Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- Initiation of STRIBILD in patients taking quetiapine: Consider alternative antiretroviral therapy to avoid increases in quetiapine exposure. If coadministration is necessary, reduce the quetiapine dose to 1/6 of the current dose and monitor for quetiapine-associated adverse reactions. Refer to the quetiapine prescribing information for recommendations on adverse reaction monitoring.
- Initiation of quetiapine in patients taking STRIBILD: Refer to the quetiapine prescribing information for initial dosing and titration of quetiapine
Hepatitis C Antiviral Agents:
- The safety of increased tenofovir concentrations in the setting of HARVONI and STRIBILD has not been established. Coadministration is not recommended
- updated with information related to the anticonvulsant medications carbamazepine, phenobarbital, and phenytoin.
PATIENT INFORMATION SECTION
- “Who should not take Stribild?” section updated with information regarding use with carbamazepine, phenobarbital, and phenytoin.
WARNINGS AND PRECAUTIONS
*Additions to Section 5.4, “Avoid Use with other antiretroviral products”
*Added Section 5.5, “Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions”
*Added in Section 6.1- “In HIV-1-Infected Subjects With No Antiretroviral Treatment History In Virologically-Suppressed HIV-1-Infected Subjects”
*Modifications to Table 6, “Established and Other Potentially Significanta Drug Interactions: Alteration in Dose or Regimen May Be Recommended Based on Drug Interaction Studies or Predicted Interaction”
PATIENT COUNSELING INFORMATION
*The following was added:
- Stribild should not be administered in combination with…Tybost…Vitekta…Triumeq…
*This section was edited