Venclexta Patient Counseling Information

Advise the patient to read the approved patient labeling (Medication Guide).
Tumor Lysis Syndrome: Advise patients of the potential risk of TLS, particularly at treatment initiation, during the ramp-up phase, and with resumption after an interruption and to immediately report any signs and symptoms associated with this event (fever, chills, nausea, vomiting, confusion, shortness of breath, seizure, irregular heartbeat, dark or cloudy urine, unusual tiredness, muscle pain, and/or joint discomfort) to their health care provider (HCP) for evaluation [see Tumor Lysis Syndrome under Precautions].
Advise patients to be adequately hydrated every day when taking VENCLEXTA to reduce the risk of TLS. The recommended volume is 6 to 8 glasses (approximately 56 ounces total) of water each day. Patients should drink water starting 2 days before and on the day of the first dose, and every time the dose is increased [see Risk Assessment and Prophylaxis for Tumor Lysis Syndrome under Dosage & Administration].
Advise patients of the importance of keeping scheduled appointments for blood work or other laboratory tests [see Risk Assessment and Prophylaxis for Tumor Lysis Syndrome under Dosage & Administration].
Advise patients that it may be necessary to take VENCLEXTA in the hospital or medical office setting to allow monitoring for TLS.
Neutropenia: Advise patients to contact their HCP immediately if they develop a fever or any signs of infection. Advise patients of the need for periodic monitoring of blood counts [see Neutropenia under Precautions].
Infections: Advise patients to contact their HCP immediately if they develop a fever or any signs of infection [see Infections under Precautions].
Drug Interactions: Advise patients to avoid consuming grapefruit products, Seville oranges, or starfruit during treatment with VENCLEXTA. Advise patients that VENCLEXTA may interact with some drugs; therefore, advise patients to inform their health care provider of the use of any prescription medication, over-the-counter drugs, vitamins and herbal products [see Contraindications; Effects of Other Drugs on VENCLEXTA under Interactions].
Immunizations: Advise patients to avoid vaccination with live vaccines because they may not be safe or effective during treatment with VENCLEXTA [see Immunization under Precautions].
Embryo-Fetal Toxicity: Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Embryo-Fetal Toxicity under Precautions; Pregnancy under Use in Pregnancy & Lactation].
Advise female patients of reproductive potential to use effective contraception during therapy and for at least 30 days after the last dose [see Females and Males of Reproductive Potential under Use in Pregnancy & Lactation].
Lactation: Advise women not to breastfeed during treatment with VENCLEXTA and for 1 week after the last dose [see Lactation under Use in Pregnancy & Lactation].
Infertility: Advise males of reproductive potential that VENCLEXTA may impair fertility [see Females and Males of Reproductive Potential under Use in Pregnancy & Lactation].
Administration: Advise patients to take VENCLEXTA exactly as prescribed and not to change their dose or to stop taking VENCLEXTA unless they are told to do so by their HCP. Advise patients to take VENCLEXTA orally once daily, at approximately the same time each day, according to their HCP's instructions and that the tablets should be swallowed whole with a meal and water without being chewed, crushed, or broken [see Administration under Dosage & Administration].
Advise patients with CLL to keep VENCLEXTA in the original packaging during the first 4 weeks of treatment, and not to transfer the tablets to a different container.
Advise patients that if a dose of VENCLEXTA is missed by less than 8 hours, to take the missed dose right away and take the next dose as usual. If a dose of VENCLEXTA is missed by more than 8 hours, advise patients to wait and take the next dose at the usual time [see Administration under Dosage & Administration].
Advise patients not to take any additional dose that day if they vomit after taking VENCLEXTA, and to take the next dose at the usual time the following day.