Venclexta
Pronunciation: ven-KLEKS-tuh
Generic name: venetoclax
Dosage form: oral tablets
Drug class: Miscellaneous antineoplastics
What is Venclexta?
Venclexta (venetoclax) may be used to treat adults with certain blood cancers, such as chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or newly diagnosed acute myeloid leukemia (AML) in those 75 and older or with other conditions that prevent the use of intensive chemotherapy. For AML, Venclexta is used with azacitidine, decitabine, or low-dose cytarabine.
Venclexta's mechanism of action involves targeting a specific protein called BCL-2. BCL-2 acts like a cell's on/off switch for death, preventing cells from programmed cell death (apoptosis). Cancerous blood cells, particularly in CLL, SLL, and AML, often overproduce BCL-2, making them resistant to traditional chemotherapy. Venclexta binds directly to BCL-2, turning the cell's death switch back on and triggering apoptosis. Venclexta is not chemotherapy, it is a targeted treatment (see Is Venclexta chemotherapy? for more information).
Venclexta gained FDA approval on April 11, 2016. There is no Venclexta generic available.
Venclexta side effects
The most common side effects of Venclexta are:
- Laboratory test changes, such as low white cell counts, low platelet counts, and low red blood cell counts
- Diarrhea
- Nausea
- Upper respiratory tract infections (such as a cold)
- Cough
- Muscle and joint pain
- Tiredness
- Swelling of your arms, legs, hands, and feet.
Other side effects that are common when Venclexta is used to treat AML include:
- Constipation
- Fever
- Vomiting
- Shortness of breath
- Bleeding
- Rash
- Stomach (abdominal) pain
- An infection in your blood
- Muscle and joint pain
- Dizziness
- Sore throat
- Low blood pressure.
Serious side effects and warnings
Venclexta can cause the following serious side effects.
Tumor lysis syndrome (TLS), which can lead to kidney failure, dialysis treatment, and possibly death. TLS is caused by the fast breakdown of cancer cells and your healthcare provider will do tests to check your risk of TLS before you start taking Venclexta, and will give you medicines to help reduce your risk before starting and during treatment. Make sure you keep your regular appointments for blood tests and tell your healthcare provider right away if you have any symptoms of TLS during treatment, such as fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain
- 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, to help reduce your risk of getting TLS.
- When restarting Venclexta 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 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 during treatment and may pause dosing.
Infections. Serious, sometimes fatal, infections such as pneumonia and blood infections (sepsis) have occurred during treatment with Venclexta. Tell your healthcare provider right away if you develop any symptoms of an infection, such as fever, difficulty breathing, rash, tiredness, or feeling faint.
Venclexta may harm an unborn child. Females who can have children should use effective contraception while taking Venclexta and for 30 days after the last dose. Venclexta may also cause fertility problems in males which may affect their ability to father a child. Talk to your healthcare provider if you have concerns about fertility.
Venclextax may cause an allergic reaction. Get emergency medical help if you have signs of an allergic reaction to Venclexta. Symptoms may include hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.
Do not receive live attenuated vaccines (such as MMR, chickenpox, Monkeypox) before, during, or after treatment with Venclexta until your B-cells have made a full recovery.
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.
These are not all the possible side effects of Venclexta. 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
Venclexta price
The price of Venclexta 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 Venclexta is safe for you, tell your healthcare provider 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 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. 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
Venclexta may harm an unborn baby. You may need a pregnancy test to make sure you are not pregnant. Use birth control while using Venclexta 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 Venclexta 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 Venclexta?
Take Venclexta 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.
- Venclexta is usually taken 1 time a day.
- Venclexta dosing begins with a 5-week ramp-up (see dosing information below).
- Your healthcare provider will tell you what dose of Venclexta to take. Your dose usually started low and then increased slowly over several weeks.
- You may receive your first dose in a hospital or clinic setting to quickly treat any serious side effects.
Take Venclexta 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 the 100 mg Venclexta 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 Venclexta. Also, drink 6 to 8 glasses of water on the day you first take this medicine, and whenever your dose is changed.
- Venclexta is usually taken for 12 months in previously untreated CLL or SLL. For other types of blood cancers, or in previously treated patients the Venclexta dosage may vary (see How long do you take Venclexta for?).
Do not stop using this medicine without first asking your doctor.
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).
Venclexta dosing
Recommended dosage of Venclexta for CLL/SLL
The dosage of Venclexta is usually increased slowly over 5 weeks, as described by the Venclexta Package Insert:
- Week 1: Venclexta 20 mg 1 time a day
- Week 2: Venclexta 50 mg 1 time a day
- Week 3: Venclexta 100 mg 1 time a day
- Week 4: Venclexta 200 mg 1 time a day
- Week 5 and beyond: Vencelxta 400 mg 1 time a day.
The Venclexta Starting Pack provides the first 4 weeks of venetoclax according to the ramp-up schedule.
- The ongoing dosage of Venclexta is 400 mg once daily after completion of the 5-week ramp-up dosing schedule.
- Venclexta should be continued until disease progression or unacceptable toxicity occurs.
Recommended dosage of Venclexta for AML
The dosage of Venclexta is usually increased slowly over 3 or 4 days, as described by the Venclexta Package Insert:
- Day 1: Venclexta 100 mg 1 time a day
- Day 2: Venclexta 200 mg 1 time a day
- Day 3: Venclexta 400 mg 1 time a day
- Day 4 and beyond: Venclexta 400 mg 1 time a day of each 28-day cycle in combination with azacitidine or decitabine OR Venclexta 600 mg 1 time a day of each 28-day cycle in combination with low-dose cytarabine.
Venclexta should be continued in combination with combination with azacitidine, decitabine, or low-dose cytarabine until disease progression or unacceptable toxicity occurs.
Related/similar drugs
Imbruvica, Brukinsa, rituximab, cyclophosphamide, Rituxan, Calquence, ibrutinib, venetoclax, azacitidine, vincristine
What happens if I miss a dose?
If you miss a dose of Venclexta 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 Venclexta, 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 Venclexta?
Avoid receiving a "live" vaccine with Venclexta. The vaccine may not work as well while you are using Venclexta. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).
Grapefruit, starfruit, and Seville oranges may interact with Venclexta and lead to unwanted side effects. Avoid consuming grapefruit products, starfruit, and orange marmalades.
What other drugs will affect Venclexta?
Other drugs may interact with Venclexta, 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 Venclexta will need adjusting.
- Strong or moderate CYP3A inducers, such as carbamazepine, fosphenytoin, or dexamethasone. Taking these drugs at the same time as Venclexta 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 Venclexta.
You should also avoid grapefruit, grapefruit products, Seville oranges, or starfruit during treatment with Venclexta because these prevent Venclexta 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
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.
Available as 10 mg, 50 mg, and 100 mg tablets.
Who makes Venclexta?
AbbVie Inc., makes Venclexta.
Popular FAQ
Is Venclexta (venetoclax) chemotherapy?
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
How effective is Venclexta?
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
How long do you take Venclexta for?
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
Can Venclexta be used for Multiple Myeloma?
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
How is Venclexta (venetoclax) used for AML?
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
How does Venclexta work?
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
More about Venclexta (venetoclax)
- Check interactions
- Compare alternatives
- Pricing & coupons
- Reviews (10)
- Drug images
- Side effects
- Dosage information
- Patient tips
- During pregnancy
- FDA approval history
- Drug class: miscellaneous antineoplastics
- Breastfeeding
Professional resources
Related treatment guides
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.