Side Effect Management

PIQRAY® (alpelisib) tablets

Tips for Managing Selected 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.

 

High Blood Sugar (Hyperglycemia)

As hyperglycemia is common 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. If you experience high blood sugar while on PIQRAY, your health care provider may prescribe a medication along with suggested lifestyle changes, and will monitor your blood sugar levels more frequently. Your doctor may require dose interruption, reduction, or discontinuation based on the severity of hyperglycemia.

 

If you experience hyperglycemia while taking PIQRAY, remember in the clinical study it was generally:

  • Manageable—in the clinical study, 87% of patients* with hyperglycemia were managed with anti-hyperglycemic medication. Your doctor can help manage your hyperglycemia.
  • Reversible—in nearly all patients (96%), elevated blood sugar returned to pre-treatment level after stopping treatment with PIQRAY in the clinical study

It's also important to understand the difference between hyperglycemia and diabetes. Hyperglycemia is high blood sugar due to any cause and is 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. In Type 2 diabetes, your body either doesn't make enough insulin or is unable to use it correctly. In general, hyperglycemia that may be caused by PIQRAY is not diabetes. In a clinical study, nearly all patients (96%)† who experienced elevated blood sugar levels returned to pre-treatment levels after stopping treatment with PIQRAY. 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.

 

Signs of high blood sugar include:

  • Excessive thirst
  • Urinating more often than usual or having a higher amount of urine than normal
  • Dry mouth
  • Increased appetite with weight loss

 

Contact your doctor immediately if you experience any signs and symptoms of hyperglycemia. Your doctor may require dose interruption, reduction, or discontinuation based on the severity of hyperglycemia.

*Of the 187 patients with hyperglycemia, 163 were managed with anti-hyperglycemic medication.

Of the 54 patients with elevated blood sugar levels, 52 had levels that returned to baseline after discontinuing PIQRAY.

 

Diarrhea

Diarrhea is common with PIQRAY, and can be severe. Follow your health care provider’s instructions for how to manage diarrhea.

 

  • Your health care provider may suggest that you have an antidiarrheal medicine on hand to help manage your diarrhea. Use this medicine only as directed under the supervision of your doctor.
  • Talk to your doctor if antidiarrheal medicine does not help with your diarrhea.
  • If you have diarrhea, your doctor may need to interrupt, reduce your dose of, or discontinue PIQRAY.

 

Help manage diarrhea by watching what you eat and drink

  • Diarrhea can cause you to lose more fluid than you’re taking in, so it’s important to stay hydrated. Drink at least 8 glasses of clear liquids per day (such as water, broth, or sports drinks).
  • Eat frequent, small meals and bland, easily digestible foods. Try the BRAT Diet: Bananas, Rice, Applesauce, and Toast.
  • Avoid spicy and/or greasy foods, alcohol, coffee, tea, and soda with caffeine.
  • Avoid milk and dairy products.
  • Eat food high in protein, such as chicken, turkey, eggs, and fish.

Talk to your doctor before making any changes to your diet.

 

Rash

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.

 

Treatment: If a rash occurs, your doctor may prescribe one of the following types of medication to help with the symptoms, depending on their severity:

  • Topical corticosteroids: creams applied directly to the skin that may reduce swelling and redness
  • Oral antihistamines: medicines taken by mouth that may relieve the itching
  • Systemic corticosteroids: medicines taken by mouth or injection that may reduce swelling

 

Here are some tips for taking care of a rash at home:

  • Wear loose clothing.
  • Avoid hot showers; use cool or lukewarm water.
  • Use mild soap and unscented detergent.
  • Gently pat your skin dry after bathing.
  • Protect your skin from the sun with sunscreen or long, loose clothing.

 

Your doctor may require dose interruption, reduction, or discontinuation based on the severity of the rash.