- Low white blood cell count (neutropenia) which is common and can sometimes be severe and lead to infections that can be life-threatening or cause death. Your healthcare provider should check your blood cell counts during treatment. If your white blood cell count is too low, your healthcare provider may need to lower your dose, 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: fever, chills, cough, shortness of breath, or burning or pain when you urinate.
- Severe diarrhea. Diarrhea is common and can be severe. Severe diarrhea can lead to loss of too much body fluid (dehydration) and kidney problems. Your healthcare provider should monitor you for diarrhea and give you medicine as needed to help control it. If you lose too much body fluid, your healthcare provider may need to give you fluids and electrolytes to replace body salts. If you develop diarrhea during your treatment with TRODELVY, your healthcare provider should check to see if it 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.
- Call your healthcare provider right away the first time that you get diarrhea during treatment with TRODELVY; if you have black or bloody stools; if you have symptoms of dehydration, such as lightheadedness, dizziness, or faintness; if you are unable to take fluids by mouth due to nausea or vomiting; or if you are not able to get your diarrhea under control within 24 hours.
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:
- have been told that you carry a gene for UGT1A1*28, which can increase your risk of getting side effects with TRODELVY, especially low white blood cell counts, with or without a fever, and low red blood cell counts.
- have liver problems.
- are pregnant or plan to become pregnant. TRODELVY can harm your unborn baby. Your healthcare provider should check to see if you are pregnant before you start receiving TRODELVY. TRODELVY may cause fertility problems in females, which could affect your ability to have a baby. Talk to your healthcare provider if fertility is a concern for you.
- Females who can become pregnant should use effective birth control during treatment and for 6 months after your last dose of TRODELVY. Talk to your healthcare provider about birth control choices that may be right for you during this time. Tell your healthcare provider right away if you become pregnant during treatment with TRODELVY.
- Males with a female partner who can become pregnant should use effective birth control during treatment and for 3 months after your last dose of TRODELVY.
- are breastfeeding or plan to breastfeed. It is not known if TRODELVY passes into your breastmilk and can harm your baby. Do not breastfeed during treatment and for 1 month after your last dose of TRODELVY.
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.
FAQs
A median overall survival time of 7-8 months is usual in these patients. A total of 27 percent of the 113 patients enrolled in cohort 1 of the TROPHY-U-01 trial also successfully responded to treatment (objective response rate). The expected response rate in these patients without Trodelvy is about 10 percent.
How common is hair loss on TRODELVY? ›
Treatment-related all grade alopecia occurred in 40.4% (n=200) of patients and was one of the most common TRAEs. Alopecia was not reported as a common reason for treatment interruption, dose reduction, or treatment discontinuation.
What is the success rate of sacituzumab govitecan? ›
In clinical trials, sacituzumab govitecan has demonstrated high efficacy. In the IMMU-132 trial, the ORR was found to be 33.3% including complete response in three patients. The clinical benefit rate, including stable disease for >6 months was 45.4%.
What is the response rate for sacituzumab govitecan? ›
Sacituzumab govitecan gave 35% objective response, which was 5% with chemotherapy. Neutropenia was among the treatment-related grade 3 or higher adverse events, the incidence of which was higher in the sacituzumab govitecan arm.
When does TRODELVY fail? ›
In the Phase III Evoke-01 study, Trodelvy failed to meet the endpoint of overall survival in previously treated metastatic non-small cell lung cancer patients when put up against the chemotherapy docetaxel. Gilead said it will explore “potential pathways” to “further understand the role” the drug has in these patients.
Does TRODELVY shrink tumors? ›
Study findings:
Of the patients who took Trodelvy: 1/3 (33 percent) saw their cancers shrink. More than half (55 percent) had no cancer growth for six months.
What to avoid while on TRODELVY? ›
Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). If you have been told that you carry a certain gene (uridine diphosphate-glucuronosyl transferase A1), you may have a higher risk of side effects with this medication, especially low white blood cell counts.
Does everyone lose their hair on TRODELVY? ›
TRODELVY is likely to cause hair loss, even for patients who have not lost hair before. This may happen soon after starting treatment. Are there things I can do to help with certain side effects?
Do you lose all your hair on TRODELVY? ›
Hair thinning or hair loss
Sacituzumab govitecan may cause hair loss. Any hair loss caused should be temporary and in most cases your hair will begin to grow back once your treatment has ended. Read more information about hair loss.
What are the side effects of sacituzumab govitecan? ›
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.
The recommended dosage of TRODELVY is 10 mg/kg administered as an intravenous infusion once weekly on Days 1 and 8 of 21-day treatment cycles. Continue treatment until disease progression or unacceptable toxicity.
How long does a Sacituzumab infusion take? ›
Infusion. Your first infusion will take approximately 3 hours. Your healthcare team will observe you during the infusion. After that, if prior treatment was well tolerated, your infusions with TRODELVY may take 1 to 2 hours.
How does sacituzumab govitecan work? ›
Sacituzumab govitecan is composed of a chemotherapy drug, called irinotecan, which is attached to an antibody. Antibodies are proteins normally made by the immune system that bind to substances that don't belong in the body to prevent harm. Sacituzumab govitecan binds to the cancer cells and kills them.
What were the results of Trodelvy Phase 3? ›
Trodelvy was generally well tolerated, and no new safety signals were identified in this patient population. A more than three-month difference in median OS favoring SG was observed in a sub-group of patients non-responsive to last prior anti-PD-(L)1 therapy, representing over 60% of the trial population.
Does Sacituzumab cross the blood brain barrier? ›
Sacituzumab govitecan (SG) is an antibody drug conjugate (ADC) that targets Trop-2 for the selective delivery of SN-38 to tumors. SG carries SN-38, a topoisomerase inhibitor active in the nanomolar range for most cells (including TNBC and GBM) and freely cross the blood brain barrier.
How long can you live with Stage 4 TNBC? ›
It tends to have a worse prognosis than other forms of breast cancer. The 5-year relative survival rate for people with a diagnosis of distant TNBC between 2011 and 2017 was 12%. This number comes from the Surveillance, Epidemiology, and End Results (SEER) database.
How many cycles of TRODELVY are there? ›
You will receive TRODELVY from your doctor as an infusion into your vein. Each treatment cycle is 3 weeks, which means treatment cycles repeat every 21 days. Doses are given once a week for 2 weeks, on Day 1 and Day 8, followed by 1 week off. Treatment cycles repeat every 21 days.
What is the overall survival of metastatic TNBC? ›
Metastatic TNBC has traditionally been treated with sequential single-agent chemotherapy, with initial progression-free survival (PFS) of about 6 months and overall survival (OS) of 15 to 20 months.
What is 5 year survival for metastatic TNBC? ›
On average, 77% of people with this cancer will live 5 years after diagnosis compared with those without this form of cancer. This survival rate is 8–16% lower than that of hormone receptor-positive breast cancer, where the cancer cells have estrogen receptors, progesterone receptors, or both.
