First Oral Rx for COVID-19 Gets FDA Nod

FDA approves Paxlovid (nirmatrelvir and ritonavir) to treat COVID

(RxWiki News) The US Food and Drug Administration (FDA) has approved the the first oral treatment for COVID through an emergency use authorization (EUA).

This medication is found under the name Paxlovid. It comes in tablet form and is a combination of nirmatrelvir and ritonavir:

  • Nirmatrelvir stops the virus from copying itself.
  • Ritonavir works to keep nirmatrelvir in the body at a higher amount and for a longer period of time.

This new drug is approved to treat mild to moderate coronavirus disease in both adults and children.

This medication is only approved for those 12 years of age and older and those who weigh at least 40 kilograms (about 88 pounds).

This prescription-only drug is only meant for those who test positive for COVID-19 and face a higher risk of severe symptoms that could result in hospitalization or death.

For Paxlovid to work, it must be taken as soon as possible after getting a COVID-19 diagnosis and within five days of showing symptoms, the FDA noted.

The dose is three tablets (two tablets of nirmatrelvir and one tablet of ritonavir) taken twice a day for five days in a row.

“Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in a press release. “This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19."

Paxlovid does not prevent COVID-19. It is important to note that this medication is not a substitute for vaccination.

Side effects of Paxlovid may include an impaired sense of taste, diarrhea, high blood pressure and muscle aches.

This drug contains ritonavir, which can interact with several medications. Always tell your doctor and pharmacist all of the medications you are taking. This includes prescriptions, over-the-counter drugs, and herbal and nutritional supplements.

If you have severe kidney or severe liver impairment, this drug is not recommended.

The FDA issued the EUA of Paxlovid for Pfizer, the manufacturer of the drug.