Laferron-farmbiotek®

INSTRUCTIONS for medical use of the medicinal product Laferon-PharmBiotek® (Laferon-PharmBiotek®)

Composition:

Active substance: human recombinant interferon alfa-2b;

One suppository contains 250,000 IU, 500,000 IU, 1 million IU, or 3 million IU of human recombinant interferon alfa-2b;

Excipients: dextran 70, polysorbate 80, citric acid monohydrate, sodium hydroxide, edetate disodium, emulsifier T-2, hard fat.

Pharmaceutical form. Rectal suppositories.

Main physicochemical properties: cylindrical-shaped suppository with a pointed end, white to light yellow in color, of uniform consistency; a funnel-shaped depression at the cross-section may be present.

Pharmacotherapeutic group.

Immunostimulants. Interferon alfa-2b. ATC code L03AB05.

Pharmacological Properties

Pharmacodynamics

Laferon-FarmBiotech® has a broad spectrum of biological activity. The most important effects are its pronounced antiviral and immunostimulatory actions, as well as activation of antitumor defense. Interferons (IFN) regulate interactions between cellular and humoral immunity. Under the influence of IFN, differentiation and activity of natural killer cells and T-lymphocytes are enhanced, thereby promoting an active course of cellular immune responses. IFN regulate the production of inflammatory mediators, influence migration of inflammatory cells to the pathological focus, stimulate phagocytosis and other bactericidal reactions, thus normalizing the dynamics of the inflammatory process. IFN also directly inhibit viral replication and transcription; they affect key stages of replication of intracellular pathogens, halting their proliferation and ensuring effective lysis of infectious agents. IFN are characterized by high antiviral and anti-chlamydial activity.

The use of Laferon-FarmBiotech® as part of complex treatment for chronic infectious and inflammatory diseases enhances the efficacy of antibacterial and other drugs used in therapy, reduces their systemic toxic effects, and shortens the duration of treatment.

Pharmacokinetics

Not studied.

Clinical characteristics.

Indications.

Laferon-FarmBiotech®, rectal suppositories, are used in children and adults as monotherapy and as part of complex treatment for various viral and viral-bacterial infections. The drug is indicated for:

• influenza and acute respiratory viral infections (ARVI),
• viral-bacterial infections of the respiratory tract,
• childhood viral infectious diseases (epidemic parotitis, measles, rubella, varicella, mononucleosis),
• rotavirus infection,
• chronic viral hepatitis B in children,
• intrauterine infections (TORCH infections), pneumonia, sepsis, meningitis in children,
• cervical dysplasia associated with human papillomavirus (HPV),
• chronic infectious-inflammatory diseases of the urogenital tract.

The drug is used for rehabilitation of children who frequently suffer from respiratory infections.

Contraindications.

Individual hypersensitivity to alpha-2b interferon or other components of the drug; severe forms of allergic diseases in medical history; 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 liver cirrhosis; 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 medical history; myeloid hematopoiesis suppression. Pregnancy or breastfeeding (the safety of using the drug during pregnancy has not been established).

Interaction with other medicinal products and other types of interactions.

Laferon-FarmBiotech® is compatible with antibiotics and hormones used in the treatment of viral, viral-bacterial, and autoimmune diseases.

Since alpha interferon alters cellular metabolism, there is a potential possibility of modifying the effects of other medicinal products. Alpha interferon may alter oxidative metabolic processes, which should be taken into account when co-administering drugs metabolized via this pathway (cimetidine, phenytoin, warfarin, theophylline, aminophylline, diazepam, propranolol).

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

The drug should be used with caution when administered simultaneously with opioid medicinal products, analgesics, hypnotics, and sedatives (potentially causing myelosuppressive effects).

Concomitant use with zidovudine increases the risk of developing neutropenia.

Special precautions.

Laferon-FarmBioTek® should be used under the supervision of a physician. Patients should be informed about the benefits of this therapy and possible adverse reactions.

Alcohol consumption must be avoided during treatment with this medication.

The drug should be prescribed with caution in patients with a history of diseases such as diabetes mellitus with episodes of ketoacidosis, chronic obstructive pulmonary diseases, and coagulation disorders.

