Pronunciation: Troh-DELL-vee
Generic name: sacituzumab govitecan-hziy
Dosage form: injection for intravenous infusion
Drug class: Miscellaneous antineoplastics

Medically reviewed by Melisa Puckey, BPharm. Last updated on Oct 20, 2024.

What is Trodelvy?

Trodelvy is a targeted anticancer treatment used to treat types of bladder cancer and breast cancer that are locally advanced or have spread to other parts of the body (metastatic). Trodelvy may help increase the length of time before your cancer progresses and increase your life expectancy. Trodelvy works by targeting and binding to a protein (Trop-2) on the cancer cells and then delivering an anticancer medicine directly into the cancer cells. This kills the cancer cells, so there is decreased tumor growth, and may cause fewer side effects.

Trodelvy (sacituzumab govitecan-hziy) is given as an intravenous infusion, which takes 3 hours for the first dose, and then the next doses take only 1 to 2 hours.

Trodelvy FDA approval was originally received on April 22, 2020. Now, Trodelvy FDA approval is for metastatic urothelial cancer (MUC), metastatic triple-negative breast cancer (mTNBC), and HR+/HER2- metastatic breast cancer in certain adult patients.

Trodelvy may be used to treat adults with the following cancers that have spread (metastasized) or cannot be removed by surgery:

• triple-negative breast cancer (negative for estrogen and progesterone hormone receptors and HER2 [TNBC]) who have received at least 2 prior treatments, including at least one for metastatic disease.
• hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer who have previously received endocrine therapy and at least 2 additional treatments for metastatic disease
• bladder cancer and cancers of the urinary tract who have received a platinum-containing chemotherapy medicine and an immunotherapy medicine. Bladder cancer and cancers of the urinary tract is also called metastatic urothelial cancer (MUC). Continued FDA approval for MUC may be dependent on confirmatory clinical trials showing a benefit.

How does Trodelvy work?

Trodelvy mechanism of action (MOA) is as a Trop-2-directed antibody-drug conjugate (ADC) . 

Trodelvy works differently than traditional chemotherapy as it delivers the anticancer medicine directly into the cancer cells. Many breast cancers and bladder cancers have a large number of proteins called Trop-2 on the outside of the cancer cells, which Trodelvy can target. Trodelvy is a medicine that has two active sections: the antibody and the anticancer medicine. The antibody section finds and binds to a protein (Trop-2 ) on the cancer cells, and then the anticancer medicine (SN-38) is delivered directly to the cancer cells, which causes the cancer cells to die and slows the progression of cancer. 

Trodelvy lung cancer clinical trials by Gilead

Trodelvy has been studied for lung cancer in the Phase 3 EVOKE-01 study, which evaluated Trodelvy vs. docetaxel in patients with metastatic or advanced non-small cell lung cancer (NSCLC) that had progressed on or after platinum-based chemotherapy and checkpoint inhibitor therapy.  On January 22, 2024, Gilead announced the trial did not meet its primary endpoint of overall survival (OS) in previously treated metastatic NSCLC.

Trodelvy side effects

Common Trodelvy side effects

Common Trodelvy side effects are hair loss (alopecia), diarrhea, nausea or vomiting, stomach pain, loss of appetite, constipation, low blood cell counts, high blood sugar hyperglycemia), abnormal blood tests, abnormal liver or kidney function tests and feeling tired or weak. These common Trodelvy side effects occurred in 25 % or more of patients.

Serious Trodelvy side effects

Trodelvy side effect - infusion-related reactions and allergic reactions

This infusion can cause severe or life-threatening allergic reactions. Get emergency medical help if you have signs of an allergic reaction such as hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection or within 24 hours afterward. Tell your medical caregivers if you feel dizzy, light-headed, itchy, sweaty, or have a fever, chills, trouble breathing, or swelling in your face or throat.

Trodelvy side effect - infection 

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

• pain or burning when you urinate;
• low red blood cells (anemia) - pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
• low white blood cell counts - fever, mouth sores, skin sores, sore throat, cough, trouble breathing.

