200 mg\u00a0Powder for concentrate for\u00a0infusion solution, solution
Sacituzumab govitecan<\/p>\n\n\n\n
Trodelvy is a cancer medicine that contains the active substance sacituzumab govitecan. Part of the drug is a monoclonal antibody that specifically attaches to a protein on the surface of certain breast cancer cells called Trop-2. The other active part of Trodelvy is SN-38, a substance that can kill cancer cells. Once the drug is attached to cancer cells, SN-38 enters the cancer cells and kills them, helping to fight your cancer.<\/p>\n\n\n\n
Trodelvy is used to treat a type of breast cancer in adults called triple-negative<\/strong> breast cancer.<\/p>\n\n\n\n The medicine is used when it is not possible to remove cancer with surgery because cancer has spread to areas outside the breast (locally advanced) or has spread to other places in the body (metastatic).\u00a0Trodelvy must not be given until the patient has received at least two other treatments for their cancer, including at least one of them for locally advanced cancer or metastatic cancer.<\/p>\n\n\n\n Talk to your doctor or nurse if you have any questions about how Trodelvy works or why this medicine has been prescribed for you. You must not be given<\/u> Trodelvy<\/strong> if you are allergic<\/strong> to sacituzumab govitecan<\/strong> or any of the other ingredients<\/strong> of this medicine (listed in section 6). If you think you may be allergic, consult your doctor. Infusion-related reactions<\/p>\n\n\n\n Trodelvy is given as a drip in a vein. Some people may experience infusion-related reactions which can be serious or life-threatening. Seek emergency medical attention<\/u><\/strong> if you experience any of the following signs or symptoms of infusion-related reactions:<\/strong><\/p>\n\n\n\n Your doctor may give you medicine before you receive Trodelvy to relieve symptoms. During each infusion and for 30 minutes afterward, you will be closely monitored for these signs and symptoms of infusion-related reactions. Your doctor will slow down the infusion rate or stop the infusion if you develop a serious infusion-related reaction.<\/p>\n\n\n\n Neutropenia<\/p>\n\n\n\n This medicine can cause\u00a0neutropenia, a condition where there are too few\u00a0neutrophils\u00a0in the blood, which increases the risk of\u00a0infection.\u00a0These\u00a0infections\u00a0can be serious and life-threatening.\u00a0Seek\u00a0emergency\u00a0medical attention<\/u><\/strong>\u00a0if you develop any of the following signs or symptoms of\u00a0neutropenia\u00a0or infections:<\/strong><\/p>\n\n\n\n Your doctor will take blood tests to check the levels of neutrophils in your blood. You will not be given Trodelvy if your neutrophils are below a certain value on day 1 or day 8 of any treatment cycle.<\/p>\n\n\n\n Your doctor will adjust the amount of medicine you receive if you have severe\u00a0neutropenia.<\/p>\n\n\n\n Diarrhea<\/p>\n\n\n\n Seek emergency medical attention<\/u><\/strong> if you suffer from severe diarrhea<\/strong> while receiving Trodelvy.<\/p>\n\n\n\n Your Trodelvy treatment will be delayed until your diarrhea has improved.\u00a0You will be given loperamide to treat diarrhea, as long as you do not have an\u00a0infection.\u00a0If appropriate, you will also be given fluids.<\/p>\n\n\n\n Your doctor may also give medicine, such as atropine, to help with stomach cramps, diarrhea, and excessive saliva in the mouth before the next\u00a0infusion\u00a0of treatment.<\/p>\n\n\n\n Nausea and vomiting<\/p>\n\n\n\n This medicine may cause nausea and vomiting. Seek emergency medical attention<\/u><\/strong> if you suffer from severe nausea and vomiting<\/strong> while receiving Trodelvy.<\/p>\n\n\n\n The doctor will give you some medicines before the cancer treatment and between the infusions to relieve nausea and vomiting.\u00a0You will\u00a0not receive<\/strong>\u00a0Trodelvy if you\u00a0experience severe nausea and vomiting,<\/strong>\u00a0but will only receive Trodelvy when your symptoms are under control.