Recommended VENCLEXTA dose modifications for adverse reactions* | |
---|---|
TLS | |
Any occurrence: Blood chemistry changes or symptoms suggestive of TLS |
Withhold the next day’s dose. If resolved within 24-48 hours of last dose, resume at same dose. |
For any blood chemistry changes requiring more than 48 hours to resolve, resume at a reduced dose. See dose-reduction guidelines by scrolling down on current page. | |
For any events of clinical TLS,† resume at a reduced dose following resolution. Scroll down to see dose-reduction guidelines. | |
Non-hematologic adverse reactions | |
1st occurrence: Grade 3 or 4 nonhematologic toxicities 2nd and subsequent occurrences: Grade 3 or 4 nonhematologic toxicities |
Interrupt VENCLEXTA. Once the toxicity has resolved to Grade 1 or baseline level, VENCLEXTA therapy may be resumed at the same dose. |
Interrupt VENCLEXTA. Follow dose-reduction guidelines when resuming VENCLEXTA treatment after resolution. A larger dose reduction may occur at the discretion of the physician. Scroll down to see dose-reduction guidelines. | |
Hematologic adverse reactions | |
1st occurrence: Grade 3 neutropenia with infection or fever, or Grade 4 hematologic toxicities (except lymphopenia) 2nd and subsequent occurrences: Grade 3 neutropenia with infection or fever, or Grade 4 hematologic toxicities (except lymphopenia) |
Interrupt VENCLEXTA. Once the toxicity has resolved to Grade 1 or baseline level, VENCLEXTA therapy may be resumed at the same dose. |
Interrupt VENCLEXTA. Follow dose-reduction guidelines when resuming VENCLEXTA treatment after resolution. A larger dose reduction may occur at the discretion of the physician. Scroll down to see dose-reduction guidelines. |
*Adverse reactions were graded using NCI CTCAE version 4.0.
†Clinical TLS was defined as laboratory TLS with clinical consequences such as acute renal failure, cardiac arrhythmias, or sudden death and/or seizures.
NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events.
Dose at interruption, mg | Restart dose, mg‡§ |
---|---|
400 | 300 |
300 | 200 |
200 | 100 |
100 | 50 |
50 | 20 |
20 | 10 |
‡During the ramp-up phase, continue the reduced dose for 1 week before increasing the dose.
§If a dosage interruption lasts more than 1 week during the ramp-up phase or more than 2 weeks after completion of ramp-up, reassess the risk of TLS and determine if reinitiation at a reduced dosage is necessary.
VENCLEXTA® and its design are registered trademarks of AbbVie Inc.
GAZYVA® is a registered trademark of Genentech, Inc.
VENCLEXTA Prescribing Information.
VENCLEXTA Prescribing Information.
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GAZYVA Prescribing Information.
GAZYVA Prescribing Information.
Data on file, AbbVie Inc. ABVRRTI69608.
Data on file, AbbVie Inc. ABVRRTI69608.
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Data on file, AbbVie Inc. ABVRRTI69609.
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Data on file, AbbVie Inc. ABVRRTI72219.
Data on file, AbbVie Inc. ABVRRTI72219.
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Data on file, AbbVie Inc. ABVRRTI71322.
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CRESEMBA Prescribing Information. December 2019.
CRESEMBA Prescribing Information. December 2019.
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