Tips to reduce the risk of infection:

• Remember to wash your hands often with soap and warm water and dry them well
• Try to avoid large groups of people and stay away from people who are sick
• Have good food hygiene, wash your hands before preparing or eating food, and wash raw fruits and vegetables before eating them

Trodelvy side effect - diarrhea

This medicine can cause severe diarrhea. Severe diarrhea can cause a loss of too much body fluid (dehydration) and lead to kidney problems. Tell your doctor right away if you have:

• diarrhea (the first time it occurs);
• diarrhea lasting longer than 24 hours (even if you use anti-diarrhea medicine);
• black or bloody stools;
• severe or ongoing vomiting, especially if you can't keep liquids down; or
• a light-headed feeling, like you might pass out.

Tips that may help control mild diarrhea:

• Drink small amount of cool, clear liquids throughout the day to help keep you hydrated
• Eat small meals often, try bland foods that are low in fiber including bananas, white rice, and toast
• Avoid drinking alcohol and caffeine containing drinks.
• Avoid greasy or spicy foods, and limit dairy products and raw vegetables.
•  

Trodelvy side effects - nausea and vomiting 

Trodelvy can cause nausea and vomiting that can sometimes be severe. You will be given antinausea medication before your infusion and also to take home with you to help prevent nausea and vomiting. Contact your healthcare provider immediately if you have nausea or vomiting that is not beng controlled with the medicines you have been prescribed. Your healthcare provider may reduce your Trodelvy dose or stop it if your nausea and vomiting is severe and is not controlled with anti-nausea medicines. 

Tips that may help control mild nausea or vomiting.

• Eat more small meals or snacks a day rather than large meals
• Eat bland foods, such as rice, toast and crackers
• Eat small amounts of foods that are high in calories
• Drink small sips 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
• Ice chips or frozen juice chips may help you take in fluids more easily

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Warnings

Serious hypersensitivity and infusion-related reactions, including anaphylaxis, can occur with Trodelvy. Do not receive this infusion if you have had a severe allergic reaction to the active ingredient sacituzumab govitecan-hziy or any of the inactive ingredients in the injection. There is a full list of ingredients at the bottom of this document.

Diarrhea (Severe): If you have diarrhea, you should be given fluid and electrolytes as needed. At the onset of diarrhea, you will be evaluated for infectious causes, and if negative, you will be promptly given a diarrhea medicine (loperamide). If severe diarrhea occurs, Trodelvy will be stopped until diarrhea has resolved to ≤ Grade 1, and subsequent doses will be reduced.

Neutropenia (severe or life-threatening). Neutropenia is a low level of neutrophils, a type of white blood cell. If your absolute neutrophil count is below 1500/mm3 or you have neutropenic fever, your Trodelvy treatment will be stopped. Your blood cell counts will be monitored periodically during treatment. You may be given granulocyte colony-stimulating factor (G-CSF) to help your white cell levels recover. Antiinfective treatment will be given without delay if you have febrile neutropenia.

Nausea and vomiting. This medicine may cause nausea and vomiting, which can be severe. Your healthcare provider should prescribe antiemetic preventive treatment and withhold Trodelvy for patients with Grade 3 nausea or Grade 3-4 vomiting at the time of treatment.

Reduced UGT1A1 activity. Patients with reduced UGT1A1 activity are at increased risk of side effects of Trodelvy, such as low blood cell counts such as neutropenia (low levels of neutrophils – a type of white blood cell), febrile neutropenia, and anemia (low levels red blood cells).

Fetal harm. Trodelvy can cause fetal harm. Women of childbearing potential should use adequate contraception during treatment.

It is not known if Trodelvy is safe and effective in people with moderate or severe liver problems or in children.

Before taking this medicine

You should not be treated with Trodelvy if you have ever had a severe allergic reaction to it.

Before taking having this medicine tell your doctor if you have ever had:

• liver disease; or
• if you've been told that you carry a gene called UGT1A1*28, which may increase your risk of getting infections while using this medicine.

Pregnancy

Trodelvy can harm an unborn baby if the mother or the father is using it.

