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Stemokine® (Solution, Spray, Drops) Instructions for Use

ATC Code

L04AX (Other immunosuppressants)

Clinical-Pharmacological Group

Immunomodulator

Pharmacotherapeutic Group

Immunomodulatory agent

Pharmacological Action

An immunomodulatory agent, the sodium salt of a synthetic peptide consisting of L-amino acid residues of isoleucine, glutamic acid, and tryptophan.

It has an immunomodulatory effect, increases the body’s resistance to local and generalized infections, causes normalization of altered immunological parameters (relative and absolute lymphocyte count, CD3+, CD8+, CD19+, CD16+ lymphocytes, monocyte phagocytic capacity against St. aureus) and an increase in spontaneous chemiluminescence parameters and antibody affinity to the common antigenic determinant, and the number of HLA-DR+ lymphocytes. Maximum tropism has been identified for the bone marrow.

The mechanism of action is based on a direct effect on the process of proliferation and differentiation of early cells – hematopoietic precursors, a regulatory effect on cellular and humoral immunity reactions, and the body’s non-specific resistance.

It affects the processes of lymphoid cell differentiation, inducing the expression of differentiation antigens on leukocytes. After exposure to radiation, cytostatic drugs, it accelerates the recovery of the population of committed and pluripotent hematopoietic precursor cells. Along with the immunomodulatory effect, it has a pronounced detoxifying activity, which is determined by the structure and molecular nature of the drug.

Pharmacokinetics

When administered intranasally, it is rapidly absorbed; Cmax in the blood is reached in 10-15 minutes. In the bone marrow, liver, kidneys, and lymph nodes, Cmax is observed 30-40 minutes after administration.

When the drug is administered parenterally, Cmax in the blood is reached in 5 minutes; in the bone marrow, liver, kidneys, and lymph nodes, Cmax is observed 30-40 minutes after administration.

The T1/2 of the active substance is 24 hours; it is completely eliminated from the body within 72 hours from the moment of administration. Metabolites are excreted mainly in the urine – up to 60%, up to 20% – in the feces.

Indications

Treatment and prevention of chronic recurrent furunculosis in adults.

ICD codes

ICD-10 code Indication
L02 Cutaneous abscess, furuncle and carbuncle
ICD-11 code Indication
1B75.0 Furuncle
1B75.1 Carbuncle
1B75.2 Furunculosis
1B75.3 Pyogenic skin abscess

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

For intranasal administration using the solution, spray, or drops, apply a single dose into each nostril.

Administer the dose one to two times daily. Continue this regimen for 7 to 10 days.

For intramuscular administration, inject a single dose daily. Continue the injections for 10 days.

During the remission phase for chronic recurrent furunculosis, administer a single intramuscular dose daily. Continue this course for 5 to 7 days.

If clinically required, the duration of therapy or the dosing frequency may be increased based on the physician’s assessment of the patient’s condition and treatment response.

Adverse Reactions

Rarely allergic reactions.

Contraindications

Pregnancy, age under 18 years, hypersensitivity to the active substance.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy.

During breastfeeding, use is possible only if the expected benefit of therapy for the mother outweighs the potential risk for the child.

Use in Hepatic Impairment

Intramuscular administration is not recommended for patients with chronic liver diseases.

Use in Renal Impairment

Intramuscular administration is not recommended for patients with chronic kidney diseases.

Pediatric Use

Use in children has not been studied.

Special Precautions

Intramuscular administration is not recommended for patients with chronic liver and kidney diseases.

Effect on the ability to drive vehicles and mechanisms

Does not affect motor coordination; however, during the period of use, caution should be exercised when engaging in potentially hazardous activities that require special attention and speed of psychomotor reactions (driving vehicles, working with moving mechanisms, work of a dispatcher and operator).

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Immunotech LLC (Russia)

Manufactured By

Moscow Endocrine Plant FSUE (Russia)

Dosage Form

Bottle Rx Icon Stemokine® Nasal drops 100 mcg/1 ml: bottle 5 ml

Dosage Form, Packaging, and Composition

Nasal drops as a colorless, transparent liquid; a characteristic odor may be present.

1 ml
L-Isoleucyl-L-glutamyl-L-tryptophan sodium 100 mcg

Excipients: sodium chloride – 9 mg, sodium hydroxide solution 1M – to pH 6.0-7.5, water for injections – to 1 ml.

5 ml – glass bottles (1) complete with a dropper cap – cardboard packs.
5 ml – glass bottles (1) complete with a dropper cap – cardboard packs.

Marketing Authorization Holder

Pharma Vid, LLC (Russia)

Manufactured By

Moscow Endocrine Plant FSUE (Russia)

Dosage Form

Bottle Rx Icon Stemokine® Solution for intramuscular injection 100 mcg/1 ml: amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intramuscular injection colorless, transparent; a characteristic odor may be present.

1 ml
L-Isoleucyl-L-glutamyl-L-tryptophan sodium 100 mcg

Excipients: sodium chloride – 9 mg, sodium hydroxide solution 1M – to pH 6.0-7.5, water for injections – to 1 ml.

1 ml – glass ampoules (5) – plastic contour packs (1) – cardboard packs.
1 ml – glass ampoules (5) – plastic contour packs (2) – cardboard packs.

Marketing Authorization Holder

Pharma Vid, LLC (Russia)

Manufactured By

MBNPK Cytomed, JSC (Russia)

Dosage Form

Bottle Rx Icon Stemokine® Nasal spray, metered 25 mcg/1 dose: 3 ml bottle (24 doses), 5 ml (40 doses) or 10 ml (80 doses) with dosing pump

Dosage Form, Packaging, and Composition

Nasal spray, metered as a colorless, transparent liquid; a characteristic odor may be present.

1 dose
L-Isoleucyl-L-glutamyl-L-tryptophan sodium 25 mcg

Excipients: sodium chloride – 9 mg, sodium hydroxide solution 1M – to pH 6.0-7.5, benzalkonium chloride – 100 mcg, water for injections – to 1 ml.

3 ml (24 doses) – glass bottles (1) with a dosing pump – cardboard packs.
5 ml (40 doses) – glass bottles (1) with a dosing pump – cardboard packs.
10 ml (80 doses) – glass bottles (1) with a dosing pump – cardboard packs.

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