<\/p>\n\n\n\n Patients who have the UGT1A1*28 gene<\/p>\n\n\n\n Some patients are more likely to have certain\u00a0side effects\u00a0from the drug because of their genetic make-up.\u00a0In people who have the UGT1A1*28 gene, the body breaks down the drug more slowly.\u00a0This means that they are more likely to have certain\u00a0side effects\u00a0(such as\u00a0neutropenia\u00a0with or without fever and low\u00a0red blood cell counts\u00a0(anemia)) than those who do not have the gene.\u00a0These patients will be followed up closely by their doctors.<\/p>\n\n\n\n Talk to your doctor or nurse before you start receiving Trodelvy if you:<\/strong><\/p>\n\n\n\n While you receive Trodelvy, your doctor will monitor you closely for\u00a0side effects.\u00a0If you get any serious\u00a0side effects, your doctor may give you other medicines to treat these\u00a0side effects, he\/she may change how much Trodelvy you receive or may stop giving you Trodelvy altogether.<\/p>\n\n\n\n See section 4 for a list of all possible side effects related to Trodelvy. Trodelvy should not be given to children and adolescents under the age of 18 because there is no information on how it works in this age group. Tell your doctor if you are taking, have recently taken, or might be taking\u00a0other medicines.<\/p>\n\n\n\n Some medicines can affect how Trodelvy works and can increase the level of Trodelvy’s active substance in your blood, which increases the risk of\u00a0side effects.\u00a0They are:<\/p>\n\n\n\n Certain medicines can lower the level of Trodelvy’s active substance in your blood, making it less effective:<\/p>\n\n\n\n Pregnancy<\/strong><\/p>\n\n\n\n Trodelvy\u00a0should not be used<\/strong>\u00a0during pregnancy as it may harm the baby.\u00a0Tell your doctor immediately if you are pregnant, think you may be pregnant, or are planning to have a baby.<\/p>\n\n\n\n Contraceptives for men and women<\/strong><\/p>\n\n\n\n Women who could become pregnant must use effective contraception during treatment with Trodelvy and for at least 6 months after the last dose of Trodelvy.<\/p>\n\n\n\n Men who have female partners who could become pregnant must use effective contraception during treatment and for 3 months after the last dose of Trodelvy.<\/p>\n\n\n\n Breast-feeding<\/strong><\/p>\n\n\n\n Do not<\/strong>\u00a0breast-feed during treatment with Trodelvy and for 1 month after the last\u00a0dose.\u00a0It is unknown if this medicine passes into breast milk and can affect the baby. Trodelvy can affect your ability to drive and use machines, e.g.\u00a0a feeling of dizziness, or fatigue.\u00a0You should therefore be careful when driving, and using tools or machinery after receiving Trodelvy. You will only be given Trodelvy by your doctor or a nurse experienced in the use of cancer treatments.<\/p>\n\n\n\n Your doctor or nurse who has specialized in your care must confirm that you can take this medicine by taking a blobreastfeedre treatment.<\/p>\n\n\n\n Medicines are given before treatment with Trodelvy<\/p>\n\n\n\n You will be given some medicines before you receive Trodelvy to help counteract infusion-related reactions and possible nausea and vomiting. Your doctor will decide which medicines you may need and how much to take.<\/p>\n\n\n\n How much Trodelvy you will get<\/p>\n\n\n\n Treatment for your cancer is repeated in cycles of 21 days (3 weeks). The recommended dose of Trodelvy is 10 mg for each kg of your body weight<\/strong> at the start of each cycle (Day 1 of each cycle) and again one week later (Day 8 of each cycle).<\/p>\n\n\n\n How you will receive your medicine<\/p>\n\n\n\n A doctor or nurse will give the medicine via an intravenous infusion (drip into the vein).<\/p>\n\n\n\n First\u00a0infusion\u00a0one<\/strong>: You will receive your first\u00a0infusion\u00a0of the medicine over 3 hours.<\/p>\n\n\n\n Second infusion and subsequent infusions:<\/strong> You will receive other infusions over 1 to 2 hours if your first infusion was uneventful.