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Co-administration of PREVYMIS with strong and moderate inducers of transporters (e.g., P-gp) and/or enzymes (e.g., UGTs) is not recommended due to the potential for a decrease in letermovir plasma concentrations (see Table 6).
Rifampin co-administration resulted in an initial increase in letermovir plasma concentrations (due to OATP1B1/3 inhibition) that is not clinically relevant, followed by clinically relevant decreases in letermovir plasma concentrations with continued rifampin co-administration [see Table 3, PHARMACOLOGY: Pharmacokinetics: Drug Interaction Studies under ACTIONS].
Effects of PREVYMIS on Other Drugs: Co-administration of PREVYMIS with midazolam results in increased midazolam plasma concentrations, indicating that letermovir is a moderate inhibitor of CYP3A. Co-administration of PREVYMIS with drugs that are CYP3A substrates may result in clinically relevant increases in the plasma concentrations of co-administered CYP3A substrates [see CONTRAINDICATIONS and Risk of Adverse Reactions or Reduced Therapeutic Effect Due to Drug Interactions under PRECAUTIONS] and Table 6.
Letermovir is an inhibitor of OATP1B1/3 transporters. Co-administration of PREVYMIS with drugs that are substrates of OATP1B1/3 transporters may result in a clinically relevant increase in plasma concentrations of co-administered OATP1B1/3 substrates (see Table 6).
Established and Other Potential Drug Interactions: If dose adjustments of concomitant medications are made due to treatment with PREVYMIS, doses should be readjusted after treatment with PREVYMIS is completed.
When PREVYMIS is co-administered with cyclosporine, the combined effect on CYP3A substrates may be similar to a strong CYP3A inhibitor. Refer to the prescribing information for dosing of the CYP3A substrate with a strong CYP3A inhibitor.
When PREVYMIS is co-administered with cyclosporine, the combined effect on agents that are both CYP3A and OATP1B1/3 substrates may be different than when they are administered with PREVYMIS alone. Refer to the prescribing information for both the co-administered drug and for cyclosporine.
Table 6 provides a listing of established or potentially clinically significant drug interactions. The drug interactions described are based on studies conducted with PREVYMIS or are predicted drug interactions that may occur with PREVYMIS [see Risk of Adverse Reactions or Reduced Therapeutic Effect Due to Drug Interactions under PRECAUTIONS]. (See Tables 6a and 6b.)
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Click on icon to see table/diagram/imageDrugs without Clinically Significant Interactions with PREVYMIS: There was no clinically relevant interaction when PREVYMIS was co-administered with itraconazole, a P-gp/BCRP inhibitor.
There were no clinically relevant changes in plasma concentrations of digoxin, a P-gp substrate, and acyclovir, an OAT3 substrate, following co-administration with PREVYMIS in clinical studies.
The interaction between letermovir and the following drugs was evaluated in clinical studies: mycophenolate mofetil, fluconazole, posaconazole, and oral contraceptives. No dose adjustments are needed when PREVYMIS is used with these drugs.
