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Generic Name: venetoclax (ven ET oh klax)
Brand Names: Venclexta, Venclexta Starting Pack

What is Venclexta?

Venclexta (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.

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

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

Important information

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.

Before taking this medicine

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

Some medicines can interact with Venclexta 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 Venclexta 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 Venclexta 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 Venclexta. 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.

How should I take Venclexta?

Take Venclexta exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Drink 6 to 8 glasses of water daily for 2 days before you start taking Venclexta. Also drink 6 to 8 glasses of water on the day you first take Venclexta, and whenever your dose is changed.

Your doctor may want to give your first dose of this medicine in a hospital or clinic setting to quickly treat any serious side effects that occur.

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

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

If you vomit shortly after taking Venclexta, do not take another tablet. Wait until the next day to take your medicine at the scheduled time.

Venclexta can lower blood cells that help your body fight infections. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Do not stop using this medicine without first asking your doctor.

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

Venclexta dosing information

Usual Adult Dose for Chronic Lymphocytic Leukemia:

-Initial Dose:
Weekly Ramp-Up Schedule Over 5 Weeks:
Week 1: 20 mg orally per day
Week 2: 50 mg orally per day
Week 3: 100 mg orally per day
Week 4: 200 mg orally per day
Week 5: 400 mg orally per day

-Maintenance Dose: 400 mg orally per day
-Duration of Therapy: Until disease progression or unacceptable toxicity is observed.

-Select patients based on the presence of 17p deletions in blood specimens.
-Retest patients without 17p deletion at relapse as acquisition of 17p deletion can occur.

Use: Treatment of patients with chronic lymphocytic leukemia (CLL) with 17P deletion, as detected by an approved test, who have received at least one prior therapy.

See also: Dosage Information (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If you are more than 8 hours late, skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid while taking Venclexta?

Do not receive a "live" vaccine while using Venclexta. 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 Venclexta.

Venclexta side effects

Get emergency medical help if you have signs of an allergic reaction to Venclexta: 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 Venclexta 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.

See also: Side effects (in more detail)

What other drugs will affect Venclexta?

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.

Where can I get more information?

  • Your pharmacist can provide more information about Venclexta.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Venclexta only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2018 Cerner Multum, Inc. Version: 1.02. Revision Date: 2016-05-27, 7:51:45 AM.