What is PAXLOVID (nirmatrelvir tablets; ritonavir tablets)?
PAXLOVID, also referred to as SARS-CoV-2 3CL protease inhibitor, is a treatment for SARS-CoV-2 main protease (Mpro) infection. It was created to be taken orally so that it may be prescribed right away after an infection, possibly saving patients from developing serious sickness (which can lead to hospitalisation and death). The emergency use of PAXLOVID is only permitted while the Act’s Section 564(b)(1), 21 U.S.C. 360bbb-3(b)(1), is in effect, unless the declaration is revoked earlier or circumstances justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic are declared to exist.
Is PAXLOVID by FDA USA?
The FDA has approved PAXLOVID for use in treating mild-to-moderate COVID-19 in adults and children (12 years of age and older, weight at least 40 kg) who are at high risk of developing severe COVID-19.
Who can take PAXLOVID?
- Paxlovid is typically safe to use in people over the age of 18.
- you’re in the highest risk group
- you’ve had a positive lateral flow test.
- You experienced coronavirus (COVID-19) symptoms within the previous five days, or seven days if a doctor prescribed it.
Some individuals in the highest risk group have a history of:
- Any chromosomal condition that affects your immune system, such as Down’s syndrome,
- having some cancers or having undergone therapy for certain cancers
- sickle cell disease
- certain conditions affecting their blood
- chronic kidney disease (CKD) stage 4 or 5
- severe liver disease
- had an organ transplant
- certain autoimmune or inflammatory conditions (such as rheumatoid arthritis or inflammatory bowel disease)
- HIV or AIDS and have a weakened immune system
- a disease that compromises their immune system
- a rare condition affecting the brain or nerves (multiple sclerosis, motor neurone disease, Huntington’s disease or myasthenia gravis)
Who cannot take PAXLOVID?
You have an allergy to ritonavir, nirmatrelvir, or any other component of PAXLOV. You are taking any of the following medicines:
- alfuzosin
- amiodarone
- apalutamide
- carbamazepine
- colchicine
- dihydroergotamine
- dronedarone
- eletriptan
- eplerenone
- ergotamine
- finerenone
- flecainide
- flibanserin
- ivabradine
- lomitapide
- lovastatin
- lumacaftor/ivacaftor
- lurasidone
- methylergonovine
- midazolam (oral)
- naloxegol
- phenobarbital
- phenytoin
- pimozide
- primidone
- propafenone
- quinidine
- ranolazine
- rifampin
- St. John’s Wort (hypericum perforatum)
- sildenafil (Revatio®) for pulmonary arterial hypertension
- silodosin
- simvastatin
- tolvaptan
- triazolam
- ubrogepant
- voclosporin
Combining PAXLOVID with these drugs may have serious, potentially fatal adverse effects, or alter how PAXLOVID functions.
- are breastfeeding, trying to get pregnant, or
- have problems with your kidneys
- have problems with your liver
- have lactase insufficiency or glucose-galactose malabsorption are lactose or galactose intolerant (nirmatrelvir includes a lot of lactose)
How to use PAXLOVID?
The two medications that make up PAXLOVID are nirmatrelvir and ritonavir pills. For five days, the two medications must be combined and administered twice daily.
- Nirmatrelvir is an oval, pink tablet
- Ritonavir is a white or off-white tablet
- Two-dose packs of PAXLOVID are offered. Your physician will recommend the PAXLOVID Dose Pack that is ideal for you.
- If you have kidney illness, your doctor might advise taking less medication. To ensure that you obtain the appropriate dose pack, consult your healthcare professional.
- Prior to taking your dose, do not remove the PAXLOVID tablets from the blister card.
- Depending on when you pick up your prescription, take your first PAXLOVID dose in the morning or evening, or as directed by your healthcare practitioner.
- Completely swallow the tablets. Avoid crushing, chewing, or breaking the tablets.
- Take PAXLOVID with or without food
- Even if you feel better, do not stop taking PAXLOVID without first consulting your doctor.
- You should continue taking your medication as directed by your healthcare practitioner if you are using a drug that contains ritonavir or cobicistat to treat hepatitis C or human immunodeficiency virus (HIV).
What kind of COVID-19 test is required to prescribe PAXLOVID?
To find out if you have COVID-19, you can use any FDA-approved COVID-19 viral test that is available (such as RT-PCR, fast antigen, etc.). A viral test can be carried out at a laboratory, at a testing location, at home, or anyplace else, according to the Centers for Disease Control and Prevention (CDC), and analyses samples from the nose or mouth. Speak with a healthcare provider right away if your COVID-19 test results are positive.
Cost of PAXLOVID?
The American government has acquired PAXLOVID from Pfizer as part of the Emergency Use Authorization and is providing it free of charge to patients. There can be extra administrative costs.
Side effects of PAXLOVID?
Even after just one dose of PAXLOVID, allergic responses, including severe allergic reactions (also known as “anaphylaxis”), can occur. If you have any of the following signs of an adverse reaction, stop taking PAXLOVID and contact your doctor right away:
- hives
- trouble swallowing or breathing
- swelling of the mouth, lips, or face
- throat tightness
- hoarseness
- skin rash
- Liver problem: If you experience any of the following signs and symptoms of liver disease, contact your healthcare practitioner right away: lack of appetite, jaundice, dark urine, pale faeces, itchiness of the skin, or abdominal pain.
- If your HIV infection is left untreated, PAXLOVID may cause some HIV medications to stop working as well in the future.
- Alterations in taste, diarrhoea, high blood pressure, muscle aches, abdominal pain, nausea, and overall malaise are some additional adverse effects that could occur.
Not all of PAXLOVID’s potential negative effects. Few individuals have used PAXLOVID. There could be serious and unexpected negative effects. Since PAXLOVID is still under investigation, it’s conceivable that not all of th