Atazanavir and cobicistat
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Allison Tu [2]
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Overview
Atazanavir and cobicistat is a combination of a human immunodeficiency virus protease inhibitor and a CYP3A inhibitor that is FDA approved for the treatment of HIV-1 infection in combination with other antiretroviral agents. Common adverse reactions include abnormal bilirubin levels, jaundice, and scleral icterus.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
EVOTAZ® is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults.
Limitations of Use: Use of EVOTAZ in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions.
Dosing Information
- EVOTAZ is a fixed-dose combination product containing 300 mg of atazanavir and 150 mg of cobicistat.
- In treatment-naive and -experienced adults, the recommended dosage of EVOTAZ is one tablet taken once daily orally with food.
- Administer EVOTAZ in conjunction with other antiretroviral agents.
- When coadministered with H2-receptor antagonists or proton-pump inhibitors, dose separation may be required.
- Dosage in Patients with Renal Impairment
- EVOTAZ is not recommended in HIV-1 treatment-experienced patients with end-stage renal disease managed with hemodialysis.
- EVOTAZ coadministered with tenofovir DF is not recommended in patients with estimated creatinine clearance below 70 mL/min. Coadministration of EVOTAZ and tenofovir DF in combination with concomitant or recent use of a nephrotoxic agent is not recommended.
- Not Recommended in Patients with Any Degree of Hepatic Impairment
- EVOTAZ is not recommended in patients with any degree of hepatic impairment.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Atazanavir and cobicistat in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Atazanavir and cobicistat in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Atazanavir and cobicistat FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Atazanavir and cobicistat in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Atazanavir and cobicistat in pediatric patients.
Contraindications
EVOTAZ is contraindicated:
- In patients with previously demonstrated clinically significant hypersensitivity (e.g., Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of this product.
- When coadministered with drugs that are highly dependent on CYP3A or UGT1A1 for clearance, and for which elevated plasma concentrations of the interacting drugs are associated with serious and/or life-threatening events (see Table 1).
- When coadministered with drugs that strongly induce CYP3A and may lead to lower exposure and loss of efficacy of EVOTAZ (see Table 1).
Table 1 displays drugs that are contraindicated with EVOTAZ.
Warnings
There is limited information regarding Atazanavir and cobicistat Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Atazanavir and cobicistat Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Atazanavir and cobicistat Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Atazanavir and cobicistat Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Atazanavir and cobicistat in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Atazanavir and cobicistat in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Atazanavir and cobicistat during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Atazanavir and cobicistat in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Atazanavir and cobicistat in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Atazanavir and cobicistat in geriatric settings.
Gender
There is no FDA guidance on the use of Atazanavir and cobicistat with respect to specific gender populations.
Race
There is no FDA guidance on the use of Atazanavir and cobicistat with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Atazanavir and cobicistat in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Atazanavir and cobicistat in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Atazanavir and cobicistat in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Atazanavir and cobicistat in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Atazanavir and cobicistat Administration in the drug label.
Monitoring
There is limited information regarding Atazanavir and cobicistat Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Atazanavir and cobicistat and IV administrations.
Overdosage
There is limited information regarding Atazanavir and cobicistat overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Atazanavir and cobicistat Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Atazanavir and cobicistat Mechanism of Action in the drug label.
Structure
There is limited information regarding Atazanavir and cobicistat Structure in the drug label.
Pharmacodynamics
There is limited information regarding Atazanavir and cobicistat Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Atazanavir and cobicistat Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Atazanavir and cobicistat Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Atazanavir and cobicistat Clinical Studies in the drug label.
How Supplied
There is limited information regarding Atazanavir and cobicistat How Supplied in the drug label.
Storage
There is limited information regarding Atazanavir and cobicistat Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Atazanavir and cobicistat Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Atazanavir and cobicistat interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Atazanavir and cobicistat Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Atazanavir and cobicistat Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.