10 mg, 50 mg, and 100 mg\u00a0film-coated tablets
venetoclax<\/p>\n\n\n\n
What Venclyxto is<\/strong><\/p>\n\n\n\n Venclyxto is a cancer medicine that contains the active substance venetoclax.\u00a0It belongs to a group of medicines called ‘BCL-2 inhibitors.<\/p>\n\n\n\n What Venclyxto is used for<\/strong><\/p>\n\n\n\n Venclyxto is used to treat patients with<\/p>\n\n\n\n CLL\u00a0is a type of cancer that affects the\u00a0white blood cells\u00a0called\u00a0lymphocytes\u00a0and the lymph nodes.\u00a0In\u00a0CLL, the\u00a0lymphocytes\u00a0are formed\u00a0too quickly and live too long, which means that there are too many of them in the blood.<\/p>\n\n\n\n AML is a type of cancer that affects the white blood cells called myeloid cells. In AML, the myeloid cells become more numerous and grow very quickly in the bone marrow and the blood. This means that there are too many myeloid cells and too few red blood cells in the blood.<\/p>\n\n\n\n How Venclyxto works<\/strong><\/p>\n\n\n\n Venclyxto works by blocking a\u00a0protein\u00a0in the body called ‘BCL-2’.\u00a0This\u00a0protein\u00a0helps cancer cells survive.\u00a0By blocking this\u00a0protein, the cancer cells die and their number decreases.\u00a0It also slows down the deterioration of the disease. Ask your doctor if you can start using these medicines again once your dose of Venclyxto has been increased to the full standard dose.<\/p>\n\n\n\n You must inform your doctor, pharmacist, or nurse about all medicines you are taking, including prescription and non-prescription medicines,\u00a0vitamins,\u00a0and herbal supplements.\u00a0Your doctor may ask you to stop using certain medicines when you start taking Venclyxto and for the first few days or weeks while your\u00a0dose\u00a0is increased to the full standard dose.<\/p>\n\n\n\n Talk to your doctor, pharmacist, or nurse before taking Venclyxto if:<\/p>\n\n\n\n If any of the above apply to you or you are not sure, talk to your doctor, pharmacist, or nurse before taking this medicine.<\/p>\n\n\n\n Tumor lysis syndrome<\/strong><\/p>\n\n\n\n Some people may develop abnormal levels of certain body salts (such as\u00a0potassium\u00a0and\u00a0uric acid\u00a0) in their blood during treatment because the cancer cells are broken down so quickly.\u00a0This can lead to changes in kidney function, abnormal heartbeats, or seizures.\u00a0This is called tumor lysis syndrome (TLS).\u00a0There is a risk of TLS during the first days or weeks of treatment with Venclyxto while the\u00a0dose\u00a0is increased.<\/p>\n\n\n\n The following applies if you have CLL<\/strong><\/p>\n\n\n\n Your doctor, pharmacist, or nurse will take blood tests to check for signs of TLS.<\/p>\n\n\n\n Before you start treatment with Venclyxto, your doctor will also give you medicines that prevent uric acid from accumulating in the body.<\/p>\n\n\n\n By drinking a lot of water, at least 1.5 to 2 liters a day, you help the body to get rid of the breakdown products of the cancer cells through the urine and this can reduce the risk of TLS (see section 3).<\/p>\n\n\n\n Tell your doctor, pharmacist, or nurse straight away if you get any of the symptoms of TLS listed in section 4.<\/p>\n\n\n\n If there is a risk that you will get TLS, you may need to be treated in the hospital so that you can receive fluids in a vein if needed, have blood tests more often, and be checked for\u00a0side effects.\u00a0This is done so that you can continue to take this medicine safely.<\/p>\n\n\n\n The following applies if you have AML<\/strong><\/p>\n\n\n\n You may be treated in a hospital where a doctor or nurse will make sure you have enough water\/fluids, give you medicine to prevent\u00a0uric acid\u00a0from building up in your body, and take blood tests before you start taking Venclyxto, while they increase your\u00a0dose\u00a0and when you start taking the full\u00a0dose\u00a0one.<\/p>\n\n\n\n Venclyxto should not be used by children and adolescents. This is because it has not been studied in these age groups.<\/a><\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking any of the following medicines as they may increase or decrease the amount of venetoclax in your blood:<\/p>\n\n\n\n Your doctor may need to change your dose of Venclyxto.