Safety

Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) Fixed Dose Combination Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

February 2016

Summary View

DRUG INTERACTIONS

Antipsychotics:

quetiapine

  • 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:

ledipasvir/sofosbuvir

  • The safety of increased tenofovir concentrations in the setting of HARVONI and STRIBILD has not been established. Coadministration is not recommended

 

July 2015

Summary View

CONTRAINDICATIONS

  • 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.

 

December 2014

Summary View

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”

ADVERSE REACTIONS

*Added in Section 6.1- “In HIV-1-Infected Subjects With No Antiretroviral Treatment History In Virologically-Suppressed HIV-1-Infected Subjects”

DRUG INTERACTIONS

*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…

PATIENT INFORMATION

*This section was edited

Page Last Updated: 03/14/2016
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