PAXLOVID FILM-COATED TABLETS [SIN16877P]

Product Info

PAXLOVID FILM-COATED TABLETS

[SIN16877P]

4.1. Therapeutic indications

PAXLOVID is indicated for the treatment of mild-to-moderate Coronavirus Disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.

4.2. Posology and method of administration

PAXLOVID is nirmatrelvir tablets co-packaged with ritonavir tablets.

Nirmatrelvir must be co-administered with ritonavir. Failure to correctly co-administer nirmatrelvir with ritonavir may result in plasma levels of nirmatrelvir that are insufficient to achieve the desired therapeutic effect.

Posology

The recommended dosage is 300 mg nirmatrelvir (two 150 mg tablets) with 100 mg ritonavir (one 100 mg tablet) all taken together orally twice daily for 5 days. PAXLOVID should be given as soon as possible after a diagnosis of COVID-19 has been made and within 5 days of symptom onset even if baseline COVID-19 symptoms are mild. If a patient requires hospitalization due to severe or critical COVID-19 after starting treatment with PAXLOVID, it is recommended that the patient should complete the full 5-day treatment course per the healthcare provider’s discretion.

If the patient misses a dose of PAXLOVID within 8 hours of the time it is usually taken, the patient should take it as soon as possible and resume the normal dosing schedule. If the patient misses a dose by more than 8 hours, the patient should not take the missed dose and instead take the next dose at the regularly scheduled time. The patient should not double the dose to make up for a missed dose.

Patient selection

The following medical conditions or other factors place adult patients at high risk for progression to severe COVID-19:

• Older age (e.g., 60 years of age and older)

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

• Current smoker

• Chronic kidney disease

• Diabetes

• Immunosuppressive disease or immunosuppressive treatment

• Cardiovascular disease (including congenital heart disease) or hypertension

• Chronic lung disease [e.g., 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’s syndrome) or other conditions that confer medical complexity (e.g., genetic or metabolic syndromes and severe congenital anomalies)

• Active cancer

• Medical-related technological dependence not related to COVID-19 (e.g., tracheostomy, gastrostomy, or positive pressure ventilation)

Other medical conditions or factors (e.g., race or ethnicity) may also place individual patients at high risk for progression to severe COVID-19 and are not limited to the medical conditions or factors listed above. Healthcare providers should consider the benefit-risk for an individual patient.

Special populations

Pediatric population
The safety and efficacy of PAXLOVID have not been studied in patients younger than 18 years of age.

Renal impairment
No dosage adjustment is needed 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 PAXLOVID should be reduced to nirmatrelvir/ritonavir 150 mg/100 mg twice daily for 5 days.

Note: The daily blister contains two separated parts each containing two tablets of nirmatrelvir and one tablet of ritonavir corresponding to the daily administration at the standard dose. Therefore, patients with moderate renal impairment should be alerted on the fact that only one tablet of nirmatrelvir with the tablet of ritonavir should be taken every 12 hours.

PAXLOVID is not recommended in patients with severe renal impairment (eGFR <30 mL/min) until more data are available; the appropriate dosage for patients with severe renal impairment has not been determined (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment
No dosage adjustment is needed in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment.

No pharmacokinetic or safety data are available regarding the use of nirmatrelvir or ritonavir in participants with severe (Child-Pugh Class C) hepatic impairment; therefore, PAXLOVID is not recommended for use in patients with severe hepatic impairment (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Concomitant therapy with ritonavir- or cobicistat-containing regimen
No dose adjustment is needed; the dose of PAXLOVID is 300 mg/100 mg twice daily for 5 days.

Patients diagnosed with human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection who are receiving ritonavir- or cobicistat-containing regimen should continue their treatment as indicated.

Method of administration

For oral use.

PAXLOVID can be taken with or without food (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The tablets should be swallowed whole and not chewed, broken, or crushed.

4.3. Contraindications

PAXLOVID is contraindicated in patients with a history of clinically significant hypersensitivity to the active substances (nirmatrelvir/ritonavir) or to any of the product excipients.

PAXLOVID is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated concentrations are associated with serious and/or life-threatening reactions (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Drugs listed in this section and section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information are a guide and not considered a comprehensive list of all possible drugs that may be contraindicated with PAXLOVID.

• Alpha 1-adrenoreceptor antagonist: alfuzosin

• Antianginal: ranolazine

• Antiarrhythmic: amiodarone, dronedarone, flecainide, propafenone, quinidine

• Anti-gout: colchicine

• Antipsychotics: lurasidone, pimozide

• Benign prostatic hyperplasia agents: silodosin

• Cardiovascular agents: eplerenone, ivabradine

• Ergot derivatives: dihydroergotamine, ergotamine, methylergonovine

• HMG-CoA reductase inhibitors: lovastatin, simvastatin

• Immunosuppressants: voclosporin

• Microsomal triglyceride transfer protein inhibitor: lomitapide

• Migraine medications: eletriptan, ubrogepant

• Mineralocorticoid receptor antagonists: finerenone

• Opioid antagonists: naloxegol

• PDE5 inhibitor: sildenafil when used for pulmonary arterial hypertension (PAH)

• Sedative/hypnotics: triazolam, oral midazolam

• Serotonin receptor 1A agonist/serotonin receptor 2A antagonist: flibanserin

• Vasopressin receptor antagonists: tolvaptan

PAXLOVID is contraindicated with drugs that are potent CYP3A inducers where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance. PAXLOVID cannot be started immediately after discontinuation of any of the following medications due to the delayed offset of the recently discontinued CYP3A inducer (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Anticancer drugs: apalutamide, enzalutamide

• Anticonvulsant: carbamazepine, phenobarbital, primidone, phenytoin

• Antimycobacterials: rifampin, rifapentine

• Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor

• Herbal products: St. John’s Wort (Hypericum perforatum)