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Cobicistat / Elvitegravir / Emtricitabine / Tenofovir Dosage

Applies to the following strength(s): 150 mg-150 mg-200 mg-300 mg ; 150 mg-150 mg-200 mg-10 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for HIV Infection

1 tablet orally once a day with food

Comments:
-Patients should be tested for HBV infection before starting this drug.
-In all patients, estimated CrCl, urine glucose, and urine protein should be assessed before starting cobicistat/elvitegravir/emtricitabine/tenofovir disoproxil fumarate (DF).

Use: As a complete regimen for the treatment of HIV-1 infection in patients with no antiretroviral treatment history or to replace the current antiretroviral regimen in patients 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 this drug

Usual Pediatric Dose for HIV Infection

12 years or older and at least 35 kg:
-Cobicistat/elvitegravir/emtricitabine/tenofovir alafenamide: 1 tablet orally once a day with food

Comments:
-Patients should be tested for HBV infection before starting this drug.
-In all patients, estimated CrCl, urine glucose, and urine protein should be assessed before starting cobicistat/elvitegravir/emtricitabine/tenofovir DF.

Use: As a complete regimen for the treatment of HIV-1 infection in patients with no antiretroviral treatment history or to replace the current antiretroviral regimen in patients 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 this drug

Renal Dose Adjustments

Cobicistat/elvitegravir/emtricitabine/tenofovir alafenamide:
-Estimated CrCl less than 30 mL/min: Not recommended.

Cobicistat/elvitegravir/emtricitabine/tenofovir DF:
-Estimated CrCl less than 70 mL/min prior to therapy: Not recommended.
-If estimated CrCl falls below 50 mL/min during therapy: This drug should be discontinued.

Liver Dose Adjustments

Mild or moderate liver dysfunction (Child-Pugh A or B): No adjustment recommended.
Severe liver dysfunction (Child-Pugh C): Not recommended.

Precautions

US BOXED WARNINGS:
-LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS: Lactic acidosis and severe hepatomegaly with steatosis (including fatalities) reported with nucleoside analogs in combination with other antiretrovirals.
-POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B: This drug is not approved for treatment of chronic HBV infection; safety and efficacy not established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B reported in patients coinfected with HBV and HIV-1 after stopping products containing emtricitabine and/or tenofovir DF, and may occur when tenofovir alafenamide-containing products are stopped. Hepatic function of coinfected patients should be closely monitored with clinical and laboratory follow-up for at least several months after stopping this drug. If appropriate, initiation of antihepatitis B therapy may be necessary.

Cobicistat/elvitegravir/emtricitabine/tenofovir alafenamide: Safety and efficacy have not been established in patients younger than 12 years or weighing less than 35 kg.

Cobicistat/elvitegravir/emtricitabine/tenofovir DF: Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Comments:
-Cobicistat/elvitegravir/emtricitabine/tenofovir alafenamide should not be started in patients with estimated CrCl less than 30 mL/min.
-Cobicistat/elvitegravir/emtricitabine/tenofovir DF should not be started in patients with estimated CrCl less than 70 mL/min.

Other Comments

Administration advice:
-Administer with food.
-Consult the manufacturer product information regarding missed doses.
-Administer antacids at least 2 hours before or after this drug.

Storage requirements:
-Store and dispense in original container; keep bottle tightly closed.
-Cobicistat/elvitegravir/emtricitabine/tenofovir alafenamide: Store below 30C (86F).
-Cobicistat/elvitegravir/emtricitabine/tenofovir DF: Store at 25C (77F); excursions permitted to 15C to 30C (59F to 86F).

Monitoring:
-Hepatic: Hepatic function of HIV-1/HBV coinfected patients with clinical and laboratory follow-up (for at least several months after stopping therapy)
-Infections/Infestations: For chronic HBV infection in all patients (before therapy)
-Metabolic: Serum phosphorus in patients with chronic kidney disease using cobicistat/elvitegravir/emtricitabine/tenofovir alafenamide and in patients at risk for renal dysfunction using cobicistat/elvitegravir/emtricitabine/tenofovir DF (routinely)
-Musculoskeletal: Bone mineral density in patients with history of pathologic bone fracture or other risk factors for osteoporosis or bone loss
-Renal: Estimated CrCl, urine glucose, and urine protein in all patients (before starting therapy and routinely during therapy); renal safety if serum creatinine increases more than 0.4 mg/dL from baseline

Patient advice:
-Read the US FDA-approved patient labeling (Patient Information).
-Stop this drug if symptoms suggesting lactic acidosis or pronounced hepatotoxicity (including nausea, vomiting, unusual/unexpected stomach discomfort, and weakness) develop.

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