PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets) 7 DRUG INTERACTIONS

(nirmatrelvir tablets; ritonavir tablets)

PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets) Prescribing Information

Download PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets) Prescribing Information

7 DRUG INTERACTIONS

7.1 Potential for PAXLOVID to Affect Other Drugs

PAXLOVID (nirmatrelvir co-packaged with ritonavir) is a strong inhibitor of CYP3A, and an inhibitor of CYP2D6, P-gp and OATP1B1. Co-administration of PAXLOVID with drugs that are primarily metabolized by CYP3A and CYP2D6 or are transported by P-gp or OATP1B1 may result in increased plasma concentrations of such drugs and increase the risk of adverse events. Co-administration of PAXLOVID with drugs highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated [see Contraindications (4) and Drug Interactions (7.3) Table 2]. Co-administration with other CYP3A substrates may require a dose adjustment or additional monitoring as shown in Table 2.

7.2 Potential for Other Drugs to Affect PAXLOVID

Nirmatrelvir and ritonavir are CYP3A substrates; therefore, drugs that induce CYP3A may decrease nirmatrelvir and ritonavir plasma concentrations and reduce PAXLOVID therapeutic effect [see Contraindications (4) and Drug Interactions (7.3) Table 2].

7.3 Established and Other Potentially Significant Drug Interactions

Table 2 provides a listing of clinically significant drug interactions, including contraindicated drugs [see Contraindications (4) and Warnings and Precautions (5.1)]. Drugs listed in Table 2 are a guide and not considered a comprehensive list of all possible drugs that may interact with PAXLOVID. The healthcare provider should consult other appropriate resources such as the prescribing information for the interacting drug for comprehensive information on dosing or monitoring with concomitant use of a strong CYP3A inhibitor such as ritonavir.

