sacituzumab govitecan-hziy 180 mg intravenous solution

Generic name:
Sacituzumab govitecan - injection

Pronunciation
(SAK-i-TOOZ-ue-mab GOE-vi-TEE-kan)

Brand name(s)
Trodelvy

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).

Severe diarrhea may occur. To prevent a serious loss of body water (dehydration), drink plenty of fluids. Tell your doctor right away if you have diarrhea. Your doctor may prescribe antidiarrheal medication to take during treatment with this medication.

This medication is used to treat certain types of breast cancer. It works by slowing or stopping the growth of cancer cells.

Read the Patient Information Leaflet if available from your pharmacist before you start using sacituzumab govitecan and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into a vein by a health care professional. It is given as directed by your doctor, usually on days 1 and 8 of every treatment cycle. Each treatment cycle is 21 days. The first dose is usually injected slowly over 3 hours, and you will be monitored for at least 30 minutes after each injection. If you can take the first dose well, later doses may be given over 1 to 2 hours.

The dosage is based on your medical condition, weight, and response to treatment.

Infusion reactions may happen during the infusion of this drug and for 24 hours afterward. Your doctor may prescribe other medications before each treatment to help prevent these side effects. Tell your doctor right away if you have any symptoms of infusion reactions such as fever, chills, flushing, dizziness, or shortness of breath. Your doctor may slow down or stop your treatment for some time.

Your doctor should prescribe medications before each dose to help prevent side effects such as infusion reactions, nausea, and vomiting.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

See also Warning and How to Use sections.

Numbness/tingling in your hands/feet, tiredness, trouble sleeping, loss of appetite, change in how food tastes, constipation, headache, dizziness, muscle/joint pain, or dry/itchy skin may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Pain or sores in the mouth and throat may occur. Brush your teeth carefully/gently, avoid using mouthwash that contains alcohol, and rinse your mouth often with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.

Nausea and vomiting are common and can sometimes be severe. Nausea, vomiting, or diarrhea that doesn't stop may result in dehydration. Your doctor may prescribe medication to prevent or relieve nausea, vomiting, and diarrhea. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. Contact your doctor right away if you are not able to get your diarrhea under control within 24 hours, or if you notice any symptoms of dehydration, such as unusual decreased urination, unusual dry mouth/thirst, fast heartbeat, or dizziness/lightheadedness.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including:

• easy bruising/bleeding
• black/bloody stools

Sacituzumab govitecan can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before receiving sacituzumab govitecan, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• liver problems
• nerve problems (such as numbness/tingling)

Sacituzumab govitecan can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using sacituzumab govitecan before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

If you have been told that you carry a certain gene (uridine diphosphate-glucuronosyl transferase A1), you may have a higher risk of side effects with this medication, especially low white blood cell counts. Ask your doctor for details.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be at greater risk for infections while using this drug.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using sacituzumab govitecan. Sacituzumab govitecan may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Women using this medication should ask about reliable forms of birth control during treatment and for 6 months after the last dose. Men using this medication should ask about reliable forms of birth control during treatment and for 3 months after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for 1 month after the last dose. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as complete blood counts) should be done while you are using this medication. Keep all medical and lab appointments.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a hospital or clinic or doctor's office and will not be stored at home.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.