Instructions for Nirmatrelvir/Ritonavir combination (Nirmatrelvir/Ritonavir)

1. Generic name: nematvir/ritonavir tablet combination

Product name:Paxlovid

Other names: paxlovid, paxlovid, paxlovid, paxlovid

2. Indications:

Nematrelvir/Ritonavir combination (Nirmatrelvir/Ritonavir) is indicated for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk of progression to severe novel coronavirus infection, including hospitalization or death.

Restrictions on use: The nematvir/ritonavir tablet combination is not approved for pre-exposure or post-exposure prophylaxis to prevent novel coronavirus infection.

3. Usage and dosage:

NematrevirThe combination of nematvir/ritonavir tablets includes severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) major protease (Mpro: also known as 3CLpro or nsp5 protease) inhibitor nematvir and HIV-1 protease inhibitor and CYP3A inhibitor ritonavir. The two must be used together. Failure to correctly combine nematvir/ritonavir tablets may cause the plasma level of nematvir to be insufficient to achieve the required therapeutic effect.

Completing the full 5-day course of treatment and continuing to isolate in accordance with public health recommendations is critical to maximize virus clearance and minimize the spread of the novel coronavirus. After diagnosis of novel coronavirus infection, the 5-day nematvir/ritonavir tablet combination treatment should be started as soon as possible. Even if the baseline novel coronavirus infection symptoms are mild, it should be started within 5 days after the onset of symptoms. If a patient requires hospitalization due to severe or critical novel coronavirus infection after starting treatment with the nematvir/ritonavir tablet combination, the patient should complete the complete 5-day treatment course according to the judgment of the medical staff.

1. Recommended dose: The recommended dose of nematvir/ritonavir tablet combination is 300mg nematvir (two 150mg tablets) and 100mg ritonavir (one 100mg tablet). Three tablets should be taken orally together, twice a day for a total of 5 days.

2. Dosage adjustment:

For patients with moderate renal impairment (eGFR ≥30 to <60 mL/min), the dose of the nematvir/ritonavir tablet combination is 150 mg nematvir (one 150 mg tablet) and 100 mg ritonavir (one 100 mg tablet), taken together twice daily for 5 days.

It is not recommended for patients with severe liver and renal impairment(eGFR<30mL/min) to be treated with the combination of nematvir/ritonavir tablets.

4. Adverse reactions:

In clinical trials, adverse reactions of the nematvir/ritonavir tablet combination include dysgeusia, diarrhea, hypertension and myalgia. Other side effects may include hypersensitivity reactions, hepatotoxicity and the development of HIV drug resistance in patients with uncontrolled or undiagnosed HIV infection. Anaphylaxis (hypersensitivity) may manifest as rash, urticaria, difficulty swallowing, difficulty breathing, angioedema, and/or anaphylaxis. Hepatotoxicity may manifest as elevated transaminases and clinical hepatitis, including symptoms such as loss of appetite, jaundice (yellowing of the skin and whites of the eyes), dark urine, light-colored stools, itchy skin, and abdominal pain.

5. Storage:

NematrevirThe ritonavir tablet combination is stored at USP-controlled room temperature of 20°C to 25°C (68°F to 77°F); excursions allowed between 15°C and 30°C (59°F to 86°F).

6. Taboo:

1. A history of clinically significant allergic reaction to the active ingredient (nematvir/ritonavir) or any other ingredient.

2. Combined use with drugs that are highly dependent on CYP3A clearance and whose elevated concentrations are associated with severe and/or life-threatening reactions.

3. When combined with strong CYP3A inducers, the significantly reduced plasma concentrations of nematvir/ritonavir may be related to the loss of virological response and possible drug resistance.

7. Mechanism of action:

Nirmatrelvir (Nirmatrelvir) is an antiviral drug for severe acute respiratory syndrome coronavirus type 2 (new coronavirus). Ritonavir is an HIV-1 protease inhibitor but has no activity against the new coronavirus Mpro. Ritonavir inhibits CYP3A-mediated metabolism of nematvir, resulting in increased plasma concentrations of nematvir.

NematvirThe /ritonavir tablet combination has been launched in China. Due to its short time on the market, it has not been included in the medical insurance. The domestic price has not yet been determined. The original drug of nematvir/ritonavir tablet combination marketed overseas, the specification is nematvir 150mg + ritonavir 100mg)*30 tablets per box, the price may be around 2,000 yuan (the price may fluctuate due to the exchange rate), India The price of each box of the generic Nematvir/Ritonavir tablet combination produced by the pharmaceutical factory may be around RMB 1,000 (the price may fluctuate due to the exchange rate). The ingredients of the two drugs are basically the same. For more drug information and specific prices, please consult Yaode Medical Consultant.