Understanding Side Effects

PIQRAY® (alpelisib) tablets and proactive planning with your health care team

The importance of preparing for potential side effects of PIQRAY

With any new treatment option, it’s natural to have concerns about the potential side effects. The most serious side effects of PIQRAY include severe allergic reactions, severe skin reactions, high blood sugar levels (hyperglycemia), lung problems (pneumonitis), and diarrhea, but everyone experiences therapies differentlyKnowing what side effects you may encounter can help you and your doctor take action at the earliest signs.

 

PIQRAY may also 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 its complications 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, and its complications including:    

  • excessive thirst
  • dry mouth
  • more frequent urination than usual or a higher amount of urine than normal
  • increased appetite with weight loss
  • confusion
  • nausea
  • vomiting
  • fruity odor on breath
  • difficulty breathing
  • dry or flushed skin

If you experience hyperglycemia, this does not necessarily mean you have diabetes, though your health care provider may monitor your blood sugar levels more often if you have a history of type 2 diabetes.

It’s also important to understand the difference between hyperglycemia and diabetes. 

 

  • Hyperglycemia is high blood sugar due to any cause, and also a characteristic of diabetes.
  • Type 1 Diabetes is a condition where your body stops making the insulin it needs to allow blood sugar to enter the cells of the body.
  • Type 2 Diabetes is a condition where your body either doesn't make enough insulin or is unable to use it correctly.

The safety of PIQRAY in patients with type 1 and uncontrolled type 2 diabetes has not been established. If you have a history of diabetes, talk to your doctor about how that could affect your experience with PIQRAY.

 

In general, hyperglycemia that may be caused by PIQRAY is not diabetes.

 

If you experience hyperglycemia while taking PIQRAY, remember:

 

Managing hyperglycemia while taking PIQRAY
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
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.
 
 

 

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. 

Common side effects

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

Rash Icon

Rash

Nausea Icon

Nausea

Fatigue Icon

Tiredness and Weakness

Decrease Appetite Icon

Decreased Appetite

Mouth Sores Icon

Mouth Sores

Vomiting Icon

Vomiting

Weight Loss Icon

Weight Loss

Hair Loss Icon

Hair Loss

Blood Test Icon

Changes in Certain Blood Tests

Frequently asked questions about managing certain side effects

Below are some suggestions that your doctor may offer for managing some of the side effects of PIQRAY. Always talk to your doctor before making any changes to your diet or exercise routine.

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Although not all the side effects of PIQRAY can be managed, your health care team may offer suggestions to help manage some of them. It’s important to talk with your doctor or nurse about the side effects you experience and the best ways to manage them. 

 

Get more tips about managing some side effects.

Your doctor will monitor your blood sugar levels before starting and while taking PIQRAY. Your doctor may also have you monitor your blood sugar levels at home, which you should do in the morning, before eating or drinking. Your doctor may monitor your blood sugar levels more often if you have a history of type 2 diabetes. Your doctor may also monitor more frequently for the first few weeks during treatment if you have risk factors for high blood sugar.

 

Visit our side effect management page for guidance on a recommended monitoring schedule and more information.

 

Hyperglycemia is high blood sugar due to any cause, and also a characteristic of diabetes. Type 1 Diabetes is a condition where your body stops making the insulin it needs to allow blood sugar to enter the cells of the body. Type 2 Diabetes is a condition where your body either doesn't make enough insulin or is unable to use it correctly.

 

If you have a history of diabetes, talk to your doctor about how that could affect your experience with PIQRAY.

Visit our side effect management page for guidance on managing hyperglycemia.

Rash is one of the most common side effects of PIQRAY when used with fulvestrant, and can appear within 2 weeks. Your doctor may require dose interruption, reduction, or discontinuation based on the severity of rash.

 

Before a rash appears: Your doctor may prescribe an antihistamine to help reduce the chances of a rash developing. Taking antihistamines before a rash appears may decrease the chances of rash and severity of rash, based on the clinical trial. 

 

If a rash does occur: Your doctor may prescribe one or more types of medication to help with symptoms, depending on their severity. Additionally, tips such as wearing loose clothing and using mild and unscented detergent may help you take care of a rash at home. 

 

Learn more tips about managing rash and ask your doctor for clarification on any medication you're not familiar with.

Your doctor may suggest that you take an antidiarrheal medicine to help you manage your diarrhea. Use this medicine only as directed by your doctor. Talk to your doctor if antidiarrheal medicine does not help. Your doctor may also need to interrupt, reduce your dose of, or discontinue PIQRAY. You can also manage diarrhea by watching what you eat and drink. Some suggestions include staying hydrated, avoiding dairy products, and eating frequent, small meals. Talk to your doctor before making any changes to your diet. 

 

Find more recommendations for managing diarrhea.