Contraindications & Drug Interactions

STRIBILD can interact with other drugs1

Cobicistat is an inhibitor of, and is metabolized by, CYP3A and CYP2D6. Elvitegravir is metabolized by CYP3A. STRIBILD is contraindicated with the following drugs due to the potential for serious and/or life-threatening events or loss of efficacy and development of possible resistance to STRIBILD.1

Contraindications

Drug class Drug name
Alpha 1-adrenoreceptor antagonist Alfuzosin
Antimycobacterial Rifampin
Ergot derivatives dihydroergotamine, ergotamine, methylergonovine
GI motility agent Cisapride
Herbal products St. John’s wort
HMG-CoA reductase inhibitors lovastatin, simvastatin
Neuroleptic pimozide
PDE-5 inhibitor sildenafil when dosed as Revatio® for the treatment of pulmonary arterial hypertension
Sedative/hypnotics triazolam, orally administered midazolam

STRIBILD is a complete regimen for the treatment of HIV-1 infection and should not be administered with other antiretroviral products.1

Emtricitabine and tenofovir, components of STRIBILD, are primarily excreted by the kidneys by a combination of glomerular filtration and active tubular secretion; therefore, coadministration of STRIBILD with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of emtricitabine and tenofovir, and the risk of adverse reactions.1

Drug interactions1

CYP3A substrates CYP3A inducers Acid-reducing agents
  • STRIBILD can alter the concentration of drugs metabolized by CYP3A or CYP2D6
  • Do not use with drugs highly dependent on these factors for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening adverse events
  • Drugs that induce CYP3A can decrease the concentrations of components of STRIBILD
  • Do not use with drugs that strongly induce CYP3A as this may lead to loss of efficacy and possible resistance to STRIBILD
  • STRIBILD can be used in combination with proton pump inhibitors (PPIs) or H2-receptor antagonists with no dose adjustments
  • It is recommended to separate STRIBILD and antacids, other than PPIs or H2-receptor antagonists, by at least 2 hours

Consult the full Prescribing Information for STRIBILD for more information on potentially significant drug interactions, including clinical comments.

Important Safety Information

BOXED WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH
STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

  • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate (tenofovir DF), a component of STRIBILD, in combination with other antiretrovirals.
  • STRIBILD is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of STRIBILD have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued emtricitabine or tenofovir DF, components of STRIBILD. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue STRIBILD. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Indication

STRIBILD is indicated as a complete single-tablet regimen for the treatment of HIV-1 infection in adults who are antiretroviral treatment-naive.

Reference:

  • STRIBILD [package insert]. Foster City, CA: Gilead Sciences, Inc; 2014.

Please click here to view full Prescribing Information for STRIBILD, including BOXED WARNING

Important Safety Information

Drug interactions

  • CYP3A substrates: STRIBILD can alter the concentration of drugs metabolized by CYP3A or CYP2D6. Do not use with drugs highly dependent on these factors for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening adverse events.
  • CYP3A inducers: Drugs that induce CYP3A can decrease the concentrations of components of STRIBILD. Do not use with drugs that strongly induce CYP3A as this may lead to loss of efficacy and possible resistance to STRIBILD.
  • Drugs affecting renal function: Coadministration of STRIBILD with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of emtricitabine and tenofovir and the risk of adverse reactions.
  • Antacids: Separate STRIBILD and antacid administration by at least 2 hours.
  • Prescribing information: Consult the full Prescribing Information for STRIBILD for more information on potentially significant drug interactions, including clinical comments.

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