Elvitegravir

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Elvitegravir
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: Alberto Plate [2]

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Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Elvitegravir 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 Elvitegravir in adult patients.

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Elvitegravir 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 Elvitegravir in pediatric patients.

Non–Guideline-Supported Use

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

Contraindications

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

Warnings

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

Adverse Reactions

Clinical Trials Experience

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

Postmarketing Experience

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

Drug Interactions

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

Use in Specific Populations

Pregnancy

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

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

Monitoring

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

IV Compatibility

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

Overdosage

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

Mechanism of Action

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

Structure

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

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

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

Storage

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

Precautions with Alcohol

Alcohol-Elvitegravir 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 Elvitegravir Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Elvitegravir 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.

Elvitegravir (EVG) is an investigational drug for the treatment of HIV. It acts as an integrase inhibitor. It is undergoing clinical trials conducted by the pharmaceutical company Japan Tobacco.[1][2]

According to the results of the phase II clinical trial, patients taking once-daily elvitegravir boosted by ritonavir had greater reductions in viral load after 24 weeks compared to individuals randomized to receive a ritonavir-boosted protease inhibitor.[3]

References

  1. Shimura K, Kodama E, Sakagami Y; et al. (2007). "Broad Anti-Retroviral Activity and Resistance Profile of a Novel Human Immunodeficiency Virus Integrase Inhibitor, Elvitegravir (JTK-303/GS-9137)". J Virol. doi:10.1128/JVI.01534-07. PMID 17977962.
  2. Stellbrink HJ (2007). "Antiviral drugs in the treatment of AIDS: what is in the pipeline ?". Eur. J. Med. Res. 12 (9): 483–95. PMID 17933730.
  3. Thaczuk, Derek and Carter, Micheal. ICAAC: Best response to elvitegravir seen when used with T-20 and other active agents Aidsmap.com. 19 Sept. 2007.

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