Actor portrayals.
Having open discussions with your healthcare team can help you develop a plan to proactively manage potential side effects. When discussing side effect management with your healthcare team, be sure to:
Ask
Ask about other treatments or medications you may be able to take before, during, or after treatment
Share
Share any side effects you may have experienced with previous therapies
List
Provide a list of all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain medicines may affect the way TRODELVY works
Be sure to tell your healthcare team about any side effects you have while receiving TRODELVY.
Treatment modification
Your HCP may decrease your dose or delay treatment to help you manage certain side effects and potentially continue treatment, if appropriate. In some cases, your treatment with TRODELVY may need to be delayed or permanently stopped by your HCP based on the experience you have with serious side effects.
Side effect management
There may also be some lifestyle changes you can make to help manage some of the most common side effects. Be sure to discuss any side effects you may have with your HCP.
The most common side effects of TRODELVY when used alone include decreased white blood cell and red blood cell counts, nausea, diarrhea, feeling tired or weak, hair loss, increased sugar levels (glucose) in the blood, constipation, vomiting, decreased protein levels (albumin) in the blood, increased alkaline phosphatase in the blood, decreased appetite, stomach pain, decreased creatinine clearance, and decreased magnesium and potassium levels in the blood.
Be sure to tell your HCP about any side effects you have while receiving TRODELVY and refer to the Important Facts for a list of possible side effects. If you develop serious side effects, your HCP may treat you with certain medicines, delay treatment, lower your dose, or permanently stop treatment with TRODELVY. Do not make any changes to your treatment plan, or usage of medicines prescribed to you, without being instructed to do so by your HCP.
Low white blood cell counts are common with TRODELVY and can sometimes be severe and lead to infections that can be life-threatening or cause death as early as the first cycle of treatment.
Your HCP should check your blood cell counts during treatment with TRODELVY and may give a medicine to help prevent low blood cell count starting in the first cycle of treatment if you have an increased risk for developing low white blood cell count with a fever (febrile neutropenia).
Contact your HCP immediately if you experience any of these signs of infection: fever, chills, cough, shortness of breath, or burning or pain when you urinate.
The following tips may also help reduce the risk of infection:
- Wash your hands often with soap and warm water
- Avoid large crowds and stay away from people who are sick
- Thoroughly wash raw fruits and vegetables before eating them
If you develop serious side effects, your HCP may treat you with certain medicines, delay treatment, lower your dose, or permanently stop treatment with TRODELVY.
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Severe diarrhea can lead to loss of too much body fluid (dehydration) and kidney problems. Your HCP should monitor you for diarrhea and give you medicine as needed to help control it. If you lose too much body fluid, your HCP may need to give you fluids and electrolytes to replace body salts. If you develop diarrhea during your treatment with TRODELVY, your HCP should check to see if it may be caused by an infection.
Call your HCP right away:
- The first time that you get diarrhea during treatment with TRODELVY
- If you develop black or bloody stools
- If you develop symptoms of losing too much body fluid and body salts, such as lightheadedness, dizziness, or faintness
- If you cannot take fluids by mouth due to nausea or vomiting
- If you cannot get your diarrhea under control within 24 hours
The following tips may also help control diarrhea:
- Slowly sip cool, clear liquids throughout the day to stay hydrated
- Eat frequent, small meals that are bland and low in fiber, such as bananas, white rice, and toast
- Avoid alcohol, caffeine, greasy or spicy foods, and limit dairy products and raw vegetables
If you develop serious side effects, your HCP may treat you with certain medicines, delay treatment, lower your dose, or permanently stop treatment with TRODELVY.
TRODELVY can cause serious or life-threatening allergic and infusion-related reactions.
These reactions are more common within 24 hours of receiving TRODELVY. Tell your HCP right away if you get any of the following symptoms during or at any time after your TRODELVY infusion: 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 passing out; chills or shaking chills (rigors); chest pain.
Nausea and vomiting can 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. Tell your HCP right away if you develop nausea or vomiting that is not controlled with the medicines prescribed for you. Your HCP may decide to decrease your dose, delay treatment, or permanently stop TRODELVY if your nausea and vomiting is severe and cannot be controlled with anti-nausea medicines. These tips may also help:
- Eat 5 to 6 small meals or snacks a day rather than 3 large meals
- Eat bland foods, such as toast and crackers
- Try eating small amounts of foods that are high in calories
- Slowly sip cool, clear liquids such as ginger ale, apple juice, broth, or tea throughout the day to stay hydrated
- Try to take deep, slow breaths or get fresh air when you begin to feel sick
- If you are vomiting, eating ice chips or frozen juice chips may help you take in fluids more easily
It’s common for treatment to leave you feeling weak and tired. Help manage your fatigue using the following tips:
- Plan time to relax and rest, and create a schedule that works for you
- Take short naps and try to get 7 to 8 hours of sleep each night
- Try to stay active but talk with your HCP before starting a new exercise routine
- Drink plenty of water and eat well
- Reduce stress by trying meditation, yoga, reading, or keeping a diary
Modification
Your HCP may decrease your dose of TRODELVY and adjust the medicines given before and after treatment to help you manage certain side effects and continue treatment if appropriate. In certain instances, your treatment with TRODELVY may need to be delayed or permanently stopped by your HCP based on the experience you have with serious side effects.
The most important things to remember:
- Your healthcare team is here to help, but they need to know what’s going on in order to understand how to best manage possible side effects
- Keep track of everything you feel and share it with your healthcare team—even if you aren’t sure whether it’s a side effect or don’t think that it’s serious
- Do not make any changes to your treatment plan or the medicines you take unless your healthcare team instructs you to do so
What is trodelvy?
important safety information
TRODELVY can cause serious side effects, including low white blood cell count and diarrhea:
TRODELVY® (sacituzumab govitecan-hziy) is a prescription medicine used to treat adults with
What is Trodelvy?