Table 2: Established and Other Potentially Significant Drug Interactions
Drug Class	Drugs within Class	Effect on Concentration	Clinical Comments
* See Pharmacokinetics, Clinical Drug Interaction Studies (12.3).
Alpha 1- adrenoreceptor antagonist	alfuzosin	↑ alfuzosin	Co-administration contraindicated due to potential hypotension [see Contraindications (4)].
Alpha 1- adrenoreceptor antagonist	tamsulosin	↑ tamsulosin	Avoid concomitant use with PAXLOVID.
Antianginal	ranolazine	↑ ranolazine	Co-administration contraindicated due to potential for serious and/or life-threatening reactions [see Contraindications (4)].
Antiarrhythmics	amiodarone, dronedarone, flecainide, propafenone, quinidine	↑ antiarrhythmic	Co-administration contraindicated due to potential for cardiac arrhythmias [see Contraindications (4)].
Antiarrhythmics	lidocaine (systemic), disopyramide	↑ antiarrhythmic	Caution is warranted and therapeutic concentration monitoring is recommended for antiarrhythmics if available.
Anticancer drugs	apalutamide, enzalutamide	↓ nirmatrelvir/ritonavir	Co-administration contraindicated due to potential loss of virologic response and possible resistance [see Contraindications (4)].
Anticancer drugs	abemaciclib, ceritinib, dasatinib, encorafenib, ibrutinib, ivosidenib, neratinib, nilotinib, venetoclax, vinblastine, vincristine	↑ anticancer drugs	Avoid co-administration of encorafenib or ivosidenib due to potential risk of serious adverse events such as QT interval prolongation. Avoid use of neratinib, venetoclax or ibrutinib. Co-administration of vincristine and vinblastine may lead to significant hematologic or gastrointestinal side effects. For further information, refer to the individual product prescribing information for anticancer drug.
Anticoagulants	warfarin	↑↓ warfarin	Closely monitor international normalized ratio (INR) if co-administration with warfarin is necessary.
	rivaroxaban	↑ rivaroxaban	Increased bleeding risk with rivaroxaban. Avoid concomitant use.
	dabigatran*	↑ dabigatran	Increased bleeding risk with dabigatran. Depending on dabigatran indication and renal function, reduce dose of dabigatran or avoid concomitant use. Refer to the dabigatran prescribing information for further information.
	apixaban	↑ apixaban	Combined P-gp and strong CYP3A inhibitors increase blood levels of apixaban and increase the risk of bleeding. Dosing recommendations for co-administration of apixaban with PAXLOVID depend on the apixaban dose. Refer to the apixaban prescribing information for more information.
Anticonvulsants	carbamazepine*, phenobarbital, primidone, phenytoin	↓ nirmatrelvir/ritonavir	Co-administration contraindicated due to potential loss of virologic response and possible resistance [see Contraindications (4)].
Anticonvulsants	clonazepam	↑ anticonvulsant	A dose decrease may be needed for clonazepam when co-administered with PAXLOVID and clinical monitoring is recommended.
Antidepressants	bupropion	↓ bupropion and active metabolite hydroxy-bupropion	Monitor for an adequate clinical response to bupropion.
	trazodone	↑ trazodone	Adverse reactions of nausea, dizziness, hypotension, and syncope have been observed following co-administration of trazodone and ritonavir. A lower dose of trazodone should be considered. Refer to the trazadone prescribing information for further information.
Antifungals	voriconazole	↓ voriconazole	Avoid concomitant use of voriconazole.
	ketoconazole, isavuconazonium sulfate, itraconazole*	↑ ketoconazole ↑ isavuconazonium sulfate ↑ itraconazole	Refer to the ketoconazole, isavuconazonium sulfate, and itraconazole prescribing information for further information.
		↑ nirmatrelvir/ritonavir	A nirmatrelvir/ritonavir dose reduction is not needed.
Anti-gout	colchicine	↑ colchicine	Co-administration contraindicated due to potential for serious and/or life-threatening reactions in patients with renal and/or hepatic impairment [see Contraindications (4)].
Anti-HIV protease inhibitors	atazanavir, darunavir, tipranavir	↑ protease inhibitor	For further information, refer to the respective protease inhibitors' prescribing information. Patients on ritonavir- or cobicistat-containing HIV regimens should continue their treatment as indicated. Monitor for increased PAXLOVID or protease inhibitor adverse events.
Anti-HIV	efavirenz, maraviroc, nevirapine, zidovudine, bictegravir/ emtricitabine/ tenofovir	↑ efavirenz ↑ maraviroc ↑ nevirapine ↓ zidovudine ↑ bictegravir ↔ emtricitabine ↑ tenofovir	For further information, refer to the respective anti-HIV drugs prescribing information.
