From the FDA Drug Label
PAXLOVID is not recommended in patients with severe renal impairment (eGFR <30 mL/min). Dose reduction for moderate renal impairment (eGFR ≥30 to <60 mL/min): 150 mg nirmatrelvir (one 150 mg tablet) with 100 mg ritonavir (one 100 mg tablet), with both tablets taken together twice daily for 5 days.
Paxlovid is not suitable for patients with impaired renal function undergoing dialysis, as dialysis is typically required for patients with severe renal impairment (eGFR <30 mL/min) and the label states that PAXLOVID is not recommended in these patients 1.
From the Research
Paxlovid can be used in patients on dialysis, but requires dose adjustment due to reduced kidney function, with a recommended dose of nirmatrelvir 150 mg with ritonavir 100 mg taken together twice daily for 5 days, as supported by the most recent study 2.
Key Considerations
- The dose adjustment is necessary to avoid excessive concentrations of nirmatrelvir, which can increase the risk of adverse events, as seen in a study where patients with severe renal impairment had higher nirmatrelvir concentrations compared to those with normal renal function 3.
- The medication should be started as soon as possible after COVID-19 diagnosis and within 5 days of symptom onset for maximum effectiveness.
- Ritonavir boosts nirmatrelvir levels by inhibiting its metabolism, and patients should inform their healthcare provider about all medications they take, as dose adjustments or temporary discontinuation of certain medications may be necessary during Paxlovid treatment.
Potential Risks and Benefits
- Common side effects of Paxlovid include altered taste, diarrhea, increased blood pressure, and muscle aches.
- Paxlovid has shown significant efficacy in reducing hospitalization and death in high-risk patients with COVID-19, making it an important treatment option for dialysis patients who are at increased risk for severe COVID-19 outcomes.
- A study on the pharmacokinetics of nirmatrelvir/ritonavir in patients with renal impairment found that the medication was well-tolerated, but the dose should be adjusted according to the degree of renal impairment 3.
Clinical Implications
- Healthcare providers should carefully monitor patients with renal impairment who are taking Paxlovid, as they may require dose adjustments or closer monitoring for adverse events.
- The use of Paxlovid in patients on dialysis should be individualized, taking into account the patient's specific clinical circumstances and medical history.
- Further studies are needed to fully understand the safety and efficacy of Paxlovid in patients with severe renal impairment, including those on dialysis, as noted in a recent review on the use of COVID-19 antiviral drugs in patients with chronic kidney disease 4.