Understanding Side Effects

PIQRAY® (alpelisib) tablets

Understanding side effects

With any new treatment option, it’s natural to have concerns about the potential side effects. PIQRAY may cause side effects that you may not be familiar with. Your health care provider may decrease your dose, have you take a break from treatment, or tell you to completely stop taking PIQRAY if you develop certain serious side effects.

Serious side effects

Severe allergic reactions Severe allergic reactions. Tell your health care 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 Severe skin reactions. Tell your health care provider or get medical help right away if you get a severe rash or a 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) High blood sugar levels (hyperglycemia). Hyperglycemia is common with PIQRAY and can be severe. Your health care provider will monitor your blood sugar levels before you start and during treatment with PIQRAY. Your health care provider may monitor your blood sugar levels more often if you have a history of Type 2 diabetes. Tell your health care provider right away if you develop symptoms of hyperglycemia, including:

  • excessive thirst
  • urinate more often than usual or have a higher amount of urine than normal
  • dry mouth
  • increased appetite with weight loss

Lung problems (pneumonitis)Lung problems (pneumonitis). Tell your health care provider right away if you develop new or worsening symptoms of lung problems, including:

  • shortness of breath or trouble breathing
  • cough
  • chest pain

PIQRAY® (alpelisib) and Diarrhea 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 health care provider right away. Your health care provider may tell you to drink more fluids or take medicines to treat diarrhea.

Common side effects

The most common side effects of PIQRAY when used with fulvestrant include:

 Common side effects of PIQRAY® (alpelisib)

 Managing hyperglycemia while taking PIQRAY

 

PIQRAY may affect fertility in males and in females who are able to become pregnant. Talk to your health care provider if this is a concern for you.

 

Tell your health care provider if you have any side effect that bothers you or that does not go away.

 

These are not all the possible side effects of PIQRAY. Call your doctor for medical advice about side effects. You are encouraged to report side effects to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. 

 

Discover ways to help manage some of the side effects of PIQRAY.