Leucinferon (Suppositories) Instructions for Use

Marketing Authorization Holder

Intekor Science And Production Firm, LLC (Russia)

ATC Code

L03AB01 (Interferon alfa)

Active Substance

Interferon alfa (Rec.INN registered by WHO)

Dosage Form

Leucinferon

Rectal suppositories 40 thousand IU: 10 pcs.

Dosage Form, Packaging, and Composition

10 pcs. – 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 exerts antiviral, immunostimulatory, and antiproliferative effects.

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 alters the properties of the cell membrane, stimulates specific enzymes, acts on viral RNA, and prevents its replication.

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

Pharmacokinetics

When administered 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 use: 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 radiotherapy and chemotherapy in patients with oncological diseases.

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

ICD codes

Dosage Regimen

Administer Leucinferon rectally. The dosage regimen is determined by the specific indication, disease severity, and individual patient response.

For acute and chronic viral hepatitis, administer 1 suppository (40,000 IU) twice daily. The standard treatment course is 10 days.

For immunodeficiencies during radiotherapy or chemotherapy, use 1 suppository twice daily for 5-10 days.

For the prevention and treatment of influenza and acute respiratory viral infections (ARVI), administer 1 suppository twice daily for 5 days.

For pediatric patients, the dose is determined by the physician based on the child’s age and body surface area.

Adhere strictly to the prescribed duration of therapy. Do not interrupt the course without medical advice.

Monitor blood cell counts and liver function parameters during prolonged treatment.

Adverse Reactions

Flu-like symptoms with parenteral use – 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 CNS functions; hepatic failure; diabetes mellitus with ketoacidosis; pregnancy, breastfeeding period.

For inhalation and intranasal use: no contraindications.

With caution

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

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

Use in Pregnancy and Lactation

Intramuscular administration is contraindicated during pregnancy and breastfeeding.

Inhalation and intranasal use of interferon alfa drugs during pregnancy and breastfeeding is possible only in cases where the intended benefit to the mother outweighs the potential risk to 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

Used in children by inhalation and intranasally in the corresponding dosage forms.

Geriatric Use

Inhalation and intranasal use is permitted in elderly patients.

Special Precautions

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

Effect on ability to drive vehicles and operate machinery

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

Combinations with drugs that have a depressant effect on the CNS, immunosuppressants, and ethanol should be avoided.

Experimental studies have shown that simultaneous use of interferon alfa drugs for inhalation and intranasal administration with methyluracil or lysozyme results in a synergistic effect.

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.