Decision

Patient Information Leaflet for Paxlovid

Updated 26 October 2022

Package leaflet: Information for the user

Paxlovid 150 mg/100 mg film-coated tablets

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Paxlovid is and what it is used for
2. What you need to know before you take Paxlovid
3. How to take Paxlovid
4. Possible side effects
5. How to store Paxlovid
6. Contents of the pack and other information

1. What Paxlovid is and what it is used for

Paxlovid is an antiviral medicine used for treating mild-to-moderate COVID-19. COVID-19 is caused by a virus. Paxlovid stops the virus multiplying in cells and this stops the virus multiplying in the body. This can help your body to overcome the virus infection, and may help you get better faster.

Paxlovid contains the active substances PF-07321332 and ritonavir. PF-07321332 is active against the virus that causes COVID-19. Ritonavir prolongs the therapeutic effect of PF-07321332.

Paxlovid is used in adults 18 years of age and older with mild-to-moderate COVID-19. It is only used in patients who are at high risk for progression to severe COVID 19, including hospitalisation or death.

You must talk to a doctor if you do not feel better or if you feel worse while on treatment with Paxlovid.

2. 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 this medicine (listed in section 6).
• if you have severe liver or kidney disease.
• if you are taking any of the following medicines. Taking Paxlovid with these medicines may cause serious or life-threatening side effects or affect how Paxlovid works:
  • alfuzosin (used to treat symptoms of an enlarged prostate)
  • 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 conditions and correct irregular heartbeats)
  • fusidic acid (used to treat bacterial infections)
  • colchicine (used to treat gout)
  • astemizole, terfenadine (used to treat allergies)
  • lurasidone (used to treat depression)
  • pimozide, clozapine, quetiapine (used to treat schizophrenia, bipolar disorder, severe depression and abnormal thoughts or feelings)
  • dihydroergotamine and ergotamine (used to treat migraine headaches)
  • ergonovine, methylergonovine (used to stop excessive bleeding that may occur following childbirth or an abortion)
  • cisapride (used to relieve certain stomach problems)
  • lovastatin, simvastatin, lomitapide (used to lower blood cholesterol)
  • avanafil, vardenafil (used to treat erectile dysfunction [also known as impotence])
  • sildenafil (Revatio®) used to treat pulmonary arterial hypertension (high blood pressure in the pulmonary artery)
  • clonazepam, diazepam, estazolam, flurazepam, triazolam, midazolam taken orally (used to relieve anxiety and/or trouble sleeping)
  • carbamazepine, phenobarbital, phenytoin (used to prevent and control seizures)
  • rifampin (used to treat tuberculosis)
  • St. John’s Wort (Hypericum perforatum) (a herbal remedy used for depression and anxiety)

Warnings and precautions

Paxlovid treatment may result in medicines used to treat HIV becoming less effective.

Liver disease

Tell your healthcare provider if you have or have had a liver disease. Do not take Paxlovid if you have severe liver disease.

Children and adolescents

Do not give Paxlovid to children and adolescents under 18 years because Paxlovid has not been studied in children and adolescents.

Other medicines and Paxlovid

There are other medicines that may not mix with Paxlovid. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including prescription and over the counter medicines, vitamins and herbal supplements.

Please tell your doctor if you are taking oral contraceptive pills as you may need to take extra contraceptive precautions such as using a condom (see below ‘Pregnancy, breast-feeding and fertility’).

In particular, you should inform your doctor or pharmacist if you are taking any of the following:

• medicines used to treat attention disorders, such as amphetamine derivates e.g. methylphenidate and dexamfetamine
• medicines used to treat severe pain, such as morphine, fentanyl, methadone, buprenorphine, norbuprenorphine and other morphine-like medicines
• medicines used to treat heart conditions and correct irregular heartbeats, such as digoxin
• medicines used to treat cancer, such as afatinib, abemaciclib, apalutamide, ceritinib, dasatinib, nilotinib, vincristine, vinblastine, encorafenib, fostamatinib, ibrutinib and ivosidenib
• medicines used to thin the blood (anticoagulants), such as warfarin, apixaban, dabigatran, rivaroxaban and vorapaxar
• medicines used to treat convulsions, such as divalproex, lamotrigine and phenytoin
• medicines used to treat depressions, such as amitriptyline, fluoxetine, imipramine, nortriptyline, paroxetine, sertraline and desipramine
• medicines used to treat allergies, such as fexofenadine and loratadine
• medicines used to treat fungal infections (antifungals), such as ketoconazole, itraconazole and voriconazole
• medicines used to treat bacterial infections (antibiotics and antimycobacterials), such as rifabutin, erythromycin, atovaquone, bedaquiline, clarithromycin and sulfamethoxazole/trimethoprim
• medicines used to treat HIV infection, such as amprenavir, atazanavir, darunavir, fosamprenavir, efavirenz, maraviroc, raltegravir and zidovudine
• medicines used to treat mental or mood disorders, such as haloperidol, risperidone and thioridazine
• medicines used to treat asthma and other lung-related problems such as chronic obstructive pulmonary disease (COPD), such as salmeterol and theophylline
• medicines used to treat high blood pressure (hypertension), such as amlodipine, diltiazem and nifedipine
• medicines used to treat high blood pressure in the blood vessels that supply the lungs, such as bosentan and riociguat
• medicines used to treat hepatitis C virus infection, such as glecaprevir/pibrentasvir
• medicines used to lower blood cholesterol, such as atorvastatin, fluvastatin, pravastatin and rosuvastatin
• medicines used to suppress your immune system, such as cyclosporine, tacrolimus and everolimus
• medicines used to treat erectile dysfunction (also known as impotence), such as sildenafil and tadalafil
• medicines used as sedatives, hypnotics and sleeping agent, such as alprazolam, buspirone and zolpidem
• steroids including corticosteroids used to treat inflammation, such as budesonide, dexamethasone, fluticasone propionate, prednisolone and triamcinolone
• any of the following other specific medicines:
  • bupropion (used for smoking cessation)
  • oral or patch contraceptive containing ethinylestradiol used to prevent pregnancy
  • midazolam administered by injection (used for sedation [an awake but very relaxed state of calm or drowsiness during a medical test or procedure] or anaesthesia)
  • levothyroxine (used to treat an underactive thyroid gland [hypothyroidism])

