Piqray
Piqray (alpelisib) is an oral medication that treats breast cancer with a specific set of receptors and mutations. It’s typically reserved for breast cancer that has spread or is considered advanced. It's also only approved for females who’ve already gone through menopause and for males. Piqray (alpelisib) treatment is convenient because it’s taken by mouth, only once daily. But it’s typically given in combination with fulvestrant (Faslodex), another anticancer medication that needs to be injected. Some common side effects of Piqray (alpelisib) include higher blood sugar levels and diarrhea.
What is Piqray (alpelisib)?
What is Piqray (alpelisib) used for?
- Metastatic or advanced breast cancer that’s hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, with PIK3CA mutations (in females who’ve gone through menopause and in males)
How Piqray (alpelisib) works
Piqray (alpelisib) is a kinase inhibitor. It targets proteins made by the PIK3CA gene. Typically, these proteins send signals to help cells grow and divide.
In people with certain types of breast cancer, there are changes to their PIK3CA gene (mutations). These mutations cause the proteins made by the PIK3CA gene to send too many signals. This leads to the cancer cells growing and dividing very fast.
Piqray (alpelisib) blocks the PIK3CA proteins from sending too many signals to cancer cells. With less signals to grow, the cancer cells won’t be able to grow as fast.
Drug facts
Side effects of Piqray (alpelisib)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- High blood sugar (79%)
- Higher creatinine levels (67%)
- Diarrhea (up to 58%)
- Low white blood cell count (52%)
- Higher liver enzyme levels (up to 52%)
- Rash (up to 52%)
- Nausea (up to 45%)
- Tiredness (up to 42%)
- Low red blood cell count (42%)
- Loss of appetite (up to 36%)
- Painful sores in the mouth and throat (up to 30%)
- Vomiting (up to 27%)
- Weight loss (up to 27%)
- Lower calcium, potassium, and magnesium levels (up to 27%)
- Longer activated partial thromboplastin time (aPTT) (21%)
- Hair loss (up to 20%)
Please note: These side effects are reported by people who took Piqray (alpelisib) along with fulvestrant (Faslodex) and might not be caused by Piqray (alpelisib) alone.
Less Common Side Effects
- Mucosal inflammation
- Change in how things taste
- Headache
- Itchy or dry skin
- Stomach pain
- Swelling in your arms and legs
- Fever
- Dryness of mouth and female genital areas
- Heartburn
- Pain or burning while urinating, needing to urinate more often, or other symptoms of urinary tract infection
Piqray (alpelisib) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Dangerously high blood sugar: dry mouth, feeling thirsty, confusion, headache, nausea or vomiting, fruity breath, dry or flushed skin, fast breathing, urinating more often, experiencing weight loss while feeling more hungry
- Serious lung problems: trouble breathing, dry cough, feeling very tired or weak, not feeling hungry, chest pain and discomfort
- Severe allergic reaction: hives, difficulty breathing, swelling of the lips, tongue, or face
- Severe skin reactions: skin rash, blisters on skin, peeling skin, fever
The following Piqray (alpelisib) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
- Dry cough, shortness of breath or trouble breathing
- High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
- Pancreatitis—severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting
- Rash, fever, and swollen lymph nodes
- Redness, blistering, peeling, or loosening of the skin, including inside the mouth
- Sudden or severe stomach pain, bloody diarrhea, fever, nausea, vomiting
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Pros and cons of Piqray (alpelisib)
Pros
- Only medication approved by the FDA for HR+, HER2- breast cancer with a PIK3CA mutation
- Taken once daily
- Comes in a blister pack to help keep you on track with your doses
Cons
- Might affect your ability to have a child
- Commonly causes diarrhea and rash
- Raises blood sugar levels, so need frequent monitoring of blood sugars
Pharmacist tips for Piqray (alpelisib)
- Swallow Piqray (alpelisib) tablets whole. Don’t chew, crush, or split the tablets.
- Take Piqray (alpelisib) with food at the same time every day.
- If you miss a dose of Piqray (alpelisib) and less than 9 hours have passed since when you normally take the medication, then take the missed dose as soon as possible. If it's been more than 9 hours since the dose was due, skip the dose for that day and continue your normal dosing schedule the next day. Don't take two tablets to make up the missed dose because this can lead to side effects.
- If you vomit shortly after taking your Piqray (alpelisib) dose, don't take an additional dose that day. Continue your normal dosing schedule the next day.
