Venetoclax (ven-ET-oh-klax)

Treats chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) or acute myeloid leukemia (AML).

Brand Name(s):

Venclexta, Venclexta Starter Pack

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Take this medicine with food and water at the same time each day. Swallow the tablet whole. Do not break, crush, or chew it.
• Drink plenty of water each day to help prevent tumor lysis syndrome. Your doctor may also give medicine to decrease uric acid in the blood (including allopurinol).
• Do not change your dose or stop using this medicine without first asking your doctor.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose:
  • 8 hours or less: Take the missed dose as soon as you can, then take your next dose at the regular time.
  • More than 8 hours: Skip the missed dose and just take your next dose at the regular time. Do not take extra medicine to make up for a missed dose.
  • If you vomit after you take a dose, do not take another dose to make up for it. Just take the next dose at the regular time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep the tablets in the original package during the first 4 weeks of treatment. Do not transfer the medicine to a pillbox or another container.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir, posaconazole, ritonavir, telaprevir, or voriconazole.
• Some foods and medicines can affect how venetoclax works. Tell your doctor if you are using amiodarone, azithromycin, bosentan, captopril, carbamazepine, carvedilol, ciprofloxacin, cyclosporine, diltiazem, dronedarone, efavirenz, erythromycin, etravirine, felodipine, fluconazole, modafinil, nafcillin, phenytoin, quercetin, quinidine, ranolazine, rifampin, St John's wort, ticagrelor, verapamil, or a blood thinner (including warfarin).
• If you are also using digoxin, everolimus, or sirolimus, take these medicines 6 hours before using venetoclax.
• Do not drink grapefruit juice or eat grapefruit, starfruit, or Seville oranges while you are using this medicine.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control during treatment and for at least 30 days after your last dose.
• Do not breastfeed during treatment and for at least 1 week after the last dose.
• Tell your doctor if you have kidney disease, liver disease, gout, or a history of high uric acid levels in the blood.
• This medicine may cause the following problems:
  • Tumor lysis syndrome (electrolyte and metabolic problem), which can be life-threatening
  • Serious infections (including pneumonia, sepsis)
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Talk with your doctor before using this medicine if you plan to have children. Some men who use this medicine have become infertile (unable to have children).
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Confusion, trouble breathing, seizures, uneven heartbeat, joint pain, stiffness, or swelling
• Decrease in how much or how often you urinate, lower back or side pain
• Fever, chills, cough, sore throat, body aches
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, nausea, vomiting, stomach pain

If you notice other side effects that you think are caused by this medicine, tell your doctor

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