Venetoclax
Pronunciation: ven-neet-o-clacks
Generic name: venetoclax
Brand name: Venclexta
Dosage form: oral tablets, starter pack
Drug class: Miscellaneous antineoplastics
What is venetoclax?
Venetoclax is an oral, targeted cancer treatment that may be used to treat:
- chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults
- newly diagnosed acute myeloid leukemia (AML) in adults aged 75 years or older, or who have other conditions that prevent the use of intensive chemotherapy. It is used in combination with azacitidine, decitabine, or low-dose cytarabine.
Venetoclax a was FDA approved on April 11, 2016 under the brand name Venclexta. Venetoclax is a targeted treatment, it is not chemotherapy. The brand name for venetoclax is Venclexta. There is no generic available in the United States.
How does venetoclax work?
Venetoclax works by blocking a protein called BCL-2. This protein helps determine whether cells live or die. It’s called an anti-apoptotic protein because it blocks apoptosis. Apoptosis is a process that causes cell death and is used by the body to get rid of unnecessary or abnormal cells. Venetoclax binds directly to BCL-2, displacing other proteins and activating apoptosis.
CLL, SLL, and AML cancer cells overexpress BCL-2, which is to say they have more of it than normal cells do. This makes these types of blood cancer cells resistant to chemotherapy but vulnerable to venetoclax. By blocking BCL-2, these cells will now die. Venetoclax is called a BCL-2 inhibitor.
Venetoclax side effects
Venetoclax can cause serious side effects, including:
- Tumor lysis syndrome (TLS) is caused by the fast breakdown of cancer cells and can lead to kidney failure, the need for dialysis treatment, and possibly death. Your healthcare provider will do tests to check your risk of getting TLS before you start taking venetoclax and will give you other medicines before starting and during treatment to help reduce your risk. 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 venetoclax, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain
- Drink plenty of water during treatment with venetoclax 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, and each time your dose is increased.
- When restarting venetoclax after stopping for 1 week or longer, your healthcare provider may again check for your risk of TLS and change your dose.
- Low white blood cell count (neutropenia). Low white blood cell counts are common with venetoclax but can also be severe. Your healthcare provider will do blood tests to check your blood counts during treatment and may pause dosing.
- Infections. Death and serious infections such as pneumonia and blood infection (sepsis) have happened during treatment with venetoclax. Your healthcare provider will closely monitor and treat you right away if you have a fever or any signs of infection during treatment. Tell your healthcare provider right away if you have a fever or any signs of an infection during treatment.
The most common side effects of venetoclax for CLL or SLL affecting 20% or more people when it is used in combination with other drugs or alone, include low white 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, legs, hands, and feet.
The most common side effects of venetoclax for AML affecting 30% or more people when it is used in combination with other drugs include nausea, diarrhea, low platelet count; constipation; low white blood cell count; fever with low white blood cell count; tiredness; vomiting; swelling of arms, legs, hands, or feet; fever, a lung infection; shortness of breath; bleeding; low red blood cell count; rash; stomach (abdominal) pain; an infection in your blood; muscle and joint pain; dizziness; cough; sore throat; and low blood pressure
Venetoclax 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.
Get emergency medical help if you have signs of an allergic reaction to venetoclax: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- symptoms of sepsis - confusion, severe drowsiness, rapid breathing, feeling very ill
- signs of pneumonia - cough with yellow or green mucus, stabbing chest pain, wheezing, trouble breathing
- low blood cell counts - fever, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed
- signs of tumor cell breakdown - chills, joint or muscle pain, feeling tired or short of breath, fast or slow heartbeats, nausea, vomiting, dark or cloudy urine, or seizure (convulsions).
These are not all the possible side effects of venetoclax. Call your doctor for medical advice about side effects. You may report side effects to AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Related/similar drugs
Imbruvica, Jaypirca, rituximab, cyclophosphamide, Rituxan, vincristine, Calquence
Warnings
Venetoclax can cause serious side effects, such as tumor lysis syndrome (TLS), low white blood cell counts, and infections (see venetoclax side effects above). Call your doctor at once if you have a fever, chills, joint or muscle pain, tiredness, confusion, shortness of breath, fast or slow heartbeats, nausea, vomiting, dark or cloudy urine, or a seizure (convulsions).
You should not receive live attenuated vaccines (such as MMR, chickenpox, Monkeypox) before, during, or after treatment with venetoclax until your B-cells have made a full recovery.
May cause harm to an unborn child. Females of reproductive potential should use effective contraception.
People with multiple myeloma being treated with venetoclax in combination with bortezomib plus dexamethasone should only be done inside a controlled clinical trial.
Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.
Venetoclax cost
Venetoclax is only available as the brand Venclexta. The cost of prescription drugs varies depending on your insurance plan and which pharmacy you use. Refer to our price guide page for more information about Venclexta 's cost.
You may also be eligible for an Venclexta coupon, or Venclexta copay card. Ask your doctor or pharmacist if you qualify. There is no Venclexta generic.
Before taking this medicine
To make sure venetoclax is safe for you, tell your doctor if you:
- have kidney problems
- have liver problems
- have problems with your body salts or electrolytes, such as potassium, phosphorus, or calcium
- 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 venetoclax 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. These vaccines may not be safe or may not work as well during treatment.
- are pregnant or plan to become pregnant
- are breastfeeding or plan to breastfeed.
