultaneously with other medications, but in a separate syringe.

Overdose

Data on cases of overdose of the drug Affinoleukin^® have not been provided.

Drug Interactions

No drug interactions of Affinoleukin^® with other medicinal products have been identified.

Storage Conditions

The drug should be stored at a temperature between 2°C (35.6°F) and 8°C (46.4°F) in a place inaccessible to children.

Shelf Life

Shelf life – 2 years.

The drug should be transported in accordance with SP.3.2.1248-03 at a temperature between 2°C (35.6°F) and 8°C (46.4°F).

Dispensing Status

The drug is dispensed by prescription.

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.