Alpelisib tablets

What is this medication?

Alpelisib (AL pe LIS ib) treats breast cancer. It targets proteins in cancer cells and stops the cells from growing.

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

COMMON BRAND NAME(S): PIQRAY

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

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
• 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, crush or chew this medicine. Swallow the tablets whole. Take it with food. Keep taking it unless your care team tells you to stop.

Talk to your care team about the use of this medication in children. Special care may be needed.

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?

This medication may interact with the following:

• Certain medications for seizures like carbamazepine, phenobarbital, phenytoin
• Rifampin
• St. John's Wort
• 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?

This medication may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your care team tells you to stop.

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.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Avoid taking medications that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your care team. These medications may hide a fever.

Be careful brushing or flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medication.

This medication may increase blood sugar. Ask your care team if changes in diet or medicines are needed if you have diabetes.

Do not become pregnant while taking this medication or for 1 week after stopping it. Women should inform their health care provider 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 health care provider for more information. Do not breast-feed an infant while taking this medicine or for 1 week after stopping it.

This medication may make it more difficult to get pregnant or father a child. Talk with your health care provider 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
• Bloody or watery diarrhea
• Diarrhea
• Dry cough, shortness of breath or trouble breathing
• High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Rash, fever, or swollen lymph nodes
• 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):

• Hair loss
• Loss of appetite with weight loss
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Nausea, vomiting
• Stomach pain

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 care team. 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.