Uses of Piqray:

• It is used to treat breast cancer.

What do I need to tell my doctor BEFORE I take Piqray?

• If you are allergic to Piqray (200 MG Daily Dose) (alpelisib); any part of Piqray (200 MG Daily Dose) (alpelisib); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have high blood sugar (diabetes).
• If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with Piqray (200 MG Daily Dose) (alpelisib), like certain drugs that are used for HIV, infections, or seizures. There are many drugs that must not be taken with Piqray (200 MG Daily Dose) (alpelisib).
• If you are breast-feeding. Do not breast-feed while you take Piqray (200 MG Daily Dose) (alpelisib) and for 1 week after your last dose.

This is not a list of all drugs or health problems that interact with Piqray (200 MG Daily Dose) (alpelisib).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Piqray (200 MG Daily Dose) (alpelisib) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Piqray?

• Tell all of your health care providers that you take Piqray (200 MG Daily Dose) (alpelisib). This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may be used with other drugs to treat your health condition. If you are also taking other drugs, talk with your doctor about the risks and side effects that may happen.
• It is common to have diarrhea when taking Piqray (200 MG Daily Dose) (alpelisib). Some cases of diarrhea may cause fluid loss and kidney problems that can sometimes be deadly. Call your doctor right away if you have diarrhea that does not go away or if you have severe diarrhea. Do not try to treat diarrhea without first checking with your doctor.
• High blood sugar has happened with Piqray (200 MG Daily Dose) (alpelisib). Check blood sugar as you have been told. Talk with your doctor if you have questions.
• Tell your doctor if you have signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Low blood cell counts have happened with Piqray (200 MG Daily Dose) (alpelisib). If blood cell counts get very low, this can lead to bleeding problems, infections, or anemia. Call your doctor right away if you have signs of infection like fever, chills, or sore throat; any unexplained bruising or bleeding; or if you feel very tired or weak.
• If you are 65 or older, use Piqray (200 MG Daily Dose) (alpelisib) with care. You could have more side effects.
• This medicine may affect fertility. Fertility problems may lead to not being able to get pregnant or father a child.
• Men with a partner who may get pregnant must use birth control while taking Piqray (200 MG Daily Dose) (alpelisib) and for some time after the last dose. Use a condom and another form of birth control that you can trust. Ask your doctor how long to use birth control. If your partner gets pregnant, call the doctor right away.
• This medicine may cause harm to an unborn baby. A pregnancy test will be done before you start Piqray (200 MG Daily Dose) (alpelisib) to show that you are NOT pregnant.
• Women must use birth control while taking Piqray (200 MG Daily Dose) (alpelisib) and for some time after the last dose. Ask your doctor how long to use birth control. If you get pregnant, call your doctor right away.

How is this medicine (Piqray) best taken?

Use Piqray (200 MG Daily Dose) (alpelisib) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take Piqray (200 MG Daily Dose) (alpelisib) with food.
• Swallow whole. Do not chew, break, or crush.
• Do not take chipped or broken tablets.
• Take Piqray (200 MG Daily Dose) (alpelisib) at the same time of day.
• Keep taking Piqray (200 MG Daily Dose) (alpelisib) as you have been told by your doctor or other health care provider, even if you feel well.
• If you throw up after taking a dose, do not repeat the dose. Take your next dose at your normal time.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it, with food.
• If it has been more than 9 hours since the missed dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of lung or breathing problems like shortness of breath or other trouble breathing, cough, or fever.
• Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
• Signs of fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Swelling in the arms or legs.
• Vaginal dryness.
• Signs of a very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.

What are some other side effects of Piqray?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Hair loss.
• Mouth sores.
• Feeling tired or weak.
• Dry skin.
• Weight loss.
• Change in taste.
• Headache.
• Stomach pain or heartburn.
• Diarrhea, throwing up, upset stomach, and feeling less hungry are common with Piqray (200 MG Daily Dose) (alpelisib). If these happen, talk with your doctor about ways to lower these side effects. Call your doctor right away if any of these effects bother you, do not get better, or get very bad.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Piqray?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Piqray (200 MG Daily Dose) (alpelisib), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.