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.
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.
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.
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.
*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.
Diarrhea is common with PIQRAY and may be severe. Follow your health care provider’s instructions for how to manage diarrhea.
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.
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.
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
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 antihistamineto 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.
Topical corticosteroids:
Creams applied directly to the skin that may reduce swelling and redness
Oral antihistamines:
Medicines taken by mouth that may relieve itching
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.
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
Important Safety Information
Do not take PIQRAY if you have had a severe allergic reaction to PIQRAY or are allergic to any of the ingredients in PIQRAY.
PIQRAY may cause serious side effects, including:
Severe allergic reactions: Tell your health care provider or get medical help right away if you have trouble breathing, swelling of the face or throat, flushing, rash, fever, or fast heart rate during treatment with PIQRAY...
Do not take PIQRAY if you have had a severe allergic reaction to PIQRAY or are allergic to any of the ingredients in PIQRAY.
PIQRAY may cause serious side effects, including:
Severe allergic reactions: Tell your health care provider or get medical help right away if you have trouble breathing, swelling of the face or throat, flushing, rash, fever, or fast heart rate during treatment with PIQRAY
Severe skin reactions: Tell your health care provider or get 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
High blood sugar levels (hyperglycemia): Hyperglycemia is common with PIQRAY and may 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, dry mouth, urinating more often than usual or having a higher amount of urine than normal, increased appetite with weight loss, confusion, nausea, vomiting, fruity odor on breath, difficulty breathing, or dry or flushed skin
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, or chest pain
Diarrhea or colitis (inflammation of your intestines): Diarrhea is common with PIQRAY and may be severe. Severe diarrhea can lead to the loss of too much body water (dehydration) and kidney injury. Tell your health care provider right away, if you develop diarrhea, stomach-area (abdominal) pain, or see mucus or blood in your stool during treatment with PIQRAY. Your health care provider may tell you to drink more fluids or take medicines to treat diarrhea or colitis
Your health care provider may tell you to decrease your dose, temporarily stop your treatment, or completely stop your treatment with PIQRAY if you get certain serious side effects.
Before you take PIQRAY, tell your health care provider about all of your medical conditions, including if you:
have a history of diabetes
have a history of skin rash, redness of skin, blistering of the lips, eyes or mouth, or skin peeling
are pregnant or plan to become pregnant. PIQRAY can harm your unborn baby
Females who are able to become pregnant:
Your health care provider will check to see if you are pregnant before you start treatment with PIQRAY
You should use effective birth control during treatment with PIQRAY and for 1 week after the last dose. Talk to your health care provider about birth control methods that may be right for you during this time
If you become pregnant or think you are pregnant, tell your health care provider right away
Males with female partners who are able to become pregnant should use condoms and effective birth control during treatment with PIQRAY and for 1 week after the last dose. If your female partner becomes pregnant, tell your health care provider right away.
are breastfeeding or plan to breastfeed. It is not known if PIQRAY passes into your breast milk. Do not breastfeed during treatment with PIQRAY and for 1 week after the last dose
You should also read the full Prescribing Information of fulvestrant for important pregnancy, contraception, infertility, and lactation information.
Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. PIQRAY and other medicines may affect each other causing side effects. Know the medicines you take. Keep a list of them to show your health care provider or pharmacist when you get a new medicine.
The most common side effects of PIQRAY when used with fulvestrant include:
rash
nausea
tiredness and weakness
decreased appetite
mouth sores
vomiting
weight loss
hair loss
changes in certain blood tests
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.
These are not all the possible side effects of PIQRAY. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch ↗, or call 1-800-FDA-1088.
Please see full Prescribing Information, including Patient Information. ↗
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Approved Use
PIQRAY® (alpelisib) tablets 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 breast cancer or breast cancer that has spread to other parts of the body (metastatic), with an abnormal phosphatidylinositol-3-kinase catalytic subunit alpha (PIK3CA) gene, and...
PIQRAY® (alpelisib) tablets 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 breast cancer or breast cancer that has spread to other parts of the body (metastatic), with an abnormal phosphatidylinositol-3-kinase catalytic subunit alpha (PIK3CA) gene, and
whose disease has progressed on or after endocrine 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.