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Venclexta® AML, CLL, SLL | Venetoclax AML, CLL, SLL : Treatment, Price and Side Effects

Venclexta® is a prescription drug that costs approximately $97 for each 100mg tablet in the US. The price of Venclexta, also called venetoclax and venclyxto, in India is far less than it is in the US.  Abbvie has negotiated rights to market this drug outside of the US. The generic version of Venclexta is now available in India. The Food and Drug Administration has described it as a “breakthrough discovery” for the treatment of chronic lymphocytic leukemia, small lymphocytic lymphoma and recently acute myeloid leukemia.

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Venetoclax is a prescription medication to treat CLL or chronic lymphocytic leukemia for those who were not receptive to first attempt at treatment. Acute myeloid leukemia (AML) and small lymphocytic lymphona responds well to this treatment. Venetoclax is available in 10mg, 50mg and 100mg tablets.

It is the second line of treatment for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

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Venclexta® Side Effects:

Most common side effects of venetoclax are low blood cell count, fatigue, upper respiratory tract infection, diarrhea, anemia and low platelet count.

Some patients experience these major side effects like tumor lysis syndrome and severe low white blood cell count.

Male patients on venetoclax sometimes can experience fertility problems.

What to avoid when taking Venclyxto®?

The following will increase venetoclax/Venclexta in your blood:

  • Grapefruit
  • Grapefruit juice
  • Seville oranges (often used in marmalade)
  • Starfruit

What is the patient profile of chronic lymphocytic leukemia or CLL?

CLL accounts for 37% of all cases of leukemia in adults. The average age of a patient diagnosed with CLL is 70 years of age, more common in older adults. 12,990 men and 7,950 women will be diagnosed for CLL this year.

What is the patient survival rate after diagnosis of chronic lymphocytic leukemia or CLL?

Compared to other cancers CLL has a higher survival rate. On average a CLL patient after diagnosis will be alive for 5 years. However, some patients may live longer due to on and off treatment because CLL recurs.

Venetoclax® Important Safety Information & Uses

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 healthcare provider 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 healthcare provider will do blood tests to check for TLS when you first start treatment and during treatment with VENCLEXTA.|When you first start treatment and during treatment with VENCLEXTA, your healthcare provider will do blood tests to check for TLS.} It is important to keep your appointments for blood tests.

Tell your healthcare provider 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|cloudy or dark} urine, unusual tiredness, or muscle or joint pain.|Your healthcare provider will do tests to check your risk of getting TLS before you start taking VENCLEXTA.

Your healthcare provider will do blood tests to check for TLS when you first start treatment and during treatment with VENCLEXTA. Tell your healthcare provider 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|cloudy or dark} urine, unusual tiredness, or muscle or joint pain.}

Drink plenty of water during treatment with 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 healthcare provider may delay, decrease your dose, or stop treatment with VENCLEXTA if you have side effects.

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 because of the risk of increased TLS.|Because of the risk of increased TLS, certain medicines must not be taken when you first start taking VENCLEXTA and while your dose is being slowly increased.}

Tell your healthcare provider 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 healthcare provider.

Before taking VENCLEXTA, tell your healthcare provider about all of your medical conditions, including if you:

  • have kidney problems.
  • have problems with your body salts or electrolytes, such as {potassium, phosphorus, or calcium|potassium, calcium, or phosphorus|phosphorus, potassium, or calcium|phosphorus, calcium, or potassium|calcium, potassium, or phosphorus|calcium, phosphorus, or potassium}.
    have a history of high uric acid levels in your blood or gout.
    {are scheduled to receive a vaccine.
  • You should not receive a “live vaccine” before, during, or after treatment with VENCLEXTA, until your healthcare provider tells you it is okay. {If you are not sure about the type of immunization or vaccine, ask your healthcare provider.|Ask your healthcare provider if you are not sure about the type of immunization or vaccine.} These vaccines may not be safe or may not work as well during treatment with VENCLEXTA.|You should not receive a “live vaccine” before, during, or after treatment with VENCLEXTA, until your healthcare provider tells you it is okay. These vaccines may not be safe or may not work as well during treatment with VENCLEXTA.}
  • {are pregnant or plan to become pregnant. VENCLEXTA may harm your unborn baby. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with VENCLEXTA, and you should use effective birth control during treatment and for at least 30 days after the last dose of VENCLEXTA.
  • {If you become pregnant or think you are pregnant, tell your healthcare provider right away.|Tell your healthcare provider right away if you become pregnant or think you are pregnant.}|VENCLEXTA may harm your unborn baby.
  • If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with VENCLEXTA, and you should use effective birth control during treatment and for at least 30 days after the last dose of VENCLEXTA.}
    are breastfeeding or plan to breastfeed.
  • {It is not known if VENCLEXTA passes into your breast milk.|If VENCLEXTA passes into your breast milk, it is not known.} Do not breastfeed during treatment with VENCLEXTA.

What should I avoid while taking VENCLEXTA?

You should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while you are taking this medication. These products may increase the amount of VENCLEXTA in your blood.

What are the possible side effects of VENCLEXTA?

VENCLEXTA can cause serious side effects, including:

Low white blood cell counts (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.

Infections. Death and serious infections such as pneumonia and blood infection (sepsis) have happened during treatment. {Your healthcare provider will closely monitor and treat you right away if you have a fever or any signs of infection during treatment. If you have a fever or any signs of infection during treatment, your healthcare provider will closely monitor and treat you right away.}

{Tell your healthcare provider right away if you have a fever or any signs of an infection during treatment.  If you have a fever or any signs of an infection during treatment, tell your healthcare provider right away.}

Most Common Side Effects

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 white blood cell counts; low platelet counts; low red blood cell counts; diarrhea; nausea; upper respiratory tract infection; cough; muscle and joint pain; tiredness; and swelling of your arms, feet, hands, and legs.

The most common side effects of VENCLEXTA in combination with azacitidine or decitabine or low-dose cytarabine in people with AML include low white blood cell counts; 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|legs, feet, and hands|hands, legs, and feet|hands, feet, and legs|feet, legs, and hands|feet, hands, and legs}; vomiting; tiredness; shortness of breath; bleeding; infection in lung; stomach (abdominal) pain; pain in muscles or back; cough; and 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.

Your healthcare provider will do blood tests to check for TLS when you first start treatment and during treatment. Tell your healthcare provider right away if you have any symptoms of TLS during treatment, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, {dark or cloudy|cloudy or dark} urine, unusual tiredness, or muscle or joint pain.

If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment, and you should use effective birth control during treatment and for at least 30 days after the last dose of VENCLEXTA. Your healthcare provider will do blood tests to check your blood counts during treatment.

Your healthcare provider will closely monitor and treat you right away if you have a fever or any signs of infection during treatment.


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