<\/p>\n\n\n\n Tell your doctor if you are taking any of the following medicines as Venclyxto can affect their effect:<\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking, have recently taken, or may be taking other medicines, including over-the-counter medicines and herbal medicines, and dietary supplements.\u00a0This is because Venclyxto can affect the effectiveness of certain other medicines.\u00a0In addition, some other medicines can affect the effect of Venclyxto.<\/p>\n\n\n\n Do not eat products containing grapefruit, bitter orange (a citrus fruit with a bitter taste), or star fruit (carambola) while taking Venclyxto.\u00a0This includes eating fruits, drinking juice from them, or taking a dietary supplement containing them.\u00a0This is because they can increase the amount of venetoclax in your blood.<\/p>\n\n\n\n Pregnancy<\/strong><\/p>\n\n\n\n You may feel tired or dizzy after taking Venclyxto, which may affect your ability to drive and use tools or machines.<\/a> Always take this medicine exactly as your doctor, pharmacist or nurse has told you.\u00a0Consult a doctor, pharmacist, or nurse if you are unsure.<\/p>\n\n\n\n How much to take<\/strong><\/p>\n\n\n\n The following applies if you have CLL<\/strong><\/p>\n\n\n\n You will start treatment with a low dose of Venclyxto for 1 week. The doctor will gradually increase the dose by one over the next 4 weeks until you reach the full standard dose. During the first 4 weeks, you will receive a new pack every week.<\/p>\n\n\n\n Your\u00a0dose\u00a0may need to be adjusted due to\u00a0side effects.\u00a0The doctor will inform you about the\u00a0dose\u00a0to take.<\/p>\n\n\n\n The following applies if you have AML<\/strong><\/p>\n\n\n\n You start treatment with Venclyxto at a lower\u00a0dose.\u00a0The doctor increases the\u00a0dose\u00a0gradually by one each day during the first 3 days.\u00a0After 3 days, take the full standard dose.\u00a0Does\u00a0one (the tablets) is taken once a day.<\/p>\n\n\n\n The doses\u00a0are given in the table below<\/strong><\/p>\n\n\n\n The doctor will give you Venclyxto together with another medicine (azacytidine or decitabine).<\/p>\n\n\n\n You will continue to take the full\u00a0dose\u00a0of Venclyxto until your AML gets worse or until you cannot take Venclyxto because you have had serious\u00a0side effects.<\/p>\n\n\n\n How to take Venclyxto<\/strong><\/p>\n\n\n\n If you vomit after taking Venclyxto, do not take an extra dose that day. Take the next dose at the usual time the next day. Talk to your doctor if you have problems taking this medicine.<\/p>\n\n\n\n drink a lot of water<\/strong><\/p>\n\n\n\n The following applies if you have CLL<\/strong><\/p>\n\n\n\n You must drink plenty of water while taking Venclyxto during the first 5 weeks of treatment.\u00a0It helps remove the cancer cells’ breakdown products from the blood via the urine.<\/p>\n\n\n\n You should start by drinking at least 1.5 to 2 liters of water daily, two days before you start taking Venclyxto.\u00a0You can also count non-alcoholic and caffeine-free drinks in that amount, but don’t drink juice with grapefruit, orange, or star fruit (carambola).\u00a0You should continue to drink at least 1.5 to 2 liters of water on the day you start taking Venclyxto.\u00a0Drink the same amount of water (at least 1.5 to 2 liters daily) two days before and on the day your\u00a0dose\u00a0is increased.<\/p>\n\n\n\n If your doctor thinks you are at risk of developing TLS, you may need to be treated in the hospital so that you can receive extra fluids in a vein if needed, have more frequent blood tests, and be monitored for\u00a0side effects.\u00a0This is done to check that you can continue to take this medicine safely.<\/p>\n\n\n\n The following applies if you have AML<\/strong><\/p>\n\n\n\n You must drink plenty of water while taking Venclyxto, especially when starting treatment and increasing the\u00a0dose.\u00a0Drinking water helps to remove the cancer cells’ breakdown products from the blood via the urine.\u00a0If you are in the hospital, a doctor or nurse may give you fluids into a vein if needed to make sure this happens.<\/p>\n\n\n\n If you take too much Venclyxto, you should immediately contact a doctor, pharmacist, or nurse or seek hospital care.\u00a0Take the tablets and this leaflet with you.<\/p>\n\n\n\n Do not stop taking this medicine unless your doctor tells you to.\u00a0If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.