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Paxlovid is a brand name for Nirmatrelvir. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Paxlovid is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and paediatric patients 6 years of age and older weighing at least 20 kg who do not require supplemental oxygen and who are at increased risk for progressing to severe COVID-19 (see section 5.1).
Verbatim from this product's EMA label. Tap a section to expand.
Posology Adults The recommended dose in adults is 300 mg nirmatrelvir (two 150 mg tablets) with 100 mg ritonavir (one 100 mg tablet) all taken together orally every 12 hours for 5 days. Paediatric patients 6 years of age and older weighing at least 20 kg The recommended dose in paediatric patients 6 years of age and older weighing at least 20 kg is shown below in Table 1.
3 Table 1: Recommended dose for paediatric patients 6 years of age and older weighing at least 20 kg Patient population Recommended dose Paediatric patients ≥6 years of age weighing ≥40 kg 300 mg nirmatrelvir (two 150 mg tablets) with 100 mg ritonavir (one 100 mg tablet) all taken together orally every 12 hours for 5 days Paediatric patients ≥6 years of age weighing ≥20 to <40 kg 150 mg nirmatrelvir (one 150 mg tablet) with 100 mg ritonavir (one 100 mg tablet) taken together orally every 12 hours for 5 days Special attention for paediatric patients 6 years of age and older weighing at least 20 kg to less than 40 kg There is a pack specific for paediatric patients 6 years of age and older weighing at least 20 kg to less than 40 kg.
This pack contains 5 blister cards with two separated parts each containing one tablet of nirmatrelvir and one tablet of ritonavir for administration every 12 hours. Paxlovid should be administered as soon as possible after a diagnosis of COVID-19 has been made and within 5 days of symptom onset.
Completion of the full 5-day treatment course is recommended even if the patient requires hospitalisation due to severe or critical COVID-19 after starting treatment with this medicinal product. If the patient misses a dose 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. Special populations Renal impairment No dose adjustment is needed in patients with mild renal impairment [estimated glomerular filtration rate (eGFR) ≥ 60 to < 90 mL/min].
In adult patients with moderate renal impairment (eGFR ≥ 30 to < 60 mL/min) or with severe renal impairment [eGFR < 30 mL/min, including patients with End Stage Renal Disease (ESRD) under haemodialysis], the dose should be reduced as shown in Table 2 to avoid over-exposure.
2%). Tabulated list of adverse reactions The safety profile of the product is based on adverse reactions reported in clinical trials and spontaneous reporting. The adverse reactions in Table 4 are listed below by system organ class and frequency.
Frequencies are defined as follows:
Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); not known (frequency cannot be estimated from the available data). 25 Table 4: Adverse reactions with Paxlovid System organ class Frequency category Adverse reactions Immune system disorders Uncommon Hypersensitivity Rare Anaphylaxis Nervous system disorders Common Dysgeusia, headache Vascular disorders Uncommon Hypertension Gastrointestinal disorders Common Diarrhoea, vomiting, nausea Uncommon Abdominal pain Skin and subcutaneous tissue disorders Uncommon Rash* Rare Toxic epidermal necrolysis, Stevens-Johnson syndrome, Pruritus* Musculoskeletal and connective tissue disorders Uncommon Myalgia General disorders and administration site conditions Rare Malaise * These adverse reactions are also manifestations of hypersensitivity reaction.
Description of selected adverse reactions Patients with severe renal impairment Based on limited data from a Phase 1, open-label study, the safety profile of Paxlovid in participants with severe renal impairment, including those requiring haemodialysis, was consistent with the safety profile observed in clinical trials.
1). In the study analysis, 75 participants 6 to less than 18 years of age weighing at least 20 kg were included in the assessment of safety. The adverse reaction profile observed in this study is similar to that in the adult population.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix Ⅴ.
Risk of serious adverse reactions due to interactions with other medicinal products Management of drug-drug interactions (DDIs) in high-risk COVID-19 patients receiving multiple concomitant medications can be complex and require a thorough understanding of the nature and magnitude of interaction with all concomitant medications.
, involving physicians and specialists in clinical pharmacology) should be considered for management of DDIs especially if concomitant medications are withheld, their dose is reduced, or if monitoring of side effects is necessary. 5).
5). Effects of other medicinal products on Paxlovid Initiation of medicinal products that inhibit or induce CYP3A may increase or decrease concentrations of Paxlovid, respectively. These interactions may lead to: • Clinically significant adverse reactions with severe, life-threatening or fatal events from greater exposures of concomitant medicinal products.
• Clinically significant adverse reactions from greater exposures of Paxlovid. • Loss of therapeutic effect of Paxlovid and possible development of viral resistance. 5). Potential for interactions should be considered with other medicinal products prior to and during Paxlovid therapy; concomitant medicinal products should be reviewed during Paxlovid therapy and the patient should be monitored for the adverse reactions associated with the concomitant medicinal products.
8). If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue this medicinal product and initiate appropriate medications and/or supportive care. Severe hepatic impairment No pharmacokinetic and clinical data are available in patients with severe hepatic impairment.