Anti-infective	clarithromycin, erythromycin	↑ clarithromycin ↑ erythromycin	Refer to the respective prescribing information for anti-infective dose adjustment.
Antimycobacterial	rifampin, rifapentine	↓ nirmatrelvir/ritonavir	Co-administration contraindicated due to potential loss of virologic response and possible resistance. Alternate antimycobacterial drugs such as rifabutin should be considered [see Contraindications (4)].
Antimycobacterial	bedaquiline	↑ bedaquiline	Refer to the bedaquiline prescribing information for further information.
	rifabutin	↑ rifabutin	Refer to the rifabutin prescribing information for further information on rifabutin dose reduction.
Antipsychotics	lurasidone, pimozide	↑ lurasidone ↑ pimozide	Co-administration contraindicated due to serious and/or life-threatening reactions such as cardiac arrhythmias [see Contraindications (4)].
Antipsychotics	quetiapine	↑ quetiapine	If co-administration is necessary, reduce quetiapine dose and monitor for quetiapine-associated adverse reactions. Refer to the quetiapine prescribing information for recommendations.
	clozapine	↑ clozapine	If co-administration is necessary, consider reducing the clozapine dose and monitor for adverse reactions.
Benign prostatic hyperplasia agents	silodosin	↑ silodosin	Co-administration contraindicated due to potential for postural hypotension [see Contraindications (4)].
Calcium channel blockers	amlodipine, diltiazem, felodipine, nicardipine, nifedipine, verapamil	↑ calcium channel blocker	Caution is warranted and clinical monitoring of patients is recommended. A dose decrease may be needed for these drugs when co-administered with PAXLOVID. If co-administered, refer to the individual product prescribing information for calcium channel blocker for further information.
Cardiac glycosides	digoxin	↑ digoxin	Caution should be exercised when co-administering PAXLOVID with digoxin, with appropriate monitoring of serum digoxin levels. Refer to the digoxin prescribing information for further information.
Cardiovascular agents	eplerenone	↑ eplerenone	Co-administration with eplerenone is contraindicated due to potential for hyperkalemia [see Contraindications (4)].
	ivabradine	↑ ivabradine	Co-administration with ivabradine is contraindicated due to potential for bradycardia or conduction disturbances [see Contraindications (4)].
Cardiovascular agents	aliskiren, ticagrelor, vorapaxar clopidogrel	↑ aliskiren ↑ ticagrelor ↑ vorapaxar ↓ clopidogrel active metabolite	Avoid concomitant use with PAXLOVID.
	cilostazol	↑ cilostazol	Dosage adjustment of cilostazol is recommended. Refer to the cilostazol prescribing information for more information.
	mavacamten	↑ mavacamten	Co-administration with mavacamten may increase mavacamten plasma concentration and increase the risk of heart failure. Discontinue mavacamten for the duration of PAXLOVID treatment. Resumption of mavacamten within 5 days of completing PAXLOVID may result in higher exposure of mavacamten. Refer to the mavacamten prescribing information for more information.
Corticosteroids primarily metabolized by CYP3A	betamethasone, budesonide, ciclesonide, dexamethasone, fluticasone, methylprednisolone, mometasone, triamcinolone	↑ corticosteroid	Co-administration with corticosteroids (all routes of administration) of which exposures are significantly increased by strong CYP3A inhibitors can increase the risk for Cushing’s syndrome and adrenal suppression. However, the risk of Cushing’s syndrome and adrenal suppression associated with short-term use of a strong CYP3A inhibitor is low. Alternative corticosteroids including beclomethasone, prednisone, and prednisolone should be considered.
Cystic fibrosis transmembrane conductance regulator potentiators	lumacaftor/ivacaftor	↓ nirmatrelvir/ritonavir	Co-administration contraindicated due to potential loss of virologic response and possible resistance [see Contraindications (4)].
Cystic fibrosis transmembrane conductance regulator potentiators	ivacaftor elexacaftor/tezacaftor/ ivacaftor tezacaftor/ivacaftor	↑ ivacaftor ↑ elexacaftor/tezacaftor/ ivacaftor ↑ tezacaftor/ivacaftor	Reduce dosage when co-administered with PAXLOVID. Refer to the individual product prescribing information for more information.
Dipeptidyl peptidase 4 (DPP4) inhibitors	saxagliptin	↑ saxagliptin	Dosage adjustment of saxagliptin is recommended. Refer to the saxagliptin prescribing information for more information.