<\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.\u00a0The following serious\u00a0side effects\u00a0can occur with this medicine:<\/p>\n\n\n\n Tumor lysis syndrome<\/strong> (common – may affect up to 1 in 10 people)<\/p>\n\n\n\n Stop taking Venclyxto and seek medical attention immediately if you experience any of the symptoms of TLS:<\/p>\n\n\n\n Low white blood cell count ( neutropenia ) and infection<\/strong> (very common – may affect more than 1 in 10 people )<\/strong><\/p>\n\n\n\n The doctor will check your blood levels during treatment with Venclyxto.\u00a0A low number of\u00a0white blood cells\u00a0can increase the risk of\u00a0infection.\u00a0Signs of\u00a0infection\u00a0may include fever, chills, feeling weak or confused, coughing, pain, or burning when urinating.\u00a0Some\u00a0infections\u00a0can be serious and lead to death.\u00a0Tell your doctor right away if you develop signs of an\u00a0infection\u00a0while taking this medicine.<\/p>\n\n\n\n Tell your doctor if you get any of the following side effects:<\/strong><\/p>\n\n\n\n The following applies if you have CLL<\/strong><\/p>\n\n\n\n Very common<\/strong> (may affect more than 1 in 10 users)<\/p>\n\n\n\n Blood tests can also show:<\/p>\n\n\n\n Common<\/strong> (may affect up to 1 in 10 users)<\/p>\n\n\n\n Blood tests can also show:<\/p>\n\n\n\n The following applies if you have AML<\/strong><\/p>\n\n\n\n Very common<\/strong> (may affect more than 1 in 10 users)<\/p>\n\n\n\n Blood tests can also show<\/p>\n\n\n\n Common<\/strong> (may affect up to 1 in 10 users)<\/p>\n\n\n\n Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n Use before the expiry date which is stated on the carton and blister after EXP.<\/p>\n\n\n\n No special storage instructions.<\/p>\n\n\n\n Medicines must not be thrown into the drain or among the household waste.\u00a0Ask the pharmacist how to dispose of medicines that are no longer used.\u00a0These measures will help to protect the environment. The active substance is venetoclax.<\/p>\n\n\n\n Other ingredients are:<\/p>\n\n\n\n In the filming:<\/p>\n\n\n\n Venclyxto 10 mg film-coated tablet is light yellow, round, and 6 mm in diameter, with V on one side and 10 on the other side.<\/p>\n\n\n\n Venclyxto 50 mg film-coated tablet is beige, oblong, and 14 mm long, with V on one side and 50 on the other side.<\/p>\n\n\n\n Venclyxto 100 mg film-coated tablet is light yellow, oblong, and 17.2 mm long, with V on one side and 100 on the other side.<\/p>\n\n\n\n Venclyxto tablets are packed in blisters in the following cartons:<\/p>\n\n\n\n Venclyxto 10 mg film-coated tablets:<\/p>\n\n\n\n Venclyxto 50 mg film-coated tablets:<\/p>\n\n\n\n Venclyxto 100 mg film-coated tablets:<\/p>\n\n\n\n
<\/p>\n\n\n\nWhat you need to know before you take Venclyxto<\/h2>\n\n\n\n
Do not take Venclyxto if:<\/h2>\n\n\n\n
Warnings and precautions<\/h2>\n\n\n\n
Children and young people<\/h2>\n\n\n\n
Other medicines and Venclyxto<\/h2>\n\n\n\n
Venclyxto with food and drink<\/h2>\n\n\n\n
Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
Contraceptive<\/strong><\/li><\/ul>\n\n\n\n
Breast-feeding<\/strong> does not breast-feed while taking this medicine.\u00a0It is unknown whether the active substance in Venclyxto is excreted in breast milk.
Fertility<\/strong>Animal studies suggest that Venclyxto may cause male\u00a0infertility\u00a0(low or no sperm).\u00a0This can affect your ability to have children.\u00a0Ask your doctor for advice on saving sperm before you start treatment with Venclyxto.<\/li><\/ul>\n\n\n\nDriving ability and use of machinery<\/h2>\n\n\n\n
<\/a><\/p>\n\n\n\nHow to take Venclyxto<\/h2>\n\n\n\n
Day<\/strong><\/td> A daily\u00a0dose\u00a0of Venclyxto<\/strong><\/td><\/tr> 1<\/td> 100 mg (one 100 mg tablet)<\/td><\/tr> 2<\/td> 200 mg (two 100 mg tablets)<\/td><\/tr> 3 and beyond<\/td> 400 mg (four 100 mg tablets)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n If you have taken too much Venclyxto<\/h2>\n\n\n\n
If you forget to take Venclyxto<\/h2>\n\n\n\n
Do not stop taking Venclyxto<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
How to store Venclyxto<\/h2>\n\n\n\n
<\/p>\n\n\n\nContents of the packaging and other information<\/h2>\n\n\n\n
Contents declaration<\/h2>\n\n\n\n
Appearance and package sizes of the medicine<\/h2>\n\n\n\n