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IMPORTANT INFORMATION ABOUT VENCLEXTA®
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) or acute myeloid leukemia (AML). 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. If you are taking Venclexta for AML, your doctor will gradually increase your dose up to the full dose over 3, or 4 days, depending on the combination medicine used. 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: ketoconazole, posaconazole, voriconazole, itraconazole, fluconazole, clarithromycin, ciprofloxacin, erythromycin, ritonavir, 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.
©2023 AbbVie. All rights reserved. AbbVie® is a registered trademark of AbbVie Inc. VENCLEXTA® is a registered trademark of AbbVie Manufacturing Management Unlimited Company. AbbVie Limited, PO Box 11437, Manners Street, Wellington 6142.TAPS BG2511. NZ-VEN-200006. ONO0093. April 2023.