Algeron

Description overdue on 30.07.2014

• Latin name: Algeron
• ATC code: L03AB
• Active substance: Pegylated interferon alfa-2b (Tsepeginterferon alpha-2b)
• Manufacturer: JSC "BIOCAD", Russia

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• Composition
• Product form
• Pharmacological action
• Pharmacodynamics and pharmacokinetics
• Indications
• Contraindications
• Side effects
• Algeron: instructions for use and dosing regimen of the drug
• Overdose
• Cooperation
• Terms of sale
• Storage conditions
• Shelf life
• Reviews
• Price, where to buy

Composition

Algeron available as a solution for subcutaneous administration. One milliliter it contains 200 mg of active ingredient, which is P egilirovanny   Interferon alfa-2b And auxiliary substances:

• sodium acetate trihydrate   (2, 617 mg);
• acetic acid glacial   to pH 5, 0;
• sodium chloride   (8 mg);
• Polysorbate 80   (0, 05 mg);
• disodium edetate dihydrate   (0, 056 mg);
• Water for Injection (1 mL).

Product form

The clear solution for subcutaneous injection is colorless or slightly yellowish tint.

Algeron available in three formats:

• one syringe;
• four of the syringe;
• en bloc "three packs of four syringe."

Pharmacological action

Application Algerona provides immunostimulatory and antiviral effects. The mechanism of action of the drug, as well as the biological and clinical effects of its use are determined by the activity of being a part of of pegylated interferon alpha-2b   ( Peg-IFN alfa-2b ), Which is formed by the polymer compound of structure (polyethylene glycol (PEG) having a molecular weight of 20 kDa) to a molecule interferon alfa-2b .

IFN alfa-2b   prepared biosynthetically by recombinant DNA technology, i.e. an artificial human DNA sequence, portions of which can be chemically synthesized using the polymerase chain reaction. He also produced a strain E. coli Escherichia coli In which, using the techniques of genetic engineering of human interferon gene is introduced.

Like other interferons The IFN alpha-2b provides:

• immunomodulatory ;
• antiviral ;
• antiproliferative effect .

Its effectiveness against viruses due to the ability to bind to specific cell receptors. The result of this process is the launch of a complex mechanism of certain intracellular reactions which are suppressed as a result of the viral genome and the development of viral proteins. Immunomodulatory effect IFN alfa-2b   It expressed increasing the protective properties of the immune system. The action of interferon is aimed at:

• increasing the cytotoxicity of T-killers and other natural killer cells;
• increase in phagocytic activity of macrophages;
• differentiation with of T-helpers;
• protect T cells from programmed cell death ( of apoptosis ).

Immunomodulatory effects in those treated Algeronom, is also conditioned by the fact that interferon has the ability to influence the production of cytokines (eg, interleukins   or interferon gamma ).

Pharmacodynamics and pharmacokinetics

Formulations containing as an active ingredient Peg-IFN alfa-2b Provoke increasing concentration indicators effector proteins, which include Serum neopterin , and 2'5'-oligoadenylate synthetase . After a single administration of a group of volunteers solution for injection Algeron they noted a dose-dependent increase in indicators of neopterin in the serum. The maximum growth of this indicator was observed 48 hours after injection. The introduction of the drug in a single weekly dose of 1, 5 mg per 1 kg weight of the patient, maintains the serum of patients suffering from   Hepatitis C Stably high level of concentration Neopterin .

During the   in vitro   experiments were marked antiviral activity of unmodified IFN alfa-2b . Studies have confirmed, that as a result pegylation of the molecule IFN alfa-2b :

• slows its absorption from the injection site;
• increased volume of distribution;
• significantly reduced clearance (which in turn provokes a more than tenfold increase in the length of the terminal half-life Peg-IFN alfa-2b   compared to IFN alfa-2b   unmodified type).

Period deducing Algerona from an organism exceeds 153 hours, representing approximately 6, 5 days. As a result, a subcutaneous injection once a week for patients undergoing treatment   Hepatitis C , Observed dose-dependent increase in the concentration gradually Algerona up to eight weeks, after which its further accumulation was not noted.

In patients with impaired renal function has not been fixed relationship between pharmacokinetics Algerona and creatinine clearance. Indicators of the maximum concentration Peg-IFN alfa-2b , The period of its half-life and AUC values ​​increased in proportion to the severity of renal failure. If you have any patients with severely and moderately impaired renal function any adverse reactions to the introduction of the drug is recommended careful medical monitoring and dose adjustment in the direction of its reduction.

With hepatic dysfunction in patients suffering from hepatitis type B or C, and n irroza   liver , Pharmacokinetic parameters Algerona remain unchanged compared with healthy people. Do not use the drug in patients with a severe degree of liver dysfunction, since this group of pharmacokinetics Peg-IFN alfa-2b   It has not been studied.

Pharmacokinetic parameters Peg-IFN alfa-2b   It does not depend on the patient's age, so the elderly people do not require a dose adjustment Algerona.

Indications

Appointment Algerona suitable for the treatment of chronic form Primary HCV   patients with positive RNA virus Hepatitis C   (HCV), if the latter is not diagnosed with symptoms of decompensated liver disease. The most effective treatment is considered to be complex therapy, the intended use of alpha interferon preparations (including PEG-IFN alfa-2b) in combination with ribavirin .

