Sacituzumab govitecan-hziy (Intravenous)

Sacituzumab govitecan-hziy injection is used to treat triple-negative breast cancer that has spread (metastatic) or cannot be removed by surgery (unresectable locally advanced). It is given to patients who have received 2 or more cancer treatments, including at least 1 treatment for metastatic disease.

Sacituzumab govitecan-hziy injection is also used to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread (metastatic) or cannot be removed by surgery (unresectable locally advanced) in patients who have received endocrine treatment and at least 2 treatments for metastatic disease.

Sacituzumab govitecan-hziy injection is also used to treat urothelial cancer (bladder cancer and cancer of the urinary tract) that has spread or cannot be removed by surgery in patients who have received other cancer medicines (for example, immunotherapy medicine, platinum-containing cancer medicine).

Sacituzumab govitecan-hziy belongs to the group of medicines called antineoplastics (cancer medicines). It interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by the medicine, other effects may also occur. Some of these may be serious and must be reported to your doctor.

This medicine is to be given only by or under the immediate supervision of your doctor.

It is very important that your doctor checks your progress closely while you are receiving this medicine and at regular visits. This will help your doctor see if the medicine is working properly and to decide if you should keep receiving it. Blood tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is receiving it when his sexual partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting the treatment. Female patients should use effective birth control during treatment with this medicine and for at least 6 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 3 months after the last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis and infusion reaction, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have chest tightness, chills, dizziness, fever, hives, hoarseness, itching, skin rash, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive the medicine.

Sacituzumab govitecan-hziy often causes diarrhea. Diarrhea can start while you are receiving a dose of medicine or shortly afterward, or it may occur more than 24 hours later. Your doctor may give you medicine to treat diarrhea. Follow instructions carefully.

Talk with your doctor before receiving this medicine if you plan to have children. Some women who receive this medicine have become infertile (unable to have children).

Sacituzumab govitecan-hziy can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

In deciding to use a medicine, you and your doctor need to weigh the risks against the benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also let your healthcare professional know if you have other allergies, like to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies done on how sacituzumab govitecan-hziy injection affects children. Safety and effectiveness have not been established for this age group.

Geriatric

Current studies have not shown any specific problems for older adults that would limit the use of sacituzumab govitecan-hziy injection.

Breast Feeding

There are no adequate studies in women to determine if this medication poses a risk to infants when breastfeeding. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be taken together, while others may be used together with precautions. When receiving this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are significant but not an exhaustive list.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed, your doctor may adjust the dose or frequency for one or both.

• Probenecid

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken with food or certain types of food, as interactions may happen. Drinking alcohol or using tobacco with certain medicines can also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may impact the use of this medicine. Be sure to inform your doctor about any other medical conditions, especially:

• Infection or
• Neutropenia (low white blood cells)—This may lower your body's ability to fight infections.

• Liver disease, moderate or severe—The use of this medicine has not been studied in these patients.

• Reduced UGT1A1 activity (an enzyme issue)—This may increase the risk of serious side effects.

Along with its intended effects, a medicine can also cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor or nurse right away if you experience any of the following side effects:

More common

• Agitation
• black, tarry stools
• bladder pain
• bleeding of the gums
• bloody or cloudy urine
• blurred vision
• bone pain
• burning, itching, and pain in hairy areas, pus at the root of hair
• burning, tingling, numbness or pain in the hands, arms, feet, or legs
• coma
• confusion
• cough
• decreased urine output
• depression
• difficult or labored breathing with exertion
• difficult, burning, or painful urination
• dizziness
• drowsiness
• dry mouth
• fainting
• fast heartbeat
• fever or chills
• flushed, dry skin
• fruit-like breath odor
• hostility
• increased hunger
• increased thirst
• increased urination
• irregular heartbeat
• irritability
• lethargy
• lightheadedness
• loss of appetite
• lower back or side pain
• mood or mental changes
• muscle pain, spasms, or twitching
• pale skin
• pinpoint red spots on the skin
• rapid, shallow breathing
• rapid weight gain
• seizures
• severe diarrhea
• severe nausea and vomiting
• sneezing
• sore throat
• stomach pain or tenderness
• stuffy or runny nose
• stupor
• sweating
• swelling
• swelling of the face, ankles, or hands
• tightness in the chest
• trembling
• ulcers, sores, or white spots in the mouth
• unexplained weight loss
• unusual bleeding or bruising
• unusual tiredness or weakness

Less common

• Chest pain
• pain in the groin or legs, especially the calves
• severe, sudden headache
• slurred speech
• sudden loss of coordination
• sudden, severe weakness or numbness in the arm or leg
• vision changes

Rare

• Difficulty swallowing
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

Some side effects may happen that usually do not need medical attention. These side effects may go away as your body adjusts to the medicine. Your health care professional may also provide ways to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects persist, bother you, or if you have any questions about them:

More common

• Change in taste
• constipation
• cracked lips
• hair loss
• loss of taste
• rash
• swelling or inflammation of the mouth
• trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Trodelvy

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Sacituzumab Govitecan

Find detailed information on biosimilars for this medication.

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A doctor or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. The medicine must be given slowly, so the needle will have to stay in place for at least 3 hours for the first dose, then 1 or 2 hours for the next doses. The injection is usually given once a week on Days 1 and 8 of a 21-day treatment cycle.

Sacituzumab govitecan-hziy often causes nausea and vomiting. However, it is very important that you continue to receive this medicine even if you begin to feel ill. You may receive other medicines to help with the nausea and vomiting. Ask your doctor for other ways to lessen these effects.

You may also receive extra fluids and other medicines (eg, allergy medicine, fever medicine, steroids) to help prevent unwanted side effects from the injection.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.