Venetoclax

Venetoclax
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: Martin Nino [2]

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Overview

Venetoclax is a BCL-2 inhibitor that is FDA approved for the treatment of of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Common adverse reactions include neutropenia, diarrhea, nausea, anemia, upper respiratory tract infection, thrombocytopenia, and fatigue (≥20%).

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

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

Off-Label Use and Dosage (Adult)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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

Off-Label Use and Dosage (Pediatric)

Contraindications

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

Warnings

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

Adverse Reactions

Clinical Trials Experience

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

Postmarketing Experience

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

Drug Interactions

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

Use in Specific Populations

Pregnancy

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

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

Monitoring

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

IV Compatibility

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

Overdosage

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

Mechanism of Action

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

Structure

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

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

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

Storage

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

Precautions with Alcohol

Alcohol-Venetoclax interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Venetoclax Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Venetoclax 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.