What is 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.
What is Trodelvy used for?
Trodelvy is a prescription medicine used to treat adults with:
- a type of breast cancer that is estrogen and progesterone hormone receptor (HR) negative, and human epidermal growth factor receptor 2 (HER2)-negative (also called triple-negative breast cancer). Trodelvy may be used:
- when your breast cancer has spread to other parts of the body (metastatic) or cannot be removed by surgery, and
- if you previously received two or more prior treatments, including at least one treatment for metastatic disease.
- bladder cancer and cancers of the urinary tract that have spread or cannot be removed by surgery. Trodelvy may be used if you have:
- received a platinum-containing chemotherapy medicine and
- also received an immunotherapy medicine.
It is not known if this medication is safe and effective in people with moderate or severe liver problems.
It is not known if this medication is safe and effective in children.
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:
- 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
Who should not receive Trodelvy?
Do not receive Trodelvy if you have had a severe allergic reaction to Trodelvy. Ask your healthcare provider if you are not sure.
What should I tell my doctor before receiving Trodelvy?
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 uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28. People who carry this gene have an increased risk of getting side effects with this medication, especially low white blood cell counts, a fever while your white blood cell count is low, and low red blood cell counts. See 'Important Information' above.
- have liver problems.
How should I receive Trodelvy?
- Your healthcare provider will give you Trodelvy into your vein through an intravenous (IV) line.
- Trodelvy is given 1 time each week, on Day 1 and on Day 8 of a 21-day treatment cycle.
- You will receive the first dose of this medication over 3 hours. If you tolerate the first dose well, future doses may be given over 1 to 2 hours.
- 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.
- Your healthcare provider will decide how long you will continue to receive Trodelvy.
What happens if I miss a dose?
If you miss or forget an appointment for Trodelvy, call your doctor or infusion center right away to reschedule your infusion. It is important not to miss a planned appointment. Do not skip an appointment.
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.
What are the side effects of Trodelvy?
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
- skin rash, itching, or flushing of your skin
- 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
- 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.
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.
Pregnancy and breastfeeding
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.
- Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of reconstitution. Do not freeze.
- Trofelvy is a hazardous drug. Follow applicable special handling and disposal procedures.
What are the ingredients in Trodelvy?
Active ingredient: sacituzumab govitecan-hziy
Inactive ingredients: 2-(N-morpholino) ethane sulfonic acid (MES), polysorbate 80 and trehalose dihydrate
Trodelvy is manufactured by Gilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA 94404, USA.
How does Trodelvy work?
Trodelvy (sacituzumab govitecan-hziy) works by preventing repair of DNA damage in the cancer cell which leads to cell death. It is a Trop-2-directed antibody and topoisomerase inhibitor conjugate. It binds to the antigen Trop-2, a protein found in many cancers, and delivers the anticancer medicine into the tumor. Trop-2 biomarker testing is not required for use with Trodelvy.
Does Trodelvy cause hair loss?
Hair loss (alopecia) is one of the most common side effects associated with Trodelvy and may happen soon after you start treatment. In studies in patients being treated for metastatic triple negative breast cancer (mTNBC), alopecia was reported in 47% of patients compared to 16% of patients receiving a single-agent chemotherapy drug (such as eribulin, capecitabine, gemcitabine or vinorelbine).
Trodelvy (sacituzumab govitecan-hziy) is effective for the treatment of triple-negative breast cancers and urothelial cancers in patients with a poor prognosis and limited treatment options who have already been treated with other therapies and who have advanced tumors or tumors that have spread.
About 30 percent of patients treated with Trodelvy have a complete or partial response to treatment meaning that their tumors shrink in size. It help some patients gain extra months of life during which time there cancer does not get worse. It also helps some patients live for months longer than they might have otherwise. Continue reading
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