Gedatolisib Injection

Gedatolisib injection is used to treat certain types of breast cancer. Gedatolisib is in a class of medications called kinase inhibitors. It works by stopping tumor growth.

Gedatolisib injection comes as a powder to be mixed with liquid to be given intravenously (into the vein). It is given over 30 minutes by a doctor or nurse at a healthcare facility or clinic on days 1, 8 and 15 of a 28-day cycle. Your doctor will determine how many cycles you will receive.

Your doctor may adjust your dose or stop gedatoloisib injection if you have certain side effects while receiving gedatolisib injection. It is important to talk to your doctor about how you are feeling during treatment.

Your doctor will prescribe a mouthwash for you to use during gedatolisib injection treatment to prevent mouth sores that may occur during treatment. It is important that you use this mouthwash four times a day for at least the first 8 weeks of treatment. Your doctor may recommend you use it longer.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving gedatolisib injection,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you have or have ever had diabetes
• tell your doctor if you or your partner are pregnant or plan to become pregnant. You or your partner should not become pregnant while you are receiving gedatolisib injection. You may have to take a pregnancy test before starting treatment. You and your partner should use effective birth control to prevent pregnancy during treatment and for 2 weeks after your final dose. Talk to your doctor about what birth control would work best for you and your partner. If you or your partner become pregnant while receiving gedatolisib injection, call your doctor immediately. Gedatolisib injection may harm the fetus.
• do not breastfeed during treatment with gedatolisib injection and for 2 weeks after your final dose.
• do not breastfeed during treatment with gedatolisib injection and for 2 weeks after your final dose.
• you should know that gedatolisib injection may decrease fertility in men or women (ability to get pregnant or father a child). Talk to your doctor about risks of receiving gedatolisib injection.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving gedatolisib injection.
• plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Sunlight may increase the risk of rash occurring with gedatolisib injection.
• do not have any vaccinations without talking to your doctor.
• you should know that gedatolisib injection has caused hyperglycemia (high blood sugar). Before starting gedatolisib injection and periodically during treatment, your doctor will test your blood for elevated sugar and may recommend starting medicines to help control blood sugar. Tell your doctor if you experience any of the following during treatment: increased thirst, dry mouth, needing to urinate more, feeling tired or weak.

Unless your doctor tells you otherwise, continue your normal diet.

If you miss an appointment to receive gedatolisib injection, call your doctor to reschedule right away. Do not wait until your next scheduled dose. Your doctor will adjust your cycle schedule after that,

Gedatolisib injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea, vomiting, diarrhea, constipation, abdominal pain
• extreme tiredness, dizziness
• fever
• dry mouth, changes in taste, loss of appetite
• itching
• cough

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• painful sores on lips or in mouth or throat; redness or swelling of mouth, lips, throat; burning sensation in mouth or throat
• rash
• fever, difficulty or painful urination, lower back pain
• pain, redness, swelling or changes in skin color in one leg or arm
• coughing blood, shortness of breath, feeling of racing heartbeat, chest pain, dizziness, lightheadedness

Gedatolisib injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to gedatolisib injection.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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