This product is packaged in a combination of nematvir tablets and ritonavir tablets. It is an oral small molecule novel coronavirus treatment drug. It is used to treat mild to moderate novel coronavirus pneumonia (COVID-19) in adults with high risk factors for progression to severe disease, such as patients with advanced age, chronic kidney disease, diabetes , cardiovascular disease, chronic lung disease and other severe high risk factors.
Patients should take the medication strictly according to the instructions under the guidance of a physician. During use, they should pay close attention to the information on interactions with other drugs listed in the instructions.
Indications:
is used to treat adult patients with mild to moderate novel coronavirus pneumonia (COVID-19) with high risk factors for 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
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;
Requires medical support (not related to COVID-19) (e.g., Tracheostomy, gastrostomy, or positive pressure ventilation, etc.).
Mechanism of action
This product is a combination package of nematvir tablets and ritonavir tablets. The main ingredients are nematvir and ritonavir .
Nematvir is a peptidomimetic inhibitor of the main SARS-CoV-2 protease Mpro (also known as 3C-like protease, 3CLpro). Inhibiting SARS-CoV-2 Mpro makes it unable to process polyprotein precursors, thereby preventing the replication of virus .
Ritonavir inhibits CYP3A-mediated metabolism of nematvir, thereby increasing the plasma concentration of nematvir.
Precautions before use
Read the drug instructions carefully before taking the medicine.
According to the "Diagnosis and Treatment Plan for Novel Coronavirus Pneumonia (Trial Ninth Edition)", it is recommended that the combination package of nematvir tablets/ritonavir tablets (i.e. Paxlovid) is suitable for: adults and adolescents (12-17 years old, weight 40kg) with mild and common types within 5 days of onset and with high risk factors for progression to severe disease.
Prohibited population
It is prohibited for patients who are allergic to the active ingredients (nematvir/ritonavir) or any excipients in this product.
Use with caution.
Those with a history of liver disease, abnormal liver enzymes or hepatitis should use with caution.
Medication Instructions for Special Populations
Children: The safety and effectiveness of this medicine in children under 18 years of age are not yet clear.
Women of childbearing potential
There are currently no data on the use of this product during pregnancy, so the risk of drug-related adverse developmental outcomes is unknown; women of childbearing potential should avoid becoming pregnant during treatment with this product and for 7 days after the end of treatment with this product.
The efficacy of hormonal contraceptives may be reduced when used concomitantly with ritonavir. Advise patients taking combined hormonal contraceptives to use an effective alternative or additional barrier method of contraception during treatment with this product and for one menstrual cycle following the discontinuation of this product.
Pregnant women
There are currently no data on the use of this product by pregnant women.
This product should be used during pregnancy only if the potential benefit to the mother outweighs the potential risk to the fetus. Please follow your doctor's advice for details.
Lactating women
There is currently no data on the use of this product during lactation. It is unknown whether nematvir is excreted in human or animal milk, its effects on breastfed neonates/infants, or its effects on milk secretion.
There is no information on the effects of ritonavir on breastfed neonates/infants or on the effects of the drug on milk production. Risk to neonates/infants cannot be excluded. Therefore, breastfeeding should be stopped during treatment with this product and 7 days after the end of treatment with this product.
Elderly
Reference Adult Medication. No dose adjustments are currently recommended for elderly patients.
Patients with liver function impairment:
There are currently no pharmacokinetic and clinical data on patients with severe liver 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 renal function impairment: Patients with severe renal impairment (eGFR30 mL/min) should not use this product, including patients with end-stage renal disease (ESRD) under hemodialysis .
Interactions
Nematrevir/ritonavir are inhibitors of CYP3A and may increase plasma concentrations of drugs metabolized by CYP3A. Drugs that are extensively metabolized by CYP3A and have high first-pass metabolism may be most affected and result in a substantial increase in their own exposure when coadministered with nematvir/ritonavir. Therefore, nematvir/ritonavir should not be used in combination with drugs that are highly dependent on CYP3A for clearance and whose elevated plasma concentrations may lead to serious and/or life-threatening adverse reactions.
