Laferobion®

I N S T R U C T I O N for medical use of the medicinal product LAFEROBION® LAFEROBIONUM®

Composition:

Active substance: interferon alfa-2b

1 suppository contains: recombinant human interferon alfa-2b – 150,000 IU or 500,000 IU;

Excipients: refined sunflower oil, tocopheryl acetate, sodium ascorbate, ascorbic acid, hard fat.

Pharmaceutical form. Suppositories.

Main physicochemical properties: spherical-shaped suppositories of whitish-yellow color and homogeneous consistency. Slight color heterogeneity may occur during storage.

Pharmacotherapeutic group. Immune stimulants. Interferons. Interferon alfa-2b.

ATC code L03A B05.

Pharmacological Properties.

Pharmacodynamics.

Recombinant alpha-2b interferon exerts pronounced antiviral, antiproliferative, and immunomodulatory effects. The active ingredient of the medicinal product Laferobion® – recombinant alpha-2b interferon – exerts immunomodulatory effects on T- and B-lymphocytes, normalizes immunoglobulin E levels, and possesses antiviral activity. Neutralizing antibodies against the antiviral activity of recombinant alpha-2b interferon do not develop, even after administration for up to 2 years, and the functioning of the endogenous system is normalized.

Pharmacokinetics.

Pharmacokinetic properties of recombinant alpha-2b interferon are poorly studied.

Clinical characteristics.

Indications.

For children: in complex therapy of acute respiratory viral infections (ARVI).

Contraindications.

Hypersensitivity to the components of the drug; presence of thyroid dysfunction in the patient; presence of severe visceral disorders in patients with Kaposi's sarcoma; severe cardiovascular diseases; psoriasis; pronounced impairment of liver and/or kidney function; epilepsy and other CNS disorders (including functional); chronic hepatitis on the background of progressive or decompensated cirrhosis of the liver; chronic hepatitis in patients who are receiving or have recently received immunosuppressive therapy (except for a short course of corticosteroid therapy); autoimmune hepatitis or other autoimmune diseases in history. Myeloid hematopoiesis suppression.

Interaction with other medicinal products and other types of interactions. The drug should be used with caution when administered simultaneously with opioid medicinal products, analgesics, hypnotics and sedatives (potentially causing myelosuppressive effect).

When used concomitantly with drugs metabolized via oxidation pathways (including xanthine derivatives – aminophylline and theophylline), possible influence of Laferobion® on oxidative metabolic processes should be taken into account. Serum theophylline concentration should be monitored and dosage regimen adjusted if necessary.

When the drug is used in combination with chemotherapeutic agents (cytarabine, doxorubicin, teniposide, cyclophosphamide), the risk of developing life-threatening toxic effects (increased severity and duration) increases.

When used concomitantly with zidovudine, the risk of developing neutropenia increases.

Special precautions for use

Treatment with Laferobion® should be carried out under medical supervision.

With prolonged use of the drug, monitoring of complete blood count, liver and kidney function, and thyroid function is required.

All patients should undergo a comprehensive analysis of peripheral blood before starting treatment and regularly during therapy, including mandatory qualitative and quantitative assessment of blood parameters, as well as biochemical blood analysis, including determination of electrolyte levels, calcium, liver enzymes, and creatinine.

All patients receiving the drug should have careful monitoring of serum albumin levels and prothrombin time.

The drug should be administered with caution in patients with a history of diabetes mellitus with episodes of ketoacidosis, chronic obstructive pulmonary diseases, coagulation disorders (including pulmonary artery thrombophlebitis), and severe myelosuppression.

During treatment with the drug, adequate hydration of the body must be ensured; if fever occurs, other potential causes should be ruled out.

It is recommended to use the drug concomitantly with antihistamine and antipyretic therapy.

Development of severe or moderate adverse effects requires dose adjustment or, in some cases, discontinuation of treatment with the drug.

