Chronic lymphocytic leukemia (CLL) and Small lymphocytic lymphoma (SLL) are types of slow-growing cancers that affect a type of white blood cell called a lymphocyte. Lymphocytes are cells that help your body fight infections. CLL and SLL cause your body to make too many lymphocytes that don’t work correctly. Both of these cancers are classified as non-Hodgkin’s lymphoma, which is a group of cancers that affects white blood cells.
Venclexta (ven-KLEKS-tuh) was approved in 2019 for the treatment of CLL and SLL. The medicine works to stop the growth and spread of cancer cells. Your health care provider may prescribe Venclexta for you to take it by itself or with other medicines.
How Does It Work for CLL and SLL?
CLL and SLL are different forms of the same cancer. In CLL, the cancer cells are primarily found in the blood and bone marrow, which makes blood cells for your body. In SLL, the cancer cells are primarily found in your lymph nodes, which helps your body filter out foreign substances, such as cancer cells.
There is no cure for CLL and SLL, but the disease can be managed with other treatment options such as medicine and chemotherapy. CLL and SLL may have the following symptoms:
- Pain, swelling, or fullness in your stomach
- Swelling of the lymph nodes in your neck, groin, or armpit
- Tiredness
- Shortness of breath
- Low red blood cell count (anemia)
- Night sweats
- Weight loss
- Infections
Venclexta is known as a targeted therapy. A targeted therapy is one that targets a specific protein inside cancer cells, which helps stop the cancer cells from growing and spreading.
Venclexta specifically targets a protein called B-cell lymphoma-2 (BCL-2). When the cells in your body are old or damaged, your body will trigger your cells to self-destruct, which causes these cells to die. This process is called apoptosis. BCL-2 is a protein that stops the cells in your body from self-destructing. In CLL and SLL, there is too much BCL-2 in your body, which can cause a buildup of cancer cells in your body. Venclexta attaches to the BCL-2 protein, which helps restore the process of apoptosis and allows the cancer cells in your body to self-destruct.
How Do I Take It?
Venclexta comes as a tablet in the following doses: 10 milligrams (mg), 50 mg, and 100 mg. Venclexta is taken once a day, around the same time each day, with food and water. Do not crush, chew, or break the tablets. Swallow the tablets whole. Take the medicine exactly as your health care provider tells you to. If you vomit after taking Venclexta, you should not take another dose. Take your next dose as scheduled. Tell your health care provider if you have trouble swallowing the 100 mg Venclexta tablets. Your health care provider may be able to prescribe your dose in smaller-sized tablets.
Venclexta is typically started at a low dose, with your health care provider increasing the dose weekly over five weeks. This helps lower your risk of developing a serious condition called tumor lysis syndrome, which can cause a large number of cells in your body to die quickly.
How Was It Studied?
Multiple studies were done with Venclexta to test its safety and efficacy.
Along with other medicines
In one clinical study, people took either Venclexta with obinutuzumab (another cancer medicine) or obinutuzumab with chlorambucil (another cancer medicine). People in the study had CLL that was previously untreated as well as other conditions. The study looked at progression-free survival – the amount of time it takes for your cancer to progress or get worse after you start a certain medicine. The median age (midpoint age of all the people in the study) was 72 years old, and the study included White people (90%), Black people (1%), Native Hawaiian or Other Pacific Islander (0.7%), Native Americans or Alaskan Natives (0.2%), and Hispanic or Latino people (10%) Most of the people in this study were men (67%).
In the second clinical study, people took either Venclexta for up to 2 years plus rituximab for 6 months or bendamustine plus rituximab for 6 months. Bendamustine and rituximab are cancer medicines. The study looked at progression-free survival as well as overall survival – the amount of time a person remains alive after starting treatment with a medicine. The median age was 65 years old, and the study included White people (92%), Asian people (3%), Hispanic or Latino people (2%), and Black people (0.5%). Most of the people in this study were men (74%).
Venclexta by itself
In the third clinical study, people received only Venclexta and researchers looked at the overall response to the drug. An overall response looks at how many people respond to the medicine. A partial response is a decrease in the amount of cancer in your body. A complete response is when there are no signs of cancer in your body. The average age was 67 years old, and the study included White people (96%) and Black people (3%). Most of the people in the study were men (65%).
In the fourth clinical study, people received only Venclexta and researchers looked at the overall response to the drug. The median age was 66 years old, and the study included White people (92%), Black people (6%), and Asian people (2%). Most of the people in the study were men (70%).
