Alpelisib (Piqray) is used in combination with fulvestrant (Faslodex) to treat a certain type of breast cancer that has spread to nearby tissues or other parts of the body in adults whose cancer got worse during or after certain other treatments. Alpelisib (Vijoice) is used to treat adults and children 2 years of age or older who have certain types of PIK3CA Related Overgrowth Spectrum (PROS; a genetic condition that causes overgrowth and abnormalities in certain body tissues). Alpelisib is in a class of medications called kinase inhibitors. It works to treat cancer by blocking the signals that cause cancer cells to multiply, which helps to stop the spread of cancer cells. It works to treast PROS by blocking the signals that cause overgrowth and abnormalities in certain body tissues, which reduces the size of the overgrowths and improves symptoms.

Alpelisib comes as a tablet to take by mouth. It is usually taken with food once a day for as long as your doctor recommends treatment. Take alpelisib at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take alpelisib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them. Do not take a tablet that is broken, cracked, or is damaged.

If you are taking alpelisib (Vijoice) for PROS and are unable to swallow the tablets whole, you may dissolve them in water. Place the tablet(s) into a drinking glass that contains 2 to 4 ounces (60 to 120 mL) of water. Wait 5 minutes and then crush the tablets and stir the mixture with a spoon. Drink the mixture immediately. Add another 2 to 3 tablespoons of water to the glass and stir with the same spoon to rinse out any particles that are still in the glass. Drink all of this mixture to be sure that you receive all of the medication and repeat if necessary.

If you vomit after taking alpelisib, do not take another dose. Continue your regular dosing schedule.

Your doctor may decrease your dose of alpelisib, treat you with other medications, or interrupt or stop your treatment if you experience certain side effects. Be sure to tell your doctor how you are feeling during your treatment with alpelisib.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

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

Before taking alpelisib,

• tell your doctor and pharmacist if you are allergic to alpelisib, any other medications, herbal products, or any of the ingredients in alpelisib tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, or nutritional supplements you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• The following nonprescription or herbal products may interact with alpelisib: St John’s wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking alpelisib. Do not start any of these medications while taking alpelisib without discussing with your healthcare provider.
• tell your doctor if you have ever had a rash with red sores on the lips, mouth or skin, or shedding, blistering skin; or have or have ever had diabetes or kidney disease.
• tell your doctor if you or your partner are pregnant, or plan to become pregnant. You or your partner should not become pregnant during your treatment with alpelisib. If you are a female that can become pregnant, you will need to have a pregnancy test before you begin treatment, and you should use effective birth control during your treatment and for 1 week after your final dose. If you are a male with a female partner that can become pregnant, use a condom and effective birth control during your treatment and for 1 week after your final dose. If you or your partner become pregnant while taking alpelisib, call your doctor. Alpelisib may harm the fetus.
• tell your doctor if you are breast-feeding. Your doctor will tell you not to breast-feed during your treatment and for 1 week after your final dose.
• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of taking alpelisib.
• you should know that alpelisib may cause an increase in blood glucose. If you have diabetes or high blood sugar, check your blood sugar as often as directed by your doctor. Your doctor may tell you to take a certain medication to prevent and treat high blood sugar before you start taking alpelisib. If your blood sugar is higher than usual, call your doctor. Tell your doctor immediately if you have any of the following symptoms while you are taking alpelisib: extreme thirst, frequent urination, extreme hunger, blurred vision, confusion, or weakness. It is very important to call your doctor as soon as you have any of these symptoms, because high blood sugar that is not treated can cause a serious condition called ketoacidosis. Ketoacidosis may become life-threatening if it is not treated at an early stage. Symptoms of ketoacidosis include dry mouth, upset stomach and vomiting, shortness of breath, breath that smells fruity, and decreased consciousness. Call your doctor if you are unable to eat or drink normally due to nausea, vomiting, or diarrhea while you are taking alpelisib. Your doctor may need to change your diet or medication to help control your blood sugar while you are taking alpelisib.

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

Take the missed dose as soon as you remember it. However, if more than 9 hours passed since the missed dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

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

• nausea
• vomiting
• extreme tiredness
• decreased appetite
• change in the way things taste
• weight loss
• abdominal pain
• heartburn
• hair loss
• headache
• itching
• dry skin
• dry mouth
• mouth sores
• vaginal dryness
• fever
• swelling of the arms or legs

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

• trouble swallowing or breathing; rash; hives; flushing; fever; or fast heartbeat
• swelling of the face, throat, tongue, lips, eyes, hands, or feet
• rash; blistering, peeling, or reddened skin; blistering of the lips, eyes, or mouth; flu-like symptoms; and swollen glands, with or without fever
• shortness of breath, cough, chest pain, difficulty breathing
• severe diarrhea, dry mouth, cramps, weakness, decreased urination, swelling of legs or ankles
• watery or bloody diarrhea, stomach pain
• frequent, painful, or urgent urination

Alpelisib 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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• nausea
• lack of energy
• rash
• increased thirst and appetite
• dry mouth
• urinating more often or larger amounts

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.

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• Vijoice^®