SAFETY INFORMATION and
Side Effects for VENCLEXTA

WHAT SIDE EFFECTS CAN VENCLEXTA CAUSE?

Like all medicines, VENCLEXTA can have side effects and sometimes they can be serious. It is important to be aware of what the potential side effects are so you can get help from your healthcare team immediately if needed.

Are there any side effects with VENCLEXTA? (4m 03s)

Tumour Lysis Syndrome (TLS):

TLS is caused by the rapid breakdown of cancer cells resulting in high levels of certain chemicals and low levels of calcium circulating in the blood.

This situation can cause serious damage to the kidneys as well as other organs in the body and can be fatal.

TLS is most likely to occur in the first weeks of your treatment, which is why you need to follow all your doctor's instructions carefully, especially when you start treatment with VENCLEXTA.

TLS can occur within six to eight hours after the first dose and at each dose increase during the gradual dose increase phase.

Having your blood tested is important to prevent and treat TLS. It is important for you to keep your scheduled appointments for blood tests. The changes in your blood that could lead to TLS may have no symptoms until the situation becomes very serious.

Follow all your doctor’s instructions carefully, especially when you start treatment with VENCLEXTA. Tell your doctor, nurse or pharmacist if you have or have had kidney problems as this can increase the risk of TLS.

Take any additional medicines your doctor may prescribe to help prevent TLS (if you are at higher risk).

Symptoms of TLS

Tell your doctor immediately or go straight to the Emergency Department at your nearest hospital if you notice any of the following TLS symptoms.

Symptoms associated with TLS:
  • Fever or chills
  • Feeling confused
  • Your urine looks dark or cloudy
  • Being short of breath
  • Feeling unusually tired
  • Nausea
  • Convulsions or fits
  • Pain in the muscles or joints
  • Feeling sick or vomiting
  • Changes in your heart rate – slow, fast or irregular

For more information on TLS and what you and your doctor can do to help reduce the risk of TLS, please read the ‘Consumer Medicine Information’. You should also speak to your doctor if you would like further information or if you have any concerns or questions about the TLS.

To help reduce your risk of TLS:

Follow all your doctor’s instructions carefully, especially when you start treatment with VENCLEXTA.
Drink plenty of water when taking VENCLEXTA. It is important to remain hydrated throughout your treatment to reduce the risk of TLS.
Drink six to eight glasses (1.5 to 2 litres) of water each day, especially starting two days before and on the day of your first dose of VENCLEXTA and every time the dose is increased to reduce the risk of TLS. You may receive other medicines before starting and during treatment with VENCLEXTA to help reduce your risk of TLS. You may also need to receive intravenous (IV) fluids. Your doctor will advise if this is necessary.
Your doctor will do blood tests in your first five weeks of treatment with VENCLEXTA to check for TLS. It is important to follow your doctor or nurse’s instructions very carefully regarding when to have your blood tests.
Your doctor may delay, decrease your dose, or stop treatment with VENCLEXTA if you have signs of TLS developing.
Call your doctor right away or go to the Emergency Department at your nearest hospital if you notice any symptoms of TLS during treatment with VENCLEXTA, including fever, chills, nausea, vomiting, confusion, shortness of breath, convulsions or fits, changes in your heart rate, dark or cloudy urine, unusual tiredness, or muscle or joint pain.

Low white blood cell count (neutropenia):

You may experience a low number of neutrophils (a type of white blood cell) – this can be severe and need treatment.  Your doctor will check your blood counts during treatment with VENCLEXTA.

A low white blood count can increase your risk for infection.

Infections

You may experience infections during treatment with VENCLEXTA. Some infections can be very serious or even fatal.

Call your doctor straight away or go straight to the Emergency Department at your nearest hospital if you notice any of these symptoms:

  • Fever or chills
  • Feeling weak
  • Feeling confused
  • Cough, runny nose, sore throat
  • Congestion on the chest
  • Pain or burning when passing urine

Your doctor will closely monitor and treat you right away if you have fever or any signs of infection during treatment with VENCLEXTA.

