Frequently Asked Questions

PIQRAY® (alpelisib) tablets

Questions and Answers About PIQRAY

Click below to find answers to some of the most common questions about PIQRAY.

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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 or metastatic breast cancer with an abnormal PIK3CA gene whose disease has progressed on or after endocrine (hormone) therapy. 

 

Your health care provider will test your cancer for an abnormal PIK3CA gene to make sure that PIQRAY is right for you.

 

It is not known if PIQRAY is safe and effective in children.

 

Click here to learn more about who is eligible for PIQRAY.

PIQRAY is a biomarker-driven treatment approach that specifically targets proteins created by an abnormal (or mutated) PIK3CA gene, which are linked to cancer growth. PIQRAY affects cancer cells, but can also affect healthy cells. Although PIQRAY has been studied in patients with HR+, HER2- mBC, how PIQRAY works has only been demonstrated in laboratory studies.

 

Learn how PIQRAY and fulvestrant may help.

PIK3CA mutations can only be detected through a specific genomic test ordered by your doctor. Even if you’ve had genetic testing done before, ask your doctor about getting tested specifically for a PIK3CA mutation.

Combination therapy is a treatment strategy of taking multiple medicines. By combining PIQRAY and fulvestrant, you’ll have 2 medicines working differently, but together, to help treat your HR+, HER2- metastatic breast cancer (mBC) with a PIK3CA mutation. 

 

Learn how PIQRAY and fulvestrant may help.

The most common side effects of PIQRAY when used with fulvestrant include hyperglycemia, diarrhea, rash, nausea, tiredness and weakness, decreased appetite, mouth sores, vomiting, weight loss, hair loss, and changes in certain blood tests. PIQRAY can also cause more serious side effects. Learn more about potential side effects here.

The most serious side effects of PIQRAY include:

 

  • Severe Hypersensitivity
  • Severe Cutaneous Adverse Reactions (SCARs), including Stevens-Johnson syndrome (SJS), erythema multiforme (EM), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS)
  • Hyperglycemia, in some cases associated with hyperglycemic hyperosmolar non-ketotic syndrome (HHNKS) or ketoacidosis
  • Pneumonitis
  • Diarrhea
  • Embryo-Fetal Toxicity
Please see full Prescribing Information, including Patient Information.

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 side effects you experience and the best ways to manage them. Get 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. 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. 

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.

 

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 can 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. 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.

PIQRAY is a once-daily oral tablet that is prescribed with fulvestrant, an injectable hormone therapy administered by your health care provider. Take PIQRAY exactly as your health care provider tells you. Your doctor will prescribe the dose of PIQRAY that’s right for you. Take PIQRAY at the same time each day, 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. Do not change your dose or stop taking PIQRAY unless your health care provider tells you to do so. Learn more about taking PIQRAY here.

If you take too much PIQRAY, call your health care provider or go to the nearest hospital emergency room right away.

 

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.

Learn about financial resources here.

Store PIQRAY at room temperature between 68°F to 77°F (20°C to 25°C). Keep PIQRAY and all medicines out of the reach of children.