Liferon 3 million IU 5 pcs vial lyophilisate for solution for intramuscular injection

Lifeferon® is used in combination therapy for adults:

• for acute viral hepatitis B - moderate and severe forms during the early jaundice period up to the 5th day of jaundice (the drug is less effective if administered later; it is ineffective in developing hepatic coma and cholestatic course of the disease);

• for acute prolonged hepatitis B and C, chronic active hepatitis B and C including with delta agent, without signs of cirrhosis and with the appearance of signs of liver cirrhosis;

• for viral (influenza, adenoviral, enteroviral, herpes, mumps), viral-bacterial, and mycoplasmal meningoencephalitis. The use of the drug is most effective in the first 4 days of the disease;

• for stage IV kidney cancer, hairy cell leukemia, malignant lymphomas of the skin (mycosis fungoides, primary reticulosis, reticulosarcomatosis), Kaposi's sarcoma, basal cell and squamous cell skin cancers, keratoacanthoma, chronic myeloleukemia, Langerhans cell histiocytosis, subleukemic myelosis, essential thrombocythemia;

• for multiple sclerosis;

• for viral conjunctivitis, keratoconjunctivitis, keratitis, keratoiridocyclitis, keratouveitis.
Lifeferon® is used in combination therapy for children from 1 year:

• for acute lymphoblastic leukemia in the remission period after the completion of induction chemotherapy (in the 4th-5th month of remission);

• for juvenile respiratory papillomatosis of the larynx, starting from the next day after the removal of papillomas.

Liferon® is administered intramuscularly, to the focus or under the focus of the lesion, subconjunctivally, or locally. Immediately before use, the contents of the ampoule (vial) are dissolved in water for injections or in a 0.9% sodium chloride solution (1 ml for intramuscular administration and to the focus, 5 ml for subconjunctival and local administration). The solution should be colorless, with slight opalescence, free of sediment and foreign inclusions. The dissolution time should be about 10 minutes.

Intramuscular administration
In acute viral hepatitis B, the drug is administered at a dose of 1 million ME twice a day for 5-6 days, then the dose is reduced to 1 million ME per day and continued for another 5 days. If necessary (after control biochemical blood tests), the treatment course may be extended to 1 million ME twice a week for 2 weeks. The total course dose is 15-21 million ME.
In acute prolonged and chronic viral hepatitis B, excluding the delta agent and without signs of liver cirrhosis, the drug is administered at a dose of 1 million ME twice a week for 1-2 months. If there is no effect, treatment may be extended to 3-6 months or after completing 1-2 months of treatment, conduct 2-3 similar courses with intervals of 1-6 months.
In chronic viral hepatitis B with the delta agent without signs of liver cirrhosis, the drug is administered at a dose of 0.5-1 million ME per day twice a week for 1 month. A repeat treatment course is given after 1-6 months.
In chronic viral hepatitis B with the delta agent and signs of liver cirrhosis, the drug is administered at a dose of 0.25-0.5 million ME per day twice a week for 1 month. If signs of decompensation appear, similar repeat courses are conducted with intervals of at least 2 months.
In acute prolonged and chronic active hepatitis C without signs of liver cirrhosis, the drug is administered at a dose of 3 million ME three times a week for 6-8 months. If there is no effect, treatment may be extended to 12 months. A repeat treatment course is given after 3-6 months.
In viral, viral-bacterial, and mycoplasmal meningoencephalitis, the drug is administered at a dose of 1 million ME twice a day for 10 days, in combination with antiviral and antibacterial chemotherapeutics. The dose and treatment regimen are determined individually, depending on the severity of the patient's condition.
In kidney cancer, the drug is used at a dose of 3 million ME daily for 10 days. Repeat treatment courses (3-9 or more) are conducted with intervals of 3 weeks. The total amount of the drug is from 120 million ME to 300 million ME or more.
In hairy cell leukemia, the drug is administered daily at a dose of 3-6 million ME for 2 months. After normalization of the blood count, the daily dose is reduced to 1-2 million ME. Then, supportive therapy is prescribed at a dose of 3 million ME twice a week for 6-7 weeks. The total amount of the drug is 420-600 million ME or more.
In acute lymphoblastic leukemia in children during the remission period after the completion of induction chemotherapy (in the 4th-5th month of remission) - at a dose of 1 million ME once a week for 6 months, then once every 2 weeks for 24 months. Supportive chemotherapy is conducted simultaneously.
In malignant lymphomas and Kaposi's sarcoma, the drug is administered at a dose of 3 million ME daily for 10 days in combination with cytostatics (prospidine, cyclophosphamide) and glucocorticosteroids. In the tumor stage of mycosis fungoides, primary reticulosis, and reticulosarcomatosis, it is advisable to alternate intramuscular administration of the drug at 3 million ME and local administration at 2 million ME for 10 days.
In patients with erythrodermic stage of mycosis fungoides with a temperature rise above 39°C and in case of exacerbation of the process, the administration of the drug should be discontinued. If there is insufficient therapeutic effect after 10-14 days, a repeat treatment course is prescribed. After achieving a clinical effect, supportive therapy is prescribed at a dose of 3 million ME once a week for 6-7 weeks.
In chronic myeloleukemia, the drug is administered at a dose of 3 million ME daily or 6 million ME every other day. The treatment duration is from 10 weeks to 6 months.
In Langerhans cell histiocytosis, the drug is administered at a dose of 3 million ME daily for 1 month. Repeat courses are given with intervals of 1-2 months for 1-3 years.
In subleukemic myelosis and essential thrombocythemia for correcting hyperthrombocytosis - at a dose of 1 million ME daily or every other day for 20 days.
In juvenile respiratory papillomatosis of the larynx, the drug is administered at a dose of 0.1-0.15 million ME per kg of body weight daily for 45-50 days, then at the same dosage 3 times a week for 1 month. The second and third courses are conducted with intervals of 2-6 months.
In multiple sclerosis, the drug is prescribed at a dose of 1 million ME for pyramidal syndrome 3 times a day, for cerebellar syndrome - 1-2 times a day for 10 days, followed by administration of 1 million ME once a week for 5-6 months. The total amount of the drug is 50-60 million ME.
In individuals with a high pyrogenic reaction (39°C and above) to the administration of the drug, simultaneous use of paracetamol or indomethacin is recommended.

