Leyfferon - instructions for use, dose, side effects, contraindications

LIFFERON® is a human recombinant interferon alfa-2b, a protein synthesized by E. coli strain, into the genetic apparatus of which two genes of human leukocyte interferon alpha-2 are built. The drug is identical to human leukocyte interferon alpha-2.

One ampoule contains 500,000 IU, 1,000,000 IU, 3,000,000 IU, or 5,000,000 IU of Interferon alfa-2 human recombinant.

Excipients: sodium chloride - 7.5 mg; sodium hydrophosphate dodecahydrate - 4.53 mg; sodium dihydrogen phosphate dihydrate - 1.5 mg; disodium edetate 0.1 mg; Tween 80-0.1 mg; oxyglutathione - 0.03 mg; nipagin - 1.0 mg, water for injection - up to 1 ml.

Description:The preparation is a colorless transparent or slightly opalescent solution.

Pharmacotherapeutic group:Cytokine

ATX: & nbsp

L.03.A.B.05 Interferon alfa-2b

Pharmacodynamics:

LIFFERON® has antiviral, antitumor, immunomodulating activity.

LIFFERHON® under parenteral administration undergoes disintegration, partially excreted unchanged, mainly through the kidneys. Like all interferons, in individuals with prolonged use of the drug may cause the appearance of antibodies to interferon, which leads to a decrease in the therapeutic effect.

Indications:

LIFFERON® is used in complex therapy in adults

- with acute viral hepatitis B - moderate and severe forms at the beginning of the icteric period before the 5th day of jaundice (at a later date, the administration of the drug is less effective, the drug is not effective in developing hepatic coma and the cholestatic course of the disease);

- with acute prolonged hepatitis B and C, chronic active hepatitis B, C and D without signs of cirrhosis and with the appearance of signs of cirrhosis;

- at viral (influenza, adenovirus, enterovirus, herpetic, parotitis), viral-bacterial and mycoplasma meningoencephalitis. The drug is most effective in the first 4 days of the disease;

- with viral conjunctivitis, keratoconjunctivitis, keratitis, keratouveitis;

- with stage IV kidney cancer, hairy cell leukemia, malignant skin lymphomas (mushroom mycosis, primary reticulosis), Kalosha sarcoma, basal cell and squamous cell carcinomas, keratoacanthoma, chronic myeloid leukemia, histocytosis-X, subleukemic myelosis, essential thrombocytopenia;

- with multiple sclerosis.

LIFFERON® is used in complex therapy in children:

- with acute lymphoblastic leukemia in remission after the end of inductive chemotherapy (at 4-5 months of remission);

- with juvenile respiratory papillomatosis of the larynx, starting from the next day after removal by papillomas.

Contraindications:

- In severe forms of allergic diseases;

- during pregnancy.

Dosing and Administration:

LIFFERON® is administered intramuscularly, into the focus or under the lesion, subconjunctivalally or locally.

Intramuscular injection

In acute hepatitis B the drug is administered to 1 million ME 2 times a day for 5-6 days, then the dose is reduced to 1 million ME per day and injected for another 5 days. If necessary (after control biochemical blood tests), the treatment course can be continued for 1 million ME 2 times a week for 2 weeks. The exchange rate is 15-21 million ME.

With acute lingering and chronic active hepatitis B with the exception of delta infection and without signs of liver cirrhosis, the drug is administered 1 million ME 2 times a week for 1-2 months. If there is no effect, prolong the treatment to 3-6 months or after the end 1-2 months of treatment to carry out 2-3 similar courses at intervals of 1-6 months.

In acute chronic and chronic hepatitis C without signs of cirrhosis, the drug is administered 3 million ME 3 times a week for 6-8 months. If there is no effect, prolong the treatment to 12 months. Repeated course of treatment after 3-6 months.

With chronic active hepatitis A without signs of liver cirrhosis the drug is injected at 500 thousand - 1 million ME per day 2 times a week for 1 month. Repeated course of treatment after 1-6 months.