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 6 months after your last dose.
• It may be harder for you to get pregnant while you are using this medicine. You should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.
• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.
• Tell your doctor right away if a pregnancy occurs.

Breastfeeding

Do not breastfeed while using this medicine, and for at least 1 month after your last dose.

How is Trodelvy given?

Your healthcare provider will give Trodelvy into your vein through an intravenous (IV) line, the infusion will initially be given over 3 hours. If you tolerate the first dose well, future doses may be given over 1 to 2 hours.

• Trodelvy is given 1 time each week, on Day 1 and Day 8 of a 21-day treatment cycle.
• Before each dose, you will receive medicines to help prevent infusion reactions and nausea and vomiting.
• You will be monitored for side effects during and for at least 30 minutes after you receive each infusion of this medication.
• Your healthcare provider may slow down or temporarily stop your infusion if you have an infusion-related reaction, or permanently stop this medication if you have a life-threatening infusion-related reaction.

This medicine commonly causes diarrhea. Severe diarrhea can lead to dehydration, which may require medical treatment. Tell your doctor right away the first time you have diarrhea while receiving this medicine.

You may get infections more easily, even serious or fatal infections. You may need frequent medical tests, and your cancer treatments may be delayed based on the results.

Your doctor will determine how long to treat you with this medicine.

Trodelvy dosing information

Usual adult dose of Trodelvy breast cancer

Dose: 10 mg/kg IV once a week on Days 1 and 8 of 21-day treatment cycles
Maximum dose: 10 mg/kg per dose
Duration of therapy: Until disease progression or unacceptable toxicity
Uses:
For the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received 2 or more prior systemic therapies, at least 1 of them for metastatic disease.
For the treatment of patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (immunohistochemistry [IHC] 0, IHC 1+, or IHC 2+/in situ hybridization [ISH]-) breast cancer who have received endocrine-based therapy and at least 2 additional systemic therapies in the metastatic setting.

Usual adult dose for Trodelvy bladder cancer and urinary tract cancer

Dose: 10 mg/kg IV once a week on Days 1 and 8 of 21-day treatment cycles
Maximum dose: 10 mg/kg per dose
Duration of therapy: Until disease progression or unacceptable toxicity
Use: For the treatment of patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.

General dosing information

Do NOT substitute Trodelvy for or use with other drugs containing irinotecan or its active metabolite SN-38.
For intravenous infusion only. Do not administer as an intravenous push or bolus.

Related/similar drugs

Verzenio, Keytruda, Arimidex, pembrolizumab, Femara, Xeloda, Ibrance, nivolumab, Herceptin, Opdivo

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your infusion

What happens if I overdose?

In a medical setting an overdose would be treated quickly

Interactions

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.

• Concomitant administration of UGT1A1 inhibitors such as flunitrazepam or propofol may increase the incidence of side effects due to a potential increase in systemic exposure to SN-38. Avoid co-administration.
• Exposure to SN-38 may be reduced in patients concomitantly receiving UGT1A1 Inducers such as phenytoin and phenobarbital. Avoid co-administration.

This list is not complete. Many other drugs may interact with this medicine including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Trodelvy Package Insert

Review the Trodelvy Package Insert for more detailed information about this medicine. 

The Trodelvy Package Insert contains more detailed information including warnings, indications, dosage, contraindications, adverse reactions, clinical trial results, drug interactions, clinical, and more.  It also contains the Patient Information leaflet which is a summary of Trodelvy information for the patient. 

The Package Insert is sometimes called Trodelvy Prescribing Information (PI) or Trodelvy label.

Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

Storage

Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect them from light until the time of reconstitution. Do not freeze.

Trodelvy is a hazardous drug. Follow applicable special handling and disposal procedures.

Ingredients

Active ingredient: sacituzumab govitecan-hziy

Inactive ingredients: 2-(N-morpholino) ethane sulfonic acid (MES), polysorbate 80, and trehalose dihydrate

Manufactured by: Gilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA 94404, USA

Manufacturer

Trodelvy Gilead Sciences, Inc. 333 Lakeside Dr., Foster City, CA 94404, USA

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