Endothelin receptor antagonists	bosentan	↑ bosentan ↓ nirmatrelvir/ritonavir	Discontinue use of bosentan at least 36 hours prior to initiation of PAXLOVID. Refer to the bosentan prescribing information for further information.
Ergot derivatives	dihydroergotamine, ergotamine, methylergonovine	↑ dihydroergotamine ↑ ergotamine ↑ methylergonovine	Co-administration contraindicated due to potential for acute ergot toxicity characterized by vasospasm and ischemia of the extremities and other tissues including the central nervous system [see Contraindications (4)].
Hepatitis C direct acting antivirals	elbasvir/grazoprevir	↑ antiviral	Increased grazoprevir concentrations can result in alanine transaminase (ALT) elevations.
	glecaprevir/pibrentasvir		Avoid concomitant use of glecaprevir/pibrentasvir with PAXLOVID.
	ombitasvir/paritaprevir/ritonavir and dasabuvir		Refer to the ombitasvir/paritaprevir/ritonavir and dasabuvir label for further information.
	sofosbuvir/velpatasvir/voxilaprevir		Refer to the sofosbuvir/velpatasvir/voxilaprevir prescribing information for further information. Patients on ritonavir-containing HCV regimens should continue their treatment as indicated. Monitor for increased PAXLOVID or HCV drug adverse events with concomitant use.
Herbal products	St. John's Wort (hypericum perforatum)	↓ nirmatrelvir/ritonavir	Co-administration contraindicated due to potential loss of virologic response and possible resistance [see Contraindications (4)].
HMG-CoA reductase inhibitors	lovastatin, simvastatin	↑ lovastatin ↑ simvastatin	Co-administration contraindicated due to potential for myopathy including rhabdomyolysis [see Contraindications (4)]. If treatment with PAXLOVID is considered medically necessary, discontinue use of lovastatin and simvastatin at least 12 hours prior to initiation of PAXLOVID, during the 5 days of PAXLOVID treatment, and for 5 days after completing PAXLOVID.
HMG-CoA reductase inhibitors	atorvastatin	↑ atorvastatin	Consider temporary discontinuation of atorvastatin during treatment with PAXLOVID. Atorvastatin does not need to be withheld prior to or after completing PAXLOVID.
Hormonal contraceptive	ethinyl estradiol	↓ ethinyl estradiol	An additional, non-hormonal method of contraception should be considered during the 5 days of PAXLOVID treatment and until one menstrual cycle after stopping PAXLOVID.
Immunosuppressants	voclosporin	↑ voclosporin	Co-administration contraindicated due to potential for acute and/or chronic nephrotoxicity [see Contraindications (4)].
Immunosuppressants	calcineurin inhibitors: cyclosporine, tacrolimus	↑ cyclosporine ↑ tacrolimus	Avoid concomitant use of calcineurin inhibitors with PAXLOVID when close monitoring of immunosuppressant concentrations is not feasible. If co-administered, dose adjustment of the immunosuppressant and close and regular monitoring for immunosuppressant concentrations and adverse reactions are recommended during and after treatment with PAXLOVID. Obtain expert consultation to appropriately manage the complexity of this co-administration [see Warnings and Precautions (5.1)].
	mTOR inhibitors: everolimus, sirolimus	↑ everolimus ↑ sirolimus	Avoid concomitant use of everolimus and sirolimus and PAXLOVID. Refer to the individual immunosuppressant prescribing information and latest guidelines for further information.
Janus kinase (JAK) inhibitors	tofacitinib	↑ tofacitinib	Dosage adjustment of tofacitinib is recommended. Refer to the tofacitinib prescribing information for more information.
	upadacitinib	↑ upadacitinib	Dosing recommendations for co-administration of upadacitinib with PAXLOVID depends on the upadacitinib indication. Refer to the upadacitinib prescribing information for more information.
Long-acting beta-adrenoceptor agonist	salmeterol	↑ salmeterol	Avoid concomitant use with PAXLOVID. The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations, and sinus tachycardia.
Microsomal triglyceride transfer protein (MTTP) inhibitor	lomitapide	↑ lomitapide	Co-administration contraindicated due to potential for hepatotoxicity and gastrointestinal adverse reactions [see Contraindications (4)].
Migraine medications	eletriptan	↑ eletriptan	Co-administration of eletriptan within at least 72 hours of PAXLOVID is contraindicated due to potential for serious adverse reactions including cardiovascular and cerebrovascular events [see Contraindications (4)].
	ubrogepant	↑ ubrogepant	Co-administration of ubrogepant with PAXLOVID is contraindicated due to potential for serious adverse reactions [see Contraindications (4)].