Perifocal administration
In basal cell and squamous cell carcinoma, keratoacanthoma, the drug is administered under the focus of the lesion at a dose of 1 million ME once a day for 10 days. In case of pronounced local inflammatory reactions, administration under the focus of the lesion is performed after 1-2 days. After completing the course, if necessary, cryodestruction is performed.

Subconjunctival administration
In stromal keratitis, keratoiridocyclitis, keratouveitis, subconjunctival injections of the drug are prescribed at a dose of 60,000 ME in a volume of 0.5 ml daily or every other day, depending on the severity of the process. Injections are performed under local anesthesia with a 0.5% solution of dikain. The treatment course is from 15 to 25 injections.

Local application
For local application, the contents of the ampoule (vial) of the drug with an activity of 1 million ME are dissolved in 5 ml of a 0.9% sodium chloride solution for injections. If the solution of the drug is stored, it is necessary, following the rules of asepsis and antiseptics, to transfer the contents of the ampoule to a sterile vial with a stopper and store the solution in the refrigerator at (4-10) °C for no more than 12 hours.
In conjunctivitis and superficial keratitis, 2 drops of the solution are applied to the conjunctiva of the affected eye 6-8 times a day. As inflammatory phenomena disappear, the number of instillations is reduced to 3-4 times a day. The treatment course is 2 weeks.

Each ampoule or bottle contains: active ingredient - 3 million IU of recombinant human interferon alpha-2b; excipients: sodium chloride - 9.2 mg; sodium phosphate dodecahydrate (disodium phosphate 12-hydrate) - 2.74 mg; sodium dihydrogen phosphate dihydrate (monosodium phosphate 2-hydrate) - 0.37 mg; dextran with a molecular weight of 30,000 to 40,000 (in the form of "Reopoliglyukin" solution, containing 100 mg/ml of dextran in 0.9% sodium chloride solution) - 8.0 mg; sorbitol (D-sorbitol) - 3.0 mg; urea - 0.1 mg.

A powder or porous mass of white color. Hygroscopic.

• In case of hypersensitivity to the components of the product;

• in severe forms of allergic diseases;

• during pregnancy and lactation.
Pregnancy and lactation:
The product is contraindicated for use during pregnancy and lactation.

In the case of severe side effects or their persistence for an extended period, at the discretion of the physician, a temporary reduction in dosage is allowed (if the platelet count drops to less than 50,000 cells per μL, absolute neutrophil count less than 750 cells per μL) or discontinuation of treatment (if the platelet count drops to less than 25,000 cells per μL, absolute neutrophil count less than 500 cells per μL).
Effect of the drug on the ability to drive vehicles and operate machinery:
During the use of the drug, patients experiencing fatigue, drowsiness, or disorientation should refrain from engaging in potentially dangerous activities that require increased attention and quick psychomotor responses.

When administered parenterally, the drug may cause chills, fever, fatigue, headache, malaise, and flu-like syndrome. These side effects can be partially alleviated with paracetamol or indomethacin.
When applied locally to the mucous membrane of the eye, possible side effects include conjunctival infection, hyperemia of the mucous membrane of the eye, isolated follicles, and swelling of the conjunctiva of the lower fornix.
The use of the drug may lead to deviations from normal laboratory parameters, manifesting as leukopenia, lymphopenia, thrombocytopenia, and elevated levels of alanine aminotransferase and alkaline phosphatase. To timely detect these deviations during therapy, complete blood counts should be repeated every 2 weeks, and biochemical tests every 4 weeks. Generally, these changes are usually minor, asymptomatic, and reversible.

No cases of overdose have been observed. Considering that the active substance is interferon alpha-2b, overdose may lead to an increased severity of side effects.
Treatment: discontinuation of the medication; symptomatic therapy may be administered if necessary.

Interferon alpha-2b can reduce the activity of cytochrome P450 and, consequently, interfere with the metabolism of cimetidine, phenytoin, dipyridamole, theophylline, diazepam, propranolol, warfarin, and some cytostatics. It may enhance the neurotoxic, myelotoxic, or cardiotoxic effects of medications prescribed previously or concurrently with it. Co-administration with CNS depressants and immunosuppressive agents (including corticosteroids) should be avoided.
Alcohol consumption during treatment is not recommended.

Liferon® has antiviral, antitumor, and immunomodulatory activity.
Liferon® undergoes degradation upon parenteral administration, with a portion excreted unchanged, primarily through the kidneys. As with all interferons, in some individuals, prolonged use of the drug may lead to the development of antibodies to interferon, resulting in a reduced therapeutic effect.