CLEXTA unless they are told to do so by their doctor. Advise patients to take VENCLEXTA orally once daily, at approximately the same time each day, according to their doctor's instructions and that the tablets should be swallowed whole with a meal and water without being chewed, crushed, or broken [see Dosage and Administration (2.2)].
Advise patients 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 Dosage and Administration (2.6)].
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.
Manufactured and Marketed by:
AbbVie Inc.
North Chicago, IL 60064
and
Marketed by:
Genentech USA, Inc.
A Member of the Roche Group
South San Francisco, CA 94080-4990
© 2016 AbbVie Inc.
© 2016 Genentech, Inc.
03-B232 April 2016
MEDICATION GUIDE
MEDICATION GUIDE
VENCLEXTATM (ven-KLEKS-tuh)
(venetoclax)
tablets
What is the most important information I should know about VENCLEXTA?
VENCLEXTA can cause serious side effects, including:
Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. Your doctor will do tests to check your risk of getting TLS before you start taking VENCLEXTA. You will receive other medicines before starting and during treatment with VENCLEXTA to help reduce your risk of TLS. You may also need to receive intravenous (IV) fluids into your vein. Your doctor will do blood tests in your first 5 weeks of treatment to check you for TLS during treatment with VENCLEXTA. It is important to keep your appointments for blood tests. Tell your doctor right away if you have any symptoms of TLS during treatment with VENCLEXTA, including:
fever
chills
nausea
vomiting
confusion
shortness of breath
seizures
irregular heartbeat
dark or cloudy urine
unusual tiredness
muscle or joint pain
Drink plenty of water when taking VENCLEXTA to help reduce your risk of getting TLS. Drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before your first dose, on the day of your first dose of VENCLEXTA, and each time your dose is increased.
Your doctor may delay, decrease your dose, or stop treatment with VENCLEXTA if you have side effects.
See "What are the possible side effects of VENCLEXTA?" for more information about side effects.
What is VENCLEXTA?
VENCLEXTA is a prescription medicine used to treat people with chronic lymphocytic leukemia (CLL) with 17p deletion, who have received at least one prior treatment.
It is not known if VENCLEXTA is safe and effective in children.
Who should not take VENCLEXTA? Certain medicines must not be taken when you first start taking VENCLEXTA and while your dose is being slowly increased.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. VENCLEXTA and other medicines may affect each other causing serious side effects.
Do not start new medicines during treatment with VENCLEXTA without first talking with your doctor |
