Locferon (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Biomed named after I.I.Mechnikov, PJSC (Russia)

ATC Code

L03AB01 (Interferon alfa)

Active Substance

Interferon alfa (Rec.INN registered by WHO)

Dosage Form

Locferon

Lyophilisate for preparation of solution for topical application 8 thousand IU: vial 1 pc.

Dosage Form, Packaging, and Composition

8000 IU – vials (1) – cardboard packs.

Clinical-Pharmacological Group

Interferon. An immunomodulatory drug with antiviral action

Pharmacotherapeutic Group

MIBP-cytokine

Pharmacological Action

Interferon alfa is a mixture of various subtypes of natural alpha-interferon from human blood leukocytes.

It has antiviral, immunostimulatory, and antiproliferative action.

The antiviral action of the drug is based mainly on increasing the resistance of body cells not yet infected by the virus to possible exposure.

By binding to specific receptors on the cell surface, Interferon alfa changes the properties of the cell membrane, stimulates specific enzymes, acts on viral RNA, and prevents its replication.

The immunomodulatory action of interferon alfa is associated with stimulation of the activity of macrophages and NK (Natural killer) cells, which, in turn, participate in the body’s immune response.

Pharmacokinetics

When used by inhalation or intranasally, it is rapidly absorbed through the mucous membranes. It is eliminated from the body in the form of natural metabolites.

Indications

For parenteral application: treatment of viral infections in adults and children (as part of complex therapy with etiotropic and symptomatic agents); correction of immunodeficiency states in acute and chronic infections of various etiologies; during courses of radio- and chemotherapy in patients with oncological diseases.

For intranasal and inhalation application: prevention and treatment of influenza and other acute respiratory viral infections.

ICD codes

Dosage Regimen

Reconstitute the lyophilisate immediately before use with 2 mL of water for injections or sterile 0.9% sodium chloride solution to yield a solution containing 4,000 IU/mL.

For intranasal application, administer the solution as drops or spray. For prophylaxis of influenza and ARVI, instill 2-3 drops or 1 spray into each nostril twice daily with an interval of at least 6 hours. For treatment, use the same regimen at the first signs of illness.

For inhalation application, use through a nebulizer. For one inhalation, use the contents of 1 vial (8,000 IU) dissolved in 3-5 mL of sterile 0.9% sodium chloride solution warmed to 37°C (98.6°F). Perform inhalations twice daily for 2-3 days.

For intramuscular administration, the dose is determined by the treating physician based on the specific indication and disease severity. The typical adult dose ranges from 1 to 3 million IU administered daily or three times per week. The duration of therapy is individualized.

For pediatric patients, use only the intranasal or inhalation routes for the prevention and treatment of influenza and ARVI. Adhere strictly to the prescribed dosage and frequency.

Adjust the frequency and duration of application based on the clinical response and tolerability. Discontinue treatment if severe adverse reactions occur.

Adverse Reactions

Flu-like symptoms with parenteral application – fever, headache, myalgia, weakness.

Allergic reactions urticaria, polymorphic rash.

Contraindications

For intramuscular administration: hypersensitivity to drugs of protein origin; autoimmune diseases (including in the medical history); acute myocardial infarction; renal failure; epilepsy and/or impaired functions of the central nervous system; hepatic failure; diabetes mellitus with ketoacidosis; pregnancy, period of breastfeeding.

For inhalation and intranasal application: there are no contraindications.

With caution

For intramuscular administration: arrhythmias, post-infarction cardiosclerosis, depression of bone marrow hematopoiesis.

For intranasal and inhalation administration: hypersensitivity to antibiotics, drugs of protein origin, to chicken meat and eggs; history of allergic diseases.

Use in Pregnancy and Lactation

Intramuscular administration is contraindicated during pregnancy and the period of breastfeeding.

Inhalation and intranasal application of interferon alfa drugs during pregnancy and the period of breastfeeding is possible only in cases where the intended benefit for the mother outweighs the potential risk for the fetus or breastfed infant.

Use in Hepatic Impairment

Parenteral administration is contraindicated in hepatic failure.

Use in Renal Impairment

Parenteral administration is contraindicated in renal failure.

Pediatric Use

It is used in children by inhalation and intranasally in the appropriate dosage forms.

Geriatric Use

Inhalation and intranasal application in elderly patients is permitted.

Special Precautions

During treatment, the content of blood formed elements and liver function should be monitored.

Influence on the ability to drive vehicles and mechanisms

During treatment, caution should be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

Avoid combinations with drugs that have a depressant effect on the central nervous system, immunosuppressants, ethanol.

Experimental studies have shown that with simultaneous use of interferon alfa drugs for inhalation and intranasal administration with methyluracil or lysozyme, a synergism of action is observed.

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.