Elderly patients. There is no clear effect of patient age on the pharmacokinetics of interferon alfa-2b. If intolerance to the drug occurs, it should be discontinued. Since elderly patients often receive medications for concomitant conditions, and interferon alfa-2b is known to alter cellular metabolism, there is a potential for modification of the effects of other drugs (see section "Interaction with other medicinal products and other forms of interaction"). This should be taken into account when treating such patients, and their health status should be monitored due to insufficient data on the use of interferon alfa-2b in elderly patients.

During prolonged treatment, regular monitoring of complete blood count, liver and kidney function, and thyroid function should be performed.

All patients should undergo a comprehensive peripheral blood analysis before starting treatment and at regular intervals during therapy, including qualitative and quantitative assessment of blood parameters, as well as biochemical blood tests, including electrolytes, calcium, liver enzymes, bilirubin, and creatinine.

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

Adequate hydration should be ensured during treatment with this drug; if fever occurs, other causes of fever should be ruled out.

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

During prolonged parenteral administration of medicinal products containing the active substance interferon alfa-2b, the development of severe or moderate adverse effects requires dose adjustment or, in some cases, discontinuation of treatment. Therefore, the drug should be discontinued in case of prolonged blood clotting time (in patients with chronic hepatitis), pulmonary syndrome, radiological detection of infiltrates or impaired lung function, onset or worsening of visual disturbances, thyroid dysfunction (abnormal TSH levels), decreased serum albumin levels, and reduced prothrombin time values.

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

Use during pregnancy or breastfeeding.

There is insufficient data on the use of the drug during pregnancy or breastfeeding. Use is contraindicated.

Ability to affect reaction speed when driving vehicles or operating machinery.

Medicinal products containing the active substance interferon alfa-2b may cause drowsiness, weakness, fatigue, and lead to reduced psychomotor reaction speed. In such cases, patients should refrain from driving vehicles or operating machinery.

Method of Administration and Dosage

The drug is administered rectally.

For the treatment of diseases with a prolonged course, the treatment regimen with Laferon-FarmBiotech® is established individually, taking into account the clinical picture and disease progression.

In complex therapy of influenza and acute respiratory viral infections (ARVI):

• For children aged 0 to 1 year: Laferon-FarmBiotech® 250,000 IU twice daily for 5 days;
• For children aged 1 to 7 years: Laferon-FarmBiotech® 250,000 IU twice daily for 5 days;
• For children aged 7 years and older, and adults: Laferon-FarmBiotech® 500,000 IU twice daily for 5 days.

If necessary, the treatment course may be repeated after a 5-day interval.

In cases of severe ARVI and influenza, the single dose may be doubled.

In complex therapy of viral-bacterial respiratory tract infections:

• For children aged 1 to 7 years: Laferon-FarmBiotech® 250,000 IU twice daily for 10 days;
• For children aged 7 years and older, and adults: Laferon-FarmBiotech® 500,000 IU twice daily for 10 days.

Subsequently, maintenance therapy with interferon preparation may be prescribed for 1–12 months according to an individual regimen.

For the treatment of childhood viral infectious diseases (epidemic parotitis, measles, rubella, varicella, mononucleosis):

• For children aged 1 to 7 years: Laferon-FarmBiotech® 250,000 IU twice daily for 5 days;
• For children aged 7 years and older: Laferon-FarmBiotech® 500,000 IU twice daily for 5 days.

For the treatment of rotavirus infection:

• For children aged 3 months to 1 year: Laferon-FarmBiotech® 250,000 IU once daily;
• For children aged 1 to 3 years: Laferon-FarmBiotech® 500,000 IU once daily;
• For children aged 3 to 7 years: Laferon-FarmBiotech® 500,000 IU twice daily.

The duration of treatment is 5 days.

In complex therapy of chronic hepatitis B, children aged 2 years and older receive Laferon-FarmBiotech® at a daily dose of 3 million IU/m² of body surface area daily for 10 days, followed by 3 times per week for 6–12 months. The duration of treatment is determined individually based on clinical and virological parameters.

In complex therapy of various infectious-inflammatory diseases (intrauterine infections, pneumonia, sepsis, meningitis, etc.), children aged 0 to 1 year receive Laferon-FarmBiotech® 250,000 IU twice daily for 5 days. If necessary, the treatment course may be repeated after a 5-day interval.