Some people may experience other side effects

Less serious side effects:
  • Diarrhoea
  • Tummy pain
  • Constipation
  • Nausea (feeling sick)
  • Vomiting
  • Reduced appetite
  • Weight loss
  • A sore inside the mouth
  • Looking pale
  • Feeling tired
  • Having little or no energy
  • Shortness of breath when exercising
  • Feeling dizzy
  • Headache
  • Low blood pressure
  • Bleeding

Tell your doctor, nurse or pharmacist if you notice any of the above side effects and they worry you.

Tell your doctor, nurse or pharmacist if you notice anything else that may be making you feel unwell.

If you have any questions or concerns about side effects, speak to your doctor, nurse or pharmacist. If you are being treated with VENCLEXTA you can get further information about potential side effects by reading the VENCLEXTA Consumer Medicine Information available at medsafe.govt.nz

DO:
  • Plan to have a conversation with your healthcare provider about all medications you take and any conditions you may have before taking VENCLEXTA.
  • Take VENCLEXTA with a meal and water around the same time of day every day. Tablets should be swallowed with a full glass of water without chewing, crushing, or breaking.
  • Drink plenty of water (six to eight glasses or 1.5 to 2 litres per day) as instructed when taking VENCLEXTA.
  • It is important to follow your doctor or nurse’s instructions very carefully regarding when to have your blood tests.
  • Tell your doctor or pharmacist if you are taking any other medications, including prescription and over-the-counter medicines, vitamins or other supplements.
  • Take VENCLEXTA exactly as your healthcare provider tells you to take it.
  • Remind any doctor or dentist you visit that you are using VENCLEXTA.
DON'T:
  • Don’t start taking VENCLEXTA until you have reviewed the instructions with your doctor.
  • Don’t crush, chew, or break the tablets. Be sure to swallow them whole.
  • Don’t drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit, as these may increase the amount of VENCLEXTA in your blood.
  • Don’t take VENCLEXTA if you are taking any of the following medicines: Ketoconazole, voriconazole, itraconazole or posaconazole, which are used to treat fungal infections. Clarithromycin, which is used to treat bacterial infections. Ritonavir, which is used to treat HIV or Hepatitis C virus.
  • Don’t take an additional dose if you vomit after taking VENCLEXTA. Take the correct dose at the usual time the next day.
  • Don’t stop using VENCLEXTA or change your dose unless your doctor tells you to.

For more information about AbbVie, the maker of VENCLEXTA, visit www.AbbVie.co.nz
For medical information enquiries regarding VENCLEXTA please contact medinfoanz@abbvie.com

  • Abbvie
  • VENCLEXTA

 

The content on this site is intended solely for New Zealand residents. The information provided on this site is not intended to take the place of discussions with your doctor or other healthcare professionals (HCPs) who are treating your CLL. This website has been developed and is funded by AbbVie Limited, Wellington.

VENCLEXTA in combination with rituximab is fully funded for relapsed or refractory chronic lymphocytic leukaemia (CLL). Special authority criteria apply. Normal prescription and doctors’ fees apply.

