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Paxlovid

Paxlovid

ritonavir

nirmatrelvir

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
4 pink tab each containing Nirmatrelvir 150 mg, 2 white tab each containing Ritonavir 100 mg
Indications/Uses
Mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19 including hospitalization or death.
Dosage/Direction for Use
Recommended dose: Nirmatrelvir 300 mg w/ ritonavir 100 mg all taken together bd for 5 days, given immediately after diagnosis & w/in 5 days of symptom onset. Patient w/ severe or critical COVID-19 after starting Paxlovid treatment Recommended to complete full 5-day treatment course. Moderate renal impairment (eGFR ≥30 to <60 mL/min) Nirmatrelvir 150 mg w/ ritonavir 100 mg bd for 5 days.
Administration
May be taken with or without food: Swallow whole. Do not chew/break/crush.
Contraindications
Hypersensitivity. Concomitant use w/ alfuzosin; ranolazine; amiodarone, dronedarone, flecainide, propafenone, quinidine; colchicine; lurasidone, pimozide; silodosin; eplerenone, ivabradine; dihydroergotamine, ergotamine, methylergonovine; lovastatin, simvastatin; voclosporin; lomitapide; eletriptan, ubrogepant; finerenone; suzetrigine; naloxegol; sildenafil (when used for pulmonary arterial HTN); triazolam, oral midazolam; flibanserin; tolvaptan. Concomitant use w/ potent CYP3A inducers (eg, apalutamide, enzalutamide; carbamazepine, phenobarb, primidone, phenytoin; rifampin, rifapentine; lumacaftor/ivacaftor; St. John's wort).
Special Precautions
Anaphylaxis, hypersensitivity reactions & serious skin reactions (including TEN & SJS). Discontinue use immediately & initiate appropriate medication &/or supportive care if signs & symptoms of clinically significant hypersensitivity reaction or anaphylaxis occur. Concomitant use w/ CYP3A-inhibitor or -inducer medications may increase or decrease Paxlovid conc. Possible severe, life-threatening & fatal adverse reactions due to drug interactions. Consider potential drug interactions prior to & during Paxlovid therapy; monitor for adverse reactions associated w/ concomitant medications. Co-administration w/ calcineurin & mTOR inhibitors. Patients w/ pre-existing liver diseases, liver enzyme abnormalities or hepatitis; possible hepatic transaminase elevations, clinical hepatitis & jaundice. Risk of HIV-1 resistance development to HIV PIs in individuals w/ uncontrolled or undiagnosed HIV-1 infection. Not recommended in patients w/ severe renal (eGFR <30 mL/min) & hepatic impairment. Avoid becoming pregnant in women of childbearing potential & for 7 days after completing treatment. Advise to use effective alternative contraceptive method or additional barrier method of contraception during treatment & until 1 menstrual cycle after stopping Paxlovid. Pregnancy. Discontinue breast-feeding during & 48 hr after completing treatment. Childn <18 yr.
Adverse Reactions
Dysgeusia, headache; diarrhea, nausea.
Drug Interactions
May increase conc of alfuzosin; tamsulosin; ranolazine; antiarrhythmic (eg, amiodarone, dronedarone, flecainide, propafenone, quinidine, lidocaine, disopyramide); anticancer drugs (eg, abemaciclib, ceritinib, dasatinib, encorafenib, ibrutinib, ivosidenib, neratinib, nilotinib, venetoclax, vinblastine, vincristine); rivaroxaban, dabigatran, apixaban; clonazepam; trazodone; ketoconazole, isavuconazonium sulfate, itraconazole; colchicine; anti-HIV PI (eg, atazanavir, darunavir, tipranavir); efavirenz, maraviroc, nevirapine, bictegravir, tenofovir; clarithromycin, erythromycin; bedaquiline, rifabutin; lurasidone, pimozide; quetiapine, clozapine; silodosin; Ca-channel blockers (eg, amlodipine, diltiazem, felodipine, nicardipine, nifedipine, verapamil); digoxin; eplerenone, ivabradine; aliskiren, ticagrelor, vorapaxar, cilostazol; corticosteroids (eg, betamethasone, budesonide, ciclesonide, dexamethasone, fluticasone, methylprednisolone, mometasone, triamcinolone); ivacaftor, elexacaftor/tezacaftor/ivacaftor, tezacaftor/ivacaftor; saxagliptin; bosentan; dihydroergotamine, ergotamine, methylergonovine; hepatitis C direct-acting antivirals (eg, elbasvir/grazoprevir, glecaprevir/pibrentasvir, ombitasvir/paritaprevir/ritonavir & dasabuvir, sofosbuvir/velpatasvir/voxilaprevir); lovastatin, simvastatin, atorvastatin, rosuvastatin; voclosporin; calcineurin (eg, cyclosporine, tacrolimus) & mTOR (eg, everolimus, sirolimus) inhibitors; tofacitinib, upadacitinib; salmeterol; lomitapide; eletriptan, ubrogepant; rimegepant; finerenone; darifenacin; fentanyl, hydrocodone, oxycodone, meperidine; suvorexant, aripiprazole, brexpiprazole, cariprazine, iloperidone, lumateperone, pimavanserin; suzetrigine & active metabolite M6-SUZ; sildenafil, tadalafil, riociguat; avanafil, sildenafil, tadalafil, vardenafil; naloxegol; triazolam, oral midazolam; sedative/hypnotics (eg, buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem), midazolam (administered parenterally); flibanserin; tolvaptan. May decrease conc w/ apalutamide, enzalutamide; carbamazepine, phenobarb, phenytoin, primidone; rifampin, rifapentine; lumacaftor/ivacaftor; St. John's wort. May decrease conc of bupropion & active metabolite hydroxy-bupropion; voriconazole; zidovudine; albendazole; clopidogrel active metabolite; ethinyl estradiol; methadone. May increase or decrease conc of warfarin; closely monitor INR.
MIMS Class
Antivirals
ATC Classification
J05AE30 - nirmatrelvir and ritonavir ; Belongs to the class of protease inhibitors. Used in the systemic treatment of viral infections.
Presentation/Packing
Form
Paxlovid FC tab
Packing/Price
(daily-dose blister card (4 pink tab + 2 white tab)) 5 × 6's
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