Contraindications

Algeron not appointed the following groups of patients:

• Humans with hypersensitivity to preparations of IFN, polyethylene glycol (PEG), as well as any of the auxiliary components Algerona.
• Patients with decompensated form of cirrhosis In which the sum of points on the scale of Child-Pugh B or a Class C
• Patients who are bleeding varicose veins .
• Patients with HIV   or hepatitis C , Y whom diagnosed cirrhosis a liver on background hepatic insufficiency .
• Patients with autoimmune hepatitis .
• Patients with diabetes   decompensated.
• Patients with hyper- or hypothyroidism .
• Patients who have the expressed oppression of bone marrow hematopoiesis. Children, pregnant and lactating women.

With care prescribe a drug to patients with mental disorders in the presence of renal impairment, people suffering from heart and vascular diseases and autoimmune diseases, as well as in conjunction with myelotoxicity drugs .

Side effects

When treating Algeronom at recommended doses instruction, including in combination with drug Ribavirin Side effects were mild or moderate and did not expect the termination of therapy. The most frequently were noted:

• headaches, irritability, depressive states . emotional lability ;
• nausea and diarrhea ;
• dry cough ;
• pain in the joints, and muscle pain;
• skin reactions, manifested in the form of increased dryness, peeling skin, itching and rash onset on them;
• local reactions at the site of administration;
• general symptoms ( fever . asthenia   etc.);
• disorders of the lymphatic and circulatory systems;
• changes in laboratory parameters.

In general, the incidence of undesirable side reactions depends, in which the patient is administered a dosage Algeron.

Algeron: instructions for use and dosing regimen of the drug

The solution for injection is recommended to inject under the skin in the fatty tissue:

• in the hip area (front thigh, except the groin and the knee);
• to the anterior abdominal wall (with the exception of the median line, and the area around the navel), alternating with the site of administration.

Optimum it is considered to do injections before bedtime. Therapy is appointed by the attending physician, throughout the course of treatment the patient should be monitored by specialized professionals with experience in the treatment of Hepatitis C .

The drug is administered once a week at the rate of 1 5 micrograms per kilogram of body weight after patient. It is important to remember that each and every bottle syringe intended for single use only. It is also forbidden to enter Algeron intravenously.

Duration therapy as and necessity in adjusting regime batching, are determined depending from viral genotype, occurrence of side effects and degree of their manifestation, indicators assays blood, availability yl absence of infringement functions of internal organs and systems (in particular, liver, kidneys, nervous system) .

Overdose

If overdose Algerona serious consequences for the patient has not been revealed. In particular, a random reception of a double dose of Peg-IFN alfa-2b   not provoke the symptoms of overdose and intoxication. To eliminate undesirable reactions do not require medical intervention and the abolition of the drug.

Guide Algerona indicates that there are descriptions of overdoses, which occurred after the administration of injection solution for 2 consecutive days without aging week interval, and after introduction of the solution every day for one week. At the same time any serious, life-threatening the patient or influencing on treatment the consequences are fixed were not. There is no specific drug antidote .

Cooperation

The combination Peg-IFN alfa-2b   and a medicament Ribavirin   It does not influence the pharmacokinetic interaction. The treatment Peg-IFN alfa-2b   No effect on:

• pharmacokinetics tolbutamide ;
• pharmacokinetics mefenitoina ;
• pharmacokinetics debrizohina ;
• pharmacokinetics dapsone ;
• activity of cytochrome P450 isoenzymes CYP1A2 and CYP3A4;
• activity N-acetyltransferase .

At the same time, however:

• increased activity of cytochrome P450 isoenzymes CYP2C8 / C9 and cytochrome CYP2D6 (for this reason, the drug is prescribed with caution in patients who are treated by other drugs in biotransformation of which involve these isoenzymes);
• isoenzyme 1A2 inhibits the activity of cytochrome P450;
• increases the area under the curve AUC of theophylline;
• increased average levels of metabolites Methadone ;
• It increases the likelihood of lactic acidosis   HIV patients who undergo therapy Vaara.

Terms of sale

The drugstore chain Algeron available on medical prescription.

Storage conditions

The drug should be stored in a well-protected from sunlight and reach of children, respecting the temperature range from 2 to 8 degrees. It is forbidden to freeze vials with a solution Algeron.

Shelf life

The drug retains its pharmacological properties within two years. The use after the expiry date is prohibited.

Reviews Algerone

Numerous studies and patient testimonials about Algerone left on the forum indicate that the use of drugs   Peg-IFN alfa-2b   in the composition of complex therapy of at the present time it is deservedly considered " gold standard "Treatment. Despite the fact that the effectiveness of the treatment depends primarily on viral genotype Nevertheless, its parameters are in the range of from 50 to 90%. So - and reviews Algerone are proof of that - SVR is achieved in more than 80% of patients with second and third genotype of hepatitis C virus, and almost 70% of patients with hepatitis C virus genotype first.

An analogue of a drug Algerona Pegasys Which has long been considered a recognized standard in the treatment of Hepatitis C . However, choosing between Pegasys and Algeronom, most patients prefer the latter. This is not least due to the fact that the course of treatment products UAB "Biocad" costs much cheaper.

Another plus in favor Algerona is that from 2013, the year the manufacturing company announced the launch of a social program " The course of recovery "Under which the support for patients who do not receive financial support from the state budget. By implementing this project, the company "Biocad" created a social network for people with hepatitis C, and is eager to destroy the stereotypes that the disease is solely a problem of anti-social groups. Once connected to the support program, patients are able to acquire Algeron at a price 35-50% below the market average.

Price Algerona

Buy Algeron in Moscow can be from July 1 of 2013. By purchasing the drug in the licensed pharmacy chains, patients with Hepatitis C   both are connected to a system of progressive discounts, allowing to reduce the price Algerona at 5-55%.

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