Trodelvy – Sacituzumab govitecan uses, dose and side effects


200 mg Powder for concentrate for infusion solution, solution
Sacituzumab govitecan

What Trodelvy is and what it is used for

Trodelvy is a cancer medicine that contains the active substance sacituzumab govitecan. Part of the drug is a monoclonal antibody that specifically attaches to a protein on the surface of certain breast cancer cells called Trop-2. The other active part of Trodelvy is SN-38, a substance that can kill cancer cells. Once the drug is attached to cancer cells, SN-38 enters the cancer cells and kills them, helping to fight your cancer.

Trodelvy is used to treat a type of breast cancer in adults called triple-negative breast cancer.

The medicine is used when it is not possible to remove cancer with surgery because cancer has spread to areas outside the breast (locally advanced) or has spread to other places in the body (metastatic). Trodelvy must not be given until the patient has received at least two other treatments for their cancer, including at least one of them for locally advanced cancer or metastatic cancer.

Talk to your doctor or nurse if you have any questions about how Trodelvy works or why this medicine has been prescribed for you.

What you need to know before getting Trodelvy

Do not use Trodelvy

You must not be given Trodelvy if you are allergic to sacituzumab govitecan or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, consult your doctor.

Warnings and precautions

Infusion-related reactions

Trodelvy is given as a drip in a vein. Some people may experience infusion-related reactions which can be serious or life-threatening. Seek emergency medical attention if you experience any of the following signs or symptoms of infusion-related reactions:

  • itching
  • sudden onset of a pale red rash or areas of swelling and redness
  • fever
  • sudden, violent shaking accompanied by a feeling of coldness
  • abnormal sweating
  • difficulty breathing and wheezing
  • chest pain, palpitations

Your doctor may give you medicine before you receive Trodelvy to relieve symptoms. During each infusion and for 30 minutes afterward, you will be closely monitored for these signs and symptoms of infusion-related reactions. Your doctor will slow down the infusion rate or stop the infusion if you develop a serious infusion-related reaction.


This medicine can cause neutropenia, a condition where there are too few neutrophils in the blood, which increases the risk of infection. These infections can be serious and life-threatening. Seek emergency medical attention if you develop any of the following signs or symptoms of neutropenia or infections:

  • fever (a temperature of 38.5°C or higher)
  • chills or sweating
  • sore throat, mouth sores, or toothache
  • stomach pain
  • pain near anus
  • pain or burning when urinating or if you urinate more often than usual
  • diarrhea or ulcers around the anus
  • cough or shortness of breath

Your doctor will take blood tests to check the levels of neutrophils in your blood. You will not be given Trodelvy if your neutrophils are below a certain value on day 1 or day 8 of any treatment cycle.

Your doctor will adjust the amount of medicine you receive if you have severe neutropenia.


Seek emergency medical attention if you suffer from severe diarrhea while receiving Trodelvy.

Your Trodelvy treatment will be delayed until your diarrhea has improved. You will be given loperamide to treat diarrhea, as long as you do not have an infection. If appropriate, you will also be given fluids.

Your doctor may also give medicine, such as atropine, to help with stomach cramps, diarrhea, and excessive saliva in the mouth before the next infusion of treatment.

Nausea and vomiting

This medicine may cause nausea and vomiting. Seek emergency medical attention if you suffer from severe nausea and vomiting while receiving Trodelvy.

The doctor will give you some medicines before the cancer treatment and between the infusions to relieve nausea and vomiting. You will not receive Trodelvy if you experience severe nausea and vomiting, but will only receive Trodelvy when your symptoms are under control.

Patients who have the UGT1A1*28 gene

Some patients are more likely to have certain side effects from the drug because of their genetic make-up. In people who have the UGT1A1*28 gene, the body breaks down the drug more slowly. This means that they are more likely to have certain side effects (such as neutropenia with or without fever and low red blood cell counts (anemia)) than those who do not have the gene. These patients will be followed up closely by their doctors.

Talk to your doctor or nurse before you start receiving Trodelvy if you:

  • have liver problems
  • have kidney problems
  • are a woman of childbearing potential (see “Pregnancy”, “Contraceptives for men and women” and “Breastfeeding”)
  • taking medicines for the treatment of medical conditions (see “Other medicines and Trodelvy”)
  • ma experienced any problems after receiving your infusion in the past?

