Venclexta

(Venetoclax)

The active ingredient in Venclexta is venetoclax. Venclexta’s mechanism of action involves targeting a protein called BCL-2, which helps cancer cells survive longer than they should. This leads to a rapid breakdown of cancer cells, which is why there is an increased risk of tumor lysis syndrome (TLS), especially during the first dose and early in treatment. TLS occurs when cancer cells release their contents into the blood too quickly, which can cause serious abnormalities in calcium and other body salts, kidney failure, and the need for dialysis.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Venclexta. However, the following is a synopsis of the general guidelines for the use of Venclexta:

• Venclexta is taken by mouth once daily with a meal and water, at about the same time each day. Tablets should be swallowed whole and not crushed, chewed, or broken. The dose of Venclexta depends on the condition being treated and where you are in your dosing schedule.
• When starting Venclexta, patients follow a dose ramp-up to lower the risk of TLS. For CLL or SLL, this is a 5-week ramp-up, where the dose is slowly increased weekly until the full dose is reached. This is sometimes referred to as a 5-week ramp-up or dose ramp-up. For AML, the ramp-up happens daily instead of weekly. Your healthcare provider may require blood tests, IV fluids, and additional medicines during this time.
• It is very important to drink plenty of water during treatment. Patients are instructed to drink 6 to 8 glasses of water per day starting two days before the first dose, on day 1, and during each dose increase.
• Avoid grapefruit products, grapefruit juice, Seville oranges, and starfruit, as these can increase venetoclax levels in the blood and raise the risk of toxicity.
• If you miss a dose and it has been less than 8 hours, take it as soon as possible. If more than 8 hours have passed, skip the missed dose and take the next dose at the usual time. If you vomit after taking Venclexta, do not take an extra dose.

Some mild or common side effects of Venclexta seen in clinical trials include:

• Diarrhea
• Nausea
• Constipation
• Tiredness
• Cough
• Upper respiratory tract infection
• Muscle or joint pain
• Swelling of the arms, legs, hands, or feet (edema)
• Blood-related side effects such as low platelet count (thrombocytopenia), low red blood cell count (anemia), and low white blood cell count are also common.
• Some individuals may experience serious side effects while using Venclexta. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:
• Tumor lysis syndrome, which may cause fever, chills, confusion, seizures, irregular heartbeat, dark urine, shortness of breath, kidney failure, or the need for dialysis
• Severe neutropenia, which increases the risk of serious infections such as pneumonia or blood infection (sepsis)
• Fever or signs of infection
• Severe bleeding
• Unusual weakness or dizziness

These are not all of the possible side effects of Venclexta. You should always seek medical advice from your healthcare provider for questions about side effects or toxicity. You may report side effects to the FDA at www.fda.gov/medwatch or by calling 1-800-FDA-1088.

Before starting Venclexta, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Kidney problems or liver problems
• A history of high uric acid, gout, or electrolyte abnormalities involving calcium, potassium, or phosphorus
• A history of infections or low white blood cell counts
• Plans to receive vaccines or immunization, especially a live vaccine
• Plans to become pregnant or concerns about fertility
• Are breastfeeding or plan to breastfeed

Do not use Venclexta if you have:

• Are using medications such as ketoconazole or posaconazole due to the risk for drug interactions

Venclexta begins affecting cancer cells soon after treatment starts. However, visible clinical response may take weeks to months, depending on the type of cancer, disease burden, and whether it is used alone or in combination with other medicines such as rituximab, obinutuzumab, azacitidine, decitabine, or low-dose cytarabine.

When Venclexta is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase side effects. Make sure that you tell your healthcare professional about anything that you are taking, including:

• Strong or moderate CYP3A inhibitors or CYP3A inducers
• P-gp inhibitors or P-gp substrates
• Warfarin
• Certain antifungal medicines
• Other oncology drugs

Venclexta tablets are available in multiple strengths, including 10 mg, 50 mg, and 100 mg tablets. The prescribed dose of Venclexta depends on your condition, treatment phase, and dosing schedule.

Store Venclexta at room temperature. Keep it in the original container to protect it from moisture. For patients with CLL or SLL, tablets should remain in the original package during the first 4 weeks of treatment. Keep out of reach of children.

Venclexta is manufactured by AbbVie Inc. and marketed by Genentech USA.

There is currently no FDA-approved generic version of Venclexta. Venetoclax is only available as the brand-name product.

Do not stop taking Venclexta without first talking to your healthcare provider. Stopping treatment suddenly may affect disease control. If treatment is interrupted for one week or longer, your provider may reassess your risk of TLS before restarting.

Venclexta may harm an unborn baby. A pregnancy test is recommended before starting treatment. Effective contraception should be used during treatment and for 30 days after the last dose. Talk to your doctor if you are pregnant or planning to become pregnant.

It is not known if venetoclax passes into breast milk. Do not breastfeed during treatment with Venclexta and for one week after the last dose. Talk to your healthcare provider about the safest option for you and your baby.