Sacituzumab govitecan is used to treat breast cancer in adults who previously received endocrine therapy and at least two other cancer medications.

Sacituzumab govitecan is also used in adults to treat cancers of the bladder and urinary tract, after treatment with a platinum cancer medicine and an immunotherapy treatment.

Sacituzumab govitecan is used when the cancer has spread to other parts of the body (metastatic) or cannot be removed with surgery.

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

You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, burning when you urinate, a cough, or trouble breathing.

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.

Sacituzumab govitecan is injected into a vein by a healthcare provider.

Sacituzumab govitecan is given in a 21-day treatment cycle. You will receive an injection only on certain days of this cycle.

This medicine must be given slowly over 1 to 3 hours.

You will be watched for a short time to make sure you do not have an allergic reaction.

You may be given other medications to help prevent serious side effects or allergic reaction. Keep taking these medicines for as long as your doctor has prescribed.

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.

You may get infections more easily, even serious or fatal infections. You may need frequent medical tests and your cancer treatments may be delayed based on the results.

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

Usual Adult Dose for Breast Cancer:

10 mg/kg IV once a week on Days 1 and 8 of 21-day treatment cycles
Maximum dose: 10 mg/kg per dose
Duration of therapy: Until disease progression or unacceptable toxicity

Use: For the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received 2 or more prior systemic therapies, at least 1 of them for metastatic disease

Usual Adult Dose for Urothelial Carcinoma:

10 mg/kg IV once a week on Days 1 and 8 of 21-day treatment cycles
Maximum dose: 10 mg/kg per dose
Duration of therapy: Until disease progression or unacceptable toxicity

Comments:
-This indication is approved under accelerated approval based on tumor response rate and duration of response; continued approval may be contingent on verification and description of clinical benefit in a confirmatory trial.

Use: For the treatment of patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor

You should not be treated with sacituzumab govitecan if you have ever had a severe allergic reaction to it.

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.

Sacituzumab govitecan can harm an unborn baby if the mother or the father is using sacituzumab govitecan.

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 6 months after your last dose.

• It may be harder for you to get pregnant while you are using this medicine. You should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

• If you are a man, use 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.

Do not breastfeed while using this medicine, and for at least 1 month after your last dose.

Call your doctor for instructions if you miss an appointment for your sacituzumab govitecan injection.

In a medical setting an overdose would be treated quickly.

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

sacituzumab govitecan can cause severe or life-threatening allergic reactions.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

• 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.

Sacituzumab govitecan can cause severe diarrhea. Tell your doctor right away if you have:

• 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 of sacituzumab govitecan may include:

• diarrhea, nausea, vomiting;

• stomach pain, loss of appetite, constipation;

• low blood cell counts;

• rash;

• high blood sugar;

• abnormal blood tests;

• abnormal liver or kidney function tests;

• hair loss; or

• feeling tired or weak.

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.

Other drugs may affect sacituzumab govitecan, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.