IMPORTANT INFORMATION ABOUT VENCLEXTA®
VENCLEXTA® is supplied in New Zealand by: AbbVie Limited, 6th floor, 156-158 Victoria Street, Wellington, 6011, New Zealand Tel: 0800 900 030.  Venclexta is a prescription medicine containing venetoclax. Venclexta is available as film-coated tablets of various strength (10 mg, 50 mg, 100 mg venetoclax). It is used to treat adults with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). Venclexta is taken alone or in combination with other medicines. Your doctor will let you know which combination medicines, how to take them, and how long to take them. Typically, you will start treatment with Venclexta at a low dose. If you are taking Venclexta for CLL or SLL, your doctor will gradually increase your dose over 5 weeks up to the full dose. Use strictly as directed by your doctor. VENCLEXTA has risks and benefits. You must not take it if you are allergic to venetoclax or to any of the inactive ingredients. For CLL or SLL, do not take Venclexta if you are taking any of the following medicines: medicines used to treat or prevent fungal infections, including ketoconazole, posaconazole, voriconazole, itraconazole; clarithromycin (an antibiotic); or ritonavir (a medicine used to treat HIV and hepatitis C). Do not drink grapefruit juice, or eat grapefruit, starfruit or Seville oranges or marmalades. Do not give Venclexta to children and adolescents under 18 years of age. Do not take Venclexta if you are pregnant or plan to become pregnant, or if you are breastfeeding or plan to breastfeed. If you are a woman of child-bearing age, you must use a highly effective form of contraception during treatment with Venclexta and for at least 30 days after your last dose. Tell your doctor, nurse, or pharmacist if you have any kidney or liver problems; if you think you may have an infection; or if you recently received or are scheduled for any vaccinations. Do not stop using Venclexta or change the dose without checking with your doctor. VENCLEXTA can cause tumour lysis syndrome (TLS), which is caused by the fast breakdown of cancer cells. TLS is a very serious side effect that can be fatal. TLS is most likely to occur when you are first starting treatment. To help prevent TLS, it is important to stay hydrated and drink water every day when taking Venclexta. Particularly, starting two days before and on the day of your first dose of Venclexta and every time the dose is increased, drink 6 to 8 glasses (approximately 1.5-2 L total) of water each day. Let your healthcare provider know immediately if you experience: fever or chills; feeling sick or vomiting; being short of breath; feeling unusually tired; changes in your heart rate (slow, fast or irregular); your urine looks dark or cloudy; feeling confused; convulsions or fits; or pain in the muscles or joints while on treatment with Venclexta. Ensure you follow all your doctor’s instructions carefully and keep all your appointments, including those for blood tests. You may experience a low number of neutrophils, a type of white blood cells – this can be severe and need treatment. Your doctor will check your blood counts during treatment with Venclexta. You may experience infections during treatment with Venclexta. Some infections can be very serious or even fatal. Your doctor will closely monitor and treat you right away if you have fever or any signs of infection during treatment with Venclexta. Tell your doctor immediately if you have signs of an infection before, or while taking Venclexta, including: fever or chills, feeling weak or confused, cough, runny nose, sore throat; congestion on the chest; or pain or burning when passing urine. Some of the less serious side effects of Venclexta include diarrhoea; tummy pain; constipation, nausea (feeling sick); vomiting; reduced appetite; weight loss; mouth sores; looking pale; feeling tired; having little or no energy; shortness of breath when exercising; feeling dizzy; headache; low blood pressure; bleeding. Tell your doctor or pharmacist if you notice anything else that is making you feel unwell. Some medicines and Venclexta may interfere with each other, so tell your doctor if you are taking medicines containing any of the following: fluconazole, ciprofloxacin, erythromycin, diltiazem, verapamil, captopril, felodipine, dronedarone, amiodarone, quinidine, rifampicin, carvedilol, ciclosporin, quercetin, ranolazine, ticagrelor, azithromycin, nafcillin, carbamazepine, phenytoin, St John’s wort (Hypericum perforatum), bosentan, efavirenz, etravirine, modafinil, warfarin, digoxin, everolimus, or sirolimus. Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without prescription. Tell any other doctors, pharmacists, dentists, or surgeons treating you that you are taking Venclexta and remind them before you start any new medicines. If you have any questions about using VENCLEXTA, including its risks and benefits, how much to use, how and when to use it, or storage conditions, ask your healthcare professional and refer to the Consumer Medicine Information (CMI) available from www.medsafe.govt.nz or free phone 0800 900 030. Ask your doctor if VENCLEXTA is right for you. Use strictly as directed. If symptoms continue, or you have side effects, see your doctor, pharmacist, or healthcare professional. V7a.

AbbVie is a registered trademark of AbbVie Inc. VENCLEXTA® is a registered trademark of AbbVie Ireland Unlimited Company. AbbVie Limited, PO Box 11437, Manners Street, Wellington 6142. TAPS BG1086. NZ-VEN-200006. ONO0073. Prepared September 2021.