While you receive Trodelvy, your doctor will monitor you closely for side effects. If you get any serious side effects, your doctor may give you other medicines to treat these side effects, he/she may change how much Trodelvy you receive or may stop giving you Trodelvy altogether.

See section 4 for a list of all possible side effects related to Trodelvy.

Children and young people

Trodelvy should not be given to children and adolescents under the age of 18 because there is no information on how it works in this age group.

Other medicines and Trodelvy

Tell your doctor if you are taking, have recently taken, or might be taking other medicines.

Some medicines can affect how Trodelvy works and can increase the level of Trodelvy’s active substance in your blood, which increases the risk of side effects. They are:

  • propofol, which is given as an anesthetic during surgery.
  • ketoconazole, which is used to treat fungal infections.
  • tyrosine kinase inhibitors, which are used to treat cancer (medicines with names ending in -nib).

Certain medicines can lower the level of Trodelvy’s active substance in your blood, making it less effective:

  • carbamazepine or phenytoin, which is used to treat epilepsy.
  • rifampicin, which is used to treat tuberculosis.
  • ritonavir or tipranavir, which is used for treatment against HIV.

Pregnancy, breastfeeding, and fertility


Trodelvy should not be used during pregnancy as it may harm the baby. Tell your doctor immediately if you are pregnant, think you may be pregnant, or are planning to have a baby.

Contraceptives for men and women

Women who could become pregnant must use effective contraception during treatment with Trodelvy and for at least 6 months after the last dose of Trodelvy.

Men who have female partners who could become pregnant must use effective contraception during treatment and for 3 months after the last dose of Trodelvy.


Do not breast-feed during treatment with Trodelvy and for 1 month after the last dose. It is unknown if this medicine passes into breast milk and can affect the baby.

Driving ability and use of machinery

Trodelvy can affect your ability to drive and use machines, e.g. a feeling of dizziness, or fatigue. You should therefore be careful when driving, and using tools or machinery after receiving Trodelvy.

How to get Trodelvy

You will only be given Trodelvy by your doctor or a nurse experienced in the use of cancer treatments.

Your doctor or nurse who has specialized in your care must confirm that you can take this medicine by taking a blobreastfeedre treatment.

Medicines are given before treatment with Trodelvy

You will be given some medicines before you receive Trodelvy to help counteract infusion-related reactions and possible nausea and vomiting. Your doctor will decide which medicines you may need and how much to take.

How much Trodelvy you will get

Treatment for your cancer is repeated in cycles of 21 days (3 weeks). The recommended dose of Trodelvy is 10 mg for each kg of your body weight at the start of each cycle (Day 1 of each cycle) and again one week later (Day 8 of each cycle).

How you will receive your medicine

A doctor or nurse will give the medicine via an intravenous infusion (drip into the vein).

First infusion one: You will receive your first infusion of the medicine over 3 hours.

Second infusion and subsequent infusions: You will receive other infusions over 1 to 2 hours if your first infusion was uneventful.

Your doctor or nurse will monitor you for signs and symptoms of infusion-related reactions during each infusion and 30 minutes after each infusion.

Infusion-related reactions

Your doctor will slow the infusion rate of your medicine if you develop an infusion-related reaction. Drug treatment will be discontinued if the infusion-related reaction is life-threatening. See section 2.

Dose of the medicine when you experience side effects

Your doctor may change or stop your dose if you experience certain side effects. See section 4.

If you have been given too much Trodelvy

Because your doctor or other appropriately trained staff will give you the infusion, it is unlikely that you will get an overdose. If you accidentally take too much of the medicine, your doctor will monitor you and give additional treatment if necessary.

If a dose of Trodelvy is missed

If you forget or miss your appointment, call the doctor or treatment center and book a new appointment as soon as possible. Don’t wait until your next scheduled visit. For the treatment to be fully effective, it is very important not to miss a dose.

If you stop treatment with Trodelvy

You should not stop treatment prematurely without first talking to your doctor.

