Clasificación: BCL-2 inhibitor
About Venetoclax (Venclexta™)
Venetoclax works by binding to and inhibiting BCL-2, which is a protein found on cancerous lymphocyte cells. Venetoclax causes the breakdown of the lymphocytes that cause CLL. Venetoclax is approved only for patients with CLL with the 17p depletion mutation.
How to Take Venetoclax
Venetoclax comes in a tablet to be taken by mouth. The starting dose is 20mg once a day, for 7 days. The dose is then slowly increased to 400mg per day over a period of 5 weeks. Take this medication around the same time every day, with a meal and water. Swallow the tablets whole; do not chew, crush or break the tablets.
If you miss a dose and it is within 8 hours of when you usually take your dose, take the missed dose and resume your normal schedule. If it has been longer than 8 hours since your normally scheduled dose, skip that dose and resume our normal schedule the next day. If you vomit after taking the dose, do not take an extra dose. Resume your normal schedule with the next dose.
The dose is increased slowly over a period of 5 weeks. During this time, proper hydration is important to prevent tumor lysis syndrome, a condition that occurs due to rapid breakdown of tumor cells.
- Patients should drink 6 to 8 glasses of non-alcoholic fluids (about 56 ounces total), starting 2 days prior to the first dose, the day of the first dose, and every time the dose is increased.
- At each increase of dose you may have blood tests drawn and imaging completed due to the rapid reduction of tumor that can be caused by venetoclax.
- The rapid breakdown of these cells can cause tumor lysis syndrome (TLS), which can lead to kidney damage. Symptoms of TLS include fever, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, muscle or joint pain, and unusual tiredness. Report any of these symptoms to your oncology team right away.
- You may be given intravenous fluids and medications to protect your kidneys.
The blood levels of this medication can be affected by medications and certain foods, so they should be avoided, especially at initiation of the medication and during dose increases. These include: grapefruit products, starfruit, Seville oranges, ketoconazole, voriconazole, ciprofloxacin, amiodarone, diltiazem, carvedilol and verapamil, among others. Be sure to tell your healthcare provider about all medications and supplements you take.
Storage and Handling
Store your medication in the original, labeled blister pack, at room temperature and in a dry location (unless otherwise directed by your healthcare provider or pharmacist). This medication should not be stored in a pillbox. Keep containers out of reach of children and pets.
If a caregiver prepares your dose for you, they should consider wearing gloves or pour the pills directly from their container into the cap, a small cup, or directly into your hand. They should avoid touching the pills. They should always wash their hands before and after giving you the medication. Pregnant or nursing women should not prepare the dose for you. Ask your oncology team where to return any unused medication for disposal. Do not flush down the toilet or throw in the trash.
Where do I get this medication?
Venetoclax is available through select specialty pharmacies. Your oncology team will work with your prescription drug plan to identify an in-network specialty pharmacy for distribution of this medication and delivery or shipment directly to your home.
This medication may be covered under your prescription drug plan. Patient assistance may be available to qualifying individuals without prescription drug coverage. Co-pay cards, which reduce the patient co-pay responsibility for eligible commercially (non-government sponsored) insured patients, may also be available. Your care team can help you find these resources, if they are available.
Possible Side Effects
There are a number of things you can do to manage the side effects of venetoclax. Talk to your doctor or nurse about these recommendations. They can help you decide what will work best for you. These are some of the most common side effects:
Low White Blood Cell Count (Leukopenia or Neutropenia)
White blood cells (WBC) are important for fighting infection. While receiving treatment, your WBC count can drop, putting you at a higher risk of getting an infection. You should let your doctor or nurse know right away if you have a fever (temperature greater than 100.4), sore throat or cold, shortness of breath, cough, burning with urination, or a sore that doesn't heal.
Tips to preventing infection:
- Washing hands, both yours and your visitors, is the best way to prevent the spread of infection.
- Avoid large crowds and people who are sick (i.e.: those who have a cold, fever or cough or live with someone with these symptoms).
- When working in your yard, wear protective clothing including long pants and gloves.
- Do not handle pet waste.
