What is PIQRAY (Alpelisib)?
PIQRAY is a prescription medicine used in combination with the medicine fulvestrant to treat women who have
gone through menopause and men:
- Who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), with an abnormal phosphatidylinositol-3-kinase catalytic subunit alpha (PIK3CA) gene, and
- Whose disease has progressed on or after endocrine
It is not known if PIQRAY is safe and effective in children.
What is the most important information I should know about PIQRAY?
PIQRAY can cause serious side effects. These serious side effects include:
- Severe allergic reactions. Tell your healthcare provider or get medical help right away if you have trouble breathing, flushing, rash, fever, or fast heart rate during treatment with PIQRAY.
- Severe skin reactions. Tell your healthcare provider or get medical help right away if you get severe rash or rash that keeps getting worse, reddened skin, flu-like symptoms, blistering of the lips, eyes or mouth, blisters on the skin or skin peeling, with or without fever.
- High blood sugar levels (hyperglycemia). Hyperglycemia is common with PIQRAY and can be severe. Your healthcare provider will monitor your blood sugar levels before you start and during treatment with PIQRAY. Your healthcare provider may monitor your blood sugar levels more often if you have a history of Type 2 diabetes. Tell your healthcare provider right away if you develop symptoms of hyperglycemia, including:
- Excessive thirst
- Dry mouth
- More frequent urination than usual or a higher amount of urine than normal
- Increased appetite with weight loss
- Lung problems (pneumonitis). Tell your healthcare provider right away if you develop new or worsening symptoms of lung problems, including: Shortness of breath or trouble breathing, Cough, Chest pain
- Diarrhea. Diarrhea is common with PIQRAY and can be severe. Severe diarrhea can lead to the loss of too much body water (dehydration) and kidney problems. If you develop diarrhea during treatment with PIQRAY, tell your healthcare provider right away. Your healthcare provider may tell you to drink more fluids or take medicines to treat diarrhea.
- The most common side effects of PIQRAY when used with fulvestrant include:
- Rash
- Nausea
- Tiredness and weakness
- Decreased appetite
- Mouth sores
- Weight loss
- Hair loss
- Changes in certain blood tests
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- Vomiting
How should I take PIQRAY?
- Take PIQRAY exactly as your healthcare provider tells you.
- Do not change your dose or stop taking PIQRAY unless your healthcare provider tells you.
- Take PIQRAY 1 time each day, at about the same time each day.
- Take PIQRAY with food.
- Swallow PIQRAY tablets whole. Do not chew, crush or split the tablets.
- Do not take any PIQRAY tablets that are broken, cracked, or that look damaged.
- If you miss a dose of PIQRAY, you may still take it with food up to 9 hours after the time you usually take it. If it has been more than 9 hours after you usually take your dose, skip the dose for that day. The next day, take the dose at your usual time. Do not take 2 doses to make up for a missed dose.
- If you vomit after taking a dose of PIQRAY, do not take another dose on that day. Take your next dose at your usual time
- If you take too much PIQRAY, call your healthcare provider or go to the nearest hospital emergency room right away.
Important Safety Information
- Do not take PIQRAY if you have had a severe allergic reaction to PIQRAY or are allergic to any of the ingredients in PIQRAY.
- You should use effective birth control during treatment with PIQRAY and for 1 week after the last dose.
- If you become pregnant or think you are pregnant, tell your healthcare provider right away.
- It is not known if PIQRAY passes into your breast milk. Do not breastfeed during treatment with PIQRAY and for 1 week after the last dose
- If you miss a dose of PIQRAY, you may still take it with food up to 9 hours after the time you usually take it. If it has been more than 9 hours after you usually take your dose, skip the dose for that day. The next day, take the dose at your usual time. Do not take 2 doses to make up for a missed dose.
- If you vomit after taking a dose of PIQRAY, do not take another dose on that day. Take your next dose at your usual time.
Ask your healthcare provider if you do not know.
What should I tell my healthcare provider before taking PIQRAY?
Tell your healthcare provider about all of your medical conditions, including if You:
- Have a history of diabetes
- Have a history of skin rash, redness of skin, blistering of the lips, eyes or mouth, or skin peeling
- Are pregnant or plan to become pregnant. PIQRAY can harm your unborn baby.
- Are breastfeeding or plan to breastfeed. It is not known if PIQRAY passes into your breast milk. Do not breastfeed during treatment with PIQRAY and for 1 week after the last dose
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements. PIQRAY and other medicines may affect each other causing side effects.
General information about PIQRAY
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not
use PIQRAY for a condition for which it was not prescribed. Do not give PIQRAY to other people, even if they
have the same symptoms you have. It may harm them.
What are the ingredients in PIQRAY?
Active ingredient: Alpelisib
Inactive ingredient: Hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, and sodium
starch glycolate. The film-coating contains hypromellose, iron oxide black, iron oxide red,
macrogol/polyethylene glycol (PEG) 4000, talc, and titanium dioxide.