Venetoclax is used to treat chronic lymphocytic leukemia or small lymphocytic leukemia in adults.

Venetoclax is also used in combination with other medicines to treat acute myeloid leukemia in adults who are 75 years or older, or who cannot use standard chemotherapy due to other medical conditions.

Venetoclax may also be used for purposes not listed in this medication guide.

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).

Drink 6 to 8 full glasses of water each day to help prevent these side effects.

Venetoclax comes as a tablet to take by mouth. It is usually taken with a meal and water once a day. Take venetoclax at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take venetoclax exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

If you vomit after taking venetoclax, do not repeat the dose. Continue your regular dosing schedule.

Your doctor will probably start you on a low dose of venetoclax and gradually increase your dose, not more than once every week for the first 5 weeks if you are being treated for CLL or SLL, and once a day for the first 3 or 4 days if you are being treated for AML.

Your doctor may need to interrupt or stop your treatment if you experience certain side effects. Be sure to tell your doctor how you are feeling during your treatment with venetoclax. For certain side effects, your doctor may tell you to start taking venetoclax at a lower dose.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with venetoclax and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may receive your first dose in a hospital or clinic setting to quickly treat any serious side effects.

Take venetoclax with food and water, at the same time each day.

Do not crush, chew, or break a venetoclax tablet. Swallow it whole.

If you vomit shortly after taking venetoclax, do not take another tablet. Take your next dose as scheduled the next day.

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 venetoclax, and whenever your dose is changed.

You may need frequent medical tests and your cancer treatments may be delayed based on the results.

Do not stop using venetoclax without first asking your doctor.

Store tablets in their original container at room temperature, away from moisture and heat. Do not put venetoclax tablets into a daily pill box.

Some drugs should not be used with venetoclax. Your treatment plan may change if you also use:

• an antibiotic or antifungal medicine;

• heart medication; or

• antiviral medicine to treat hepatitis C or HIV.

Do not start or stop using any medicine without asking your doctor.

Tell your doctor if you have ever had:

• liver or kidney disease;

• an electrolyte imbalance (such as low levels of potassium or calcium in your blood);

• gout, or high levels of uric acid in your blood; or

• if you use a blood thinner (such as warfarin) and you have routine "INR" or prothrombin time tests.

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 you using venetoclax.

You should not breastfeed while using this medicine and for at least 1 week after your last dose.

Use the medicine as soon as you can, but skip the missed dose if you are more than 8 hours late for the dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Do not transfer the medication to a different container. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Do not eat grapefruit, starfruit, or Seville oranges (sometimes used in marmalades), or drink grapefruit juice while taking this medication.

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.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Venetoclax may cause serious side effects. 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; or

• 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).

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of venetoclax may include:

• stomach pain, nausea, vomiting, diarrhea, constipation;

• feeling tired or short of breath;

• low blood pressure, feeling dizzy or lightheaded;

• muscle and joint pain;

• swelling in your arms, legs, hands, and feet;

• fever, low blood cell counts;

• pneumonia, sepsis;

• mouth pain;

• rash; or

• cold symptoms such as stuffy nose, sneezing, sore throat, cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can affect venetoclax. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body's response to venetoclax.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.