Alpelisib Oral Tablets (PIK3CA-related overgrowth spectrum (PROS))

What is this medication?

ALPELISIB (AL pe LIS ib) treats patients with PIK3CA-related overgrowth spectrum (PROS).

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Vijoice

What should I tell my care team before I take this medication?

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

• Diabetes (high blood sugar)
• Lung disease
• An unusual or allergic reaction to alpelisib, other medicines, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

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.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

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.

What may interact with this medication?

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

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

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.

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.

You may need blood work while you are taking this medication.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water may help. Contact your care team if the problem does not go away or is severe.

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.

Do not become pregnant while taking this medication or for 1 week after stopping it. Women should inform their care team if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medication and for 1 week after stopping it. There is potential for serious harm to an unborn child. Talk to your care team for more information. Do not breast-feed an infant while taking this medication or for 1 week after stopping it.

This medication may make it more difficult to get pregnant or father a child. Talk with your care team if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

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
• Diarrhea
• High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
• Lung injury—shortness of breath or trouble breathing, cough, spitting up blood, chest pain, fever
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth

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

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

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

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, 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 health care provider. If it is safe to put in the trash, take 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.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.