TRODELVY® (sacituzumab govitecan-hziy) is a prescription medicine used to treat adults with bladder cancer and cancers of the urinary tract that have spread (metastatic) or cannot be removed by surgery, and who have received a platinum-containing chemotherapy medicine and also received an immunotherapy medicine. This indication is approved based on medical studies that measured how many patients responded and how long they responded. Continued approval may depend on benefit demonstrated in additional medical studies. It is not known if TRODELVY is safe and effective in people with moderate or severe liver problems or in children.
Having open discussions with your healthcare team can help you develop a plan to proactively manage potential side effects. When discussing side effect management with your healthcare team, be sure to:
Be sure to tell your healthcare team about any side effects you have while receiving TRODELVY.
Your healthcare provider (HCP) may modify your dose to help you manage certain side effects and continue treatment. If adverse events are serious, your treatment may need to be stopped or discontinued by your HCP.
There may also be some lifestyle changes you can make to help manage some of the most common side effects. Be sure to discuss any side effects you may have with your HCP.
The most common side effects of TRODELVY include decreased white blood cell (leukocyte, neutrophil*, and lymphocyte) and red blood cell counts, diarrhea, nausea, feeling tired or weak, hair loss, constipation, increased sugar levels in the blood, decreased protein levels (albumin) in the blood, vomiting, decreased appetite, changes in kidney function test, increased levels of enzyme called alkaline phosphatase in the blood (test for liver or bone problems), and decreased levels of magnesium, potassium, and sodium in the blood.
Be sure to tell your HCP about any side effects you have while receiving TRODELVY and refer to the Important Facts for a list of possible side effects. Some side effects may require you to interrupt your treatment or permanently discontinue TRODELVY. Do not make any changes to your treatment plan, or usage of medicines prescribed to you, without being instructed to do so by your HCP.
TRODELVY may lower your neutrophils, a type of white blood cell. This is common and can sometimes be severe and lead to infections which can be life-threatening or cause death.
Your HCP should check your blood cell counts during treatment with TRODELVY. If your white blood cell count is too low, your HCP may need to lower your dose of TRODELVY, give you a medicine to help prevent low blood cell count with future doses of TRODELVY, or in some cases may stop TRODELVY. Your HCP may need to give you antibiotic medicines if you develop fever while your white blood cell count is low.
Contact your HCP immediately if you experience fever, chills, cough, shortness of breath, burning or pain when you urinate, or other signs of infection.
The following tips may also help reduce the risk of infection:
Diarrhea is common and can be severe. Severe diarrhea can lead to loss of too much body fluid (dehydration) and kidney problems. Your HCP should monitor you for diarrhea and give you medicine as needed to help control it. If you lose too much body fluid, your HCP may need to give you fluids and electrolytes to replace body salts. If you develop diarrhea during your treatment with TRODELVY, your HCP should check to see if it may be caused by an infection. Your HCP may decrease your dose or stop TRODELVY if your diarrhea is severe and cannot be controlled with anti-diarrheal medicines.
Call your HCP right away:
The following tips may also help control diarrhea:
TRODELVY can cause serious and life-threatening allergic and infusion-related reactions during infusion.
Tell your HCP right away if you get any of the following symptoms during your infusion of TRODELVY or within 24 hours: swelling of your face, lips, tongue, or throat; hives; skin rash, itching, or flushing of your skin; fever; difficulty breathing or wheezing; lightheadedness, dizziness, feeling faint or pass out; chills or shaking chills (rigors).
Nausea and vomiting are common with TRODELVY and can sometimes be severe. Before each dose of TRODELVY, you will receive medicines to help prevent nausea and vomiting along with medicines to take home with instructions about how to take them. Call your HCP right away if you have nausea or vomiting that is not controlled with the medicines prescribed for you. Your HCP may decide to decrease your dose or stop TRODELVY if your nausea and vomiting is severe and cannot be controlled with anti-nausea medicines. These tips may also help:
It’s common for treatment to leave you feeling weak and tired. Help manage your fatigue using the following tips:
TRODELVY® (sacituzumab govitecan-hziy) is a prescription medicine used to treat adults with bladder cancer and cancers of the urinary tract that have spread (metastatic) or cannot be removed by surgery, and who have received a platinum-containing chemotherapy medicine and also received an immunotherapy medicine.
This indication is approved based on medical studies that measured how many patients responded and how long they responded. Continued approval may depend on benefit demonstrated in additional medical studies.
It is not known if TRODELVY is safe and effective in people with moderate or severe liver problems or in children.
Do not receive TRODELVY if you have had a severe allergic reaction to TRODELVY. Ask your healthcare provider if you are not sure.
Allergic and infusion-related reactions which can be serious and life-threatening. Tell your healthcare provider or nurse right away if you get any of the following symptoms during your infusion of TRODELVY or within 24 hours after: swelling of your face, lips, tongue, or throat; hives; skin rash, itching, or flushing of your skin; fever; difficulty breathing or wheezing; lightheadedness, dizziness, feeling faint, or pass out; or chills or shaking chills (rigors).
Nausea and vomiting are common with TRODELVY and can sometimes be severe. Before each dose of TRODELVY, you will receive medicines to help prevent nausea and vomiting along with medicines to take home with instructions about how to take them. Call your healthcare provider right away if you have nausea or vomiting that is not controlled with the medicines prescribed for you. Your healthcare provider may decide to decrease your dose or stop TRODELVY if your nausea and vomiting is severe and cannot be controlled with anti-nausea medicines.
Before receiving TRODELVY, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain medicines may affect the way TRODELVY works.
The most common side effects of TRODELVY include decreased white blood cell (leukocyte and lymphocyte) and red blood cell counts, feeling tired or weak, hair loss, constipation, increased sugar levels in the blood, decreased protein levels (albumin) in the blood, decreased appetite, changes in kidney function test, increased levels of enzyme called alkaline phosphatase in the blood (test for liver or bone problems), and decreased levels of magnesium, potassium, and sodium in the blood.
These are not all of the possible side effects of TRODELVY. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please click to see Important Facts about TRODELVY, including Important Warning.