TRODELVY® (sacituzumab govitecan-hziy) is a prescription medicine used in adults to treat Triple-Negative Breast Cancer (TNBC), that cannot be removed by surgery (unresectable) and has spread to nearby tissues (locally advanced) or other parts of the body (metastatic).
- As the first treatment:
- alone when you are not a candidate for PD-1 or PD-L1 inhibitor-based therapy.
- with the medicine pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, when the tumors test positive for PD-L1.
It is not known if TRODELVY is safe and effective in children.
IMPORTANT SAFETY INFORMATION
TRODELVY can cause serious side effects, including low white blood cell count and diarrhea:
- Low white blood cell count (neutropenia) can be severe and lead to infections that can be life-threatening or cause death as early as the first cycle of treatment. Your healthcare provider should check your blood cell counts during treatment and may give a medicine to help prevent neutropenia starting in the first cycle of treatment if you have an increased risk for developing low white blood cell count with a fever (febrile neutropenia). Tell 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 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.
- Tell your healthcare provider right away the first time that you get diarrhea during treatment with TRODELVY; if you develop black or bloody stools; if you develop symptoms of dehydration, such as lightheadedness, dizziness, or faintness; if you cannot take fluids by mouth due to nausea or vomiting; or if you cannot get your diarrhea under control within 24 hours.
If you develop serious side effects, your healthcare provider may treat you with certain medicines, delay treatment, lower your dose, or permanently stop treatment with TRODELVY.
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 can be serious or life-threatening. These reactions are more common within 24 hours of receiving TRODELVY. Tell your healthcare provider right away if you get any of the following symptoms during or at any time after your TRODELVY infusion: 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 passing out; chills or shaking chills (rigors); chest pain.
Nausea and vomiting can 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. Tell your healthcare provider right away if you develop nausea or vomiting that is not controlled with the medicines prescribed for you.
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. It is not known if TRODELVY is safe in people with moderate or severe 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 breast milk 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 and may increase your risk of side effects.
The most common side effects of TRODELVY when used alone include decreased white blood cell and red blood cell counts, nausea, diarrhea, feeling tired or weak, hair loss, increased sugar levels (glucose) in the blood, constipation, vomiting, decreased protein levels (albumin) in the blood, increased alkaline phosphatase in the blood, decreased appetite, stomach pain, decreased creatinine clearance, and decreased magnesium and potassium levels in the blood.
The most common side effects of TRODELVY when used with pembrolizumab include decreased white blood cell and red blood cell counts, diarrhea, nausea, feeling tired or weak, hair loss, increased alkaline phosphatase, sugar (glucose), and liver enzyme levels in the blood, constipation, rash, decreased potassium levels in the blood, increased lactate dehydrogenase levels in the blood, vomiting, stomach pain, headache, increased eosinophil levels in the blood, and decreased protein levels (albumin) 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.
What is Trodelvy?
important safety information
TRODELVY can cause serious side effects, including low white blood cell count and diarrhea:
What is Trodelvy?
TRODELVY® (sacituzumab govitecan-hziy) is a prescription medicine used in adults to treat Hormone Receptor (HR) positive, Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer that cannot be removed by surgery (unresectable) and has spread to nearby tissues (locally advanced) or other parts of the body (metastatic), and you received hormonal-based therapy and at least 2 more therapies throughout the body (systemic) for metastatic breast cancer.
It is not known if TRODELVY is safe and effective in children.
IMPORTANT SAFETY INFORMATION
TRODELVY can cause serious side effects, including low white blood cell count and diarrhea:
- Low white blood cell count (neutropenia) can be severe and lead to infections that can be life-threatening or cause death as early as the first cycle of treatment. Your healthcare provider should check your blood cell counts during treatment and may give a medicine to help prevent neutropenia starting in the first cycle of treatment if you have an increased risk for developing low white blood cell count with a fever (febrile neutropenia). Tell 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 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.
- Tell your healthcare provider right away the first time that you get diarrhea during treatment with TRODELVY; if you develop black or bloody stools; if you develop symptoms of dehydration, such as lightheadedness, dizziness, or faintness; if you cannot take fluids by mouth due to nausea or vomiting; or if you cannot get your diarrhea under control within 24 hours.
If you develop serious side effects, your healthcare provider may treat you with certain medicines, delay treatment, lower your dose, or permanently stop treatment with TRODELVY.
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 can be serious or life-threatening. These reactions are more common within 24 hours of receiving TRODELVY. Tell your healthcare provider right away if you get any of the following symptoms during or at any time after your TRODELVY infusion: 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 passing out; chills or shaking chills (rigors); chest pain.
Nausea and vomiting can 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. Tell your healthcare provider right away if you develop nausea or vomiting that is not controlled with the medicines prescribed for you.
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. It is not known if TRODELVY is safe in people with moderate or severe 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 breast milk 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 and may increase your risk of side effects.
The most common side effects of TRODELVY when used alone include decreased white blood cell and red blood cell counts, nausea, diarrhea, feeling tired or weak, hair loss, increased sugar levels (glucose) in the blood, constipation, vomiting, decreased protein levels (albumin) in the blood, increased alkaline phosphatase in the blood, decreased appetite, stomach pain, decreased creatinine clearance, and decreased magnesium and potassium levels 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 see Important Facts about TRODELVY, including Important Warning.