- Keep all cuts or scratches clean.
- Shower or bath daily and perform frequent mouth care.
- Do not cut cuticles or ingrown nails. You may wear nail polish, but not fake nails.
- Ask your doctor or nurse before scheduling dental appointments or procedures.
- Ask your doctor or nurse before you, or someone you live with, has any vaccinations.
Low Red Blood Cell Count (Anemia)
Your red blood cells are responsible for carrying oxygen to the tissues in your body. When the red cell count is low, you may feel tired or weak. You should let your doctor or nurse know if you experience any shortness of breath, difficulty breathing or pain in your chest. If the count gets too low, you may receive a blood transfusion.
Low Platelet Count (Thrombocytopenia)
Platelets help your blood clot, so when the count is low you are at a higher risk of bleeding. Let your doctor or nurse know if you have any excess bruising or bleeding, including nose bleeds, bleeding gums or blood in your urine or stool. If the platelet count becomes too low, you may receive a transfusion of platelets.
- Do not use a razor (an electric razor is fine).
- Avoid contact sports and activities that can result in injury or bleeding.
- Do not take aspirin (salicylic acid), non-steroidal, anti-inflammatory medications (NSAIDs) such as Motrin®, Aleve®, Advil®, etc. as these can all increase the risk of bleeding. Unless your healthcare team tells you otherwise, you may take acetaminophen (Tylenol).
- Do not floss or use toothpicks and use a soft-bristle toothbrush to brush your teeth.
Nausea and/or Vomiting
Talk to your doctor or nurse so they can prescribe medications to help you manage nausea and vomiting. In addition, dietary changes may help. Avoid things that may worsen the symptoms, such as heavy or greasy/fatty, spicy or acidic foods (lemons, tomatoes, oranges). Try antacids, (e.g. milk of magnesia, calcium tablets such as Tums), saltines, or ginger ale to lessen symptoms.
Call your doctor or nurse if you are unable to keep fluids down for more than 12 hours or if you feel lightheaded or dizzy at any time.
Your oncology team can recommend medications to relieve diarrhea. Also, try eating low-fiber, bland foods, such as white rice and boiled or baked chicken. Avoid raw fruits, vegetables, whole grain breads, cereals and seeds. Soluble fiber is found in some foods and absorbs fluid, which can help relieve diarrhea. Foods high in soluble fiber include: applesauce, bananas (ripe), canned fruit, orange sections, boiled potatoes, white rice, products made with white flour, oatmeal, cream of rice, cream of wheat, and farina. Drink 8-10 glasses on non-alcoholic, un-caffeinated fluid a day to prevent dehydration.
Fatigue is very common during cancer treatment and is an overwhelming feeling of exhaustion that is not usually relieved by rest. While on cancer treatment, and for a period after, you may need to adjust your schedule to manage fatigue. Plan times to rest during the day and conserve energy for more important activities. Exercise can help combat fatigue; a simple daily walk with a friend can help. Talk to your healthcare team for helpful tips on dealing with this side effect.
Muscle or Joint Pain/Aches and Headache
Your doctor or nurse can recommend medication and other strategies to relieve pain.
You or anyone you live with should avoid having live or live-attenuated vaccines while receiving this medication. These include oral polio, measles , rotovirus, yellow fever, and the nasal flu vaccine (Flumist).
Tumor Lysis Syndrome
Venclexta can cause tumor lysis syndrome, a complication that occurs due to a rapid breakdown of the cancer cells. It is important to notify your provider if you are experiencing any of the following side effects which may be being caused by TLS: fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual fatigue or muscle/joint pain. Keep in mind that these side effects do not necessarily mean that you have TLS, but it is important to follow your provider’s recommendations to monitor or check for TLS due to the serious nature of this complication.
Exposure of an unborn child to this medication could cause birth defects, so you should not become pregnant or father a child while on this medication. Effective birth control is necessary during treatment and for at least 30 days after treatment. Even if your menstrual cycle stops or you believe you are not producing sperm, you could still be fertile and conceive. You should consult with your healthcare team before breastfeeding while receiving this medication.