Description
Laifferon Pharmacodynamics
Layfferon® has antiviral, antitumor, immunomodulatory activity.
Layfferon® under parenteral administration is degraded, partially excreted unchanged, mainly through the kidneys. As all interferons, in individuals with prolonged use, the drug may cause appearance of antibodies to interferon, which reduces the therapeutic effect.
Indications
Laifferon® is used in combination therapy in adults:
– in acute viral hepatitis B – moderate and severe forms at the beginning of jaundice period until the 5th day of jaundice (in later terms the drug administration is less effective; the drug is not effective in developing hepatic coma and cholestatic course of the disease);
– in acute prolonged hepatitis B and C, chronic active hepatitis B and C including delta agent, without signs of cirrhosis and in case of signs of cirrhosis;
– in viral (influenza, adenovirus, enterovirus, herpes, parotitis), viral-bacterial and mycoplasmal meningoencephalitis. Application of the drug is most effective in the first 4 days of the disease;
– in stage IV renal cancer, hairy cell leukemia, malignant skin lymphomas (mycosis fungoides, primary reticulosis, reticulosarcomatosis), Kaposi sarcoma, basal cell and squamous cell skin cancers, keratoacantoma, chronic myeloleukemia, Langerhans cell histiocytosis, subleukemic myelosis, essential thrombocythemia;
– in multiple sclerosis;
– in viral conjunctivitis, keratoconjunctivitis, keratitis, keratoiridocyclitis, keratouveitis.
Layfferon® is used in the treatment of children from 1 year of age:
– in acute lymphoblastic leukemia in the period of remission after the end of induction chemotherapy (in 4-5 months of remission);
– In juvenile respiratory papillomatosis of the larynx, starting from the next day after removal of the papillomas.
Contraindications
– Hypersensitivity to the components of the drug;
– In severe forms of allergic diseases;
– Pregnancy and lactation.
Pregnancy and lactation:
The drug is contraindicated in pregnancy and lactation.
Dosage and administration
- Layfferon® is administered intramuscularly, in or under lesions, subconjunctival or topically. Immediately before application the contents of an ampoule (vial) shall be dissolved in water for injection or in 0.9% sodium chloride solution (1 ml for intramuscular injection and injection into lesion, 5 ml for subconjunctival and local injection). The drug solution shall be colorless, with weak opalescence, without sediment and foreign inclusions. Dissolution time should be about 10 minutes.
- Intramuscular injection
In acute viral hepatitis B the preparation is administered 1 mln ME twice a day during 5-6 days, then the dose is reduced to 1 mln ME per day and administered during another 5 days. If necessary (after controlling blood biochemical tests) the treatment course can be continued in 1 million ME twice a week for two weeks. The course dose is 15-21 million ME. - In acute prolonged and chronic viral hepatitis B when delta agent is excluded and without signs of liver cirrhosis, the drug is administered 1 million ME twice a week during 1-2 months. If there is no effect, the treatment should be prolonged up to 3-6 months or after 1-2 months of treatment, 2-3 similar courses with an interval of 1-6 months should be carried out.
- In chronic viral hepatitis B with delta agent without signs of liver cirrhosis, the drug is administered 0.5-1 million ME daily two times a week for 1 month. The course of treatment is repeated in 1-6 months.
- In chronic viral hepatitis B with delta agent and signs of cirrhosis the drug is administered 0.25-0.5 million ME daily twice a week for 1 month. In case of signs of decompensation similar repeated courses are carried out at intervals of at least 2 months.
- In acute prolonged and chronically active hepatitis C without signs of cirrhosis, the drug is administered 3 mln ME 3 times a week during 6-8 months. If there is no effect, treatment should be prolonged up to 12 months. The course of treatment is repeated in 3-6 months.
- In viral, viral-bacterial and mycoplasmal meningoencephalitis the drug is administered 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 case of kidney cancer the drug is used at 3 million ME daily for 10 days. Repeated courses of treatment (3-9 and more) are carried out at intervals of 3 weeks. The total amount of drug is from 120 million ME to 300 million ME or more.
- In cases of hairy cell leukemia, the drug is administered daily in doses of 3-6 million ME for 2 months. After normalization of hemogram daily dose of the drug is decreased to 1-2 million ME. Then a maintenance therapy of 3 million ME twice a week for 6-7 weeks is prescribed. The total amount of the drug is 420-600 million ME or more.
- In children with acute lymphoblastic leukemia in the remission period after termination of induction chemotherapy (in the 4th-5th month of remission) – 1 million ME once a week for 6 months, then once every 2 weeks during 24 months. At the same time, maintenance chemotherapy is carried out.
- In malignant lymphoma and Kaposi sarcoma, the drug is administered 3 million ME daily for 10 days in combination with cytostatics (prospidine, cyclophos-fan) and glucocorticosteroids. In the tumor stage of fungal mycosis, primary reticulosis and reticulosarcomatosis, it is reasonable to alternate intramuscular administration of the drug at 3 million ME and intradermal – 2 million ME for 10 days.
- In patients with erythrodermic stage of fungal mycosis with fever over 39°C and in case of process exacerbation, the drug administration should be stopped. If the therapeutic effect is insufficient, repeat treatment in 10-14 days. After achieving the clinical effect, maintenance therapy of 3 million ME once a week for 6-7 weeks is prescribed.
In chronic myeloleukemia the drug is administered 3 million ME daily or 6 million ME every other day. Duration of treatment is from 10 weeks to 6 months. - In Langerhans cell histiocytosis the drug is administered 3 million ME daily for 1 month. Repeated courses at 1-2 month intervals for 1 to 3 years.
- In subleukemic myelosis and essential thrombocythemia for correction of hyperthrombocytosis – 1 million ME daily or every 1 day for 20 days.
In juvenile respiratory papillomatosis of the larynx the drug is given in 0.1-0.15 million ME per kg of body weight daily for 45-50 days and then in the same dosage 3 times a week for 1 month. The second and third courses are carried out with an interval of 2-6 months. - In cases of multiple sclerosis, the drug is prescribed 1 million ME 3 times a day for pyramidal syndrome and 1-2 times a day for 10 days with cerebellar syndrome, 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 patients with high pyrogenic reaction (39 °c and above) to drug administration it is recommended to use paracetamol or indomethacin simultaneously.
- Perifocal injection
In cases of basal cell cancer, squamous cell cancer and keratoacantoma the drug is injected under the lesion site 1 million ME 1 time per day every day for 10 days. In case of pronounced local inflammatory reactions, injection under the lesion site is carried out after 1-2 days. At the end of the course, if necessary, cryodestruction is performed. - Subconjunctival injection
Subconjunctival injections of the drug in a dose of 60,000 ME in 0.5 ml daily or every other day depending on the severity of the process are administered for stromal keratitis, kerato-iridocyclitis, keratouveitis. The injections are performed under local anesthesia with 0.5% dicaine solution. The course of treatment is from 15 to 25 injections. - Local application
For local application the contents of 1 ml ampoule (vial) of the drug is dissolved in 5 ml of 0.9% sodium chloride solution for injection. If the drug solution is stored, observe aseptic and antiseptic rules and transfer the ampoule contents to a sterile bottle with a cork and keep the solution in refrigerator at (4-10) °c for not more than 12 hours.
In conjunctivitis and superficial keratitis apply 2 drops of the solution to the conjunctiva of the affected eye 6-8 times a day. As inflammation disappears the number of instillations is reduced to 3-4 times a day. The course of treatment is 2 weeks.
