sacituzumab govitecan

What is the most important information I should know about sacituzumab govitecan?

Sacituzumab govitecan commonly causes diarrhea. Severe diarrhea can lead to dehydration, which may require medical treatment.

Tell your doctor right away the first time you have diarrhea while receiving this medicine, or if you have black or bloody stools, if you feel light-headed, if you can't keep liquids down because of vomiting, or if you can't get your diarrhea to stop within 24 hours.

What is sacituzumab govitecan?

Sacituzumab govitecan is used to treat HR-negative and HER2-negative (sometimes called triple-negative) breast cancer in adults.

This medicine is used when the cancer has spread to other parts of the body (metastatic), after at least two other cancer treatments did not work or have stopped working.

Sacituzumab govitecan was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, some people responded to this medicine, but further studies are needed.

Sacituzumab govitecan may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving sacituzumab govitecan?

Tell your doctor if you have ever had:

• liver disease; or
• if you've been told that you carry a gene called UGT1A1*28, which may increase your risk of getting infections while using sacituzumab govitecan.

You will need to have a negative pregnancy test before receiving sacituzumab govitecan.

• If you are a woman, do not use sacituzumab govitecan if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.
• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using sacituzumab govitecan.

This medicine may affect fertility (ability to have children) in women. However, it is important to use birth control to prevent pregnancy because sacituzumab govitecan can harm an unborn baby.

How is sacituzumab govitecan given?

Sacituzumab govitecan is given as an infusion into a vein. A healthcare provider will give you this injection.

Sacituzumab govitecan is given in a 21-day treatment cycle. You will receive the medicine only during the first 2 weeks of each cycle.

This medicine must be given slowly, and the infusion can take 1 to 3 hours to complete.

You will be watched closely for at least 30 minutes to make sure you do not have an allergic reaction.

Sacituzumab govitecan commonly causes diarrhea. Severe diarrhea can lead to dehydration, which may require medical treatment. Tell your doctor right away the first time you have diarrhea while receiving this medicine.

Sacituzumab govitecan affects your immune system. You may get infections more easily, even serious or fatal infections. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results.

Your doctor will determine how long to treat you with this medicine.

What happens if I miss a dose?

What happens if I overdose?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving sacituzumab govitecan?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of sacituzumab govitecan?

This medicine can cause severe or life-threatening allergic reactions.

Some side effects may occur during the injection or within 24 hours afterward. Tell your caregiver if you feel dizzy, light-headed, itchy, sweaty, or have a fever, chills, trouble breathing, or swelling in your face or throat.

• pain or burning when you urinate;
• low red blood cells (anemia) --pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
• low white blood cell counts --fever, mouth sores, skin sores, sore throat, cough, trouble breathing.

• diarrhea (the first time it occurs);
• diarrhea lasting longer than 24 hours (even if you use anti-diarrhea medicine);
• black or bloody stools;
• severe or ongoing vomiting, especially if you can't keep liquids down; or
• a light-headed feeling, like you might pass out.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• diarrhea, nausea, vomiting;
• stomach pain, loss of appetite, constipation;
• low blood cell counts;
• rash;
• hair loss; or
• feeling tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect sacituzumab govitecan?

Other drugs may affect sacituzumab govitecan, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about sacituzumab govitecan.