Lifferon Lyophilisate for intramuscular, subconjunctival injection and eye drops 3mlnIU vials, 5pcs

Composition

1 ampoule contains:

Active ingredient:

Interferon alfa-2b human recombinant 3 million IU;

Auxiliary substances:

sodium chloride,

sodium hydrophosphate dodecahydrate,

sodium dihydrophosphate dihydrate,

D-sorbitol,

urea,

rheo Polyglukin.

Pharmacological action

Laifferon has antiviral, antitumor and immunomodulatory activity.

Long-term use of the drug in individuals can cause the appearance of interferon antibodies, which leads to a decrease in effectiveness.

Indications

Adults in complex therapy:

• moderate and severe forms of acute viral hepatitis b (at the beginning of the icteric period before the 5th day of jaundice; later the drug less effective at developing hepatic coma and cholestatic disease the drug is ineffective);
• prolonged acute hepatitis b, chronic active hepatitis b, C and D with no signs of cirrhosis and signs of cirrhosis of the liver;
• viral (flu, adenovirus, enterovirus, herpes, mumps), virus-bacterial and mycoplasmal meningoencephalitis (the drug is most effective in the first 4 days of the disease);
• viral conjunctivitis, keratoconjunctivitis, keratitis, keratouveitis;
• kidney cancer stage IV, hairy cell leukemia, malignant lymphomas of the skin (mycosis fungoides, primary retikulez), Kaposi’s sarcoma, basal cell and squamous cell skin cancer keratoacanthoma, chronic myeloid leukemia, histiocytosis-X, subleukemic malosa, essential thrombocytopenia;
• multiple sclerosis.

Children in complex therapy:

• acute lymphoblastic leukemia in remission after the end of inductive chemotherapy (for 4-5 months of remission);
• juvenile respiratory laryngeal papillomatosis, starting from the next day after the removal of papillomas.

Use during pregnancy and lactation

The drug is contraindicated during pregnancy.

Contraindications

• severe forms of allergic diseases;
• pregnancy.

Side effects

From the body as a whole:  with parenteral use, chills, fever, fatigue, headache, malaise, and flu-like syndrome are possible. These side effects are partially stopped by paracetamol.

From the side of the organ of vision: when applied topically, conjunctival infection, hyperemia of the mucous membrane of the eye, single follicles, edema of the conjunctiva of the lower arch are possible.

From the side of laboratory parameters:  leukopenia, lymphopenia, thrombocytopenia, increased ALT and ALP activity. For timely detection of these abnormalities during therapy, general clinical blood tests should be repeated every 2 weeks, and biochemical blood tests should be repeated every 4 weeks. Generally, these changes are usually minor, asymptomatic, and reversible.

In case of severe adverse reactions or if they persist for a long time, a temporary dose reduction is allowed (if the platelet count is less than 50,000 / µl, the absolute neutrophil count is less than 750/µl) or interruption of treatment (if the platelet count is less than 25,000/µl, the absolute neutrophil count is less than 500/µl).

Interaction

When used concomitantly, Interferon alfa-2b can reduce the activity of microsomal liver enzymes of the cytochrome P450 system and, consequently, affect the metabolism of cimetidine, phenytoin, dipyridamole, theophylline, diazepam, propranolol, warfarin, and some cytostatics.

The drug may enhance the neurotoxic, myelotoxic, or cardiotoxic effects of drugs that have been prescribed previously or simultaneously.

How to take, course of use and dosage

I / m introduction. Average daily dose 1 million ME/day.

Perifocal use

In basal cell and squamous cell carcinoma, keratoacanthoma, the drug is administered under the lesion center for 1 million IU 1 time a day every day for 10 days. In the case of severe local inflammatory reactions, the injection under the lesion is carried out after 1-2 days. At the end of the course, cryodestruction is performed if necessary.

Subconjunctival introduction

For stromal keratitis and keratoiridocyclitis, subconjunctival injections of Laifferon are prescribed at a dose of 60 thousands IU (in volume 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% dicaine solution. The course of treatment is from 15 to 25 injections.

Local application

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

Special instructions

With laryngeal papillomatosis, complete or partial remission can be obtained, but the use of the drug is recommended preferably to prevent relapses with preliminary surgical removal of the tumor.

