150 mg + 100 mg film-coated tablets
PF-07321332 + ritonavir
What Paxlovid is and what it is used for
Paxlovid contains two active substances, PF-07321332, and ritonavir, in two different tablets. Paxlovid is an antiviral drug used to treat adults who do not need oxygen therapy and are at increased risk of developing severe covid-19.
Covid-19 is caused by a virus called coronavirus. Paxlovid prevents the virus from multiplying in the cells, which prevents the virus from multiplying in the body. This can help your body get rid of the viral infection and can prevent you from developing a serious illness.
If your symptoms worsen or do not improve after 5 days, talk to your doctor.
What you need to know before you take Paxlovid
Do not take Paxlovid:
- if you are allergic to PF ‑ 07321332, ritonavir, or any of the other ingredients of Paxlovid (listed in section 6).
- if you are taking any of the following medicines. Taking Paxlovid with these medicines can cause serious or life-threatening side effects or affect the way Paxlovid works:
- Alfuzosin (used to treat enlarged prostate symptoms )
- Pethidine, piroxicam, propoxyphene (used to relieve pain)
- Ranolazine (used to treat chronic chest pain [angina)
- Neratinib, venetoclax (used to treat cancer)
- Amiodarone, bepridil, dronedarone, encainide, flecainide, propafenone , quinidine (used to treat heart disease and to correct irregular heartbeats)
- Fusidic acid, rifampicin (used to treat bacterial infections)
- Carbamazepine, phenobarbital, phenytoin (used to prevent and control epileptic seizures)
- Colchicine (used to treat gout )
- Astemizole, terfenadine (used to treat allergies )
- Lurasidone (used to treat schizophrenia)
- Pimozide, clozapine, quetiapine (used to treat schizophrenia, bipolar disorder, major depression, and abnormal thoughts or feelings)
- Dihydroergotamine and ergotamine (used to treat migraine attacks)
- Ergonovine and methylergonovine (used to stop heavy bleeding that may occur after childbirth or abortion)
- Cisapride (used to relieve certain stomach problems)
- St. John’s wort ( Hypericum perforatum ) (a traditional herbal medicine used for mild depression and mild anxiety)
- Lovastatin, simvastatin, lomitapide (used to lower cholesterol in the blood)
- Avanafil, vardenafil (used to treat erection problems [also known as impotence ])
- Sildenafil (used to treat pulmonary arterial hypertension [high blood pressure in the pulmonary artery])
- Clorazepate, diazepam , estazolam, flurazepam, triazolam, midazolam took by mouth (used to relieve anxiety and/or difficulty sleeping)
Warnings and cautions
Liver disease
Tell your doctor if you have or have had liver disease. Deviating liver enzyme levels, hepatitis and jaundice have occurred in patients taking ritonavir.
Kidney disease
Tell your doctor if you have or have had kidney disease.
Risk of developing human immunodeficiency virus type 1 ( HIV ‑1) resistance
If you have an untreated or out-of-control HIV infection, Paxlovid may cause some HIV medicines to not work as well in the future.
Children and young people
Do not give Paxlovid to children and adolescents under 18 years of age as Paxlovid has not been studied in children and adolescents.