In complex treatment of cervical dysplasia, Laferon-FarmBiotech® 3 million IU is administered daily for 10 days during the sanitation phase, and also after cervical destruction during the rehabilitation period at the same dose, starting from day 7–10, for 10 days.

In complex treatment of chronic infectious-inflammatory diseases of the urogenital tract, adults receive Laferon-FarmBiotech® 1 million IU once daily for 10 days. Treatment should be administered to both sexual partners.

For rehabilitation of children aged 1 to 7 years suffering from recurrent viral-bacterial respiratory tract infections, recurrent infections of the LOR organs, or recurrent type 1 herpes, Laferon-FarmBiotech® suppositories are administered according to the following regimen:

250,000 IU twice daily for 10 days, then
250,000 IU twice daily, 3 times per week for 2 weeks, then
250,000 IU twice daily, 2 times per week for 2 weeks, then
250,000 IU once at night, 2 times per week for 2 weeks, then
250,000 IU once at night, 1 time per week for 2 weeks.

For children aged 7 to 14 years, therapy is administered according to the same regimen using a therapeutic dose of 500,000 IU.

The total duration of the course is 2 months.

Children.

Laferon-FarmBiotech® in suppositories is used in pediatric practice, including in infants (see section "Method of Administration and Dosage"). However, comprehensive studies in preterm infants have not been conducted. Therefore, before initiating therapy in preterm infants, the potential benefit and possible risks of treatment should be carefully evaluated.

Overdose.

Cases of acute overdose have not been reported.

Adverse reactions.

When using basic treatment courses with Laferon-FarmBioTek® suppositories at recommended doses, adverse effects are not observed. The rectal route of administration does not cause pronounced adverse reactions typically seen with parenteral administration of interferon preparations. In individual cases, influenza-like symptoms may occur during the first days of treatment, which subsequently diminish and disappear. To prevent these symptoms, paracetamol-containing preparations may be used at doses appropriate to the patient's age.

The following adverse effects may occur with the use of interferon alfa-2b:

General disorders: influenza-like symptoms – chills, fever, fatigue, malaise, headache, muscle and joint pain, sweating; rarely – vomiting, dizziness, hot flashes. Hypersensitivity reactions may also occur.

Blood and lymphatic system disorders: with prolonged use, leukopenia and thrombocytopenia, anemia may occur, which resolve upon dose reduction.

Gastrointestinal and hepatic disorders: with prolonged use, increased levels of ALT and AST, elevated alkaline phosphatase, loss of appetite, and impaired liver function may occur.

Endocrine disorders: with prolonged use, thyroid dysfunction may occur.

Nervous system disorders: with prolonged use, dizziness, sleep disturbances, confusion, anxiety and depressive states, increased excitability, somnolence, ataxia, and paresthesia may occur.

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

Skin and subcutaneous tissue disorders: allergic reactions, including rash (including herpetic), pruritus, hyperemia, urticaria.

Respiratory system disorders: epistaxis; with prolonged use – dyspnea, cough, pulmonary arterial hypertension*.

Immune system disorders: acute hypersensitivity reactions§, anaphylactic shock.

Other: local site reactions; with prolonged use – visual disturbances, impaired kidney function, electrolyte imbalance.

* Cases of pulmonary arterial hypertension (PAH) have been reported with parenteral administration of interferon alfa, particularly in patients with risk factors for PAH (such as portal hypertension, HIV infection, liver cirrhosis). These events have been reported at various times, usually several months after initiation of interferon alfa therapy.

§ See section "Special precautions for use".

Reporting suspected adverse reactions.

Reporting suspected adverse reactions after marketing authorization is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmacy professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.

Shelf life.

1.5 years.

Storage conditions.

Store in the original packaging at a temperature between 2 °C and 8 °C. Keep out of reach of children.

Packaging.

5 suppositories in a blister pack; 2 blister packs in a cardboard box.

Prescription status. Prescription only.

Manufacturer: LLC "Scientific and Production Company "Interpharmbiotek".

Manufacturer's address and location of business activity.

150 Zabolotnoho Street, Kyiv, 03143, Ukraine.