HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use VENCLEXTA safely and effectively. See full prescribing information for VENCLEXTA.
VENCLEXTA TM (venetoclax) tablets, for oral use
Initial U.S. Approval: 2016
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. (1)
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)
DOSAGE FORMS AND STRENGTHS
Tablets: 10 mg, 50 mg, 100 mg (3)
CONTRAINDICATIONS
Concomitant use of VENCLEXTA with strong inhibitors of CYP3A at initiation and during ramp-up phase is contraindicated. (2.5, 4, 7.1)
WARNINGS AND PRECAUTIONS
Tumor Lysis Syndrome (TLS): Anticipate TLS; assess risk in all patients. Premedicate with anti-hyperuricemics and ensure adequate hydration. Employ more intensive measures (intravenous hydration, frequent monitoring, hospitalization) as overall risk increases. (2.3, 5.1)
Neutropenia: Monitor blood counts and for signs of infection; manage as medically appropriate. (2.4, 5.2)
Immunization: Do not administer live attenuated vaccines prior to, during, or after VENCLEXTA treatment. (5.3)
Embryo-Fetal Toxicity: May cause embryo-fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment. (5.4)
ADVERSE REACTIONS
The most common adverse reactions (≥20%) were neutropenia, diarrhea, nausea, anemia, upper respiratory tract infection, thrombocytopenia, and fatigue. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Avoid concomitant use of VENCLEXTA with moderate CYP3A inhibitors, strong or moderate CYP3A inducers, P-gp inhibitors, or narrow therapeutic index P-gp substrates. (2.5, 7.1, 7.2)
If a moderate CYP3A inhibitor or a P-gp inhibitor must be used, reduce the VENCLEXTA dose by at least 50%. (2.5, 7.1)
If a strong CYP3A inhibitor must be used after the ramp-up phase, reduce the VENCLEXTA dose by at least 75%. (2.5, 7.1)
If a narrow therapeutic index P-gp substrate must be used, it should be taken at least 6 hours before VENCLEXTA. (7.2)
USE IN SPECIFIC POPULATIONS
Lactation: Discontinue breastfeeding. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 4/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Patient Selection 2.2 Recommended Dosage 2.3 Risk Assessment and Prophylaxis for Tumor Lysis Syndrome 2.4 Dose Modifications Based on Toxicities 2.5 Dose Modifications for Use with CYP3A and P-gp Inhibitors 2.6 Missed Dose 3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Tumor Lysis Syndrome 5 |
