What is the most important information I should know about TRODELVY?
TRODELVY can cause serious side effects, including:
- Low white blood cell count (neutropenia). Low white blood cell counts are common with TRODELVY and can sometimes be severe and lead to infections that can be life-threatening. Your healthcare provider should check your blood cell counts during treatment with TRODELVY. If your white blood cell count is too low, your healthcare provider 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 healthcare provider may need to give you antibiotic medicines if you develop fever while your white blood cell count is low. Call your healthcare provider right away if you develop any of the following signs of infection during treatment with TRODELVY:
- shortness of breath
- burning or pain when you urinate
- Severe diarrhea. Diarrhea is common with TRODELVY and can also be severe. Your healthcare provider should monitor you for diarrhea and give you medicine as needed to help control your diarrhea. If you lose too much body fluids (dehydration) your healthcare provider may need to give you fluids and electrolytes to replace body salts. If diarrhea happens later in your treatment, your healthcare provider may check you to see if the diarrhea may be caused by an infection. Your healthcare provider may decrease your dose or stop TRODELVY if your diarrhea is severe and cannot be controlled with anti-diarrheal medicines.
- the first time that you get diarrhea during treatment with TRODELVY
- if you have black or bloody stools
- if you have symptoms of losing too much body fluid (dehydration) and body salts, such as lightheadedness, dizziness or faintness
- if you are unable to take fluids by mouth due to nausea or vomiting
- if you are not able to get your diarrhea under control within 24 hours
Call your healthcare provider right away:
What Is Trodelvy?
TRODELVY is a prescription medicine used to treat adults with breast cancer that is:
- estrogen and progesterone hormone receptor (HR) negative, and human epidermal growth factor receptor 2 (HER2)-negative (also called triple-negative breast cancer), and
- that has spread to other parts of the body metastatic, and
- who previously received at least two therapies for metastatic disease
It is not known if TRODELVY is safe and effective in people with moderate or severe liver problems.
It is not known if TRODELVY is safe and effective in children.
General information about the safe and effective use of TRODELVY
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about TRODELVY that is written for health professionals.
What are the ingredients in TRODELVY?
Active ingredient: sacituzumab govitecan-hziy
Inactive ingredients: 2-(N-morpholino) ethane sulfonic acid (MES), polysorbate 80 and trehalose dihydrate
Manufactured by: Immunomedics, Inc., 300 The American Road, Morris Plains, NJ 07950, USA
U.S. License No. 1737
For more information about TRODELVY, go to www.TRODELVY.com or call 1-888-983-4668.