Piqray is a prescription medicine used in men and postmenopausal women with HR-positive, HER2-negative breast cancer that is advanced or has spread to other parts of the body (metastatic).

Piqray is used only if your cancer has a specific genetic marker (an abnormal "PIK3CA" gene). Your doctor will test you for this gene.

Piqray is given in combination with fulvestrant (Faslodex).

Do not take Piqray if you have had a severe allergic reaction to alpelisib or are allergic to any of the ingredients in this medicine.

Call your doctor right away if you have severe diarrhea.

Before taking this medicine

You should not use Piqray if you are allergic to alpelisib.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• diabetes; or

• a severe skin rash (skin pain, redness, peeling, burning eyes, blistering of your lips or mouth).

Although, Piqray is for use only in women who can no longer get pregnant, you may need to have a negative pregnancy test before starting this treatment. Tell your doctor if you think you may be pregnant.

Alpelisib and fulvestrant both can harm an unborn baby or cause birth defects if the mother or the father is using these medicines.

• If you are a woman, do not use Piqray if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 1 week after your last dose.

• If you are a man, use condoms and effective birth control if your sex partner is pregnant or is able to get pregnant. Keep using birth control for at least 1 week after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Piqray.

• Women who also take fulvestrant may need to prevent pregnancy for at least 1 year after treatment ends. Ask your doctor about all how long to keep using birth control.

Alpelisib and fulvestrant may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because these medicines can harm an unborn baby.

Do not breastfeed while using Piqray, and for at least 1 week after your last dose. You may not be able to breastfeed for 1 year after your last dose of fulvestrant. Ask your doctor.

Take Piqray exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Take Piqray tablets with food, at the same time each day.

Swallow the tablet whole and do not crush, chew, or break it. Do not use a cracked or broken tablet.

If you vomit shortly after taking Piqray, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

Piqray can cause severe diarrhea, which can be life-threatening if it leads to dehydration or kidney damage.

If you have diarrhea while taking Piqray: start taking anti-diarrhea medicine such as loperamide (Imodium) to quickly treat diarrhea. Drink extra fluids and call your doctor.

Fulvestrant is an injection that is usually given once every 2 weeks at first, and then once a month. A healthcare professional will give you this injection.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office.

Alpelisib and fulvestrant are usually given until your body no longer responds to the treatment, or until you have a serious side effect. Your doctor will determine how long to treat you.

Store at room temperature away from moisture and heat. Keep each tablet in the blister pack until you are ready to take one.

Usual Adult Dose for Breast Cancer:

300 mg orally once a day with food until disease progression or unacceptable toxicity; when given with this drug, the recommended dose of fulvestrant is 500 mg orally on Days 1, 15, and 29, and once monthly thereafter

Use: In combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CAmutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.

You should not use Piqray if you are allergic to alpelisib.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• diabetes; or

• a severe skin rash (skin pain, redness, peeling, burning eyes, blistering of your lips or mouth).

Although, Piqray is for use only in women who can no longer get pregnant, you may need to have a negative pregnancy test before starting this treatment. Tell your doctor if you think you may be pregnant.

Alpelisib and fulvestrant both can harm an unborn baby or cause birth defects if the mother or the father is using these medicines.

• If you are a woman, do not use Piqray if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 1 week after your last dose.

• If you are a man, use condoms and effective birth control if your sex partner is pregnant or is able to get pregnant. Keep using birth control for at least 1 week after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Piqray.

• Women who also take fulvestrant may need to prevent pregnancy for at least 1 year after treatment ends. Ask your doctor about all how long to keep using birth control.

Alpelisib and fulvestrant may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because these medicines can harm an unborn baby.

Do not breastfeed while using Piqray, and for at least 1 week after your last dose. You may not be able to breastfeed for 1 year after your last dose of fulvestrant. Ask your doctor.

Take the medicine (with food) as soon as you can, but skip the missed dose if you are more than 9 hours late for the dose. Do not use two doses at one time.

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

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

Get emergency medical help if you have signs of an allergic reaction to Piqray (hives, warmth or tingling, difficult breathing, fast heartbeats, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Call your doctor at once if you have:

• chest pain, cough, feeling short of breath;

• severe or ongoing diarrhea;

• blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;

• pale skin, unusual tiredness, cold hands and feet;

• little or no urination; or

• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor, confusion, hunger, weight loss;

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

Common Piqray side effects may include:

• nausea, vomiting;

• loss of appetite, weight loss;

• feeling weak or tired;

• mouth sores;

• rash;

• hair loss; 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.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may interact with alpelisib, 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.