Trodelvy

Generic name: Sacituzumab Govitecan-hziy
Dosage form: intravenous (infusion) injection
Drug class: Miscellaneous antineoplastics

Usage of Trodelvy

Trodelvy (sacituzumab govitecan-hziy) is a targeted-chemotherapy drug used to treat certain types of breast and urothelial cancers (a type of bladder cancer).

Trodelvy is an antibody-drug conjugate containing an antibody called sacituzumab linked to govitecan (SN-38), a chemotherapy drug.

Sacituzumab targets and attaches to a protein called Trop-2, which is overexpressed on the surface of certain cancer cells. The antibody-drug conjugate is then internalized into the cancer cell where the linker between the antibody and drug is broken by a process called hydrolysis, releasing the chemotherapeutic govitecan into the cancer cells.

Govitecan interacts with topoisomerase I within the cancer cell. Topoisomerase I is an enzyme that helps prevent problems with DNA that may block cell growth. Govitecan is a topoisomerase I inhibitor that works by preventing topoisomerase from binding together single strand breaks in DNA. This results in DNA damage within the cancer cells and leads to cell death.

Trodelvy was approved by the US Food and Drug Administration (FDA) in 2020.

Trodelvy side effects

Trodelvy can cause serious side effects, including:

See 'Important information' above.

Allergic and infusion-related reactions. Serious allergic reactions can happen during treatment with this medication, including life-threatening allergic reactions, and infusion-related reactions. Tell your healthcare provider or nurse right away if you get any of the following symptoms of an allergic or infusion-related reaction during your infusion of Trodelvy or within 24 hours after you receive a dose:

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

chills or shaking chills (rigors)

Nausea and vomiting. Nausea and vomiting are common with Trodelvy and can sometimes be severe. Before each dose of this medication you will receive medicines to help prevent nausea and vomiting. You should be given medicines to take home with you, along with instructions about how to take them to help prevent and treat any nausea and vomiting after you receive Trodelvy. 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 this medication if your nausea and vomiting is severe and cannot be controlled with anti-nausea medicines.

The most common side effects of Trodelvy include:

feeling tired or weak

hair loss

decreased red blood cell count

constipation

decreased appetite

rash. See 'Allergic and infusion-related reactions' above.

stomach-area (abdominal) pain or discomfort

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.

These are not all of the possible side effects of Trodelvy.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Trodelvy

Tell your doctor if you 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 this medication.

Females who can become pregnant should use effective birth control during treatment and for 6 months after your last dose of this medication. Talk to your healthcare provider about birth control choices that may be right for you during this time.

Males with a female partner who can become pregnant should use effective birth control during treatment and for 3 months after your last dose.

Tell your healthcare provider right away if you or your partner become pregnant during treatment with Trodelvy.

Tell your doctor if you 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.

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How to use Trodelvy

The recommended dose of Trodelvy is 10 mg/kg once weekly on Days 1 and 8 of continuous 21-day treatment cycles.

See the Full Prescribing information for further details about Trodelvy dosing.

Warnings

Trodelvy can cause serious side effects, including:

Low white blood cell count (neutropenia). Low white blood cell counts are common with this medication 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 of Trodelvy, give you a medicine to help prevent low blood cell count with future doses, or in some cases may stop treatment with this medication. 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:

fever

chills

cough

shortness of breath

burning or pain when you urinate

Severe diarrhea. Diarrhea is common with this medication 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 this medication 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 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

What other drugs will affect 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.

Disclaimer

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