What Benefits Were Seen?
In combination with other medicines
In the first study, the median progression-free survival was not reached. This means that because people in the study had a very long response to the medicine, it is not yet known how long it takes for at least half of the people to have their cancer progress. But an estimated 74% of the people who received Venclexta with obinutuzumab did not have their cancer progress by 4 years, compared to 35% of people in the obinutuzumab plus chlorambucil group.
In the second study, an estimated 57% of people who received Venclexta with rituximab did not have their cancer progress after 4 years, compared to 5% of people in the bendamustine plus rituximab group. For overall survival, an estimated 85% of people who received Venclexta with rituximab were still alive after 4 years, compared to 67% of people in the bendamustine plus rituximab group.
Venclexta by itself
In the third study, at a median time of 12 months, 79% of people achieved either a partial or complete response.
In the fourth study, at the median time of 14 months, 65% of people achieved either a partial or complete response.
How Will I Know if It Is Working?
It may take some time to see how your body responds to Venclexta. If you have symptoms due to your CLL or SLL, you may start to see them lessen or your condition start to stabilize. Your blood tests may also start to improve. Venclexta can help keep your CLL or SLL from worsening. Keep all appointments with your health care provider while taking Venclexta. Call your health care provider if your symptoms worsen. Your health care provider will decide whether to add on another medicine or switch you to a different medicine.
What Are the Possible Side Effects, and How Can I Manage Them?
The common side effects seen with Venclexta are:
- Blood disorders
- Diarrhea
- Nausea
- Infection in the nose or throat, a sore throat, or common cold symptoms
- Coughing
- Muscle or joint pain
- Tiredness
- Fluid retention
Venclexta can cause changes in your laboratory values, including low neutrophil levels (neutropenia), low platelet levels (thrombocytopenia), and low red blood cell levels (anemia). Keep all appointments with your health care provider to have your blood checked.
Diarrhea may happen while you are taking Venclexta. To limit diarrhea, you can try simple steps such as eating bland foods like rice, bananas, and toast, drinking plenty of water, and lowering the amount of caffeine you are drinking. Call your health care provider if your diarrhea symptoms are not improving or are getting worse. Your health care provider may prescribe medicines to treat this or may ask you to keep over-the-counter medicines on hand.
If you have nausea, make sure you are drinking plenty of water to prevent yourself from becoming dehydrated, and call your health care provider if your symptoms are not getting any better. You can also take these steps to lessen the symptoms:
- Avoid greasy food
- Eat bland food such as toast and crackers
- Avoid strong smells
- Eat slowly
Talk to your health care provider if you get cold symptoms, coughing, muscle or joint pain, tiredness, or have swelling of your arms, legs, hands, and feet. Your health care provider can tell you how to best manage these symptoms.
What Type of Food and Drug Interactions Can Happen?
If you are taking a medicine called a CYP3A medicine, your health care provider may alter your dose of Venclexta or not have you take Venclexta and the CYP3A medicine together. If you are taking a medicine called a PGP medicine, your health care provider may lower your Venclexta dose. These medicines include:
- Digoxin, a medicine used to treat an irregular heartbeat and some types of heart failure
- Ketoconazole and posaconazole, medicines used to treat fungal infections
- Rifampin, a medicine used to treat tuberculosis
- Ritonavir, a medicine used to treat human immunodeficiency virus (HIV)
Tell your health care provider about all the prescriptions, over-the-counter drugs, and supplements you are taking. Your health care provider will find out if you are taking a CYP3A or PGP medicine.
Taking a blood thinner called warfarin with Venclexta can increase your risk of bleeding. Keep all appointments with your health care provider to have your INR (which measures the thickness of your blood) checked.
Do not eat or drink the juice of grapefruit, Seville oranges, and starfruit while taking Venclexta. These products can increase the amount of Venclexta in your blood and increase the risk of side effects.
What Are Other Unique Considerations to Be Aware Of?
Do not get live vaccines before you take and while you are taking Venclexta. Do not get live vaccines after you have stopped Venclexta without first talking to your health care provider. These vaccines may not be safe or may not work as well if taken with Venclexta. Talk to your health care provider about any vaccines you have recently received or are planning to receive.
What Do I Need to Do to Get It? Is There a Cost Savings Program?
Venclexta is available through specialty pharmacies. Talk to your health care provider to learn more. There is a copay assistance program offered by the drugmaker that may allow you to pay as little as $0 per prescription. Whether you are eligible depends on if you have health insurance. You can find out more by talking to your health care provider.