<\/p>\n\n\n\n Your doctor or nurse will monitor you for signs and symptoms of infusion-related reactions during each\u00a0infusion\u00a0and 30 minutes after each\u00a0infusion.<\/p>\n\n\n\n Infusion-related reactions<\/p>\n\n\n\n Your doctor will slow the infusion rate of your medicine if you develop an infusion-related reaction. Drug treatment will be discontinued if the infusion-related reaction is life-threatening. See section 2.<\/p>\n\n\n\n Dose of the medicine when you experience side effects<\/p>\n\n\n\n Your doctor may change or stop your\u00a0dose\u00a0if you experience certain\u00a0side effects.\u00a0See section 4. Because your doctor or other appropriately trained staff will give you the\u00a0infusion, it is unlikely that you will get an overdose.\u00a0If you accidentally take too much of the medicine, your doctor will monitor you and give additional treatment if necessary. If you forget or miss your appointment, call the doctor or treatment center and book a new appointment as soon as possible.\u00a0Don’t wait until your next scheduled visit.\u00a0For the treatment to be fully effective, it is very important not to miss a\u00a0dose. You should not stop treatment prematurely without first talking to your doctor.<\/p>\n\n\n\n For the treatment with Trodelvy against breast cancer, several treatments are usually required. The number of infusions you receive depends on how you respond to the treatment. Therefore, you should continue with Trodelvy until your doctor decides that Trodelvy should be discontinued, even if you notice that your symptoms subside. If the treatment is stopped too soon, the symptoms may return.<\/p>\n\n\n\n If you have any further questions about this medicine, ask your doctor or nurse. Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n Serious side effects are<\/strong><\/p>\n\n\n\n Seek\u00a0emergency\u00a0medical attention if you experience any of the following very common serious\u00a0side effects\u00a0(which\u00a0<\/strong>may affect more than 1 in 10 people)<\/em>\u00a0:<\/p>\n\n\n\n Other possible side effects ar<\/strong><\/p>\n\n\n\n Other side effects\u00a0are listed below.\u00a0If any of these\u00a0side effects\u00a0become serious, talk to your doctor right away.<\/p>\n\n\n\n Very common <\/strong>(may affect more than 1 in 10 people)<\/em><\/p>\n\n\n\n Common <\/strong>(may affect up to 1 in 10 people)<\/em><\/p>\n\n\n\n Trodelvy is kept by healthcare professionals at the hospital or clinic where you are being treated. The storage instructions are as follows:<\/p>\n\n\n\n Trodelvy is a chemotherapy agent . Applicable special handling and disposal procedures must be followed. The active substance is sacituzumab govitecan. One vial of powder contains 200 mg of sacituzumab govitecan. After reconstitution , one ml of solution contains 10 mg of sacituzumab govitecan.<\/p>\n\n\n\n –<\/strong> Other ingredients are 2-(N-morpholino) ethanesulfonic acid (MES), polysorbate 80 and trehalose dihydrate.
<\/a><\/p>\n\n\n\nWhat you need to know before getting Trodelvy<\/h2>\n\n\n\n
Do not use Trodelvy<\/h2>\n\n\n\n
<\/a><\/p>\n\n\n\nWarnings and precautions<\/h2>\n\n\n\n
<\/a><\/p>\n\n\n\nChildren and young people<\/h2>\n\n\n\n
<\/a><\/p>\n\n\n\nOther medicines and Trodelvy<\/h2>\n\n\n\n
Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
<\/p>\n\n\n\nDriving ability and use of machinery<\/h2>\n\n\n\n
<\/p>\n\n\n\nHow to get Trodelvy<\/h2>\n\n\n\n
<\/p>\n\n\n\nIf you have been given too much Trodelvy<\/h2>\n\n\n\n
<\/p>\n\n\n\nIf a dose of Trodelvy is missed<\/h2>\n\n\n\n
<\/p>\n\n\n\nIf you stop treatment with Trodelvy<\/h2>\n\n\n\n
<\/a><\/p>\n\n\n\nPossible side effects<\/h2>\n\n\n\n
How Trodelvy should be stored<\/h2>\n\n\n\n
<\/a><\/p>\n\n\n\nContents of the packaging and other information<\/h2>\n\n\n\n
Contents declaration<\/h2>\n\n\n\n
<\/a><\/p>\n\n\n\nAppearance and package sizes of the medicine<\/h2>\n\n\n\n