With chronic active hepatitis B and D with signs of cirrhosis of the liver, the drug is administered for 250 -500 thousand ME per day 2 times a week for 1 month. When there are signs of decompensation, similar repeat courses are conducted at intervals of at least 2 months

With kidney cancer the drug is used for 3 million ME daily for 10 days. Repeated courses of treatment (3-9 or more) are carried out at intervals of 3 weeks. The total amount of the drug is from 120 million ME up to 300 million ME and more.

With hairy cell leukemia the drug is administered daily for 3-6 million ME within 2 months. After the normalization of the hemogram, the daily dose of the drug is reduced to 1-2 million ME. Then, supportive therapy for 3 million ME 2 times a week for 6-7 weeks. The total amount of the drug is 420-600 million ME and more.

In acute lymphoblastic leukemia in children in the remission period after the end of inductive chemotherapy (at 4-5 months of remission) - 1 million ME 1 time a week for 6 months, then 1 every 2 weeks for 24 months. Simultaneously, supportive chemotherapy is performed.

In chronic myelogenous leukemia the drug is administered to 3 million ME daily or 6 million ME in one day. The treatment period is from 10 weeks to 6 months.

With histo-cytosis-X the drug is administered to 3 million ME daily for 1 month. Repeated courses with 1-2-month intervals for 1-3 years.

With subleukemic myelosis and essential thrombocytopenia for the correction of hyperthrombocytosis, the drug is administered 1 million ME daily or after 1 day for 20 days.

With malignant lymphomas and Kaposi's sarcoma the drug is administered to 3 million ME per day daily for 10 days in combination with cytostatics (prospidin, cyclophosphamide) and glucocorticosteroids. In the tumor stage of fungal mycosis and reticulosarcomatosis, it is advisable to alternate intramuscular injection of the drug to 3 million ME and intrafocal - 2 million ME within 10 days.

In viral, viral-bacterial and mycoplasma meningoencephalitis the drug is administered to 1 million ME 2 times a day for 10 days, in combination with antiviral and antibacterial chemotherapy. The dose and treatment regimen are set individually, depending on the severity of the patient's condition.

In patients with erythrodermal stage of fungal mycosis when the temperature rises above 39 ° C and if the process worsens, the drug should be discontinued. In case of insufficient therapeutic effect, after 10-14 days a second course of treatment is prescribed. After achieving a clinical effect, a maintenance therapy of 3 million ME once a week for 6-7 weeks.

With juvenile respiratory papillomatosis of the larynx the drug is injected at 100-150 thousand ME per kg of body weight daily for 45-50 days, then in the same dosage 3 times a week for 1 month. The second and third courses are conducted at intervals of 2-6 months.

With multiple sclerosis the drug is prescribed for 1 million ME with a pyramidal syndrome 3 times a day, with cerebellar syndrome - 1-2 times a day for 10 days followed by the introduction of 1 million ME 1 time per week for 5-6 months. The total amount of the drug is 50-60 million ME.

In persons with a high pyrogenic reaction (39 ° C and above) simultaneous use of indomethacin is recommended for the administration of the drug.

Perifocal administration

For basal cell and squamous cell carcinoma, the drug is injected under the lesion for 1 million ME 1 time per day every day for 10 days. In the case of pronounced local inflammatory reactions, the injection under the lesion conduct in 1-2 days. At the end of the course, if necessary, conduct a cryodestruction.

Subconjunctival administration

With stromal keratitis and keratoiridoiditis prescribe subconjunctival injections of the drug in a dose of 60 thousand 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 dicain. The course of treatment - from 15 to 25 injections.

Local application

For topical application to the contents of the ampoule preparation with an activity of 1 million ME add 4 ml of sodium chloride solution 0.9% for injection. In case of storage of the drug solution, it is necessary, in accordance with the rules of aseptic and antiseptic, to transfer the contents of the ampoule into a sterile vial with a stopper and store the solution in the refrigerator at 4-10 ° C for no more than 12 hours.

