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VENCLEXTA™  (venetoclax) tablets

Please see package insert for additional information and possible updates. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.    [  Read the disclaimer    |   <<Back      |  Oncology - new agents led    ]
CLINICAL PHARMACOLOGY INDICATIONS AND USAGE
DOSAGE AND ADMINISTRATION HOW SUPPLIED

CLINICAL PHARMACOLOGY: top of page


Mechanism of Action:
Venetoclax is a selective and orally bioavailable small-molecule inhibitor of BCL-2, an anti-apoptotic protein. Overexpression of BCL-2 has been demonstrated in CLL cells where it mediates tumor cell survival and has been associated with resistance to chemotherapeutics. Venetoclax helps restore the process of apoptosis by binding directly to the BCL-2 protein, displacing pro-apoptotic proteins like BIM, triggering mitochondrial outer membrane permeabilization and the activation of caspases. In nonclinical studies, venetoclax has demonstrated cytotoxic activity in tumor cells that overexpress BCL-2.

INDICATIONS AND USAGE  top of page

INDICATIONS AND USAGE:
VENCLEXTA is a BCL-2 inhibitor indicated for the treatment 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.

DOSAGE AND ADMINISTRATION  top of page

Drug UPDATES:  VENCLEXTA™  (venetoclax) tablets
[Drug information  /  PDF]  
Package insert - Dosing:  Click (+) next to Dosage and Administration section (drug info link)

Initial U.S. Approval:  2016

DOSAGE AND ADMINISTRATION
Initiate therapy with VENCLEXTA at 20 mg once daily for 7 days, followed by a weekly ramp-up dosing schedule to the recommended daily dose of 400 mg. (2.2)
VENCLEXTA tablets should be taken orally once daily with a meal and water. Do not chew, crush, or break tablets. (2.2)
Perform prophylaxis for tumor lysis syndrome. (2.3)

HOW SUPPLIED top of page

HOW SUPPLIED:
DOSAGE FORMS AND STRENGTHS
Tablets: 10 mg, 50 mg, 100 mg

REFERENCE

[Drug information  /  PDF]  
Medical Calculators - A thru Z
Lab Values - A thru Z