Stribild

STRIBILD- elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate tablet, film coated
Avera McKennan Hospital

WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POSTTREATMENT 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, a component of STRIBILD, in combination with other antiretrovirals [see Warnings and Precautions (5.1)].

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 human immunodeficiency virus-1 (HIV-1). Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued EMTRIVA or VIREAD, which are 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 [see Warnings and Precautions (5.2)].

1 INDICATIONS AND USAGE

STRIBILD® is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older weighing at least 35 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of STRIBILD [see Clinical Studies (14)].

2 DOSAGE AND ADMINISTRATION

2.1 Testing Prior to Initiation and During Treatment with STRIBILD

Prior to initiation of STRIBILD, patients should be tested for hepatitis B virus infection [see Warnings and Precautions (5.2)].

It is recommended that serum creatinine, serum phosphorous, estimated creatinine clearance, urine glucose, and urine protein should be assessed before initiating STRIBILD and during therapy in all patients as clinically appropriate [see Warnings and Precautions (5.3)].

2.2 Recommended Dosage

STRIBILD is a four-drug fixed dose combination product containing 150 mg of elvitegravir, 150 of cobicistat, 200 mg of emtricitabine, and 300 mg of tenofovir DF. The recommended dosage of STRIBILD is one tablet taken orally once daily with food in adults and pediatric patients 12 years of age and older with a body weight at least 35 kg (at least 77 lbs) and creatinine clearance greater than or equal to 70 mL per minute [see Clinical Pharmacology (12.3)].

2.3 Dosage Adjustment in Patients with Renal Impairment

Initiation of STRIBILD in patients with estimated creatinine clearance below 70 mL per minute is not recommended. Because STRIBILD is a fixed-dose combination tablet, STRIBILD should be discontinued if estimated creatinine clearance declines below 50 mL per minute during treatment with STRIBILD, as the dose interval adjustment required for emtricitabine and tenofovir disoproxil fumarate (DF) cannot be achieved [see Warnings and Precautions (5.3), Adverse Reactions (6.1), Use in Specific Populations (8.6), Clinical Pharmacology (12.3), and Clinical Studies (14)].

No data are available to make dose recommendations for pediatric patients with renal impairment.

2.4 Dosage in Patients with Hepatic Impairment

STRIBILD is not recommended for use in patients with severe hepatic impairment [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

3 DOSAGE FORMS AND STRENGTHS

Each STRIBILD tablet contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 300 mg of tenofovir DF (equivalent to 245 mg of tenofovir disoproxil).

The tablets are green, capsule shaped, film coated, and debossed with “GSI” on one side and the number “1” surrounded by a square box ( image ) on the other side.

4 CONTRAINDICATIONS

Coadministration of STRIBILD is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. These drugs and other contraindicated drugs (which may lead to reduced efficacy of STRIBILD and possible resistance) are listed in Table 1 [see Drug Interactions (7.5) and Clinical Pharmacology (12.3)].

Table 1 Drugs that are Contraindicated with STRIBILD
Drug Class Drugs within Class that are Contraindicated with STRIBILD Clinical Comment
*
See Drug Interactions (7), Table 6, for sildenafil when dosed as Viagra for erectile dysfunction.
See Drug Interactions (7), Table 6, for parenterally administered midazolam.
Alpha 1-Adrenoreceptor Antagonist Alfuzosin Potential for increased alfuzosin concentrations, which can result in hypotension.
Anticonvulsants CarbamazepinePhenobarbitalPhenytoin Potential for decreased cobicistat and elvitegravir plasma concentrations, which may result in loss of therapeutic effect and development of resistance.
Antimycobacterial Rifampin Rifampin is a potent inducer of CYP450 metabolism and may cause significant decrease in the plasma concentration of elvitegravir and cobicistat. This may result in loss of therapeutic effect to STRIBILD.
Antipsychotic Lurasidone Potential for serious and/or life-threatening reactions.
Pimozide Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
Ergot Derivatives DihydroergotamineErgotamineMethylergonovine Potential for serious and/or life-threatening events such as acute ergot toxicity characterized by peripheral vasospasm and ischemia of the extremities and other tissues.
GI Motility Agent Cisapride Potential for serious and/or life-threatening events such as cardiac arrhythmias.
Herbal Products St. John’s wort (Hypericum perforatum) Coadministration of products containing St. John’s wort and STRIBILD may result in reduced plasma concentrations of elvitegravir and cobicistat. This may result in loss of therapeutic effect and development of resistance.
HMG-CoA Reductase Inhibitors LovastatinSimvastatin Potential for serious reactions such as myopathy, including rhabdomyolysis.
Phosphodiesterase-5 (PDE-5) Inhibitor Sildenafil * when dosed as Revatio for the treatment of pulmonary arterial hypertension There is increased potential for sildenafil-associated adverse events (which include visual disturbances, hypotension, priapism, and syncope).
Sedatives/Hypnotics TriazolamOrally administered midazolam Triazolam and orally administered midazolam are extensively metabolized by CYP3A4. Coadministration of triazolam or orally administered midazolam with STRIBILD may cause large increases in the concentration of these benzodiazepines. The potential exists for serious and/or life threatening events such as prolonged or increased sedation or respiratory depression.

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