State-licensed pharmacists can now prescribe Paxlovid (nirmatrelvir tablets co-packaged with ritonavir tablets) with sure limitations to eligible sufferers, in line with the Meals and Drug Administration (FDA).
Paxlovid is allowed for the remedy of delicate to average COVID-19 in sufferers 12 years of age and older weighing no less than 40kg with optimistic outcomes of direct SARS-CoV-2 testing, and who’re at excessive threat for development to extreme COVID-19, together with hospitalization or loss of life. The Emergency Use Authorization (EUA) for Paxlovid has been revised to replicate the brand new prescribing authority given to state-licensed pharmacists.
Sufferers who check optimistic for COVID-19 (both with a optimistic residence fast antigen check or a optimistic PCR check) ought to first take into account looking for care from their well being care supplier or finding a Check-to-Deal with website. Neighborhood pharmacies not collaborating as a Check-to-Deal with website can resolve if or how pharmacists will supply Paxlovid to sufferers.
Underneath the revised EUA, sufferers who check optimistic for COVID-19 should present the next data to make sure pharmacists can decide their eligibility to obtain Paxlovid:
- Digital or printed well being information lower than 12 months previous, together with the latest experiences of laboratory blood work to evaluation for renal or hepatic issues. This data can also be supplied by means of session with the affected person’s well being care supplier.
- An inventory of all drugs, together with over-the-counter drugs, in order that the pharmacist can display screen for doubtlessly severe interactions with Paxlovid.
Pharmacists ought to refer sufferers for medical analysis with a doctor, superior apply registered nurse, or doctor assistant licensed or approved to prescribe treatment if any of the next apply: 1) there may be inadequate data to evaluate renal and hepatic perform; 2) there may be inadequate data to evaluate for potential drug interactions; 3) a dosage modification of one other treatment is required to keep away from a possible drug interplay with Paxlovid; or 4) if Paxlovid is deemed to be an inappropriate therapeutic possibility primarily based on the approved Truth Sheet for Healthcare Suppliers or resulting from potential drug interactions for which advisable monitoring wouldn’t be possible.
“The FDA acknowledges the necessary function pharmacists have performed and proceed to play in combatting this pandemic,” mentioned Patrizia Cavazzoni, MD, director for the FDA’s Middle for Drug Analysis and Analysis. “Since Paxlovid should be taken inside 5 days after signs start, authorizing state-licensed pharmacists to prescribe Paxlovid may increase entry to well timed remedy for some sufferers who’re eligible to obtain this drug for the remedy of COVID-19.”
The approved dose for Paxlovid is 300mg of nirmatrelvir (two 150mg tablets) with 100mg of ritonavir (one 100mg pill) for a complete of three tablets taken collectively orally twice every day for five days. For sufferers with average renal impairment (eGFR ≥30 to <60mL/min), the approved dose is 150mg of nirmatrelvir (one 150mg pill) with 100mg ritonavir (one 100mg pill), with each tablets taken collectively twice every day for five days. The remedy isn’t advisable for sufferers with extreme renal or hepatic impairment.
Paxlovid is provided in 2 completely different dose packs:
- 300mg nirmatrelvir; 100mg ritonavir: every carton comprises 30 tablets divided in 5 daily-dose blister playing cards; every every day blister card comprises 4 nirmatrelvir tablets (150mg every) and a pair of ritonavir tablets (100mg every).
- 150mg nirmatrelvir; 100mg ritonavir: every carton comprises 20 tablets divided in 5 daily-dose blister playing cards; every every day blister card comprises 2 nirmatrelvir tablets (150mg every) and a pair of ritonavir tablets (100mg every).
Within the occasion that the Paxlovid 150mg; 100mg dose pack is unavailable, pharmacists ought to confer with the supplied directions entitled “IMPORTANT PAXLOVID™ EUA DISPENSING INFORMATION FOR PATIENTS WITH MODERATE RENAL IMPAIRMENT” for allotting of Paxlovid to sufferers with average renal impairment and sufferers must be knowledgeable that their every day blister card has been altered to make sure they obtain the right dose.
Paxlovid isn’t approved for initiation of remedy in sufferers requiring hospitalization resulting from extreme or important COVID-19; to be used as preexposure or postexposure prophylaxis for prevention of COVID-19; or to be used for longer than 5 consecutive days.
Coronavirus (COVID-19) replace: FDA authorizes pharmacists to prescribe Paxlovid with sure limitations. Information launch. US Meals and Drug Administration. Accessed July 6, 2022. https://www.prnewswire.com/news-releases/coronavirus-covid-19-update-fda-authorizes-pharmacists-to-prescribe-paxlovid-with-certain-limitations-301581671.html
This text initially appeared on MPR