alpelisib

What is the most important information I should know about alpelisib?

What is alpelisib?

Alpelisib (Piqray) is used in men and postmenopausal women with HR-positive, HER2-negative breast cancer that is advanced or has spread to other parts of the body (metastatic). This medicine is given in combination with fulvestrant (Faslodex).

Alpelisib (Vijoice) is used to treat people 2 years and older with a condition called PIK3CA-Related Overgrowth Spectrum (PROS).

Alpelisib is used only if your cancer has a specific genetic marker (an abnormal "PIK3CA" gene). Your doctor will test you for this gene.

Alpelisib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking alpelisib?

Tell your doctor if you have ever had:

• diabetes; or
• a severe skin rash (skin pain, redness, peeling, burning eyes, blistering of your lips or mouth).

Although, alpelisib is for use only in women who can no longer get pregnant, you may need to have a negative pregnancy test before starting this treatment. Tell your doctor if you think you may be pregnant.

• If you are a woman, do not use alpelisib if you are pregnant. Use effective birth control to prevent pregnancy while you are using alpelisib and for at least 1 week after your last dose.
• If you are a man, use condoms and effective birth control if your sex partner is pregnant or is able to get pregnant. Keep using birth control for at least 1 week after your last dose.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using alpelisib.
• Women who also take fulvestrant may need to prevent pregnancy for at least 1 year after treatment ends. Ask your doctor about all how long to keep using birth control.

Alpelisib and fulvestrant may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because these medicines can harm an unborn baby.

How should I take alpelisib?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

If you vomit shortly after taking alpelisib, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

Fulvestrant is an injection that is usually given once every 2 weeks at first, and then once a month. A healthcare professional will give you this injection.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office.

Alpelisib and fulvestrant are usually given until your body no longer responds to the treatment, or until you have a serious side effect. Your doctor will determine how long to treat you.

What happens if I miss a dose?

Take the medicine (with food) as soon as you can, but skip the missed dose if you are more than 9 hours late for the dose. Do not use two doses at one time.

What happens if I overdose?

What should I avoid while taking alpelisib?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of alpelisib?

• chest pain, cough, feeling short of breath;
• severe or ongoing diarrhea;
• blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;
• pale skin, unusual tiredness, cold hands and feet;
• little or no urination; or
• high blood sugar --increased thirst, increased urination, dry mouth, fruity breath odor, confusion, hunger, weight loss;

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• nausea, vomiting;
• loss of appetite, weight loss;
• feeling weak or tired;
• mouth sores;
• rash;
• hair loss; or
• abnormal blood tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect alpelisib?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may affect alpelisib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about alpelisib.