Instruction

Prescribing information for ALLOKIN-ALPHA

Marketing number: P N002829/01

Brand name: Allokin-alpha

International Non-proprietary Name or Generic Name:
Histidyl-glycyl-valyl-seryl- glycyl - histidyl - glycyl -glutaminyl- histidyl - glycyl -valyl- histidyl -glycin

Dosage form:Lyophilizate for solution for subdermal injections

Unit dose (for an ampoule): Alloferon [histidyl-glycyl-valyl-seryl- glycyl - histidyl - glycyl -glutaminyl- histidyl - glycyl -valyl- histidyl -glycin] 1.0 mg

Description: Lyophilized powder or white porous mass. Hygroscopic.

Pharmacological class: Antiviral immunomodulatory agent.

ATC-code: [J05AХ, L03A]

Pharmacological properties
Pharmacodynamics
Alloferon is an oligopeptide. It is similar to Interferon Alpha in terms of the pharmacological action pattern. Alloferon is an efficient inductor of endogen interferon synthesis and an activator of the natural killer system; it is able to stimulate recognition and lysis of defective cells by cytotoxic lymphocytes. The experiments demonstrated high efficiency in respect to infections induced by influenza A and B virus, hepatitis B and C, 1 and 2 type herpes and the human papilloma virus (oncogenic types). Alloferon is marked neither with general toxicity, allergenic properties, nor mutagenic /carcinogenic action; it produces no embriotoxic effect and does not influence reproductive function.

Pharmacokinetics
The drug is quickly absorbed into blood where it interacts with immunocompetent cells, after which Alloferon concentration measurement is hindered by the close structural similarity of its metabolites with blood serum proteins. Interferon concentration increase was observed 2 hours after the drug administration and such high level (2-2.5 times higher than usual background level) within 6-8 hours with the return to baseline values by the end of day. The increased functional activity of natural killers was observed within 7 days after the drug administration.

Indications for use
Chronic papilloma virus infection, induced by oncogenic human papilloma virus, chronic recurrent type 1 and 2 herpes; as a part of complex therapy of moderately severe (icteric) acute hepatitis B.

Counterindications
Hypersensitivity, pregnancy and breast feeding (temporary discontinuation required), expressed autoimmune diseases. Pediatric use.

Posology and method of administration
The drug is administered by a subdermal injection.
A standard course of treatment of the infections, induced by oncogenic human papilloma virus, comprises injections in the dose of 1 mg administered on alternate days; the entire course includes 6 injections.
A standard course of treatment of recurrent herpes comprises injections in the dose of 1 mg administered on alternate days; the entire course includes 3 injections.
In case of moderately severe acute Hepatitis B the drug is administered after the diagnosis verification in the dose of 1 mg 3 times a week within 3 weeks (9 injections in total).
1 ml of 0.9% of saline solution should be used as solvent for the preparation of the solution for injection.

Adverse effects
In certain cases weakness, dizziness and formation of new rash elements (in herpetic infection) are possible.

Overdosing
No cases of the drug overdosing have been established till present.

Drug-to-drug interaction
For the treatment of chronic recurrent genital herpes the drug can be indicated in combination with Acyclovir and its derivates (these drugs have different action mechanisms and they supply one another in the treatment of viral infection). In presence of acute hepatitis B the drug is indicated alongside with the conventional basic therapy. No interaction with other drugs has been found.

Special precautions
Allokin Alpha monotherapy is recommended for the treatment of papilloma virus infection, induced by oncogenic virus type in the absence of clinical or subclinical uterine neck / anogenital impairments.
As a part of complex therapy it is used for the treatment of clinical or subclinical uterine neck / anogenital impairments induced by papilloma virus infection of oncogenic type.
Treatment of the chronic recurrent type 1 and 2 herpes should be started from the first disease manifestations.
In presence of Hepatitis B the treatment should be started no later than on the 7th day of the icterus manifestation.

Effects on the abilities to drive and use machines
In case of dizziness one should abstain from driving or using machines.

Dosage form
Lyophilizate for solution for subcutaneous injections 1.0 mg.
1.0 mg in a clear glass ampoule. 1, 2, 3, 5 or 10 ampoules are placed into a blister container. 1 or 2 blister containers are placed into a carton pack together with a drug leaflet.

Storage conditions
Protect from the light; store at the temperature from 2 to 8 °С.
Keep out of the reach of children.

Shelf-life
2 years. Do not use after the expiration date.

Pharmacy purchasing terms
Available on prescription.

Manufacturers:
Federal State Unitary Enterprise “State Research Institute of Extra-Pure Biological Products” Federal Medical-Biological Agency of Russia,
197110, Russia, Saint Petersburg, Pudozhskaya Str., 7

Federal State Institution “Russian Cardiology Research-and-Production Complex” Ministry of Healthcare and Social Development of the Russian Federation – Pilot Production of Medical and Biological Products,
121552, Russia, Moscow, Tretya Cherepkovskaya Str., 15а

Address and phone of the authorized organizations (for the filing of customer complaints and claims):

Federal State Unitary Enterprise “State Research Institute of Extra-Pure Biological Products” Federal Medical-Biological Agency of Russia
197110, Russia, Saint Petersburg, Pudozhskaya Str., 7
Tel.: (812) 230-42-03, Fax: (812)230-79-55

Federal State Institution “Russian Cardiology Research-and-Production Complex” Ministry of Healthcare and Social Development of the Russian Federation – Pilot Production of Medical and Biological Products