Migraine medications	rimegepant	↑ rimegepant	Avoid concomitant use with PAXLOVID.
Mineralocorticoid receptor antagonists	finerenone	↑ finerenone	Co-administration contraindicated due to potential for serious adverse reactions including hyperkalemia, hypotension, and hyponatremia [see Contraindications (4)].
Muscarinic receptor antagonists	darifenacin	↑ darifenacin	The darifenacin daily-dose should not exceed 7.5 mg when co-administered with PAXLOVID. Refer to the darifenacin prescribing information for more information.
Narcotic analgesics	fentanyl, hydrocodone, oxycodone, meperidine	↑ fentanyl ↑ hydrocodone ↑ oxycodone ↑ meperidine	Careful monitoring of therapeutic and adverse effects (including potentially fatal respiratory depression) is recommended when fentanyl, hydrocodone, oxycodone, or meperidine is concomitantly administered with PAXLOVID. If concomitant use with PAXLOVID is necessary, consider a dosage reduction of the narcotic analgesic and monitor patients closely at frequent intervals. Refer to the individual product prescribing information for more information.
	methadone	↓ methadone	Monitor methadone-maintained patients closely for evidence of withdrawal effects and adjust the methadone dose accordingly.
Neuropsychiatric agents	suvorexant	↑ suvorexant	Avoid concomitant use of suvorexant with PAXLOVID.
	aripiprazole, brexpiprazole, cariprazine, iloperidone, lumateperone, pimavanserin	↑ aripiprazole ↑ brexpiprazole ↑ cariprazine ↑ iloperidone ↑ lumateperone ↑ pimavanserin	Dosage adjustment of aripiprazole, brexpiprazole, cariprazine, iloperidone, lumateperone, and pimavanserin is recommended. Refer to the individual product prescribing information for more information.
Non-opioid analgesic (selective blocker of Nav1.8 sodium channels)	suzetrigine	↑ suzetrigine and active metabolite M6‑SUZ	Co-administration contraindicated due to potential for serious and/or life-threatening suzetrigine adverse reactions [see Contraindications (4)].
Opioid antagonists	naloxegol	↑ naloxegol	Co-administration contraindicated due to the potential for opioid withdrawal symptoms [see Contraindications (4)].
Pulmonary hypertension agents (PDE5 inhibitors)	sildenafil (Revatio®)	↑ sildenafil	Co-administration of sildenafil with PAXLOVID is contraindicated for use in pulmonary hypertension due to the potential for sildenafil associated adverse events, including visual abnormalities hypotension, prolonged erection, and syncope [see Contraindications (4)].
Pulmonary hypertension agents (PDE5 inhibitors)	tadalafil (Adcirca®)	↑ tadalafil	Avoid concomitant use of tadalafil with PAXLOVID for pulmonary hypertension.
Pulmonary hypertension agents (sGC stimulators)	riociguat	↑ riociguat	Dosage adjustment is recommended for riociguat when used for pulmonary hypertension. Refer to the riociguat prescribing information for more information.
Erectile dysfunction agents (PDE5 inhibitors)	avanafil	↑ avanafil	Do not use PAXLOVID with avanafil because a safe and effective avanafil dosage regimen has not been established.
	sildenafil, tadalafil, vardenafil	↑ sildenafil ↑ tadalafil ↑ vardenafil	Dosage adjustment is recommended for use of sildenafil, tadalafil or vardenafil with PAXLOVID when used for erectile dysfunction. Refer to the individual product prescribing information for more information.
Sedative/hypnotics	triazolam, oral midazolam*	↑ triazolam ↑ midazolam	Co-administration contraindicated due to potential for extreme sedation and respiratory depression [see Contraindications (4)].
Sedative/hypnotics	buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem	↑ sedative/hypnotic	A dose decrease may be needed for these drugs when co-administered with PAXLOVID and monitoring for adverse events.
	midazolam (administered parenterally)	↑ midazolam	Co-administration of midazolam (parenteral) should be done in a setting which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation. Dosage reduction for midazolam should be considered, especially if more than a single dose of midazolam is administered. Refer to the midazolam prescribing information for further information.
Serotonin receptor 1A agonist/ serotonin receptor 2A antagonist	flibanserin	↑ flibanserin	Co-administration contraindicated due to potential for hypotension, syncope, and CNS depression [see Contraindications (4)].
Vasopressin receptor antagonists	tolvaptan	↑ tolvaptan	Co-administration contraindicated due to potential for dehydration, hypovolemia and hyperkalemia [see Contraindications (4)].

