Venclexta 100mg Tablets, Medicine Type : Allopathic

What is Venclexta and how is it used?
 
Venclexta is a prescription medicine used:
 
to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who:
are 75 years of age or older, or
have other medical conditions that prevent the use of standard chemotherapy.
It is not known if Venclexta is safe and effective in children.
 
What are the possible side effects of Venclexta?
 
Venclexta can cause serious side effects, including:
 
See "What is the most important information I should know about Venclexta?"
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.
Infections. Death and serious infections such as pneumonia and blood infection (sepsis) have happened during treatment with Venclexta. Your healthcare provider will closely monitor and treat you right away if you have fever or any signs of infection 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 obinutuzumab or rituximab or alone in people with CLL or SLL include:
 
low platelet counts
low red blood cell counts
diarrhea
nausea
upper respiratory tract infection
cough
muscle and joint pain
tiredness
swelling of your arms, legs, hands, and feet
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
fever with low white blood cell counts
low red blood cell counts
infection in blood
rash
dizziness
low blood pressure
fever
swelling of your arms, legs, hands, and feet
vomiting
tiredness
shortness of breath
bleeding
infection in lung
stomach (abdominal) pain
pain in muscles or back
cough
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.
 
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA1088.
 
DESCRIPTION
Venetoclax is a selective inhibitor of BCL-2 protein. It is a light yellow to dark yellow solid with the empirical formula C45H50ClN7O7S and a molecular weight of 868.44. Venetoclax has very low aqueous solubility. Venetoclax is described chemically as 4-(4-{[2-(4-chlorophenyl)-4,4- dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(-2H-pyran-4- ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide) and has the following chemical structure:
 
 
VENCLEXTA tablets for oral administration are supplied as pale yellow or beige tablets that contain 10, 50, or 100 mg venetoclax as the active ingredient. Each tablet also contains the following inactive ingredients: copovidone, colloidal silicon dioxide, polysorbate 80, sodium stearyl fumarate, and calcium phosphate dibasic. In addition, the 10 mg and 100 mg coated tablets include the following: iron oxide yellow, polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide. The 50 mg coated tablets also include the following: iron oxide yellow, iron oxide red, iron oxide black, polyvinyl alcohol, talc, polyethylene glycol and titanium dioxide. Each tablet is debossed with “V” on one side and “10”, “50” or “100” corresponding to the tablet strength on the other side.