Alpelisib Oral tablet [PIK3CA-related overgrowth spectrum (PROS)]

ALPELISIB (AL pe LIS ib) treats symptoms of PIK3CA-related overgrowth spectrum (PROS), a group of conditions that cause extra tissue growth in different parts of the body. It works by blocking a protein that causes cells to grow and multiply. This helps to slow tissue growth.

Take this medication by mouth. Take it as directed on the prescription label at the same time every day. Do not cut or chew this medication. Swallow the tablets whole. Take it with food. Keep taking it unless your care team tells you to stop.

If you cannot swallow tablets, place tablets in a glass with 2 to 4 ounces of water. After 5 minutes crush the tablets with a spoon and stir to make a suspension. Swallow the mixture right away. Add 2 to 3 tablespoons of water to the same glass, stir, and swallow all contents of the glass. Repeat until none of the dose is left.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 2 years for selected conditions, precautions do apply.

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Dry cough, shortness of breath or trouble breathing
• High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Sudden or severe stomach pain, bloody diarrhea, fever, nausea, vomiting

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Diarrhea
• Dry skin
• Headache
• Hair loss
• Pain, redness, or swelling with sores inside the mouth or throat

Keep out of the reach of children and pets.

Store between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

They need to know if you have any of these conditions:

• Diabetes
• Lung disease
• An unusual or allergic reaction to alpelisib, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin
• Cyclosporine
• Eltrombopag
• Enzalutamide
• Mitotane
• Rifampin
• St. John's wort
• Sulfasalazine
• Warfarin

If you miss a dose, take it as soon as you can unless it is more than 9 hours late. If it is more than 9 hours late, skip the missed dose. Take the next dose at the normal time.

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. You may need blood work while you are taking this medication.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms.

Check with your care team if you have severe diarrhea, nausea, and vomiting, or if you sweat a lot. The loss of too much body fluid may make it dangerous for you to take this medication.

This medication may increase blood sugar. The risk may be higher in patients who already have diabetes. Ask your care team what you can do to lower your risk of diabetes while taking this medication.

Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 1 week after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 1 week after the last dose. Your care team can help you find the option that works for you.

If your partner can get pregnant, use a condom during sex while taking this medication and for 1 week after the last dose.

Do not breastfeed while taking this medication and for 1 week after the last dose.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.