Many medicines interact with Paxlovid. Keep a list of your medicines to show your doctor and pharmacist. Do not start taking a new medicine without telling your doctor. Your doctor can tell you if it is safe to take Paxlovid with other medicines.

Pregnancy, breast-feeding and fertility

Paxlovid is not recommended during pregnancy. There is not enough information to be sure that Paxlovid is safe for use in pregnancy and it is not known if Paxlovid will harm your baby while you are pregnant.

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice. If you can become pregnant, it is recommended that you refrain from sexual activity or use effective barrier contraception while taking Paxlovid and until after one full menstrual cycle is completed after stopping Paxlovid treatment.

If you are breast-feeding or are planning to breastfeed, tell your healthcare provider before taking this medicine. Breast-feeding is not recommended during treatment and for 7 days after the last dose of Paxlovid. This is because it is not known if Paxlovid gets into breast milk and will be passed to the baby.

Driving and using machines

Paxlovid has not been specifically tested for its possible effects on the ability to drive a car or operate machines.

Paxlovid contains lactose (a type of sugar)

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Information on sodium content

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium free’.

3. How to take Paxlovid

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

If you have kidney disease, please talk to your healthcare provider for an appropriate dose of Paxlovid. If you have moderate kidney disease you will need a lower dose of Paxlovid. If you have severe kidney disease you must not take Paxlovid.

Paxlovid consists of 2 medicines: PF-07321332 and ritonavir. The recommended dose is 2 tablets of PF-07321332 with 1 tablet of ritonavir by mouth twice daily (in the morning and at night). The blister foil for each day of treatment is divided in two different coloured sections to indicate which tablets need to be taken at each time of day – one side for the morning (AM) dose and the other side for the evening (PM) dose.

A course of treatment lasts 5 days. For each dose, take all 3 tablets together at the same time.

Swallow the tablets whole. Do not chew, break or crush the tablets. Paxlovid can be taken with or without meals.

Use in children and adolescents

Paxlovid is not used to treat children and adolescents (under 18 years old).

If you take more Paxlovid than you should

If you take too much Paxlovid, call your healthcare provider or go to the nearest hospital emergency room right away.

If you forget to take Paxlovid

If you forget to take a dose of Paxlovid, take it as soon as you remember. If more than 8 hours have passed since your missed dose, then do not take the missed dose and just carry on as before.

Do not take a double dose to make up for a forgotten dose.

If you feel better

Even if you feel better, do not stop taking Paxlovid without talking to your healthcare provider.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Not many people have taken Paxlovid. Serious and unexpected side effects may happen. Paxlovid is still being studied, so it is possible that all of the risks are not known at this time.

Common: may affect up to 1 in 10 people

• Diarrhoea
• Vomiting
• Altered sense of taste

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Coronavirus Yellow Card Reporting site or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. 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 the blister after ‘EXP’. The expiry date refers to the last day of that month.

Store below 25 °C.

Do not refrigerate or freeze.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Paxlovid contains

• 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 of ritonavir.
• The other ingredients in PF 07321332 are microcrystalline cellulose, lactose monohydrate (see section 2, ‘Paxlovid contains lactose’), croscarmellose sodium, colloidal silicon dioxide and sodium stearyl fumarate. The film coating contains hypromellose, titanium dioxide, macrogol and iron oxide red.
• The other ingredients in ritonavir are copovidone, sorbitan laurate, silica colloidal anhydrous, calcium hydrogen phosphate anhydrous and sodium stearyl fumarate. The film coating contains hypromellose, titanium dioxide, macrogol, hydroxypropyl cellulose, talc, silica colloidal anhydrous and polysorbate 80.

What Paxlovid looks like and contents of the pack

Paxlovid tablets are available in 5 daily dose blister cards with a total of 30 tablets packaged in a carton.

Each daily blister card contains 4 PF-07321332 tablets (150 mg each) and 2 ritonavir tablets (100 mg each) and indicates which tablets need to be taken in the morning and evening.

PF 07321332 150 mg film-coated tablets are pink, oval-shaped and debossed with ‘PFE’ on one side and ‘3CL’ on the other side.

Ritonavir 100 mg film-coated tablets are white to off white, capsule shaped and debossed with ‘H’ on one side and ‘R9’ on the other side.

Marketing Authorisation Holder

Pfizer Limited Ramsgate Road Sandwich, Kent CT13 9NJ United Kingdom

Manufacturers

Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg
Mooswaldallee 1
79090 Freiburg
Germany

Pfizer Italia S.r.l.
Localita Marino del Tronto
631000 Ascoli, Piceno
Italy

For any information about this medicine, please contact:

Medical Information,
Pfizer Ltd,
Walton Oaks,
Dorking Road,
Tadworth, Surrey,
KT20 7NS.
Telephone 01304 616161.

This leaflet was last revised in 01/2022.

This medicine has been given ‘conditional approval’.

This means that there is more evidence to come about this medicine.

The Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.

Ref: PX 2_0