Patient Medication Information: uses, side effects, how to take - Trodelvy

Serious Warnings and Precautions

Low white blood cell count (neutropenia). 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 mainly early on in treatment. Your healthcare provider should check your blood cell counts prior to treatment with Trodelvy and prior to each dose. Your healthcare provider may give you a medicine to help prevent low white blood cell count starting in the first cycle of treatment if you have a higher risk of developing low white blood cell count with a fever (febrile neutropenia). 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 treat low white blood cell count, or in some cases may stop Trodelvy. 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 Trodelvy 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. Your healthcare provider may decrease your dose or stop Trodelvy 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 is Trodelvy used for:

Trodelvy is a prescription medicine used to treat adults 18 years or older 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), and
- that has spread to other parts of the body or cannot be removed by surgery (metastatic), and
- who previously received two or more prior therapies, at least one of them for metastatic disease.
hormone receptor-positive and HER2-negative, and
- metastatic, and
- who previously received endocrine therapy and at least two additional systemic therapies for metastatic disease.

How Trodelvy works:

Trodelvy consists of a type of medicine called a “monoclonal antibody” linked to a type of medicine called a “topoisomerase inhibitor”. Together, these medicines may slow down the growth and spread of your cancer.

The ingredients in Trodelvy are:

Medicinal ingredients: sacituzumab govitecan

Non-medicinal ingredients: 2-(N-morpholino) ethane sulfonic acid, polysorbate 80, trehalose dihydrate

Trodelvy comes in the following dosage forms:

180 mg lyophilized powder in single-dose vials for solution for injection

Do not use Trodelvy if:

You are allergic to sacituzumab govitecan or any of the other ingredients in Trodelvy.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Trodelvy. Talk about any health conditions or problems you may have, including 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 Trodelvy.
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.
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.
Tell your healthcare provider right away if you or your partner become pregnant during treatment with Trodelvy.
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 of Trodelvy.
Have been told that you carry a gene for uridine diphosphate-glucuronosyl transferase A1 (UGT1A1)*28. People who carry this gene have an increased risk of getting side effects with Trodelvy, especially low white blood cell counts.
Have liver problems.
Are younger than 18 years of age. It is not known if Trodelvy is safe and effective in children.

Other warnings you should know about:

Nausea and vomiting may occur with Trodelvy. Your healthcare provider may decrease your dose or stop Trodelvy if your nausea or diarrhea are severe and cannot be controlled with medication.
You should know that Trodelvy may affect your fertility. Talk to your healthcare practitioner if you are planning on having children.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements, or alternative medicines.

The following may interact with Trodelvy:

UGT1A1 inhibitors such as atazanavir sulfate.
UGT1A1 inducers such as efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, rifampin.

How to take 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 Trodelvy over 3 hours. If you tolerate the first dose well, future doses may be given over 1 to 2 hours.
Before each dose of Trodelvy, you will receive medicines to help prevent infusion reactions, nausea, and vomiting.
You will be monitored for side effects during and for at least 30 minutes after you receive each infusion of Trodelvy.
Your healthcare provider may slow down or temporarily stop your infusion of Trodelvy if you have an infusion-related reaction, or permanently stop Trodelvy if you have a life-threatening infusion-related reaction.
Your healthcare provider will decide how long you will continue to receive Trodelvy.

Usual dose:

10 mg/kg given 1 time each week, on Day 1 and on Day 8 of a 21-day treatment cycle.

Overdose:

If you think you, or a person you are caring for, have taken too much Trodelvy, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed Dose:

If you miss any appointments, call your healthcare professional as soon as possible to reschedule your appointment.

Possible side effects from using Trodelvy:

These are not all the possible side effects you may feel when taking Trodelvy. If you experience any side effects not listed here, contact your healthcare professional.

