Nirmatrelvir is a peptidomimetic inhibitor of the SARS-CoV-2 major protease (Mpro), also called 3C-like protease (3CLpro) or nsp5 protease. The inhibition of Mpro by SARS-CoV-2 makes it unable to recycle its polyprotein precursors, which leads to the prevention of viral replication. The effect of ritonavir as a pharmacokinetic enhancer is based on the activity of ritonavir as a potent inhibitor of metabolism mediated by the cytochrome CYP3A isoenzyme. In the combined drug SKYVIR, ritonavir, acting as a pharmacokinetic enhancer, inhibits CYP3A-mediated metabolism of nirmatrelvir, thereby leading to an increase in plasma concentrations of nirmatrelvir.

Treatment of novel coronavirus infection (COVID-19) of mild or moderate severity in adults, including those with an increased risk of disease progression to severe and not requiring additional oxygen therapy.

There are no data on cases of overdose of drugs with a combination of active substances nirmatrelvir and ritonavir.
Treatment In case of overdose of SKYVIR, treatment is recommended based on general supportive measures, including monitoring the patient's clinical condition. There is no specific antidote for SKYVIR overdose.

The use of ritonavir as a pharmacokinetic enhancer
Adverse reactions associated with the use of ritonavir as a pharmacokinetic enhancer depend on the specific HIV protease inhibitor co-administered, which should be taken into account in patients with HIV when treated with SKYVIR. For information about adverse reactions, refer to the instructions for use of a specific co-administered HIV protease inhibitor.
Adverse reactions reported in clinical trials and in the post-marketing period in adult patients.
The most common reported adverse reactions among patients receiving ritonavir monotherapy or ritonavir in combination with other antiretroviral drugs were disorders of the digestive system (including diarrhea, nausea, vomiting, abdominal pain (in the upper and lower parts)), disorders of the nervous system (including paresthesia and oral mucosa paresthesia), as well as
fatigue/asthenic syndrome.

(For more information about all possible adverse reactions, see the instructions in the leaflet)

- Hypersensitivity to nirmatrelvir, ritonavir or any other component of the SKYVIR drug - Lactose intolerance, lactase deficiency, glucose-galactose malabsorption - Severe liver failure (Child-Pugh class C)
- Severe renal insufficiency (eGFR <30 ml/min)
- Moderate renal insufficiency (eGFR from 30 to 60 ml/min), due to the inability to adjust the dose of nirmatrelvir
- Pregnancy or pregnancy planning
- Breastfeeding period
- Children under 18 years of age
- Drugs whose clearance is highly dependent on CYP3A and for which elevated concentrations are associated with serious and/or life-threatening reactions - Drugs that are powerful inducers of CYP3A, which significantly reduce the concentration of nirmatrelvir / ritonavir in blood plasma, which can lead to a loss of virological response and the possible development of resistance - SKYVIR should not be started immediately after discontinuation of therapy with any of the following CYP3A inducers due to the long half-life of the recently discontinued drug
(you can read the full list in the leaflet)

SKYVIR is an inhibitor of the CYP3A enzyme and can increase concentrations of drugs whose main pathway of metabolism depends on cytochrome CYP3A. Drugs that are extensively metabolized by cytochrome CYP3A and have a high metabolism at the first pass are the most susceptible to a significant increase in exposure when co-administered with nirmatrelvir / ritonavir.
Thus, the simultaneous use of nirmatrelvir/ ritonavir with drugs whose clearance strongly depends on cytochrome CYP3A and elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated
(For more information about the entire list, see the instructions in the leaflet)

Registration certificate holder
JSC Biochemist, Russian Federation
15A Vasenko St., Saransk, Republic of Mordovia, 430030
Manufacturer
JSC Biochemist, Russian Federation
Address: 15A Vasenko St., Saransk, 430030, Republic of Mordovia
Phone number: +7 (8342) 38 03 68
Email: biohimic@promomed.pro
Internet address: promomed.ru
An organization that accepts consumer claims
JSC Biochemist, Russian Federation
Address: 15A Vasenko str., Saransk, 430030, Republic of Mordovia
Phone number: 8 800 222 95 63; 8 800 777 86 04 ( around the clock)
Email: hot_line@promomed.pro

Store at a temperature not exceeding 25 ° C in the original packaging (pack). Keep out of reach of children.

2 years.

They are available on prescription.