Side Effect Management

Stay proactive. Plan, monitor, and manage potential side effects while taking PIQRAY® (alpelisib) tablets

How to plan for, monitor, and manage select side effects

Everyone can react to side effects differently. Some can be managed by preparing proactively with your health care team. It all comes down to planning, monitoring, and managing. 

 

At the first sign of side effects, you and your doctor can take action. To help you develop a proactive management plan, below are some suggestions that your doctor may offer for managing some of the side effects of PIQRAY.

How to manage select side effects

Because rash, diarrhea or colitis, and hyperglycemia can be serious yet common side effects of taking PIQRAY, it's important to understand how to manage these conditions so you can be ready. Watch the video below for helpful tips and information.

Tips to help you with hyperglycemia (high blood sugar)

 

Planning for potential hyperglycemia:

Hyperglycemia can appear within a median time of 15 days. At the earliest indication of high blood sugar levels, be sure to talk to your doctor and review the helpful information below.

 

Monitoring hyperglycemia:

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. Though hyperglycemia is different from diabetes, your doctor may monitor your blood sugar levels more often if you have a history of Type 2 diabetes. The chart below shows a recommended monitoring schedule.

Monitoring blood sugar levels during treatment with PIQRAY

*After starting treatment, fasting glucose (FPG or fasting blood glucose) can be monitored

Signs of high blood sugar include:

  • 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 

 

 

 

 

 

Managing hyperglycemia:

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.

 

It’s important to note that in a clinical study, 87% of patients* with hyperglycemia were able to manage it with anti-hyperglycemic medication. In nearly all patients (96%), elevated blood sugar returned to pre-treatment levels after stopping treatment with PIQRAY. 

 

*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.

 

If you experience hyperglycemia, your doctor may prescribe a medication (such as metformin), along with suggested lifestyle changes, and may require dose interruption, reduction, or discontinuation based on the severity of hyperglycemia. Always talk to your doctor before making any changes to your diet or exercise routine. 

Tips to help you with diarrhea or colitis (inflammation of your intestines)

Planning for potential diarrhea or colitis:

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

 

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Diarrhea and colitis are serious side effects of PIQRAY. Notify your doctor immediately if you develop diarrhea, stomach-area (abdominal) pain or see mucus or blood in your stool while taking PIQRAY. Your doctor may suggest that you drink more fluids or have an antidiarrheal medicine on hand to help manage your diarrhea. For colitis, your doctor may tell you to drink more fluids or take an additional treatment, such as enteric-acting and/or systemic steroids. Use these medicines only as directed by your doctor.

 

 

 

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Talk to your doctor if antidiarrheal medicine does not help with your diarrhea. If you have diarrhea or colitis, your doctor may decrease your dose, have you take a break from treatment, or tell you to completely stop taking PIQRAY.

Monitoring for diarrhea or colitis:

Diarrhea is a disorder characterized by more frequent and/or loose or watery bowel movements. Talk to your doctor as soon as you begin experiencing symptoms of diarrhea or colitis.

 

Managing diarrhea or colitis:

Watching what you eat and drink can help:

 

  • Diarrhea or colitis 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.

Tips to help you with a rash

Planning for potential 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. 

 

Ask your doctor for clarification on any medication you're not familiar with.

 

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 of the following types of medication (shown below) to help with symptoms, depending on their severity.

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Topical corticosteroids: Creams applied directly to the skin that may reduce swelling and redness

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Oral antihistamines: Medicines taken by mouth that may relieve itching

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Systemic corticosteroids:Medicines taken by mouth or injection that may reduce swelling

Ask your doctor for clarification on any medication you're not familiar with.

Monitoring rash:

Tell your doctor or seek 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. Depending on the severity, they may prescribe a stronger medication, interrupt treatment, or reduce your dose of PIQRAY.

 

Managing rash:

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

 

  • Wear loose clothing.
  • When outside, wear sunscreen or long sleeves and pants.
  • Take cool or lukewarm showers.
  • Use mild soap and unscented detergent.
  • Gently pat your skin dry after bathing.