Alpelisib (Piqray) is 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). alpelisib is given in combination with fulvestrant (Faslodex).

Alpelisib (Vijoice) is used to treat people 2 years and older with a condition called PIK3CA-Related Overgrowth Spectrum (PROS).

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

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

Call your doctor right away if you have severe diarrhea.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take alpelisib 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 alpelisib, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

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

If you have diarrhea while taking alpelisib: 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 alpelisib at room temperature away from moisture and heat.

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.

Usual Adult Dose for PIK3CA-Related Overgrowth Spectrum:

Recommended dosage: 250 mg orally once a day
Duration of therapy: Until disease progression or unacceptable toxicity

Use: Adult patients with PIK3CA- Related Overgrowth Spectrum Disorders (PROS) who require systemic therapy (accelerated approval)

Usual Pediatric Dose for PIK3CA-Related Overgrowth Spectrum:

Initial dose: 50 mg orally once a day
Maintenance dose:
-Patients younger than 6 years old: 50 mg orally once a day
-Patients 6 years and older: Increase to 125 mg orally once a day after 24 weeks of 50 mg/day
Maximum dose: 125 mg/day oral
Duration of therapy: Until disease progression or unacceptable toxicity

Comment: When the pediatric patient turns 18 years old, consider gradual dose increase up to 250 mg/day.

Use: Pediatric patients over 2 years old with PIK3CA- Related Overgrowth Spectrum Disorders (PROS) who require systemic therapy (accelerated approval)

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

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, alpelisib 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 alpelisib if you are pregnant. Use effective birth control to prevent pregnancy while you are using alpelisib 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 alpelisib.

• 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 alpelisib, 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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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

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 (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.

Alpelisib may cause serious side effects. 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 side effects of alpelisib 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 affect 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.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body's response to alpelisib.

Your doctor will order a lab test before you begin your treatment to see whether your cancer can be treated with alpelisib (Piqray).

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.