Paxlovid

Indications

It is used to treat adult patients with mild to moderate novel coronavirus pneumonia (COVID-19) who are at high risk of progression to severe disease.

If you are accompanied by at least one of the following diseases or conditions, you are considered to have a high risk factor for progression to severe COVID-19:

Advanced age (e.g., ≥ 60 years old)

Obesity or overweight (e.g., body mass index [BMI] > 25 kg/m2)

Current smokers

Chronic kidney disease: chronic glomerulonephritis, chronic interstitial nephritis, diabetic nephropathy, etc.

Diabetes

Immunosuppressive disease or immunosuppressive treatment

Cardiovascular disease (including congenital heart disease) or hypertension

Chronic lung disease (such as chronic obstructive pulmonary disease, chronic obstructive pulmonary disease, Asthma [moderate to severe], interstitial lung disease, cystic fibrosis, and pulmonary hypertension)

Sickle cell disease

Neurodevelopmental disorders (e.g., cerebral palsy, Down syndrome) or other conditions that cause medical complexity (e.g., genetic or metabolic syndromes and severe congenital anomalies)

Active cancer: A variety of malignant tumors with the potential to infiltrate or metastasize.

Need relevant medical support (not related to COVID-19) (such as tracheostomy, gastrostomy or positive pressure ventilation, etc.)

Usage and Dosage

This product can be taken with or without food. Tablets should be swallowed whole and should not be chewed, broken or crushed.

This product is a combination package of nematvir tablets and ritonavir tablets. Nematvir must be taken with ritonavir; if not taken with ritonavir, plasma levels of nematvir may not be sufficient to achieve the desired therapeutic effect.

The recommended dose is nematvir 300 mg (150 mg × 2 tablets) combined with ritonavir 100 mg (100 mg × 1 tablet), administered orally every 12 hours for 5 consecutive days. Take this product as soon as possible after diagnosis of COVID-19 and within 5 days of onset of symptoms. It is also recommended to complete 5 days of treatment if a patient requires hospitalization due to severe or critical COVID-19 after starting treatment with this product.

If the patient misses a dose of this product but within 8 hours of the usual medication time, the patient should take it as soon as possible and continue taking the medication according to the normal dosing schedule. If the patient misses a dose and it lasts more than 8 hours, the patient should not take the missed dose but should take the next dose at the prescribed time. Do not take a double dose to make up for a missed dose.

No dose adjustment is required in patients with mild renal impairment (eGFR ≥ 60 to <90 mL/min).

In patients with moderate renal impairment (eGFR ≥ 30 to <60 mL/min), the dose of nematvir/ritonavir should be reduced to 150 mg/100 mg every 12 hours for 5 days to avoid overexposure.

This product should not be used in patients with severe renal impairment (eGFR<30 mL/min), including end-stage renal disease (ESRD) under hemodialysis.

No dose adjustment is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. Patients with severe liver impairment should not use this product.

Precautions

If patients who are being treated with drugs metabolized by CYP3A start taking this product (a CYP3A inhibitor), or patients who have been treated with this product start taking drugs that are metabolized by CYP3A, the plasma concentration of drugs metabolized by CYP3A may increase.

The use of drugs that inhibit or induce CYP3A may increase or decrease the concentration of this product respectively.

Based on pharmacokinetic data, use of this product in patients with severe renal impairment may result in overexposure and potential toxicity. Therefore, this product should not be used in patients with severe renal impairment (eGFR <30 mL/min, including ESRD patients under hemodialysis).

There are currently no pharmacokinetic and clinical data in patients with severe hepatic impairment. Therefore, this product should not be used in patients with severe liver impairment.

Elevated hepatic transaminases, clinically apparent hepatitis, and jaundice have occurred in patients receiving ritonavir. Therefore, patients with a history of liver disease, abnormal liver enzymes, or hepatitis should use this product with caution.

Patients with uncontrolled or undiagnosed HIV-1 infection may be at risk of HIV-1 becoming resistant to HIV protease inhibitors if they are combined with nematvir and ritonavir.

Nematvir tablets contain lactose. This product should be contraindicated in patients with rare genetic disorders such as galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.

The sodium content of each tablet of nematvir tablets and ritonavir tablets is less than 1 mmol (23 mg), which means they are basically "sodium-free".

Refer to the medication for adults. Dosage adjustment for the elderly is currently not recommended.

The safety and effectiveness of this product in patients under 18 years of age have not been established.