In acute condyloma and plantar warts, full clinical and histological efficacy was obtained in 60% of cases. In subacute hepatitis, intraperitoneal and intravenous use significantly increases the probability of survival.

In acute hepatitis B, the use of the drug is recommended if the concentration and bilirubin or the activity of” liver” enzymes remain high 4 weeks after the onset of the disease; if the hepatitis B virus surface antigen test is positive 5 weeks after the onset of the disease; if risk factors such as immunodeficiency, taking immunosuppressive drugs due to concomitant disease, intense physical activity or taking ethanol in the prodromal or initial period of the disease appear.

The use of the drug for the treatment of adults with active chronic hepatitis B with a positive test for hepatitis B virus surface antigen resulted in 50% seroconversion 6 months after the 4-month treatment regimen. When treating children with the drug,40% of seroconversion to the hepatitis B virus surface antigen was obtained 6 months after the start of treatment. It is especially effective in immunosuppressive patients with chronic active hepatitis B.

In chronic hepatitis C, the use of the drug normalizes the activity of serum ALT in 50% of cases, although half of them relapse after discontinuation of treatment. The use of the drug for shingles reduces the duration of treatment from 7-10 days to 3-4 days. Pain usually disappears in 2-3 days (instead of 5-7 days).

The use of the drug prevents the development of postherpetic neuritis. After long-term treatment of asymptomatic HIV carriers (3-52 months) with 3 million IU 3 times a week intravenously, there was a 40-month delay in the appearance of AIDS-related symptoms.

In this group of patients, the incubation period of the disease was extended by 50 months; fewer concomitant diseases and complications were observed, and there was no significant decrease in the absolute number and percentage of CD4+lymphocytes.

Early use of interferon alpha, within the first 72 hours after the onset of Dengue virus fever, can prevent the occurrence of severe hemorrhagic complications and shock. The drug causes significant clinical regression or stabilization of the disease in hairy cell leukemia, even if the patient has previously undergone splenectomy.

In chronic myeloid leukemia, remission can be achieved with interferon monotherapy, however, since the drug gives a slower effect than cytostatics, its use is recommended to maintain remission previously achieved through chemotherapy.

The use of the drug prevents relapses for a year or more, extends the life span and significantly reduces the ratio of cells positive for the Philadelphia chromosome. In the treatment of patients with non-Hodgkin’s lymphoma, it is recommended to use the drug after remission with the help of chemotherapy and radiation therapy, while significantly reducing the frequency of relapses and increasing the survival period.

The drug should be applied immediately after dissolution. Adding water should be done carefully, along the vessel wall, avoiding the formation of foam. Do not use the drug if after dissolving it, sediment, turbidity or discoloration appear in it.

Although it has not been proven that the drug has a direct cardiotoxic effect, it is possible that side effects such as fever, chills, malaise, can lead to an exacerbation of the cardiovascular disease. The use of various interferons alpha is associated with an increased risk of allergic or autoimmune symptoms, such as bronchospasm, drug-induced lupus, psoriasis, atopic dermatitis, or thyroiditis.

Although these events were extremely rare, caution should be exercised when using the drug if the patient has a history of these diseases. Adverse reactions caused by taking the drug are reversible. If they occur, it is advisable to reduce the dose or discontinue treatment and take appropriate measures in accordance with the patient’s condition.

Despite the fact that side effects during treatment with the drug are reduced, if they persist or reappear, the patient is subject to careful monitoring. The tests performed did not reveal any teratogenic effects or effects on fertility.

Studies on the effectiveness and safety of use in pregnancy have not been conducted. Given this, the doctor should conduct a risk-benefit analysis of the drug on a case-by-case basis before prescribing it. It was used in children with viral hepatitis B, laryngeal papillomatosis, as well as with benign and malignant tumors.

Side effects were similar to those experienced in adults and consisted mainly of increased body temperature and general malaise. No growth or psychosomatic abnormalities were observed even after many months of continuous treatment with the drug.

Form of production

Lyophilizate for the preparation of a solution for intramuscular, subconjunctival use and instillation in the eye

Storage conditions

The drug should be stored in a place protected from light and inaccessible to children at a temperature of 2° to 8°C.

Shelf life

3 years

Active ingredient

Interferon alfa-2b

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection

Indications

for HPV, Flu, Hepatitis, SARS