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Atazanavir / Cobicistat Dosage

Medically reviewed on July 12, 2017.

Applies to the following strengths: 300 mg-150 mg

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for HIV Infection

1 tablet orally once a day with food

Comments:
-For therapy-naive and therapy-experienced patients
-The number of baseline primary protease inhibitor resistance substitutions should guide use in therapy-experienced patients.

Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Renal Dose Adjustments

No adjustment recommended.

When used with tenofovir disoproxil fumarate (DF):
-Estimated CrCl less than 70 mL/min: Not recommended.
-In combination with concomitant or recent use of nephrotoxic agent: Not recommended.

Liver Dose Adjustments

Any degree of liver dysfunction: Not recommended.

Precautions

CONTRAINDICATIONS:
-Clinically significant hypersensitivity (e.g., Stevens-Johnson syndrome, erythema multiforme, toxic skin eruptions) to either active component or to any of the ingredients
-Coadministration with drugs highly dependent on CYP450 3A or UGT1A1 for clearance and for which elevated plasma levels are associated with serious and/or life-threatening events
-Coadministration with strong CYP450 3A inducers that may result in lower exposure and loss of efficacy of this drug
-Coadministration with alfuzosin, ranolazine, dronedarone, carbamazepine, phenobarbital, phenytoin, rifampin, irinotecan, lurasidone, oral midazolam, triazolam, dihydroergotamine, ergotamine, methylergonovine, cisapride, elbasvir-grazoprevir, glecaprevir-pibrentasvir, St. John's wort, lovastatin, simvastatin, pimozide, drospirenone-ethinyl estradiol, nevirapine, indinavir, sildenafil (for treatment of pulmonary arterial hypertension)
-Coadministration with colchicine in patients with renal and/or liver dysfunction

Safety and efficacy have not been established in patients 3 months to less than 18 years; this drug is not recommended for use in patients younger than 3 months (due to risk of kernicterus).

Consult WARNINGS section for additional precautions.

Dialysis

HIV-1 therapy-experienced patients with ESRD managed with hemodialysis: Not recommended.

Comments:
-The components of this drug are highly protein-bound; significant removal via hemodialysis or peritoneal dialysis is not likely.

Other Comments

Administration advice:
-Perform renal laboratory testing (including serum creatinine, estimated CrCl, and urinalysis with microscopic examination) in all patients before starting this drug and continue during therapy.
-When used with tenofovir DF, assess estimated CrCl, urine glucose, and urine protein at baseline then monitor routinely during therapy.
-Perform hepatic laboratory testing in patients with underlying liver disease before starting this drug and continue during therapy.
-Use in combination with other antiretroviral agents.
-Administer with food; maintain adequate hydration.
-Dose separation may be necessary with H2-receptor antagonists or proton-pump inhibitors; consult the manufacturer product information for further guidance.
-Consult the manufacturer product information regarding missed doses.

Storage requirements:
-Store at 25C (77F); excursions permitted to 15C to 30C (59F to 86F).
-Keep bottle tightly closed.

General:
-Each fixed-dose combination tablet contains atazanavir 300 mg and cobicistat 150 mg.
-Cobicistat decreases estimated CrCl; it inhibits tubular secretion of creatinine without affecting actual renal glomerular function.

Monitoring:
-Cardiovascular: ECG in patients with preexisting conduction disorders
-Hepatic: Hepatic laboratory testing in patients with underlying liver disease (before starting and during therapy); hepatic laboratory tests in patients with HBV, HCV, or marked transaminase elevations at baseline (before starting and during therapy); for severe hyperbilirubinemia in all infants (first few days of life)
-Metabolic: Serum phosphorus in patients at risk of renal dysfunction (when used with tenofovir DF)
-Renal: Renal laboratory testing, including serum creatinine, estimated CrCl, and urinalysis with microscopic examination, in all patients (before starting and during therapy); for renal safety (if serum creatinine increases more than 0.4 mg/dL from baseline); estimated CrCl, urine glucose, and urine protein (at baseline and routinely during therapy [when used with tenofovir DF])

Patient advice:
-Read the US FDA-approved patient labeling (Patient Information).
-This drug may cause changes in ECG (e.g., PR prolongation); consult healthcare provider if dizziness/lightheadedness occurs.
-Seek medical evaluation at once if signs/symptoms of severe skin reactions or hypersensitivity reactions develop (including, but not limited to, severe rash or rash with fever, general malaise, muscle/joint aches, blisters, oral lesions, conjunctivitis, facial edema).
-Drink plenty of fluids while using this drug.
-Notify healthcare provider at once of any symptoms of infection.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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