What is this medicine?

Alpelisib (AL pe LIS ib) is a medicine that targets proteins in cancer cells and stops the cells from growing. It is used to treat breast cancer.

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 health care provider before I take this medicine?

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

  • diabetes
  • lung or breathing disease, like asthma
  • 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 medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. Take this medicine with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine 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. If your next dose is to be taken in less than 15 hours, then do not take the missed dose. Take the next dose at your regular time. Do not take double or extra doses.

What may interact with this medicine?

This medicine may interact with the following medications:

  • certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
  • cyclosporine
  • eltrombopag
  • enzalutamide
  • mitotane
  • rifampin
  • St. John's Wort
  • sulfasalazine
  • wafarin

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 medicine?

This drug 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 doctor tells you to stop.

This medicine may cause serious skin reactions. They can happen weeks to months after starting the medicine. Contact your health care provider 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 doctor or health care provider if you get an attack of severe diarrhea, nausea, and vomiting, or if you sweat a lot. The loss of too much body fluid can make it dangerous for you to take this medicine.

You may need blood work done while you are taking this medicine.

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

Call your doctor or health care provider for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care provider if you notice any unusual bleeding.

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

This medicine may interfere with the ability to have a child. Talk with your doctor or health care provider if you are concerned about your fertility.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching, or hives, swelling of the face, lips, or tongue
  • breathing problems
  • diarrhea
  • jaw pain, especially after dental work
  • redness, blistering, peeling, or loosening of the skin, including inside the mouth
  • signs and symptoms of high blood sugar such as dizziness; dry mouth; dry skin; fruity breath; nausea; stomach pain; increased hunger or thirst; increased urination
  • signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine
  • unusual bleeding or bruising

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

  • changes in taste
  • dry mouth
  • headache
  • loss of appetite
  • mouth sores
  • 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 medicine?

Keep out of the reach of children. Store between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

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.

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