Other medicines and Paxlovid
Other medicines should not be taken with Paxlovid. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines:
- drugs used to treat cancer, such as afatinib, abemaciclib, apalutamide, ceritinib, dasatinib, encorafenib, fostamatinib, ibrutinib, nilotinib, vinblastine and vincristine
- medicines used to thin the blood ( anticoagulants ), such as warfarin, rivaroxaban, and vorapaxar
- drugs used to treat seizures, such as Divalproex and lamotrigine
- drugs used for smoking cessation, such as bupropion
- medicines used to treat allergies, such as fexofenadine and loratadine
- medicines used to treat fungal infections ( antifungals ), such as itraconazole and voriconazole
- drugs used to treat Cushing’s syndrome – when the body produces an excess of cortisol – such as ketoconazole tablets
- medicines used to treat HIV infection , such as efavirenz, maravirok, raltegravir and zidovudine
- drugs used to treat infections (such as antibiotics and antimycobacterial agents), such as atovaquone, fusidic acid, clarithromycin, erythromycin, bedakilin, rifabutin, delaminate and sulfamethoxazole / trimethoprim
- medicines used to treat mental disorders or mood swings (disorders with changes in mood), such as haloperidol, risperidone, and thioridazine
- drugs used to treat high blood pressure in the blood vessels that supply the lungs, such as bosentan and riociguat
- medicines used to treat high blood pressure ( hypertension ), such as amlodipine, diltiazem, and nifedipine
- drugs used to treat heart disease and correct irregular heartbeats, such as digoxin
- medicines used to treat hepatitis C virus infection, such as telaprevir / pibrentasvir
- drugs used to lower cholesterol in the blood, such as atorvastatin, fluvastatin, pravastatin, and rosuvastatin
- drugs used to inhibit the immune system, such as ciclosporin, tacrolimus, and everolimus
- drugs used to treat severe pain, such as morphine, fentanyl, methadone , buprenorphine, norbuprenorphine, and other morphine-like drugs
- drugs used as sedatives and hypnotics, such as alprazolam, buspirone, and zolpidem
- steroids (including corticosteroids ) used to treat inflammation, such as betamethasone, budesonide, cyclonesonide, dexamethasone, fluticasone, prednisolone , methylprednisolone, mometasone, prednisone, and triamcinolone
- drugs used to treat asthma and other lung-related problems such as COPD (chronic obstructive pulmonary disease ), such as salmeterol and theophylline
- drugs used to treat depression, such as amitriptyline, fluoxetine, imipramine, nortriptyline, paroxetine, sertraline, and desipramine
- drugs used to treat erectile dysfunction (also known as impotence ), such as sildenafil and tadalafil
- drugs used as a replacement for thyroid hormones (thyroid hormones), such as levothyroxine
- any of the following specific drugs:
- contraceptives (oral or patch ) with Ethinyl estradiol used to prevent pregnancy
- midazolam was given as an injection (used for sedation [an awake but very relaxed state of calm or drowsiness during examinations or procedures] or anesthesia)
Many drugs interact with Paxlovid. Have a list of your medicines that you can show to doctors and pharmacists. Do not start taking a new medicine without telling your doctor. Your doctor may tell you if it is safe to take Paxlovid with other medicines.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
There is not enough information to be sure that Paxlovid is safe to use during pregnancy. If you are pregnant, it is not recommended that you use Paxlovid unless your condition requires this treatment. It is recommended that you refrain from sexual activity or use contraception while taking Paxlovid and for 7 days after completing treatment, as a precautionary measure. If you are taking a hormonal contraceptive it is recommended that you use a condom or other non-hormonal contraceptive method as Paxlovid may reduce the effect of the hormonal contraceptive. Your doctor will advise you on how long this necessary adjustment of your contraceptives should last.
There is no information on the use of Paxlovid during breastfeeding. You should not breastfeed your baby while taking Paxlovid and for 7 days after treatment, as a precautionary measure.
Driving and using machines
Paxlovid is not expected to have any effect on the ability to drive or use machines.
Paxlovid contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Paxlovid contains sodium
The PF-07321332 and ritonavir tablets each contain less than 1 mmol (23 mg) sodium per dose, ie are essential ‘sodium-free’.
How to take Paxlovid
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Paxlovid consists of two medicines: PF-07321332 and ritonavir. The recommended dose is 2 tablets PF-07321332 (pink tablet) with 1 tablet ritonavir (white tablet) taken orally twice daily (morning and evening).
A course of treatment lasts for 5 days. Take all 3 tablets at the same time at each dose.
If you have kidney disease, talk to your doctor about an appropriate dose of Paxlovid.
Swallow the tablets whole. The tablets should not be chewed, divided, or crushed. Paxlovid can be taken with or without food.
If you take more Paxlovid than you should
If you have taken too much Paxlovid, contact your doctor immediately or go to the nearest emergency room.
If you forget to take Paxlovid
If you miss a dose of Paxlovid within 8 hours of taking it, take it as soon as you remember. If you miss a dose of more than 8 hours, skip the missed dose and take the next dose at your usual time. Do not take 2 doses of Paxlovid at the same time.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Paxlovid
Do not stop taking Paxlovid without talking to a doctor even if you feel better.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common: may affect up to 1 in 10 people:
- Changed sense of taste
- Diarrhea
- Vomiting
- Headache
How to store Paxlovid
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or blister after “EXP”. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
Store in a cold place. Do not freeze.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substances in this medicine are PF-07321332 and ritonavir.
- Each pink film-coated PF ‑ 07321332 tablet contains 150 mg of PF-07321332.