Coadministration of herbal preparations containing St. John's wort (Hyperforatum perforatum) may decrease ritonavir serum levels. This is due to St. John's Wort (Hyperforatum perforatum)'s ability to induce drug-metabolizing enzymes. Therefore, this product should not be used in combination with Chinese herbal preparations containing St. John's wort ( Hypericum perforatum ). If the patient is taking St. John's wort (Hyperforatum perforatum), it should be stopped and viral levels should be checked if possible. Ritonavir levels may increase after you stop taking St. John's Wort and your dose may need to be adjusted. St. John's wort ( Hypericum perforatum )-induced effects may continue for at least two weeks after discontinuation of treatment.
Cardiac and neurological events have been reported when ritonavir was given with disopyramide, mexiletine, or nefazodone. The possibility of drug interactions cannot be ruled out.
In addition to the drug interactions listed above, because ritonavir has a high protein binding rate, it should be considered that when drugs are used together, treatment and toxic reactions may increase due to protein binding displacement of compatible drugs.
Therefore, if you are taking other medications, please consult your doctor before taking these medications and inform your doctor of all diagnosed illnesses and treatments you are receiving.
Usage and Dosage
This product is a combination package of nematvir tablets and ritonavir tablets. Nematvir must be taken with ritonavir. If not administered with ritonavir, plasma levels of nematvir may be insufficient to achieve the desired therapeutic effect.
This product is an oral small molecule novel coronavirus treatment drug. It is administered orally and can be taken with or without food. Tablets should be swallowed whole and should not be chewed, broken or crushed.
Main dosage forms or specifications
This product is a combination package of nematvir tablets and ritonavir tablets. Each plate contains 4 nematvir tablets (pink) and 2 ritonavir tablets (white). 5 plates/box.
specifications: nematvir tablets 150mg/ritonavir tablets 100mg.
Specific usage
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.
Patients with Renal Impairment Dosing
Patients with mild renal impairment (eGFR ≥ 60 to 90 mL/min) do not require dose adjustment.
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.
Patients with severe renal impairment (eGFR 30 mL/min) should not use this product, including patients with end-stage renal disease (ESRD) under hemodialysis.
Patients with Hepatic Impairment Dosing
Patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment do not need to adjust the dose of this product.
Patients with severe liver damage should not use this product.
Instructions after use
It is prohibited to use this product when its properties change. Please keep this product out of reach of children.
Generally speaking, if you have been allergic to certain ingredients in the medicine before, you cannot use the medicine, otherwise it may lead to another allergic reaction or even a critical situation. Common allergy symptoms include rash , itchy skin, shortness of breath, coughing, and swelling of the face, lips, or throat.
If you feel unwell after taking the medicine, please inform your doctor in time. The doctor will judge whether the medicine should be stopped or take necessary measures based on the severity of the adverse reaction.
Dose Missed Medication
If a patient misses a dose of this product within 8 hours of the usual medication time, the patient should take the missed dose as soon as possible and continue taking the medication according to the normal dosing schedule.
If a patient misses a dose and it is more than 8 hours later, 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.
Drug overdose
In the event of overdose, please consult your doctor promptly and take corresponding treatment measures. Please follow your doctor's advice for details.
Treatment of overdose of this product should include general supportive measures (including monitoring vital signs and observing the patient's clinical status, etc.). There is no specific antidote for overdose.
Adverse reactions
Gastrointestinal diseases such as diarrhea, indigestion, gastroesophageal reflux disease, vomiting, etc., as well as myalgia , taste disturbance, dizziness and other adverse reactions may occur after taking the drug.
In addition, rare adverse reactions include aphthous ulcer, colitis , dry mouth , loose stools, chest discomfort, loss of appetite, headache, abnormal sense of smell, anxiety, dyspnea, hiccups , oropharyngeal pain, maculopapular rash , skin exfoliation, etc. Abnormal
test indicators: increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), and decreased blood thyroid-stimulating hormone (TSH). Therefore, please inform the doctor that you are using this product when seeing a doctor, so as not to affect the diagnosis and treatment of the disease.
Indications for discontinuation of medication
Generally, the medication can be discontinued when symptoms are relieved. If you are allergic to this product while taking
, you should stop using it immediately.
In addition, you may experience other side effects. If you feel unwell after taking the medication, please inform your doctor in time. The doctor will determine whether the medication should be discontinued or take necessary measures based on the severity of the adverse reactions.
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