For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.
In combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
What is the most important information I should know about VENCLEXTA?
Take VENCLEXTA 1 time a day with a meal and water at about the same time each day.
Swallow VENCLEXTA tablets whole. Do not chew, crush, or break the tablets.
If the patient misses a dose of VENCLEXTA within 8 hours of the time it is usually taken, the patient should take the missed dose as soon as possible and resume the normal daily dosing schedule. If a patient misses a dose by more than 8 hours, the patient should not take the missed dose and should resume the usual dosing schedule the next day.
If the patient vomits following dosing, no additional dose should be taken that day. The next prescribed dose should be taken at the usual time.
What should avoid while taking VENCLEXTA?
You should not drink grapefruit juice, eat grapefruit, Seville oranges (often used in marmalades), or starfruit while you are taking VENCLEXTA. These products may increase the amount of VENCLEXTA in your blood.
AFINITOR can cause serious side effects. These serious side effects include:
Low white blood cell count (neutropenia). Low white blood cell counts are common with VENCLEXTA, but can also be severe. Your healthcare provider will do blood tests to check your blood counts during treatment with VENCLEXTA. Tell your healthcare provider right away if you have a fever or any signs of an infection during treatment with VENCLEXTA.
The most common side effects of VENCLEXTA when used in combination with rituximab in people with CLL include:
Diarrhea
Upper respiratory tract infection
Cough
Tiredness
Nausea
The most common side effects of VENCLEXTA when used alone in people with CLL/SLL include
Diarrhea
Nausea
Upper respiratory tract infection
Low red blood cell counts
Tiredness
Low platelet counts
Muscle and joint pain
Swelling of your arm, legs, hands, and feet
cough
The most common side effects of VENCLEXTA in combination with azacitidine or decitabine or low-dose cytarabine in people with AML include:
Nausea
Diarrhea
Low platelet counts
Constipation
Low blood pressure
Swelling of your arms, legs, hands, and feet
Vomiting
Tiredness
Cough
Low red blood cell count
Infection in blood
Rash
Dizziness
Bleeding
Infection in lung
Stomach (abdominal) pain
Pain in muscles or back
Sore throat
VENCLEXTA may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility. These are not all the possible side effects of VENCLEXTA. For more information, ask your healthcare provider or pharmacist
How should I take VENCLEXTA?
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use VENCLEXTA for a condition for which it was not prescribed. Do not give VENCLEXTA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about VENCLEXTA that is written for health professionals