Treatment with the drug should be discontinued in cases of: prolonged blood coagulation time (in patients with chronic hepatitis), pulmonary syndrome symptoms and radiological detection of infiltrates or impaired lung function, onset or worsening of visual disturbances, thyroid dysfunction (deviation from normal TSH levels), decreased serum albumin levels, and reduced prothrombin time values.

In the event of immediate-type hypersensitivity reactions (urticaria, angioneurotic edema, bronchospasm, anaphylaxis), the drug must be discontinued immediately and appropriate measures taken.

After the expiry date, use of the drug is not permitted. The drug is not subject to re-testing of quality or extension of shelf life after expiry.

This medicinal product contains less than 1 mmol (23 mg)/dose of sodium, i.e. practically sodium-free.

Use during pregnancy or breastfeeding. Data on the use of the drug during pregnancy and breastfeeding are lacking.

Ability to affect reaction speed when driving or operating machinery. Some adverse effects on the central nervous system caused by the drug may impair patients' ability to drive vehicles or operate potentially hazardous machinery.

Administration and Dosage

For children, the recommended doses in complex therapy of acute respiratory viral infections (ARVI) are as follows:

• Newborns and premature infants: administer the drug rectally at 150,000 IU, 2 suppositories per day, with a 12-hour interval. Treatment courses and intervals between courses are 5 days each.

• Premature newborns with a gestational age of less than 34 weeks: administer the drug rectally at 150,000 IU, 3 times daily (every 8 hours). The course lasts 5 days.

• Children aged 1 to 14 years: 500,000 IU twice daily for 5 days.

Children. Used in pediatric practice (see section "Administration and Dosage").

Overdose. Cases of overdose with Laferobion® have not been reported to date. However, as with overdose of any medicinal product, symptomatic therapy is recommended, along with monitoring of vital organ functions and careful observation of the patient's condition.

Adverse reactions.

All adverse reactions associated with the use of Laferobion® are mild or moderate in severity. They usually resolve after discontinuation of treatment.

The rectal administration of the drug is not accompanied by pronounced adverse reactions typically observed with parenteral administration of interferon preparations. In some cases, during the first days of treatment, influenza-like symptoms may occur, which subsequently diminish and disappear. To prevent these symptoms, paracetamol-containing preparations may be used at doses appropriate for the patient's age.

General disorders: Influenza-like conditions may occur during administration of Laferobion®: chills, fever, fatigue, malaise, as well as headache, muscle and joint pain, sweating; rarely – vomiting, dizziness, hot flushes. Hypersensitivity reactions to the drug are possible.

Blood and lymphatic system disorders: With prolonged use, leukopenia, thrombocytopenia, anemia, and nasal bleeding are possible.

Gastrointestinal and hepatic disorders: Increased levels of ALT and AST, increased alkaline phosphatase (ALP) levels, loss of appetite. Liver function abnormalities.

Endocrine disorders: Thyroid gland dysfunction.

Nervous system disorders: With prolonged use, dizziness, sleep disturbances, confusion, anxiety and depressive states, increased excitability, drowsiness, ataxia, and paresthesia are possible.

Cardiovascular disorders: Possible arterial hypertension or hypotension; rarely – tachycardia.

Skin and subcutaneous tissue disorders: Allergic reactions, including rashes (including herpetic eruptions), pruritus, hyperemia, urticaria, anaphylactic shock.

Respiratory system disorders: Cough.

Other: Local site reactions, visual disturbances, renal function abnormalities, electrolyte imbalance.

Shelf life. 2 years.

Storage conditions. Store in the original packaging protected from light at a temperature between 2 and 8 °C.

Keep out of reach of children.

Packaging.

3 or 5 suppositories in a blister pack. One blister pack containing 3 or 5 suppositories, or two blister packs containing 5 suppositories each, in a cardboard box.

Availability. Over-the-counter.

Manufacturer. FZ "STADA" LLC, Ukraine.

Manufacturer's address and location of business activity.

37, Kyivska St., Bila Tserkva, Kyiv region, 09100, Ukraine.