Pregnancy
May harm an unborn baby. You may need a pregnancy test to make sure you are not pregnant. Use birth control while using venetoclax and for at least 30 days after your last dose. Tell your doctor if you become pregnant.
It may be harder for a man to get a woman pregnant while using this medicine.
Breastfeeding
It is not known if venetoclax passes into your breast milk. You should not breastfeed while using this medicine and for at least 1 week after your last dose.
How should I take venetoclax?
Take venetoclax exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.
- You may receive your first dose in a hospital or clinic setting to quickly treat any serious side effects.
- Your healthcare provider will tell you what dose of venetoclax to take. Your dose usually started low and then increased slowly over several weeks.
Take your dose of venetoclax with food and water, at the same time each day.
- Do not crush, chew, or break a tablet. Swallow the tablet or tablet whole.
- Tell your healthcare provider if you have trouble swallowing 100 mg Venclexta (venetoclax) tablets. They may prescribe your dose in smaller-sized tablets.
- To prevent certain side effects, drink 6 to 8 glasses of water daily for 2 days before you start taking venetoclax. Also, drink 6 to 8 glasses of water on the day you first take this medicine, and whenever your dose is changed.
Do not stop using this medicine without first asking your doctor.
What happens if I miss a dose?
If you miss a dose of venetoclax and it has been less than 8 hours, take your dose as soon as possible. If you miss a dose and it has been more than 8 hours, skip the missed dose and take the next dose at your usual time.
If you vomit shortly after taking venetoclax, do not take another tablet. Take your next dose as scheduled the next day.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking venetoclax?
Avoid receiving a "live" vaccine. The vaccine may not work as well while you are using venetoclax. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).
Grapefruit, starfruit, and Seville oranges may interact with venetoclax and lead to unwanted side effects. Avoid consuming grapefruit products, starfruit, and orange marmalades.
What other drugs will affect venetoclax?
Other drugs may interact with venetoclax, and affect the blood levels of other drugs you take, which may increase side effects or make the medications less effective. Tell your pharmacist or healthcare provider about all the medicines you take, including any prescription and over-the-counter medicines, vitamins, or herbal supplements. Especially tell them if you take:
- antibiotic or antifungal medications
- heart medications
- antiviral medications to treat hepatitis C or HIV.
- Strong or moderate CYP3A inhibitors or P-gp inhibitors, such as posaconazole, clarithromycin, and ketoconazole. The dosage of venetoclax will need adjusting.
- Strong or moderate CYP3A inducers, such as carbamazepine, fosphenytoin, or dexamethasone. Taking these drugs at the same time as venetoclax should be avoided
- P-gp substrates, such as apixaban, colchicine, cyclosporine, dabigatran, digoxin, edoxaban, rivaroxaban, or tacrolimus. Take these medications at least 6 hours before venetoclax.
You should also avoid grapefruit, grapefruit products, Seville oranges, or starfruit during treatment with venetoclax because these prevent venetoclax from being metabolized properly and increase your risk of side effects.
Not all possible interactions are listed here. See the prescribing information for a full list of interactions.
Storage
Venetoclax is only available as the brand Venclexta. Store Venclexta tablets in their original container at room temperature, away from moisture and heat. Do not put the tablets into a daily pill box.
Keep out of reach of children.
Venclexta ingredients
Active ingredient: venetoclax
Inactive ingredients: copovidone, colloidal silicon dioxide, polysorbate 80, sodium stearyl fumarate, and calcium phosphate dibasic.
Film coating (10 mg and 100 mg tablets): iron oxide yellow, polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide.
Film coating (50 mg tablets): iron oxide yellow, iron oxide red, iron oxide black, polyvinyl alcohol, talc, polyethylene glycol, and titanium dioxide.
Manufacturer
AbbVie Inc.
Popular FAQ
Venclexta (venetoclax) is a targeted treatment rather than a type of chemotherapy. Chemotherapy is defined as a drug treatment that kills fast-growing cells in your body. Venclexta works by binding to a specific protein called BCL-2 which is overexpressed on cancerous cells in people with cancers such as AML and CLL. By binding to this protein Venclexta kills cancerous CLL and AML lymphocytes, in preference to other fast-growing cells. Continue reading
Venclexta (venetoclax) is effective for both CLL and AML with trials reporting significantly more people experiencing complete remission with Venclexta in combination with other treatments compared to standard therapy. Venclexta works quickly as well, with it taking an average of one month for many people to experience a reduction in disease progression. Continue reading
Venclexta is usually taken for 12 months by previously untreated patients with CLL or SLL and for 24 months for previously treated patients with CLL or SLL. For patients with AML, Venclexta is taken for as long as it is deemed safe to do so (until disease progression or unacceptable toxicity is observed). Continue reading
Although Venclexta is not FDA approved to treat MM, a subgroup analysis of the BELLINI clinical trial, which was halted early by the FDA due to safety concerns, revealed that Venclexta in combination with other treatments may be beneficial for those with relapsed or refractory MM bearing the t(11;14) translocation or with high levels of BCL-2. Continue reading
Venclexta is given once-daily with food in combination with either azacytidine, decitabine, or low-dose cytarabine in adults with AML. It works by binding to a specific protein that is over-expressed in cancerous lymphocytes, killing them. Continue reading
Vencelxta works by binding directly to a protein called BCL-2, which is overexpressed on some cancer cells. When Vencelxta binds to BCL-2 it displaces other proteins, such as BIM, which help to activate the process of apoptosis, which leads to the death of the cells. Continue reading
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