- Each white film-coated ritonavir tablet contains 100 mg ritonavir.
- The other ingredients of the PF ‑ 07321332 tablets are microcrystalline cellulose, lactose monohydrate (see section 2 “Paxlovid contains lactose”), croscarmellose sodium, colloidal silica, and sodium stearyl fumarate (see section 2 “Paxlovid contains sodium”). The film coating contains hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, and red iron oxide.
- The other ingredients in the ritonavir tablet are copovidone, sorbitan monolaurate, colloidal anhydrous silica, anhydrous calcium hydrogen phosphate, and sodium stearyl fumarate. The film coating contains hypromellose, titanium dioxide, macrogol, hydroxypropylcellulose, talc, colloidal anhydrous silica, and polysorbate 80.
What the medicine looks like and the contents of the pack
Paxlovid film-coated tablets are available in 5 daily blister cards with a total of 30 tablets packed in a carton.
Each daily blister contains 4 PF-07321332 tablets (150 mg each) and 2 ritonavir tablets (100 mg each) and indicates which tablets to take in the morning and evening (sun and moon symbols).
The 150 mg film-coated PF ‑ 07321332 tablets are pink, oval, and imprinted with “PFE” on one side and “3CL” on the other side.
The 100 mg film-coated ritonavir tablets are white to off-white, capsule-shaped, and imprinted with “H” on one side and “R9” on the other side.
Marketing Authorization Holder and Manufacturer
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium
Manufacturer
Pfizer Manufacturing Deutschland GmbH
Operating office Freiburg
Mooswaldallee 1
79090 Freiburg
Germany
Pfizer Italia SRL
Marino del Tronto locality
63100 Ascoli, Piceno
Italy
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienLuxembourg / LuxemburgPfizer NV / SATel: +32 (0) 2 554 62 11 | LithuaniaPfizer Luxembourg SARL branches in LithuaniaTel: +370 5 251 4000 |
| BulgariaPfizer Luxembourg SAUR, CloneBulgariaTel: +359 2 970 4333 | HungaryPfizer Kft.Tel .: + 36 1 488 37 00 |
| Czech RepublicPfizer, spol. s roTel: +420 283 004 111 | MaltaVivian Corporation Ltd.Tel: +356 213344610 |
| DenmarkPfizer ApSTel: +45 44 20 11 00 | The NetherlandsPfizer bvTel: +31 (0) 10 406 43 01 |
| GermanyPFIZER PHARMA GmbHTel: +49 (0) 30 550055-51000 | NorwayPfizer ASTel: +47 67 52 61 00 |
| EestiPfizer Luxembourg SARL Eesti subsidiaryTel: +372 666 7500 | AustriaPfizer Corporation Austria Ges.mbHTel: +43 (0) 1 521 15-0 |
| GreecePfizer Aλλάς AE:Ηλ: +30 210 6785800 | PolandPfizer Polska Sp. z ooTel .: +48 22 335 61 00 |
| SpainPfizer, SLTel: +34 91 490 99 00 | PortugalPfizer Laboratories, Lda.Tel: +351 21 423 5500 |
| FrancePfizerTel: +33 (0) 1 58 07 34 40 | RomaniaPfizer Romania SRLTel: +40 (0) 21 207 28 00 |
| CroatiaPfizer Croatia dooTel: +385 1 3908 777 | SloveniaPfizer Luxembourg SARLPfizer, underwriting and dryingpharmacevtske dejavnosti, LjubljanaTel: +386 (0) 1 52 11 400 |
| IrelandPfizer Healthcare IrelandTel: 1800 633 363 (toll free)+44 (0) 1304 616161 | Slovak RepublicPfizer Luxembourg SARL,organizing serviceTel: + 421 2 3355 5500 |
| IcelandIcepharma hf.Phone: +354 540 8000 | Finland / FinlandPfizer OyPuh / Tel: +358 (0) 9 430 040 |
| ItalyPfizer SrlTel: +39 06 33 18 21 | SwedenPfizer ABTel: +46 (0) 8 550 520 00 |
| .ΠροςPfizer Αλλάς Α.Ε. (Cyprus Branch)Tηλ: +357 22817690 | United Kingdom (Northern Ireland)Pfizer LimitedTel: +44 (0) 1304 616161 |
| LatviaPfizer Luxembourg SARL subsidiary LatvijāTel: + 371 670 35 775 |