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 the tablets into a cup with 4 to 8 tablespoons (2 to 4 ounces) of water. Let it stand for 5 minutes. Crush the tablets with a spoon. Stir to dissolve. Swallow the mixture right away. Add 2 to 4 tablespoons (1 to 2 ounces) of water to the same cup. Stir with the same spoon. Swallow the contents to make sure the entire dose is taken. Repeat this step until there are no tablet pieces in the cup.

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 or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
• Dry cough, shortness of breath or trouble breathing
• High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
• Pancreatitis—severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting
• Rash, fever, and swollen lymph nodes
• 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
• Hair loss
• Headache
• Pain, redness, or swelling with sores inside the mouth or throat

Keep out of the reach of children and pets.

Store at room temperature 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, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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
• If you or your partner are pregnant or trying to get pregnant
• Breastfeeding

• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin
• Rifampin
• St. John's wort
• Warfarin

This medication may affect how other medications work, and other medications may affect the way this medication works. Talk with your care team about all the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

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.

If you vomit after taking your dose, do not take another dose. Take your next dose at your usual time the next day.

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 done 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. You may also 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.