TRODELVY® (sacituzumab govitecan-hziy) is a prescription medicine used to treat adults with hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic) or cannot be removed by surgery, and who previously received endocrine therapy and at least two additional treatments for metastatic disease. It is not known if TRODELVY is safe and effective in people with moderate or severe liver problems or in children.
Breast cancer is classified by whether or not the cancer cells have certain proteins called receptors. Cancer cells may have receptors for 2 types of hormones (estrogen or progesterone) or another receptor called human epidermal growth factor receptor 2 (HER2).
If estrogen or progesterone hormone receptors are detected in at least 1 out of every 100 cancer cells, the breast cancer is hormone receptor-positive (HR+).
Hormone therapy (also called endocrine therapy) works by interfering with the activity of estrogen and/or progesterone hormones, which cancer cells can use to grow. This is why hormone therapy is a common initial treatment for HR+ breast cancer.
If tests detect low or no HER2 receptors, the breast cancer is considered HER2-negative (HER2-).
TRODELVY was designed for certain patients with previously-treated HER2- breast cancer.
Eventually, hormone therapy can stop working, so your healthcare provider may prescribe systemic treatments that more widely affect your cancer cells.
After many treatments, it’s normal to feel like you’re running out of options. TRODELVY can be used in certain adults who have received endocrine therapy and 2 or more treatments for metastatic breast cancer that is HR+ and HER2-negative, which includes cancer that is HER2-low.
Unlike some other treatments, TRODELVY does not need cancer cells to have estrogen receptors, progesterone receptors, or HER2 in order to work, which is why it is an option for people with HR+/HER2- metastatic breast cancer. TRODELVY is designed to seek out a different protein that may be present on breast cancer cells.
TRODELVY® (sacituzumab govitecan-hziy) is a prescription medicine used to treat adults with hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic) or cannot be removed by surgery, and who previously received endocrine therapy and at least two additional treatments for metastatic disease.
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.