Nirmatrelvir/Ritonavir (Paxlovid) (PO)

Criteria & Principles

Background

• Nirmatrelvir/ritonavir tablets [Paxlovid] were added to the DUHS Formulary in June 2023
• Paxlovid is FDA approved for the treatment of mild to moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.
  • It is recommended to initiate Paxlovid within 5 days of COVID-19 symptom onset
  • This is an oral therapy and the recommended duration of therapy is 5-days
• Effective, August 8th, Paxlovid will be available for prescribing to select inpatients. Paxlovid will be utilized to treat patients with mild-to-moderate COVID-19, who were not hospitalized due to COVID-19 symptoms.
  • Maestro Care will have an Order Panel to guide appropriate dosing (standard dose versus adjusted dosing for renal impairment).
• Keep in mind that Paxlovid has significant drug interactions and those will be flagged in Maestro Care.
  • To preemptively assess drug interactions the following tool can be utilized: Liverpool COVID-19 Interactions (covid19-druginteractions.org)

Pharmacy Process

• Since Paxlovid is only available in a 5-day dose pack, we need to ensure that patients who are being discharged before completion of the course, leave the hospital with the remaining doses to complete the therapy once discharged. Do not send an additional prescription to an outpatient pharmacy. 
• Hard Stop Prep Instructions will be visible to remind the pharmacist to Enter Patient Take Own Med record with a 5 day stop. Once complete, can remove the comments from the box. 
• Staff will need to print and apply both an inpatient label and an outpatient label to the Paxlovid box. 
• TIP Sheet is available to explain how to do this (see Attachments). 
• For DRH; when order for remdesivir is placed please assess patient to see if Paxlovid is indicated. If so for now during the hours of 0900-1700 (M-F) have physician electronically send Rx to DRH Out-Patient Pharmacy to fill; then send to In-Patient Pharmacy to initiate POM protocol so RN will have a barcode to scan. For those orders outside DRHOP hours, DRH has a small supply located in purchasing. Take a verbal order from clinician and fill as patient-own-med protocol. You will still have two labels to affix to both the product and the outside bag. 
• IF PATIENT HAS RECEIVED 200 MG LOADING DOSE OF REMDESIVIR IT IS NO LONGER FINANCIAL BENEFICIAL TO CHANGE TO IN-PATIENT PAXLOVID

Questions & Additional References

• Center for Medication Policy: (919) 684-5125 or DRH ID Pharmacist 470-4145
• FDA Fact Sheet for Healthcare Providers Emergency Use Authorization For Paxlovid
• Paxlovid Dosing Details (Pfizer)

Adjustment of Dose & Administration

Indication-Specific Adjustment

Usual Dose & Administration:

300mg nirmatrelvir (two 150mg tablets)+ 100mg ritonavir PO BID for 5 days.

Renal Adjustment

eGFR 30 to 59:  150mg nirmatrelvir + 100mg ritonavir PO BID for 5 days

eGFR <30 including those requiring hemodialysis*:  300mg nirmatrelvir +  100mg ritonavir once on Day1 followed by 150mg nirmatrelvir + 100 mg ritonavir once daily for day 2-5.

* On days of hemodialysis, the Paxlovid dose should be administered AFTER hemodialysis.

 

 

Hepatic Adjustment

NOT recommended in patients with severe hepatic impairment (Child-Pugh Class C).

Drug-Specific Information

Major drug-drug interactions with more common statins: If patient on simvastatin discontinue use at least 12 hours before, during and 5 days after Paxlovid therapy completed. For atorvastatin or rosuvastatin high dose consider holding statin during Paxlovid therapy.

Major drug-drug interactions with more common DOACs:  Rivaroxaban is contraindicated when on Paxlovid therapy. If patient taking rivaroxaban for arterial or venous thrombus than consult primary team for either alternative anti-coagulation therapy or alternative COVID therapies. For apixaban consider 50% dose reduction but if patient already on 2.5 mg BID reduced would hold therapy during Paxlovid and 2-3 days after completion and consider alternate means of anticoagulation.

General Notes

1. Up to date cost information, click here
2. IV antimicrobials outpatient (OPAT) dosing, click here
3. Obesity dosing weight recommendations, click here
4. Helpful drug-drug interaction check website here 
5. When dosing guidance is provided it is important to note the following:

Fixed (ie non weight-based) doses in adults are historically based on a 70 kg patient. Specific disease states or individual patients may warrant dosages that differ from the above recommendations. Since product-specific criteria for dose adjustment based on creatinine clearance exist, consult product information regarding specific recommendations for dosage adjustment based on estimated creatinine clearance.