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.
Take a minute to review some of the most common questions about treatment with TRODELVY. Be sure to share your questions with your healthcare provider (HCP) as you work through your treatment plan.
TRODELVY® (sacituzumab govitecan-hziy) is a prescription medicine used to treat adults with:
It is not known if TRODELVY is safe and effective in people with moderate or severe liver problems or in children.
TRODELVY is a type of treatment called an antibody-drug conjugate (ADC) that is designed to work differently than traditional chemotherapy. It is designed to deliver anticancer medicine directly to cells with Trop-2 proteins.
An ADC is a substance that binds to a specific protein or receptor found on certain types of cells, including cancer cells. It has 3 parts: an antibody that looks for the proteins, an anticancer drug, and a linker that connects the antibody to the drug.
In certain types of cancers, tumor cells have a higher amount of a protein called Trop-2. TRODELVY seeks out and attaches to Trop-2.
Information from laboratory studies suggests that this is how TRODELVY works. The clinical benefit of these observations is unknown.
Before your infusion, you may be given medicines to help prevent infusion reactions, including a fever reducer, antihistamines, and corticosteroids. You may also be given medicine to help prevent nausea and vomiting.
On the day of your infusion, you may have a short physical exam to check your blood pressure, pulse, breathing, and temperature. Your height and weight will also be measured to find the right dosage of TRODELVY. An intravenous (IV) tube will be put into your arm, unless you already have a port which can be used for the infusion, and a blood sample may be taken.
Doses are given once a week on Days 1 and 8, followed by 1 week off during a 21-day treatment cycle. Refer to the dosing schedule for more information.
You and your HCP will decide how many treatment cycles you receive. This may be based on factors such as whether your tumor has responded to treatment or your body’s ability to tolerate treatment.
TRODELVY may affect your body in different ways.
Before receiving TRODELVY, tell your HCP about all of your medical conditions, including if you:
TRODELVY can cause serious side effects, including:
Call your HCP right away:
TRODELVY can cause serious side effects, including:
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.
TRODELVY may cause fertility problems in females, which could affect your ability to have a baby. Talk to your HCP if fertility is a concern for you.
Before and during treatment with TRODELVY, your HCP will need to do tests to monitor your health. Tell your HCP right away if you have any new symptoms while taking TRODELVY.
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.
Tell your HCP about any side effects that occur while receiving TRODELVY. Call your HCP for medical advice about side effects.
TRODELVY can cause serious side effects, including:
Call your HCP right away:
TRODELVY may cause fertility problems in females, which could affect your ability to have a baby. Talk to your HCP if fertility is a concern for you.
Before and during treatment with TRODELVY, your HCP will need to do tests to monitor your health. Tell your HCP right away if you have any new symptoms while taking TRODELVY.
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.
If you start to feel unwell, alert the nurse or other healthcare team member immediately. They will discuss your options with you.
Hair loss is common with TRODELVY.
Yes, your HCP will discuss medicines you may take before, during, or after treatment to help manage certain side effects. These may include medicine to help prevent nausea and vomiting and antidiarrheal medicine. Your HCP may recommend treatments for other side effects as well. Granulocyte colony-stimulating factor (G-CSF) was used in patients who received TRODELVY. Your HCP may also reduce or temporarily suspend your treatment with TRODELVY if certain side effects occur. Some side effects may require your healthcare provider to permanently discontinue TRODELVY.
Do not make any changes to your treatment schedule unless instructed to by your doctor/healthcare team.
There may also be small lifestyle changes you can make to help manage some side effects. Be sure to discuss any side effects that you may have with your HCP.
LOW WHITE BLOOD CELL COUNT (neutropenia) TRODELVY may lower your neutrophils, a type of white blood cell. This can put you at higher risk of infection. The following tips may help reduce the risk of infection:
DIARRHEA Antidiarrheal medicines may be given to you by your HCP. Contact your HCP immediately if you are unable to get your diarrhea under control within 24 hours after infusion. The following tips may help control diarrhea:
NAUSEA AND VOMITING Your HCP may provide medicines to help prevent nausea and vomiting. Follow the directions from your HCP. These tips may also help:
FEELING TIRED OR WEAK (fatigue) It’s common for treatment to leave you feeling weak and tired. Help manage your fatigue using the following tips:
LOW RED BLOOD CELL COUNT (anemia) A low red blood cell count can be common with treatment. This can leave you feeling weak and tired. Following these tips may help:
HAIR LOSS (alopecia) Hair loss is common with treatment. These tips may help:
Your first infusion will take approximately 3 hours. After that, if prior treatment was well tolerated, your infusions will take 1 to 2 hours.
Treatment days can be exhausting. Here are a few tips to consider:
You do not need to have a port inserted to receive treatment with TRODELVY. However, if you already have a port, it can be used for the infusion.
A port can help reduce the number of times a nurse needs to insert a needle into your vein. This can be helpful if your veins are small or damaged.
Your HCP may recommend the following on treatment days:
Pretreatment medicine: Before your infusion, you may be given medicines to help prevent infusion reactions, including a fever reducer, antihistamines, and corticosteroids. You may also be given medicine to help prevent nausea and vomiting.
Infusion: Your first infusion will take approximately 3 hours. Your HCP will observe you during the infusion. After that, if prior treatment was well tolerated, your infusions with TRODELVY may take 1 to 2 hours.
Postinfusion observation: After each infusion, your HCP will watch for reactions for at least 30 minutes. If you experience any side effects while taking TRODELVY, tell your HCP right away. Please see the Important Safety Information for more information.
Your HCP will tell how well your treatment is working by doing different exams or tests. Ask your HCP to explain the results to you and if your treatment is working.
Keep in mind that side effects do not tell you if the treatment is, or is not, working.
Gilead Oncology Support can help you determine your benefits and coverage for TRODELVY and provide support throughout your treatment.
For additional information, contact a Gilead Oncology Support program specialist Monday through Friday, 9 AM to 7 PM ET at 1-844-TRODELVY (1-844-876-3358).
Visit Gilead Oncology Support to enroll online and get more information about support offerings.
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.