Vitaferon

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VIFERON®

Composition:

Active substance: recombinant human alpha-2b interferon;

1 suppository contains 250,000 IU of recombinant human alpha-2b interferon (VIFERON®-1), 500,000 IU (VIFERON®-2), 1,000,000 IU (VIFERON®-3), or 3,000,000 IU (VIFERON®-4);

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

Pharmaceutical form. Rectal suppositories.

Main physico-chemical properties: cylindrical-shaped suppositories 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. Interferons. Alpha-2b interferon. ATC code L03A B05.

Pharmacological properties.

Pharmacodynamics.

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

The use of VITAFERON® as part of combination therapy for chronic infectious and inflammatory diseases helps increase the efficacy of antibacterial and other drugs used in treatment, reduce their systemic toxic effects, and shorten the duration of therapy.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

VITAFERON®, 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;
• chronic infectious-inflammatory diseases of the urogenital tract.

The drug is used for rehabilitation of children suffering from recurrent respiratory infections.

Contraindications.

Individual hypersensitivity to interferon alfa-2b or other components of the drug; severe forms of allergic diseases in medical history; 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 liver cirrhosis; chronic hepatitis in patients receiving or recently treated with immunosuppressants (except for a short course of corticosteroid therapy); autoimmune hepatitis or other autoimmune diseases in medical history; myeloid suppression of hematopoiesis. Pregnancy or breastfeeding (safety of the drug use during pregnancy has not been established).

Interaction with other medicinal products and other types of interactions.

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

Since interferon alfa alters cellular metabolism, there is a potential possibility of modifying the effects of other medicinal products. Interferon alfa 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 (severity and duration) increases.

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

Concomitant use with zidovudine increases the risk of developing neutropenia.

Special precautions for use

VITAFERON® should be used under medical supervision. Patients should be informed about the benefits of this therapy and possible adverse reactions.

Alcohol consumption should 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 impact of patient age on the pharmacokinetics of interferon alfa-2b. If intolerance to the drug occurs, it should be discontinued. Since elderly patients usually receive medications for concomitant conditions, and interferon alfa-2b is known to affect cellular metabolism, there is a potential for altered effects of other medicinal products (see section "Interaction with other medicinal products and other forms of interaction"). This should be taken into account when treating this patient group, and their health status should be monitored due to limited data on the use of interferon alfa-2b in elderly patients.

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

All patients should undergo a comprehensive analysis of peripheral blood 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.

In all patients receiving the drug, serum albumin levels and prothrombin time should be carefully monitored.

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

It is recommended to use the drug concomitantly 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 may require dose adjustment or, in some cases, discontinuation of treatment. Therefore, the drug should be discontinued in case of prolonged blood coagulation time (in patients with chronic hepatitis), symptoms of pulmonary syndrome and 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, angioedema, 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 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 chronic conditions, the duration of treatment with VITAFERON® is determined individually, depending on the clinical picture and the course of the disease.

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

• For children aged 0 to 1 year, including premature infants, VITAFERON®-1 is administered at 250,000 IU twice daily for 5 days;
• For children aged 1 to 7 years, VITAFERON®-1 is administered at 250,000 IU twice daily for 5 days;
• For children aged 7 years and older, and adults, VITAFERON®-2 is administered at 500,000 IU twice daily for 5 days.

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

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

In complex therapy of viral-bacterial respiratory tract infections:

• For children aged 1 to 7 years, VITAFERON®-1 is administered at 250,000 IU twice daily for 10 days;
• For children aged 7 years and older, and adults, VITAFERON®-2 is administered at 500,000 IU twice daily for 10 days.

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

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

• For children under 7 years of age, VITAFERON®-1 is administered at 250,000 IU twice daily for 5 days;
• For children aged 7 years and older, VITAFERON®-2 is administered at 500,000 IU twice daily for 5 days.

For the treatment of rotavirus infection:

• For children under 1 year of age, VITAFERON®-1 is administered at 250,000 IU once daily;
• For children aged 1 to 3 years, VITAFERON®-2 is administered at 500,000 IU once daily;
• For children aged 3 to 7 years, VITAFERON®-2 is administered at 500,000 IU twice daily.

The duration of treatment is 5 days.

In complex therapy of chronic viral hepatitis B, children are administered VITAFERON® at a daily dose of 3 million IU/m² of body surface area daily for 10 days, followed by administration 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, including premature infants, are administered VITAFERON®-1 at 250,000 IU twice daily for 5 days. If necessary, the treatment course may be repeated with a 5-day interval.

In complex treatment of cervical dysplasia, VITAFERON®-4 is administered at 3,000,000 IU daily for 10 days during the sanitation phase, and also after cervical destruction during the rehabilitation period at the same dose from day 7–10 for 10 days.

In complex treatment of chronic infectious-inflammatory diseases of the urogenital tract, adults are administered VITAFERON®-3 at 1,000,000 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 infections, ENT organ infections, or recurrent type 1 herpes, VITAFERON® suppositories are administered according to the following regimen:

250,000 IU (VITAFERON®-1) twice daily for 10 days, followed by

250,000 IU (VITAFERON®-1) twice daily, 3 times per week for 2 weeks, followed by

250,000 IU (VITAFERON®-1) twice daily, 2 times per week for 2 weeks, followed by

250,000 IU (VITAFERON®-1) once at night, 2 times per week for 2 weeks, followed by

250,000 IU (VITAFERON®-1) once at night, once per week for 2 weeks.

For children aged 7 to 14 years, therapy is conducted according to the same regimen using a therapeutic dose of 500,000 IU (VITAFERON®-2).

The total duration of the course is 2 months.

Children.

VITAFERON® suppositories are used in pediatric practice, including in infants (see section "Method of Administration and Dosage"). However, comprehensive studies on the use in premature infants have not been conducted. Therefore, before initiating treatment in premature infants, the potential benefit and possible risk of therapy should be carefully evaluated.

Overdose.

No cases of acute overdose have been reported.

Side effects.

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

Possible side effects associated 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 flushes. Hypersensitivity reactions may occur.

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

Gastrointestinal and hepatic disorders: with prolonged use, increased levels of ALT and AST, elevated alkaline phosphatase levels, 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 system disorders: arterial hypertension or hypotension may occur; rarely – tachycardia.

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

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, and electrolyte imbalance may occur.

* 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). Events have been reported at various times, usually several months after initiation of interferon alfa therapy.

§ See section "Special precautions".

Reporting suspected adverse reactions.

Reporting suspected adverse reactions after drug registration is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: 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.

10 suppositories in a blister pack, 1 blister pack per cardboard box.

Prescription status.

By prescription only.

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

Manufacturer's address and location of manufacturing activities:

150 Zabolotnoho Street, Kyiv, 03143, Ukraine.

Marketing Authorization Holder: LLC "VALARTIN PHARMA".

Address of the Marketing Authorization Holder:

60 Hrushevskoho Street, Chayky village, Kyiv-Sviatoshyn district, Kyiv region, 08135, Ukraine.