Pegintron

Pegintron is an antiviral immunomodulatory drug. Its active ingredient is extracted from an E. coli analogue containing a plasmid hybrid obtained using genetic engineering. Such a hybrid is involved in coding the α-2β-interferon of human leukocytes. Cellular reactions of such interferons develop during synthesis with specific endings of the walls on cell surfaces. At the same time, tests with the study of other interferons revealed their species specificity.

The medication demonstrates immunomodulatory and immunostimulating activity.

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Indications Pegintrona

It is used for the treatment of chronic hepatitis subtype C.

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Release form

The therapeutic component is released in the form of a lyophilisate for intravenous injection fluid, and also inside syringe pens.

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Pharmacodynamics

The interferon element is synthesized with the cell membrane, activating individual intracellular reactions, including the induction of some enzymes. As a result, viral replication is blocked in the area of affected cells and the phagocytic effect of macrophages with lymphocytes on target cells increases. In addition, cell proliferation is suppressed.

Pharmacokinetics

When the drug is administered subcutaneously, the substance reaches the Cmax mark after 15-44 hours. This indicator is maintained for 2-3 days. A direct dependence of the Cmax and AUC values on the portion size is also noted. With repeated use, immunoreactive interferons accumulate, although their bioactivity increases only slightly.

The plasma half-life of the drug is approximately 30 hours.

After a single use of the drug in a dose of 1 mcg / kg, in individuals with renal impairment, an increase in the level of AUC and Cmax is noted, and in addition, an extension of the half-life term is observed - in accordance with the intensity of renal impairment. If renal function is very impaired (the level of CC is less than 50 ml per minute), the values of PegIntron clearance decrease.

Dosing and administration

The medication is administered by injections - subcutaneously. Often the dose size is 0.5-1 mcg/kg. Injection procedures must be performed once a week within a 6-month period.

In addition, a dose of 1.5 mcg/kg may be administered in combination with rebetol. The appropriate dosage should be selected by a medical specialist, taking into account the probable therapeutic efficacy of PegIntron and its side effects. If after 0.5 years viral RNA is still excreted from the serum, treatment is continued for another 6 months.

The dosage size of the drug may be reduced if necessary in people with renal impairment.

To prepare an injection substance, 0.7 ml of sterile injection liquid must be injected into the vial with the medicine through a syringe. Then shake the vial to dissolve the lyophilisate. The required portion of the medicine is drawn through a sterile syringe. If the liquid changes color, it is prohibited to use it. Any remaining medicine must be destroyed.

The medicine may be diluted only with the supplied solvent. It is prohibited to mix Pegintron with other therapeutic substances. It is recommended to administer the drug immediately after dissolving the powder.

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Use Pegintrona during pregnancy

There is no adequate information regarding the use of α-2β-interferon during pregnancy. Since this component has been shown to have an abortive effect in primates, there is reason to believe that Pegintron may have a similar effect. The potential risk for humans is not determined. The use of the medication during pregnancy is permitted only in situations where the likelihood of benefit is higher than the risk of complications for the fetus.

There is no data on whether the drug is excreted in human milk. Due to the possibility of adverse effects in nursing infants, breastfeeding should be discontinued before starting therapy.

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Contraindications

Main contraindications:

• use in case of severe intolerance associated with its components;
• severe stages of mental illness;
• thyroid disorders;
• epilepsy;
• severe degree of liver or kidney failure.

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Side effects Pegintrona

The following side effects may be observed: a feeling of malaise, viral infections, epidermal itching or rashes, as well as dry mouth and pain in the right hypochondrium. Flatulence, dyspepsia, thyroid dysfunction, severe agitation, paresthesia and increased blood pressure may also occur. In addition, erythema, nasal congestion, visual impairment, apathy, epidermal dryness, unstable stool and menstrual disorders are noted. Vomiting, hyperhidrosis, dyspnea, emotional instability, neutropenia, chest pain, drowsiness, cough, constipation, hot flashes, confusion and hallucinations are possible. In addition, sinusitis, hypoesthesia, decreased libido, menorrhagia, eye pain and conjunctivitis occur.

Rarely, thrombocytopenia or granulocytopenia, retinal changes, arrhythmia, diabetes mellitus, suicidal tendencies, hearing impairment, or hepatopathy may be reported.

During clinical trials, adverse events were often moderate to mild in intensity and did not require discontinuation of treatment.

If negative effects develop, the dose of the drug should be reduced by half. If this measure does not bring any effect, the therapy should be stopped.

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Interactions with other drugs

Interferon-α subtypes cause a decrease in clearance by approximately 50%, as well as a twofold increase in plasma theophylline levels. Theophylline is a substrate of the CYP1A2 component. Therefore, although Pegintron does not affect the CYP1A2 and CYP2D6 hemoproteins with CYP2C8/C9 after a single injection, and in addition to this, the liver CYP3A4 together with N-acetyltransferase, it is recommended to combine these drugs very carefully.

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Storage conditions

Peggintron should be stored in a dark and moisture-protected place at temperatures in the range of 12-15°C. The prepared liquid can be stored for 24 hours at temperatures of 2-8°C.

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Shelf life

Pegintron can be used for a period of 36 months from the date of sale of the drug.

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Application for children

In combination with ribavirin, Pegintron can be used in children over 3 years of age (in the chronic stage of previously untreated hepatitis type C, with the presence of HCV RNA and the absence of liver decompensation). However, since the use of complex treatment slows down the child's growth, which does not always recover after the end of the course, the issue of using the drug should be decided individually.

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Analogues

An analogue of the drug is Pegaltevir.

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Reviews

Pegintron gets quite a variety of reviews, but patients usually say it is a good product. People who have used the drug recommend constantly changing the injection site - to avoid irritation and pain in the injection area.

Among the negative phenomena, the possibility of developing side symptoms (for example, psychosis, hallucinations, suicidal thoughts and aggression) is highlighted.

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