Medication Guide

MEDICATION GUIDE

PATIENT INFORMATION PAXLOVID (pax-LO-vid) (nirmatrelvir tablets; ritonavir tablets) co-packaged for oral use
What is the most important information I should know about PAXLOVID? PAXLOVID can interact with other medicines causing severe or life-threatening side effects or death. It is important to know the medicines that should not be taken with PAXLOVID. Do not take PAXLOVID if: • you are taking any of the following medicines:
o alfuzosin o amiodarone o apalutamide o carbamazepine o colchicine o dihydroergotamine o dronedarone o eletriptan o enzalutamide o eplerenone o ergotamine o finerenone o flecainide o flibanserin	o ivabradine o lomitapide o lovastatin o lumacaftor/ivacaftor o lurasidone o methylergonovine o midazolam (oral) o naloxegol o phenobarbital o phenytoin o pimozide o primidone o propafenone				o quinidine o ranolazine o rifampin o rifapentine o St. John’s Wort (hypericum perforatum) o sildenafil (Revatio®) for pulmonary arterial hypertension o silodosin o simvastatin o suzetrigine o tolvaptan o triazolam o ubrogepant o voclosporin
These are not the only medicines that may cause serious or life-threatening side effects if taken with PAXLOVID. PAXLOVID may increase or decrease the levels of multiple other medicines. It is very important to tell your healthcare provider about all of the medicines you are taking because additional laboratory tests or changes in the dose of your other medicines may be necessary during treatment with PAXLOVID. Your healthcare provider may also tell you about specific symptoms to watch out for that may indicate that you need to stop or decrease the dose of some of your other medicines. • you are allergic to nirmatrelvir, ritonavir, or any of the ingredients in PAXLOVID. See the end of this leaflet for a complete list of ingredients in PAXLOVID. See “What are the possible side effects of PAXLOVID?” for signs and symptoms of allergic reactions.
What is PAXLOVID? PAXLOVID is a prescription medicine used to treat 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. PAXLOVID is not approved for use as pre-exposure or post-exposure treatment for prevention of COVID-19.
Before taking PAXLOVID, tell your healthcare provider about all of your medical conditions, including if you: • have kidney problems. You may need a different dose or dosing schedule of PAXLOVID. • have liver problems, including hepatitis. • have Human Immunodeficiency Virus 1 (HIV-1) infection. PAXLOVID may lead to some HIV-1 medicines not working as well in the future. • are pregnant or plan to become pregnant. It is not known if PAXLOVID can harm your unborn baby. Tell your healthcare provider right away if you are or if you become pregnant. • are breastfeeding or plan to breastfeed. PAXLOVID can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with PAXLOVID. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. • Your healthcare provider can tell you if it is safe to take PAXLOVID with other medicines. • You can ask your healthcare provider or pharmacist for a list of medicines that interact with PAXLOVID. • Do not start taking a new medicine without telling your healthcare provider. Tell your healthcare provider if you are taking combined birth control (hormonal contraceptive). PAXLOVID may affect how your hormonal contraceptives work. Females who are able to become pregnant should use another effective alternative form of contraception or an additional barrier method of contraception during treatment with PAXLOVID. Talk to your healthcare provider if you have any questions about contraceptive methods that might be right for you.
How should I take PAXLOVID? • Take PAXLOVID exactly as your healthcare provider tells you to take it. • PAXLOVID consists of 2 medicines: nirmatrelvir tablets and ritonavir tablets. The 2 medicines are taken together for 5 days. o Nirmatrelvir is an oval, pink tablet. o Ritonavir is a white or off-white tablet. • PAXLOVID is available in 3 Dose Packs (see Figures A, B, and C below). Your healthcare provider will prescribe the PAXLOVID Dose Pack that is right for you. Follow the instruction for the Dose Pack you receive. • If you have kidney disease, your healthcare provider may prescribe a lower dose (see Figures B and C). Talk to your healthcare provider to make sure you receive the correct Dose Pack.
Figure A
If you are prescribed PAXLOVID 300 mg; 100 mg Dose Pack Each dose contains 3 tablets taken together twice daily

How to take PAXLOVID 300 mg; 100 mg Dose Pack
				Morning Dose: Take the 2 pink nirmatrelvir tablets and 1 white to off-white ritonavir tablet together.

				Bedtime Dose: Take the 2 pink nirmatrelvir tablets and 1 white to off-white ritonavir tablet together.

Figure B
If you are prescribed PAXLOVID 150 mg; 100 mg Dose Pack Each dose contains 2 tablets taken together twice daily

How to take PAXLOVID 150 mg; 100 mg Dose Pack
			Morning Dose: Take the 1 pink nirmatrelvir tablet and 1 white ritonavir tablet together.