Therefore, this medicinal product should not be used in patients with severe hepatic impairment. Hepatotoxicity Hepatic transaminase elevations, clinical hepatitis and jaundice have occurred in patients receiving ritonavir. Therefore, caution should be exercised when administering this medicinal product to patients with pre-existing liver diseases, liver enzyme abnormalities or hepatitis.
1. 5 Medicinal products listed below are a guide and not considered a comprehensive list of all possible medicinal products that are contraindicated with Paxlovid. Medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening reactions.
• Alpha1-adrenoreceptor antagonist: alfuzosin • Antianginal: ranolazine • Antiarrhythmic: dronedarone, propafenone, quinidine • Anticancer drugs: neratinib, venetoclax • Anti-gout: colchicine • Antihistamines: terfenadine • Antipsychotics/neuroleptics: lurasidone, pimozide, quetiapine • Benign prostatic hyperplasia medicinal products: silodosin • Cardiovascular medicinal products: eplerenone, ivabradine • Ergot derivatives: dihydroergotamine, ergonovine, ergotamine, methylergonovine • GI motility agents: cisapride • Immunosuppressants: voclosporin • Lipid-modifying agents: o HMG Co-A reductase inhibitors: lovastatin, simvastatin o Microsomal triglyceride transfer protein (MTTP) inhibitor: lomitapide • Migraine medicinal products: eletriptan • Mineralocorticoid receptor antagonists: finerenone • Neuropsychiatric agents: cariprazine • Opioid antagonists: naloxegol • PDE5 inhibitor: avanafil, sildenafil, tadalafil, vardenafil • Sedative/hypnotics: clorazepate, diazepam, estazolam, flurazepam, oral midazolam and triazolam • Vasopressin receptor antagonists: tolvaptan Medicinal products that are potent CYP3A inducers where significantly reduced nirmatrelvir/ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance.
• Antibiotics: rifampicin, rifapentine • Anticancer drugs: apalutamide, enzalutamide • Anticonvulsants: carbamazepine, phenobarbital, phenytoin, primidone • Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor • Herbal products: St.
5). , involving physicians and specialists in clinical pharmacology) should be considered to determine the adequate timing for Paxlovid initiation taking into account the delayed offset of the recently discontinued CYP3A inducer and the need to initiate Paxlovid within 5 days of symptom onset.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The treatment should be administered at approximately the same time each day for 5 days. 2).
Table 2:
Recommended dose and regimen for adult patients with renal impairment Renal function Days of treatment Dose and dose frequency Moderate renal impairment (eGFR ≥ 30 to < 60 mL/min) Days 1-5 150 mg nirmatrelvir (one 150 mg tablet) with 100 mg ritonavir (one 100 mg tablet) every 12 hours Severe renal impairment (eGFR < 30 mL/min) including those requiring haemodialysis Day 1 300 mg nirmatrelvir (two 150 mg tablets) with 100 mg ritonavir (one 100 mg tablet) once Days 2-5 150 mg nirmatrelvir (one 150 mg tablet) with 100 mg ritonavir (one 100 mg tablet) once daily Abbreviation: eGFR=estimated glomerular filtration rate.
4 Special attention for patients with MODERATE renal impairment There is a pack specific for patients with moderate renal impairment. This pack contains 5 blister cards with two separated parts each containing one tablet of nirmatrelvir and one tablet of ritonavir for administration every 12 hours.
Special attention for patients with SEVERE renal impairment There is a pack specific for patients with severe renal impairment. This pack contains 1 blister card with one separated part containing two tablets of nirmatrelvir and one tablet of ritonavir for administration once on Day 1, and four additional separated parts each containing one tablet of nirmatrelvir and one tablet of ritonavir for administration once daily on Days 2 to 5.
2). Dose in paediatric patients with renal impairment weighing less than 40 kg has not been determined. Hepatic impairment No dose adjustment is needed for patients with either mild (Child-Pugh Class A) or moderate (Child- Pugh Class B) hepatic impairment.
2). Severely immunocompromised population Data are limited in severely immunocompromised individuals. g. 1). Concomitant therapy with ritonavir- or cobicistat-containing regimen No dose adjustment is needed. 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.
Paediatric population The safety and efficacy of Paxlovid in paediatric patients below 6 years of age or weighing less than 20 kg have not been established. 2). Method of administration For oral use. Nirmatrelvir must be coadministered with ritonavir.
Failure to correctly coadminister nirmatrelvir with ritonavir will result in plasma levels of this active substance that […]
7 Elevation in blood pressure Cases of hypertension, generally non serious and transient, have been reported during treatment with Paxlovid. Specific attention including regular monitoring of blood pressure should be paid notably to elderly patients since they are at higher risk of experiencing serious complications of hypertension.
Risk of HIV-1 resistance development Because nirmatrelvir is coadministered with ritonavir, there may be a risk of HIV-1 developing resistance to HIV protease inhibitors in individuals with uncontrolled or undiagnosed HIV-1 infection.
Excipients Lactose Nirmatrelvir tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Sodium Nirmatrelvir and ritonavir tablets each contain less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.