For the treatment with Trodelvy against breast cancer, several treatments are usually required. The number of infusions you receive depends on how you respond to the treatment. Therefore, you should continue with Trodelvy until your doctor decides that Trodelvy should be discontinued, even if you notice that your symptoms subside. If the treatment is stopped too soon, the symptoms may return.

If you have any further questions about this medicine, ask your doctor or nurse.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects are

Seek emergency medical attention if you experience any of the following very common serious side effects (which may affect more than 1 in 10 people) :

  • Low white blood cell count ( neutropenia ), can cause the following signs and symptoms:
    • fever, which is a body temperature of 38.5°C or higher: this is called febrile neutropenia
    • chills or sweating
    • sore throat, mouth sores, or toothache
    • stomach pain
    • pain near the anus or sores around the anus
    • pain or burning when urinating or frequent urination
    • diarrhea
    • cough or shortness of breath
  • Diarrhea (even without other signs)
  • Hypersensitivity reactions (including infusion-related reactions), may cause the following signs and symptoms:
    • swelling of the lips, tongue, eyes, throat, or face
    • swelling or raised, itchy, red rashes on the skin
    • outbreaks of pale red rashes or areas of swelling and redness that appear suddenly
    • fever
    • a sudden attack of violent shaking accompanied by a sensation of coldness
    • abnormal sweating
    • wheezing, tightness in the chest or throat, shortness of breath, dizziness, feeling faint, shortness of breath
    • chest pain, palpitations
  • Feeling sick (nausea), vomiting

Other possible side effects ar

Other side effects are listed below. If any of these side effects become serious, talk to your doctor right away.

Very common (may affect more than 1 in 10 people)

  • burning sensation when urinating and frequent and urgent need to urinate
  • cough, sore throat, runny nose, headache, and sneezing
  • anemia
  • the low number of white blood cells ( lymphocytes or leukocytes )
  • loss of appetite
  • low level of potassium or magnesium in the blood
  • high blood sugar level
  • sleeping problems
  • feelings of dizziness
  • constipation, stomach ache
  • hair loss, rash, general itching
  • back pain, joint pain
  • fatigue
  • weight loss

Common (may affect up to 1 in 10 people)

  • stuffy nose
  • pain in the free, wheezing
  • flu-like symptoms, herpes infection in the mouth
  • low level of phosphate or calcium in the blood
  • anxiety
  • altered taste perception
  • epistaxis, shortness of breath on exertion, phlegm cough
  • inflammation and soreness in the mouth, pain in the upper stomach, regurgitation, bloated stomach
  • dry skin
  • muscle pain in the chest, muscle spasms
  • blood in the urine
  • overindulge
  • the increased amount of an enzyme called alkaline phosphatase and abnormal blood test values ​​about coagulation a.

How Trodelvy should be stored

Trodelvy is kept by healthcare professionals at the hospital or clinic where you are being treated. The storage instructions are as follows:

  • Keep this medicine out of the sight and reach of children.
  • Use before the expiry date which is stated on the outer carton and vial after EXP. The expiration date is the last day of the specified month.
  • Store in a refrigerator (2 °C‑8 °C). Do not freeze.
  • Store the vial in the outer carton. Light sensitive.
  • After preparation and dilution, the infusion bag containing the diluted solution can be stored in a refrigerator (2°C-8°C) for up to 24 hours protected from light if not to be used immediately.
  • Do not use this medicine if you notice that the prepared solution is cloudy or discolored.

Trodelvy is a chemotherapy agent . Applicable special handling and disposal procedures must be followed.

Contents of the packaging and other information

Contents declaration

The active substance is sacituzumab govitecan. One vial of powder contains 200 mg of sacituzumab govitecan. After reconstitution , one ml of solution contains 10 mg of sacituzumab govitecan.

 Other ingredients are 2-(N-morpholino) ethanesulfonic acid (MES), polysorbate 80 and trehalose dihydrate.

Appearance and package sizes of the medicine

The medicine is an off-white to yellowish powder to concentrate for infusion , solution supplied in a glass vial . Each pack contains one vial .

Marketing authorization holder and manufacturer

Marketing Authorisation Holder

Gilead Sciences Ireland UC


County Cork, T45 DP77



Gilead Sciences Ireland UC

IDA Business and Technology Park


County Cork, T45 DP77


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