			Bedtime Dose: Take the 1 pink nirmatrelvir tablet and 1 white ritonavir tablet together.

Figure C
If you are prescribed PAXLOVID 300 mg; 100 mg (Day 1) and 150 mg; 100 mg (Days 2-5) Each dose is taken together once daily; on days of dialysis take PAXLOVID after receiving dialysis

How to take PAXLOVID 300 mg; 100 mg (Day 1) and 150 mg; 100 mg (Days 2-5)
		Day 1 (First Day): Take the 2 pink nirmatrelvir tablets and 1 white ritonavir tablet together (Blue part of the blister card).
		Days 2-5: Take the 1 pink nirmatrelvir tablet and 1 white ritonavir tablet together (Pink part of the blister card).
• Do not remove your PAXLOVID tablets from the blister card before you are ready to take your dose. • If you are taking PAXLOVID tablets twice daily (Figure A or Figure B), take your first dose of PAXLOVID in the morning or at bedtime, depending on when you pick up your prescription, or as your healthcare provider tells you to. Take your doses at around the same time each day. • If you have severe kidney disease and are taking PAXLOVID tablets once daily (Figure C), follow the daily dose instruction on the blister card. Take your dose at around the same time each day. • Swallow the tablets whole. Do not chew, break, or crush the tablets. • Take PAXLOVID with or without food. • Do not stop taking PAXLOVID without talking to your healthcare provider, even if you feel better. • If you miss a dose of PAXLOVID within 8 hours of the time it is usually taken, take it as soon as you remember. If you miss a dose by more than 8 hours, skip the missed dose and take the next dose at your regular time. Do not take 2 doses of PAXLOVID at the same time. • If you take too much PAXLOVID, call your healthcare provider or go to the nearest hospital emergency room right away. • If you are taking a ritonavir- or cobicistat-containing medicine to treat hepatitis C or HIV-1 infection, you should continue to take your medicine as prescribed by your healthcare provider. Talk to your healthcare provider if you do not feel better or if you feel worse after 5 days.
What are the possible side effects of PAXLOVID? PAXLOVID may cause serious side effects, including: • Allergic reactions, including severe allergic reactions (anaphylaxis) have happened during treatment with PAXLOVID. Stop taking PAXLOVID and get medical help right away if you get any of the following symptoms of an allergic reaction:
o skin rash, hives, blisters or peeling skin o painful sores or ulcers in the mouth, nose, throat or genital area o swelling of the mouth, lips, tongue or face		o trouble swallowing or breathing o throat tightness o hoarseness
• Liver problems. Tell your healthcare provider right away if you get any of the following signs and symptoms of liver problems during treatment with PAXLOVID:
o loss of appetite o yellowing of your skin and the white of eyes o dark-colored urine		o pale colored stools o itchy skin o stomach-area (abdominal) pain
The most common side effects of PAXLOVID include: altered sense of taste (such as metallic, bitter taste) and diarrhea. Other possible side effects include: • headache • vomiting • abdominal pain • nausea • high blood pressure • feeling generally unwell These are not all of the possible side effects of PAXLOVID. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store PAXLOVID? • Store PAXLOVID at room temperature between 68°F to 77°F (20°C to 25°C). Keep PAXLOVID and all medicines out of the reach of children.
General information about the safe and effective use of PAXLOVID. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use PAXLOVID for a condition for which it was not prescribed. Do not give PAXLOVID to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for more information about PAXLOVID that is written for health professionals.
What are the ingredients in PAXLOVID? Active ingredient: nirmatrelvir and ritonavir Nirmatrelvir inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, and sodium stearyl fumarate. Film-coating contains: hydroxy propyl methylcellulose, iron oxide red, polyethylene glycol, and titanium dioxide. Ritonavir inactive ingredients: anhydrous dibasic calcium phosphate, colloidal silicon dioxide, copovidone, sodium stearyl fumarate, and sorbitan monolaurate. The film coating may contain: colloidal anhydrous silica, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, polyethylene glycol, polysorbate 80, talc, and titanium dioxide.
LAB-1524-5.0 For more information, go to www.pfizer.com or call 1-800-438-1985.

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 02/2026

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