Venclexta Starting Pack

Venetoclax inhibits a certain protein in cancer cells (abnormal lymphocytes produced in chronic lymphocytic leukemia) that helps keep those cells alive and makes them resistant to chemotherapy. Venetoclax binds to this protein, which helps kill the cancerous lymphocytes in blood and bone marrow.

Venetoclax is used to treat chronic lymphocytic leukemia (CLL) in adults with 17p deletion. Venetoclax is used only if you have a specific genetic marker, for which your doctor will test.

Venetoclax is usually given after at least one other cancer medicine has been tried without success.

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

Many drugs can interact with venetoclax, and some drugs should not be used together. Tell your doctor about all medicines you use. Do not start or stop using any medicine without asking your doctor.

You should not use venetoclax if you are allergic to it.

Some medicines can interact with venetoclax and should not be used at the same time. Your doctor may need to change your treatment plan if you use any of the following drugs:

• imatinib;
• isoniazid;
• nefazodone;
• an antibiotic--clarithromycin, telithromycin;
• antifungal medicine--itraconazole, ketoconazole, posaconazole, voriconazole;
• heart medication--nicardipine, quinidine; or
• antiviral medicine to treat hepatitis C or HIV/AIDS--atazanavir, boceprevir, cobicistat, delavirdine, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir, telaprevir.

Tell your doctor about all medicines you use. Do not start or stop using any medicine without asking your doctor.

To make sure venetoclax is safe for you, tell your doctor if you have:

• 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 are scheduled to receive any vaccinations.

Do not use venetoclax if you are pregnant. It could harm the unborn baby or cause birth defects. You may need to have a negative pregnancy test before starting this treatment. Tell your doctor right away if you become pregnant while taking venetoclax. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 30 days after your last dose.

This medicine may affect fertility (ability to have children) in men. Talk to your doctor if you are concerned about this risk.

It is not known whether venetoclax passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

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

Call your doctor at once if you have:

• signs of pneumonia--cough with yellow or green mucus, stabbing chest pain, wheezing, trouble breathing;
• low blood cell counts--fever, chills, flu-like symptoms, swollen gums, mouth sores, skin sores, pale or yellowed skin, dark colored urine, confusion or weakness; or
• signs of tumor cell breakdown--fever, chills, joint or muscle pain, feeling tired or short of breath, fast or slow heartbeats, confusion, 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 may include:

• nausea, diarrhea;
• feeling tired;
• easy bruising, unusual bleeding; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

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.

Do not receive a "live" vaccine while using venetoclax. The vaccine may not work as well during this time, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Grapefruit, Seville oranges, and starfruit products may interact with venetoclax and lead to unwanted side effects. Avoid the use of juice or other products that contain these fruits while you are taking venetoclax.

Many drugs can interact with venetoclax. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

• aprepitant;
• cimetidine;
• cyclosporine;
• haloperidol;
• imatinib;
• St. John's wort;
• warfarin (Coumadin, Jantoven);
• an antibiotic--azithromycin, ciprofloxacin, clarithromycin, doxycycline, erythromycin, metronidazole, norfloxacin, rifampin, tetracycline;
• antifungal medicine--clotrimazole, fluconazole, itraconazole, ketoconazole, voriconazole;
• an antidepressant--desipramine, sertraline;
• heart or blood pressure medicine--amiodarone, captopril, carvedilol, diltiazem, dronedarone, felodipine, lidocaine, quinidine, ranolazine, verapamil; or
• HIV/AIDS medicine--lopinavir with ritonavir.

This list is not complete and many other drugs can interact with venetoclax. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Do not receive a "live" vaccine while using venetoclax. The vaccine may not work as well during this time, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Grapefruit, Seville oranges, and starfruit products may interact with venetoclax and lead to unwanted side effects. Avoid the use of juice or other products that contain these fruits while you are taking venetoclax.

• Tell all of your health care providers that you take Venclexta Starting Pack. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Other drugs will be given with this medicine to help avoid side effects.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• If you have upset stomach, throwing up, loose stools (diarrhea), or are not hungry, talk with your doctor. There may be ways to lower these side effects.
• Talk with your doctor before getting any vaccines. Use with Venclexta Starting Pack may either raise the chance of an infection or make the vaccine not work as well.
• Avoid grapefruit and grapefruit juice, Seville oranges, and starfruit.
• If you are taking warfarin, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with this medicine.
• Some drugs may need to be taken at a different time than Venclexta Starting Pack. If you also take digoxin, everolimus, or sirolimus, take it at least 6 hours before you take this medicine. There may also be other drugs as well. Talk with your doctor or pharmacist to find out if your other drugs need to be taken at a different time than Venclexta Starting Pack (venetoclax).
• This medicine may affect being able to father a child. Talk with the doctor.
• If you are able to get pregnant, a pregnancy test will be done to show that you are NOT pregnant before starting this medicine. Talk with your doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• Use birth control that you can trust to prevent pregnancy while taking Venclexta Starting Pack and for 1 month after stopping this medicine.
• If you get pregnant while taking Venclexta Starting Pack or within 1 month after your last dose, call your doctor right away.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with a meal.
• Swallow whole with a drink of water.
• Do not chew, break, or crush.
• Take Venclexta Starting Pack at the same time of day.
• Drink plenty of water when taking this medicine unless told to drink less water by your doctor. Drink 6 to 8 glasses (about 56 ounces total) of water each day. Start doing this 2 days before your first dose. Talk with your doctor if you have questions.
• To gain the most benefit, do not miss doses.
• Keep taking Venclexta Starting Pack as you have been told by your doctor or other health care provider, even if you feel well.
• If you throw up after taking a dose, do not repeat the dose. Take your next dose at your normal time.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is has been more than 8 hours since the missed dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Venclexta Starting Pack is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Venclexta Starting Pack or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Venclexta Starting Pack (venetoclax). This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017