Venetoclax Oral tablet

What is this medicine?

VENETOCLAX (ven et oh klax) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It is used to treat chronic lymphocytic leukemia.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• gout

• kidney disease

• liver disease

• high levels of uric acid in the blood

• low or high levels of potassium, phosphorus, or calcium in the blood

• scheduled to receive a vaccine

• an unusual or allergic reaction to venetoclax, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with food and a glass of water. Follow the directions on the prescription label. Do not cut, crush, or chew this medicine. Do not take with grapefruit juice or eat Seville oranges or starfruit. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If your next dose is to be taken in less than 16 hours, then do not take the missed dose. Take the next dose at your regular time. Do not take double or extra doses. If you vomit after a dose, do not take another dose; take the next day's dose at the usual time.

What may interact with this medicine?

This medicine may interact with the following medications:

• bosentan

• calcium channel blockers like diltiazem and verapamil

• captopril

• carvedilol

• certain antibiotics like azithromycin, erythromycin, and clarithromycin

• certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, and voriconazole

• certain medicines for irregular heart beat like amiodarone, dronedarone, and quinidine

• certain medicines for seizures like carbamazepine and phenytoin

• ciprofloxacin

• conivaptan

• cyclosporine

• digoxin

• efavirenz

• etravirine

• everolimus

• felodipine

• grapefruit products, Seville oranges, or starfruit

• indinavir

• live virus vaccines

• lopinavir

• modafinil

• nafcillin

• quercetin

• ranolazine

• rifampin

• ritonavir

• sirolimus

• St. John’s wort

• telaprevir

• ticagrelor

• warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

This medicine can cause serious reactions. To reduce your risk you will need to take other medicine(s) before treatment with this medicine. Take your medicine as directed.

You may need blood work done while you are taking this medicine.

Drink plenty of fluids while you are taking this medicine.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

Do not become pregnant while taking this medicine or for 30 days after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

This may interfere with the ability to father a child. You should talk to your doctor or health care professional if you are concerned about your fertility.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding

• signs and symptoms of infection like fever or chills; cough; sore throat; or pain when urinating

• signs and symptoms of tumor lysis syndrome like nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark urine, tiredness, muscle pain, and/or joint pain

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• back pain

• constipation

• diarrhea

• headache

• swelling of the ankles, feet, hands

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store below 30 degrees C (86 degrees F). Keep this medicine in the original package during the first 4 weeks of treatment. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.