Class: Biological Therapy

Generic Name: Venetoclax

Trade Name: Venclexta®

How is this drug used? Venclexta is approved for the treatment of patients with chronic lymphocytic leukemia (CLL) who have a specific chromosomal abnormality, referred to as a 17p deletion. Patients must have received at least one prior therapeutic regimen before starting treatment with Venclexta.

What is the mechanism of action? The BCL-2 protein is a type of protein that contributes to a cancer cell’s survival. Overexpression of the BCL-2 protein in CLL cells is associated with increased survival time of the cancer cells as well as resistance to standard chemotherapy. Venclexta is an agent that binds to the BCL-2 protein, thereby disabling its ability to keep cancer cells alive.

How is Venclexta given (administered)? Venclexta is taken orally.

How are patients monitored? Patients will be premedicated with anti-hyperuricemics and given adequate hydration; as overall risk increases, more intensive measures will be employed (intravenous hydration, frequent monitoring, and hospitalization). Blood will also be taken for signs of infection.

What are the most common side effects of treatment with Venclexta?

• Low blood cell count
• Diarrhea
• Nausea
• Upper respiratory tract infection
• Fatigue

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

Adequate hydration must be achieved while taking Venclexta to reduce the risk of TLS (tumor lysis syndrome). Six to 8 glasses of water should be consumed daily during treatment and 2 days prior to treatment. It is very important to keep scheduled appointments for blood work and other laboratory tests to allow monitoring for TLS.

Are there any special precautions patients should be aware of before starting treatment?

• Be advised of the potential risk of TLS before treatment begins to ensure proper understanding of the signs and symptoms associated with this event so that you may report them to their healthcare professional immediately.
• Females should be advised of the potential risk to a fetus and to use effective contraception during treatment. If lactating, discontinue breastfeeding.
• Males should be advised of the possibility of infertility, and of the use of sperm banks for reproductive potential.
• Immunizations must not be administered prior to, during, or after treatment with Venclexta.
• Avoid consuming grapefruit products, Seville oranges, or starfruit during treatment.
• Tell your doctor about any medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

When should patients notify their physician?

Contact your healthcare provider immediately if you notice any signs of TLS or if you develop a fever or any signs of infection. Signs of TLS include:

• Fever
• Chills
• Nausea
• Vomiting
• Confusion
• Shortness of breath
• Seizure
• Irregular heartbeat
• Dark or cloudy urine
• Unusual tiredness
• Muscle pain
• Joint discomfort

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Last updated on 05/16.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor.  We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information.  Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment kin selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

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