The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has issued a reminder to healthcare professionals about potential serious adverse reactions when combining Paxlovid with specific immunosuppressants. The highlighted risk arises due to drug-drug interactions, which can compromise the body’s ability to eliminate these medicines effectively.
Paxlovid, an antiviral medication used to treat COVID-19, has shown significant efficacy in reducing the risk of hospitalization or death among unvaccinated individuals. However, when administered in conjunction with calcineurin inhibitors (such as tacrolimus and ciclosporin) and mTOR inhibitors (such as everolimus and sirolimus), healthcare professionals need to actively monitor the blood levels of these medications.
Such immunosuppressants are commonly prescribed for autoimmune conditions and organ transplant recipients, and they possess a narrow safe dosage range. By diminishing the activity of the immune system, they help manage these conditions effectively. However, when combined with Paxlovid, the intricate balance of dosage and drug interactions must be carefully managed.
Proactive monitoring of blood levels and collaboration between healthcare professionals and specialists are essential to mitigate the risk for drug-drug interactions and potential serious reactions. Additionally, Paxlovid should not be coadministered with medications heavily reliant on CYP3A liver enzymes for elimination, such as the immunosuppressant voclosporin. Combining these drugs may interfere with each other’s metabolism, leading to altered blood levels, reduced effectiveness, or an increased risk of adverse reactions.
The PRAC’s thorough review has highlighted potential serious adverse reactions, including fatal cases, resulting from drug interactions between Paxlovid and specific immunosuppressants. In response, the committee has issued a direct healthcare professional communication (DHPC) to emphasize this recognized risk, as previously outlined in Paxlovid’s product information.
The DHPC will undergo further evaluation by EMA’s Committee for Medicinal Products for Human Use and will be disseminated to healthcare professionals upon adoption. The communication plan includes publication on the DHPCs page and in national registers across EU Member States.
It is crucial for healthcare professionals to be aware of the risks involved in combining Paxlovid with immunosuppressants and to stay updated with the recommendations from regulatory authorities. By maintaining vigilance and following recommended guidelines, healthcare professionals can ensure the safe and effective administration of these medications to their patients.
In summary, the PRAC has issued a reminder about the potential risks associated with combining Paxlovid and specific immunosuppressants. Healthcare professionals must actively monitor blood levels when administering these medications together and collaborate with specialists to navigate the complexities of simultaneous medication usage. By staying informed and adhering to guidelines, healthcare professionals can mitigate the risks and ensure the safe administration of these drugs to their patients.
