Peginterferon-2a alьfa

When ATH:
L03AB11

Pharmacological action

Immunomodulator with antiviral action. It is a pegylated interferon alfa-2a, formed by the conjugation of PEG (bis monomethoxypolyethylene) interferon alfa-2a.

Interferon alfa-2a is made biosynthetically by recombinant DNA technology and is a derivative product of a cloned human leukocyte interferon gene, introduced and expressed in Escherichia coli cells.

Interferons bind to specific receptors on the cell surface, launching a complex intracellular signaling mechanisms and rapid activation of gene transcription. Interferon stimulated genes modulate many biological effects, including inhibition of viral replication in infected cells, suppression of cell proliferation, immunomodulation.

In clinical studies, is effective in treating patients with chronic hepatitis C (incl. with compensated cirrhosis).

Pharmacokinetics

The data is not provided.

Testimony

Chronic hepatitis C without cirrhosis or compensated cirrhosis (Class A on Child-Pugh) adult (alone or in combination with ribavirin as a first-line therapy).

Dosage regimen

Enter n / a. Depending on the clinical situation, the recommended dose is 45-180 g 1 once a week n / a.

Side effect

From the central and peripheral nervous system: often – asthenia, drowsiness, memory impairment, paresthesia, dysgeusia, weakness, gipestezii, tremor, alarm, mood changes, nervousness, aggressiveness; in some cases – behavioral disturbances (incl. suicidal thoughts and suicide attempts), perifericheskaya neuropathy; There are cases of bleeding in the brain.

The respiratory system: often – cough, breathlessness, sore throat, nazofaringit; in some cases - pneumonia, interstitial pneumonitis with fatal outcome.

From the digestive system: often – dry mouth, krovotochivosty right, ulcerative stomatitis; in some cases - abnormal liver function, fatty liver, kholangit, erosive and ulcerative lesions, gastrointestinal bleeding, reversible reaction from the pancreas (eg, increased activity of amylase and lipase without pain or abdominal pain).

Cardio-vascular system: often - heartbeat; in some cases - Arrhythmia, endokardit, pulmonary embolism.

From the hematopoietic system: possible neutropenia, leukopenia, thrombocytopenia.

On the part of the organ of vision: often – blurred vision, inflammatory diseases of the eye; in some cases – corneal ulcer,

Metabolism: often – increased sweating (incl. at night); may be clinically significant changes in laboratory parameters of thyroid function; in some cases – diabetes.

Dermatological reactions: often – dermatitis, rash, xerosis, photosensitivity.

From the body as a whole: often – weight loss, chest pain, flu-like symptoms, malaise, chills.

Other: often – decreased libido, tides, muscle cramps, neck pain; in some cases – autoimmune reaction, infection, coma, myositis.

Contraindications

Autoimmune hepatitis; decompensated liver disease (Class B and C Child-Pugh) before or during treatment, Hypo- or hyperthyroidism, decompensated diabetes, giperkreatininemiя (more than 1.5 times the ULN), Children up to age 3 years, hypersensitivity to interferon alpha, a waste product of Escherichia coli, to polyethylene glycol.

Pregnancy and lactation

Safety of use in pregnancy has not been established. Application is possible only in cases, when the intended benefits to the mother outweighs the potential risk to the fetus.

Unknown, whether it is allocated peginterferon alfa-2a in breast milk, therefore be used with caution during lactation.

Women of childbearing age during treatment should use reliable methods of contraception.

In experimental studies found, when administered peginterferon alfa-2a (as well as other interferon alfa) female monkeys observed lengthening of the menstrual cycle, accompanied by a decrease and later onset of maximum concentrations of 17β-estradiol and progesterone. After completing the application of the menstrual cycle returned to normal. Interferon alfa-2a at doses up to 25 mln.ED / kg / day for 5 months had no effect on fertility of male rhesus monkeys.

Teratogenic effects have not been studied. The use of interferon alfa-2a resulted in a significant increase in the number of spontaneous abortions in rhesus monkeys. Offspring, born at term, no teratogenic effects were noted.

Cautions

Use under the supervision of a qualified physician, with experience in the use of such drugs.

To apply caution in patients with a history of depression, in diseases of the cardiovascular system, autoimmune diseases, psoriaze, neutropenia of less than 1,500 cells / mm, thrombocytopenia me 90 000/l, Hb less 10 g / dl, simultaneously with myelotoxicity drugs.

Monotherapy is shown in the case of intolerance or contraindications to ribavirin. The efficacy and safety in children and adolescents under the age of 18 years, as well as monotherapy or combination with ribavirin in patients after liver transplantation, or other organs, in patients with concomitant HIV or hepatitis B virus is not installed.

If therapy with thyroid dysfunction not be adequate correction, peginterferon alfa-2a should be discontinued.

With the development of anaphylactoid reactions peginterferon alfa-2a should be discontinued and assign the appropriate drug therapy.

If you have persistent or increasing pulmonary infiltrates or pulmonary function disorders peginterferon alfa-2a should be discontinued.

Before initiation of therapy is necessary to standard general clinical and biochemical blood tests. During therapy, the general clinical blood tests should be repeated every 2 of the week, and biochemical - every 4 of the week; Periodically perform additional analyzes.

It should be taken into account, that holding therapy is possible only under the following laboratory parameters: the number of platelets >90 000 cells / (patients with cirrhosis or cirrhosis transition - >75 000 cells /), absolute neutrophil count >1500 cells /, serum creatinine less, than 1.5 times the upper limit of normal, the concentration of TSH and T4 within normal limits (or adequate control of thyroid function).

Safety and efficacy in children and adolescents under the age of 18 years have not been established.

Effects on ability to drive a car and use machines

Patients, who develop dizziness, drowsiness, confusion and weakness, We should not engage in potentially hazardous activities.

Drug Interactions

While the use of theophylline may increase its concentration in the blood plasma (may require dose adjustment of theophylline).