Gedatolisib

Gedatolisib is a cancer medicine used together with fulvestrant, with or without palbociclib, to treat adults with hormone receptor (HR)-positive, HER2-negative breast cancer that is locally advanced or has spread to other parts of the body (metastatic).

Your doctor will do tests to ensure that gedatolisib is the right treatment for you.

Gedatolisib may also be used for reasons not mentioned in this medication guide.

Read all medication guides or instruction sheets for gedatolisib that you received and also for fulvestrant and palbociclib, if prescribed.

Gedatolisib is given as an infusion into a vein over 30 minutes. A healthcare provider will give you gedatolisib. It is usually given once a week for 3 weeks, followed by 1 week off. Your doctor will decide how many treatments you need.

Your doctor will monitor you for a short time for signs of a reaction to the infusion. If you have a reaction, your doctor may slow down or stop the infusion for a while. If the reaction is severe, your doctor may stop your treatment.

Your doctor will prescribe a mouthwash to help prevent mouth sores. Use it as directed.

Your blood sugar will be checked before and during treatment. You may need other medical tests.

Gedatolisib can cause serious mouth sores, skin reactions, or high blood sugar. Inform your doctor if you experience pain, redness, swelling, or sores in your mouth. Contact your doctor immediately if you develop a new rash or show signs of high blood sugar, such as increased thirst, urinating more often, blurred vision, confusion, or increased hunger with weight loss.

Before receiving gedatolisib, tell your doctor if you have diabetes.

Gedatolisib can harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you can become pregnant, your doctor will do a pregnancy test before treatment. Use effective birth control during treatment and for 2 weeks after your last dose. Tell your doctor right away if you become pregnant or think you may be pregnant.

If you are a man and your partner can become pregnant, use effective birth control during treatment and for 2 weeks after your last dose. Tell your doctor right away if your partner becomes pregnant or thinks she may be pregnant.

Your doctor will tell you if you need to use birth control longer because of fulvestrant or palbociclib.

Do not breastfeed during treatment and for 2 weeks after your last dose. Your doctor will tell you if you need to wait longer because of fulvestrant or palbociclib.

Gedatolisib may affect fertility in men and women. It may be harder to have a child.

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

Some side effects may happen during the infusion. Tell your medical caregiver if you feel dizzy, nauseous, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Gedatolisib may cause serious side effects. Call your doctor immediately if you have:

• mouth sores--pain, swelling, redness, or ulcers in your mouth;
• skin reactions--a new rash; or
• high blood sugar--increased thirst, urinating more often or passing more urine than usual, blurred vision, confusion, headache, increased hunger with weight loss, trouble breathing, or tiredness.

Common side effects when gedatolisib is given with fulvestrant and palbociclib may include:

• mouth sores;
• nausea, vomiting;
• high blood sugar;
• tiredness;
• rash or itching;
• constipation, diarrhea;
• muscle or joint pain; or
• abnormal blood tests.

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.

Call your doctor right away if you miss an appointment for your gedatolisib infusion. Do not wait until your next planned treatment cycle.

In a medical setting, an overdose would be treated quickly.

Limit your time in sunlight while you are being treated with gedatolisib.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.