Prezista

Prezista Drug Interactions

darunavir

Manufacturer:

Janssen

Distributor:

DCH Auriga - Healthcare
/
Four Star
Full Prescribing Info
Drug Interactions
See also Contraindications and Pharmacology: Pharmacokinetics: Drug Interactions under Actions.
Potential for PREZISTA/ritonavir to Affect Other Drugs: PREZISTA co-administered with ritonavir is an inhibitor of CYP3A, CYP2D6 and P-gp. Co-administration of PREZISTA and ritonavir with drugs that are primarily metabolized by CYP3A and CYP2D6, or are transported by P-gp may result in increased plasma concentrations of such drugs, which could increase or prolong their therapeutic effect and adverse events (see Table 22).
Potential for Other Drugs to Affect Darunavir: Darunavir and ritonavir are metabolized by CYP3A. In vitro data indicate that darunavir may be a P-gp substrate. Drugs that induce CYP3A activity would be expected to increase the clearance of darunavir and ritonavir, resulting in lowered plasma concentrations of darunavir and ritonavir. Co-administration of darunavir and ritonavir and other drugs that inhibit CYP3A, or P-gp may decrease the clearance of darunavir and ritonavir and may result in increased plasma concentrations of darunavir and ritonavir (see Table 22).
Established and Other Potentially Significant Drug Interactions: Table 22 provides dosing recommendations as a result of drug interactions with PREZISTA/ritonavir. These recommendations are based on either drug interaction studies or predicted interactions due to the expected magnitude of interaction and potential for serious adverse events or loss of efficacy. (See Tables 22a and 22b.)

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

In addition to the drugs included in Table 22, the interaction between PREZISTA/ritonavir and the following drugs were evaluated in clinical studies and no dose adjustments are needed for either drug [see Pharmacology: Pharmacokinetics: Drug Interactions under Actions]: atazanavir, efavirenz, etravirine, nevirapine, omeprazole, ranitidine, and rilpivirine. Using cross-trial comparisons to historical pharmacokinetic data, dolutegravir did not appear to affect the pharmacokinetics of darunavir. Darunavir/ritonavir had no clinically significant effect on the pharmacokinetics of dolutegravir. Pitavastatin had no clinically significant effect on the pharmacokinetics of darunavir/ritonavir.
Acid modifying medications are not predicted to alter darunavir exposure.
Other nucleoside reverse transcriptase inhibitors (NRTIs): Based on the different elimination pathways of the other NRTIs (abacavir, emtricitabine, lamivudine, stavudine, tenofovir disoproxil fumarate, zidovudine) that are primarily renally excreted, no drug interactions are expected for these drugs and PREZISTA/ritonavir.
Other PIs: The co-administration of PREZISTA/ritonavir and PIs other than lopinavir/ritonavir, saquinavir, atazanavir, and indinavir has not been studied. Therefore, such co-administration is not recommended.
Integrase strand transfer inhibitors: No dose adjustments are needed for either raltegravir or darunavir based on the pharmacokinetic data from literature references. Please refer to the elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate prescribing information for information regarding concomitant use with other antiretroviral medications.
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