With conjunctivitis and superficial keratitis on the conjunctiva of the affected eye, 2 drops of solution are applied 6-8 times a day.With the disappearance of inflammatory phenomena, the number of instillations is reduced to 3-4 per day. The course of treatment is 2 weeks.

Side effects:

For parenteral administration the drug may chills, fever, fatigue, headache, malaise, flu-like syndrome. These side effects are partially suppressed by acetaminophen / paracetamol.

The local application of the drug in the mucosa of the eye can conjunctival infection, hyperemia eye mucosa, isolated follicles, conjunctival edema of the lower arch.

Also, there may be deviations from the normal laboratory values, manifested leukopenia, lymphopenia, thrombocytopenia, increased alanine aminotransferase, alkaline phosphatase. For the timely detection of these common clinical blood tests should be repeated every 2 weeks, and biochemical - every 4 weeks. Typically, these changes are usually minor, asymptomatic and reversible.

In case of severe adverse reactions or preserving them for a long time, at the physician's discretion, be temporary dose reduction (with a decrease in the number of platelets to less than 50,000 cells in 1 mm,absolute number of neutrophils less than 750 cells in 1 μl) or interruption of treatment (with a decrease in the number of platelets to less than 25,000 cells in 1 μl, an absolute number of neutrophils less than 500 cells per 1 μl).

Interaction:

Interferon alfa is able to reduce the activity of P-450 cytochromes and, consequently, interfere with the metabolism of cimetidine, phenytoin, curantyl, theophylline, diazepam, propranolol, warfarin, and some cytostatics. May enhance neurotoxic, myelotoxic or cardiotoxic effects of drugs administered earlier or simultaneously with it. You should avoid co-administration with drugs, oppressive CIC, immunosuppressive drugs (including corticosteroids).

It is not recommended to drink alcohol during treatment.

Form release / dosage:

Solution for intramuscular, subconjunctival administration and instillation into the eye, 500 000 ME or 1 000 000 ME, or 3 000 000 ME, or 5 000 000 ME.

Packaging:

In glass ampoules of 1 ml each with an activity of 500 000 ME or 1 000 000 ME, or 3 000 000 ME, or 5 000 000 ME; 5 ampoules per cell pack of PVC film; 1 or 2 cell packs together with the Instruction for use and the scarifier in a cardboard box.If the ampoules have a break ring or break point, the scarifier is not put into the package.

Or 1 ampoule together with the Instruction for use and scarifier in a cardboard bundle. If the ampoules have a break ring or break point, the scarifier is not put into the package.

Or 1 ampoule together with the Instruction for use, a scarifier, a disposable syringe with a sterile and two alcohol napkins for injection in a cardboard bundle. If the ampoules have a break ring or break point, the scarifier is not put into the package.

In glass bottles of 1 ml with an activity of 500 000 ME or 1 000 000 ME, or 3 000 000 ME, or 5 000 000 ME. The bottles are sealed with rubber stoppers and crimped with aluminum caps; 5 bottles in a box of PVC; 1 pack with instructions for use in a cardboard box.

Or 1 bottle together with the Instruction for use in a cardboard pack.

Or 1 bottle together with the Instruction for Use, a disposable syringe with a sterile and two alcohol napkins for injection in a cardboard pack.

Storage conditions:

In accordance with the requirements of JV 3.3.2-1248-03.

Store in a place protected from light and inaccessible to children at a temperature of 2 to 8 ° C.

Transport at a temperature of 2 to 8 ° C.

Shelf life:

2 years.

Not applicable after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-000091

Date of registration:31.05.2007 / 24.11.2015

Expiration Date:Unlimited

The owner of the registration certificate:VECTOR-MEDICA, CJSC VECTOR-MEDICA, CJSC Russia

Manufacturer: & nbsp

VECTOR-MEDICA, CJSC Russia

Information update date: & nbsp09.02.2018

Illustrated instructions

Instructions

Layfferon® (Lifferon®)