Facts About Pfizer's Paxlovid, First FDA-Approved Antiviral Pill to Fight COVID-19

The U.S. Food and Drug Administration (FDA) has approved “emergency use authorization” for the first antiviral pill to fight COVID-19 — Pfizer’s Paxlovid tablets. It requires a prescription and it is authorized for the treatment of mild-to-moderate symptoms in adults and pediatric patients (12 years of age and older, weighing at least 88 pounds).

“It helps to speed up the recovery, and the initial data does show that it does help reduce hospitalizations and deaths,” explains Madeline Camejo, M.S., Pharm.D., chief pharmacy officer and vice president of pharmacy services for Baptist Health South Florida. “That’s the good thing about this medication. It is going to have a major impact on the pandemic, by making treatments more available at home and help by having fewer people needing to visit a hospital emergency room.”

Initial supplies of Paxlovid will be limited. It is expected to become widely available early next year. Consult with your physician.

Here’s more on Paxlovid from the FDA:

Who is a candidate for Paxlovid?

Paxlovid is for patients have to have tested positive for COVID-19 and are “at high risk for progression to severe COVID-19, including hospitalization or death,” the FDA said. Paxlovid requires a prescription. “Paxlovid is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended,” the FDA adds.

When should you take Paxlovid?

Paxlovid should be taken as soon as possible after a diagnosis of COVID-19 and within five days of symptom onset. The drug works does not work well after seven days of symptom onset, studies indicate. Paxlovid is not recommended in patients with severe kidney or severe liver impairment. In patients with moderate renal impairment, a reduced Paxlovid dose is needed.

How many tablets are needed?

After it is prescribed, Paxlovid is administered as three tablets taken together orally twice daily for five days, for a total of 30 tablets.

What are the side effects?

Possible side effects of Paxlovid include impaired sense of taste, diarrhea, high blood pressure and muscle aches, says the FDA. Using Paxlovid at the same time as certain other drugs may result in “potentially significant drug interactions.” Consult with your doctor. Using Paxlovid in people with uncontrolled or undiagnosed HIV-1 infection may lead to HIV-1 drug resistance, the FDA said.

How did Paxlovid perform in clinical studies?

Paxlovid significantly reduced the number of hospitalization or death from COVID-19 by 88 percent, compared to placebo among patients treated within five days of symptom onset — and who did not receive COVID-19 therapeutic monoclonal antibody treatment.

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