Urinary tract infection which may cause frequent and painful urination
Pain or burning sensation when urinating
Piles (swollen, inflamed veins around the anus)
Upper respiratory tract infection
Inflammation caused by a strong immune response to a severe infection throughout the body
Fungal infection like a yeast infection
Hair loss
Feeling tired
Weight loss
Decreased red blood cell count
Decreased level of white blood cells
Decreased number of a type of blood cell that helps to clot blood (platelet), causing bruising and/or bleeding
Constipation
Decreased appetite
Stomach-area (abdominal) pain, swelling or discomfort
Inflammation of the mouth and lips
Indigestion or excess passing of gas
Digestive disease in which stomach acid irritates the food pipe lining
Inflammation of the lining of the large intestine or stomach, which may occur with a decreased level of white blood cells called neutrophils
Increased saliva or dry mouth
Rash, general itching, dry skin, changes in skin colour or nails
Small, raised, acne-like bumps usually on the face, scalp, chest, or upper back
Feeling sick
Trouble with memory or feeling confused
Hot flush
Difficulty sleeping
Low blood level of albumin, potassium, phosphate, magnesium, sodium or calcium
High blood level of glucose, calcium, lactate dehydrogenase, gamma-glutamyltransferase, or alkaline phosphatase (a liver or bone enzyme)
Dehydration (when your body does not have as much water and fluid as it should)
Headache
Feeling dizzy or feeling of spinning or whirling
Tremor
Tingling, prickling or decreased sensation often in the arms, hands, legs, or feet
Swelling or pain in the arms or legs
Pain including bone pain, joint pain, back pain, mouth pain, or skin pain
Muscle spasms
Dry eye, watery eyes, or blurred vision
Change in sense of taste
Change in voice
Bleeding from the nose
Shortness of breath, cough, sore throat, runny nose, dry nose, or sneezing
Low or high blood pressure
Palpitations
Increased QT interval on electrocardiogram, which may be a sign of a heart problem
Increase in an enzyme called alkaline phosphatase, which may be a sign of a bone or liver problem
Increase in an enzyme called alanine aminotransferase or aspartate aminotransferase, which may be a sign of a liver problem
Increase in blood creatinine or excess protein in urine, which may be a sign of a kidney problem

Serious side effects and what to do about them

Frequency/Side Effect/Symptom	Talk to your healthcare professional immediately	Stop taking drug and get immediate medical help
Only if severe	In all cases
VERY COMMON
Neutropenia: Fever Chills Other signs of infection		✔
Diarrhea: The first time you experience diarrhea during treatment Black or bloody stools Symptoms of dehydration (feeling light-headed, dizzy, or faint) Inability to take fluids by mouth due to nausea or vomiting Unable to get diarrhea under control within 24 hours		✔
Uncontrolled nausea or vomiting		✔
Hypersensitivity (serious infusion reaction or anaphylaxis): Swelling of your face, lips, tongue, or throat Hives Skin rash or flushing of your skin Difficulty breathing or wheezing Light-headedness, dizziness, feeling faint, or passing out Chills or shaking chills (rigors) Fever			✔
COMMON
Pneumonia (an infection of the lungs): Fever Chills Increase in sputum production, change in sputum colour Cough or difficulty breathing		✔

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store vials in a refrigerator at 2°C to 8°C. Do not freeze.
Store in the original carton to protect from light until time of reconstitution.
Keep out of reach and sight of children.

If you want more information about Trodelvy:

Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.gilead.ca, or by calling 1-866-207-4267.

Date of Authorization: 2025-05-14

Gilead Sciences Canada, Inc. Mississauga, ON L5N 7K2

TRODELVY® is a trademark of Gilead Sciences, Inc. or its related companies.

All other marks referenced herein are the property of their respective owners.

e245379-GS-004

Rx or OTC	Prescription (Rx)?
DIN	02520788
Schedule(s)	SCHEDULE D; PRESCRIPTION
Active ingredient(s)	Sacituzumab govitecan 180 MG
Dosage form(s)	Powder For Solution
Route(s) of administration	Intravenous
Drug class (WHO ATC)	L Antineoplastic and immunomodulating agents L01 Antineoplastic agents L01FX17 Sacituzumab govitecan
Company	GILEAD SCIENCES CANADA INC
Current status	Marketed
Current status date	November 22, 2021

Trodelvy: Uses, Side Effects and Dosage