Cobicistat

Cobicistat
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gloria Picoy [2]

Disclaimer

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Overview

Cobicistat is an anti-infective agent that is FDA approved for the treatment of HIV-1 infection. Common adverse reactions include jaundice, ocular icterus, and nausea.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Cobicistat FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Cobicistat in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Cobicistat in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding 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 Cobicistat in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Cobicistat in pediatric patients.

Contraindications

There is limited information regarding Cobicistat Contraindications in the drug label.

Warnings

There is limited information regarding Cobicistat Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Cobicistat Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Cobicistat Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Cobicistat Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Cobicistat in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Cobicistat in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Cobicistat during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Cobicistat in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Cobicistat in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Cobicistat in geriatric settings.

Gender

There is no FDA guidance on the use of Cobicistat with respect to specific gender populations.

Race

There is no FDA guidance on the use of Cobicistat with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Cobicistat in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Cobicistat in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Cobicistat in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Cobicistat in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Cobicistat Administration in the drug label.

Monitoring

There is limited information regarding Cobicistat Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Cobicistat and IV administrations.

Overdosage

There is limited information regarding 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 Cobicistat Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Cobicistat Mechanism of Action in the drug label.

Structure

There is limited information regarding Cobicistat Structure in the drug label.

Pharmacodynamics

There is limited information regarding Cobicistat Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Cobicistat Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Cobicistat Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Cobicistat Clinical Studies in the drug label.

How Supplied

There is limited information regarding Cobicistat How Supplied in the drug label.

Storage

There is limited information regarding 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 Cobicistat Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-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 Cobicistat Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding 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.

Cobicistat

File:Cobicistat.svg
Clinical data
ATC code	V03AX03 (WHO)
Identifiers
IUPAC name Thiazol-5-ylmethyl N-[1-benzyl-4-[[2-[[(2-isopropylthiazol-4-yl)methyl-methyl-carbamoyl]amino]-4-morpholino-butanoyl]amino]-5-phenyl-pentyl]carbamate
CAS Number	1004316-88-4 Y
PubChem CID	25151504
ChemSpider	25084912 Y
UNII	LW2E03M5PG
ChEBI	CHEBI:72291 N
ChEMBL	ChEMBL2095208 N
E number	{{#property:P628}}
ECHA InfoCard	{{#property:P2566}}
Chemical and physical data
Formula	C40H53N7O5S2
Molar mass	776.023 g/mol
3D model (JSmol)	Interactive image
SMILES CC(C)c1nc(cs1)CN(C)C(=O)NC(CCN2CCOCC2)C(=O)NC(CCC(Cc3ccccc3)NC(=O)OCc4cncs4)Cc5ccccc5
InChI InChI=1S/C40H53N7O5S2/c1-29(2)38-43-34(27-53-38)25-46(3)39(49)45-36(16-17-47-18-20-51-21-19-47)37(48)42-32(22-30-10-6-4-7-11-30)14-15-33(23-31-12-8-5-9-13-31)44-40(50)52-26-35-24-41-28-54-35/h4-13,24,27-29,32-33,36H,14-23,25-26H2,1-3H3,(H,42,48)(H,44,50)(H,45,49)/t32-,33-,36+/m1/s1 Y Key:ZCIGNRJZKPOIKD-CQXVEOKZSA-N Y
NY (what is this?)  (verify)

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [3]; Associate Editor(s)-in-Chief: Alonso Alvarado, M.D. [4]

Overview

Cobicistat (formerly GS-9350) is a licensed drug for use in the treatment of infection with the human immunodeficiency virus (HIV).

Like ritonavir (Norvir), cobicistat is of interest for its ability to inhibit liver enzymes that metabolize other medications used to treat HIV, notably elvitegravir, an HIV integrase inhibitor. By combining cobicistat with elvitegravir, higher concentrations of the latter are achieved in the body with lower dosing, theoretically enhancing elvitegravir's viral suppression while diminishing its adverse side-effects. In contrast with ritonavir, the only other booster approved for use as a part of HAART, cobicistat has no anti-HIV activity of its own.

Cobicistat is a component of the four-drug, fixed-dose combination HIV treatment elvitegravir/cobicistat/emtricitabine/tenofovir (marketed as Stribild, and also known as the "Quad Pill"). Stribild was approved by the FDA in August 2012 for use in the United States and is owned by Gilead Sciences.

Cobicistat is a potent inhibitor of cytochrome P450 3A enzymes, including the important CYP3A4 subtype. It also inhibits intestinal transport proteins, increasing the overall absorption of several HIV medications, including atazanavir, darunavir and tenofovir alafenamide fumarate.