Venclexta

Venclexta is a prescription medication used to treat chronic lymphocytic leukemia (CLL). Venclexta belongs to a group of drugs called B-cell lymphoma 2 (BCL-2) protein inhibitors. It works to stop cancer cells from growing. 

It is available as tablets and is typically taken once daily with a meal and water. Do not chew, crush, or break tablets.

Common side effects of Venclexta include  diarrhea, nausea, and fatigue. 

Venclexta is a prescription medication used to treat chronic lymphocytic leukemia (CLL). Venclexta is approved for those who have a 17p deletion (a chromosomal abnormality) and who have been treated with at least one prior therapy.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• AbbVie Inc.

Serious side effects have been reported with Venclexta. See the "Drug Precautions" section.

Common side effects of Venclexta include:

• a decrease in blood cell counts
• diarrhea
• nausea
• upper respiratory tract infection
• fatigue

This is not a complete list of Venclexta side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that block the activity of CYP3A such as ketoconazole, conivaptan, clarithromycin, indinavir, itraconazole, lopinavir, ritonavir, telaprevir, posaconazole and voriconazole
• medications that increase the activity of the enzyme CYP3A such as carbamazepine, phenytoin, rifampin, St. John’s wort) or moderate CYP3A inducers (e.g., bosentan, efavirenz, etravirine, modafinil, nafcillin
• medications that block the p-glycoprotein transporter such as amiodarone (Cordarone, Pacerone), azithromycin (Zithromax, Zmax), captopril (Capoten), carvedilol (Coreg), clarithromycin (Biaxin), conivaptan (Vaprisol), cyclosporine (Neoral, Sandimmune, Gengraf), diltiazem (Cardizem), dronedarone (Multaq), erythromycin (EES, Ery-Tab), felodipine (Plendil),  itraconazole (Sporanox, Onmel), ketoconazole (Nizoral), lopinavir and ritonavir (Kaletra), quinidine, ranolazine (Ranexa), verapamil (Calan, Isoptin, Covera, Verelan)
• narrow therapeutic index P-gp substrates such as digoxin, everolimus, and sirolimus

This is not a complete list of Venclexta drug interactions. Ask your doctor or pharmacist for more information.

 Serious side effects have been reported with Venclexta including the following: 

• 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 doctor 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 doctor will do blood tests in your first 5 weeks of treatment to check you for TLS during treatment with Venclexta. It is important to keep your appointments for blood tests. Tell your doctor 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 urine
  • unusual tiredness
  • muscle or joint pain

To reduce the risk for TLS, be sure to drink plenty of water when taking this medication. Drink 6 to 8 glasses (about 56 ounces total) of water each day. Drinking plenty of fluids is important specifically 2 days before your first dose, on the day of your first dose of Venclexta, and each time your dose is increased. 

• Low white blood cell count (neutropenia). Low white blood cell counts are common with Venclexta, but can also be severe. Your doctor will do blood tests to check your blood counts during treatment with Venclexta. Tell your doctor right away if you have a fever or any signs of an infection. 
• Fertility problems in males. Speak to your doctor about any fertility concerns.  

Do not take Venclexta if you:

• are allergic to Venclexta or to any of its ingredients 
• take strong inhibitors of CYP3A during specific times of dosing

Grapefruit, grapefruit juice, Seville oranges, and starfruit may interact with Venclexta and lead to potentially dangerous effects. Discuss the use of Grapefruit, grapefruit juice, Seville oranges, and starfruit with your doctor.

Before taking Venclexta, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Venclexta or to any of its ingredients
• have kidney or 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 doctor tells you it is okay. If you are not sure about the type of immunization or vaccine, ask your doctor. These vaccines may not be safe or may not work as well during treatment with VENCLEXTA.
• are pregnant or plan to become pregnant
• breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

There are no well-controlled studies that have been done in pregnant women. Based on toxicity observed in mice, Venclexta may harm your unborn baby when administered to pregnant women. If Venclexta is used during pregnancy or if the patient becomes pregnant while taking Venclexta, know there is a potential risk to a fetus.

If you are able to become pregnant, your doctor should do a pregnancy test before you start treatment with Venclexta. It is recommended females who are able to become pregnant use effective birth control during treatment and for 30 days after the last dose of Venclexta. If you become pregnant or think you are pregnant, tell your doctor right away.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Venclexta crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Venclexta. Do not breastfeed during treatment with Venclexta.

Take Venclexta exactly as prescribed.

Venclexta is available as tablets and is typically taken once daily with a meal and water. Do not chew, crush, or break tablets.

Do not change your dose of Venclexta or stop taking Venclexta unless your doctor tells you to.

When you first take Venclexta:

• You may need to take Venclexta at the hospital or clinic to monitor for TLS.
• Your doctor will start Venclexta at a low dose. Your dose will be slowly increased weekly over 5 weeks up to the full dose.
• Make sure to drink plenty of fluids to reduce the risk for TLS. 
• 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 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 of Venclexta and it has been more than 8 hours, skip the missed dose and take the next dose at your usual time.

If you vomit after taking Venclexta, do not take an extra dose. Take the next dose at your usual time the next day.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended daily dose of Venclexta (venetoclax) is 400 mg. Your doctor will typically start you on 20 mg once daily for 7 days and then will increase your dose weekly until you reach a daily dose of 400 mg. 

If you take too much Venclexta, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Venclexta at or below 86°F (30°C).
• Keep Venclexta tablets in the original package during the first 4 weeks of treatment. Do not transfer the tablets to a pillbox or other container
• Keep this and all medicines out of the reach of children.