TRODELVY was studied in a phase 2 clinical trial. The trial included 112 adults with bladder cancer and cancers of the urinary tract that spread or could not be removed by surgery. Patients in the trial had previously received a platinum-containing chemotherapy and an immunotherapy medicine. Patients were given 10 mg/kg of TRODELVY as an intravenous infusion on days 1 and 8 of a 21-day treatment cycle.
Of the 27.7% of patients (31 out of 112) receiving TRODELVY who responded to treatment in the clinical trial:
TRODELVY may not work for everyone. Individual results may vary.
It’s important to understand what side effects may be expected with TRODELVY, including serious side effects. It’s also important to know that your healthcare provider may be able to help you proactively plan for some side effects with pretreatment medicine and guidance to help you manage side effects if they do occur.
If you experience any side effects, contact your healthcare provider immediately. Some side effects may require medical attention.
TRODELVY can also cause serious side effects, including neutropenia, severe diarrhea, serious infusion-related reactions and severe allergic reactions, which could be life-threatening, as well as nausea and vomiting.
For those taking TRODELVY in the clinical trial:
These are not all of the possible side effects of TRODELVY. Tell your healthcare provider about any side effects that bother you or do not go away. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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 may report side effects to FDA at 1-800-FDA-1088.
Please click to see Important Facts about TRODELVY, including Important Warning.