- If you’re experience diarrhea from Piqray (alpelisib) , make sure to stay hydrated. Let your provider know if you have symptoms such as dry mouth, not urinating as much, lightheadedness, and dizziness - these might be signs that you’ve lost too much fluids and electrolytes and need more medical care.
- You should be taking Piqray (alpelisib) at the same time as fulvestrant (Faslodex), another anticancer medication. Check with your provider if you aren’t receiving this medication.
- Ask your provider or pharmacist about the best way to handle and throw away Piqray (alpelisib) safely. Anticancer medications can be very harmful to people who handle or come into contact with them.
Common questions about Piqray (alpelisib)
No. Although there are many different types of breast cancer, Piqray (alpelisib) is only FDA-approved to treat hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer with changes in the PIK3CA gene. Before you begin treatment, your provider will perform a biopsy or surgery to help figure out the receptor type of your cancer. Knowing what type of receptor your cancer has will help you provider decide what treatment is best for you. Your provider will also test your cancer for any mutations - about 40% of people with HR+, HER2- metastatic breast cancer have a PIK3CA mutation.
If you have diarrhea from taking Piqray (alpelisib), let your provider know. They can let you know whether or not you need more immediate medication attention based on your symptoms. If your provider says that you can manage your symptoms at home, they might prescribe antidiarrheal medications, like loperamide (Imodium A-D). Your provider might also recommend that you watch what you eat and drink, such as avoiding spicy and greasy foods, and milk and other dairy products. Try sticking with foods that are more bland, such as bananas, rice, applesauce, and toast.You can also try eating smaller meals, more often throughout the day. It’s also important to stay hydrated. It’s important to drink at least 8 glasses of water (or broth, sports drink) each day to stay hydrated.
Both Piqray (alpelisib) and Vijoice (alpelisib) contain the same active ingredient, alpelisib. The difference between the two medications is what conditions they're approved to treat. Piqray (alpelisib) is taken to treat breast cancer, while Vijoice is approved to treat rare growth disorders. The dosing between the two medications is also different since they're used to treat different medical conditions.
Piqray (alpelisib) is not a chemotherapy medication. Chemotherapy is a class of medication that targets and kills cancer cells in your body. Piqray (alpelisib) doesn’t kill cancer cells. Instead, it works by slowing cancer cell growth.
You're recommended to avoid breastfeeding while receiving Piqray (alpelisib). We don’t know if the medication can pass into breast milk, but there’s a risk of serious harm to nursing infants if it does. Because of this risk, you shouldn’t breastfeed during Piqray (alpelisib) treatment and for 1 week after your last dose. But you might need to pause breastfeeding for even longer. This is because Piqray (alpelisib) is typically taken with fulvestrant (Faslodex) and breastfeeding isn’t recommended until a year after you stop fulvestrant (Faslodex) treatment. Talk with your provider if you have any questions about breastfeeding or other ways to feed your baby while receiving treatment for breast cancer.
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Risks and warnings for Piqray (alpelisib)
Piqray (alpelisib) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Severe allergic reaction
Rarely, people taking Piqray (alpelisib) experienced a severe allergic reaction. If you have a severe reaction, your provider will have you permanently stop taking Piqray (alpelisib). Get medical help right away if you experience symptoms of an allergic reaction, including trouble breathing, flushing, rash, fever, or fast heartbeat.
Serious skin reactions
Piqray (alpelisib) can cause rare, but serious, skin reactions. If you have a serious skin reaction, your provider will have you stop taking Piqray (alpelisib). If your reaction isn’t serious, your provider might lower your Piqray (alpelisib) dose or try to ease your symptoms by recommending you to apply a topical corticosteroid, or take an oral antihistamine, like diphenhydramine (Benadryl). Let your provider know immediately if you have a low-grade fever, chills, blisters on the skin or skin peeling, or a skin rash that keeps getting worse.
High blood sugar
- Risk factors: People who identify as obese | High blood sugar | Taking corticosteroids at the same time | Older adult
Piqray (alpelisib) can cause your blood sugar levels to rise. Rarely, this can lead to life-threatening medication conditions, such as ketoacidosis. You might notice a rise in your blood sugar levels as quickly as a week after the start of treatment, or as late as more than a year later. Your provider will monitor your blood sugar before you start Piqray (alpelisib) and regularly throughout treatment. They’ll also give you tips to keep your blood sugar level under control with changes to your lifestyle. If you develop high blood sugar your provider might lower your dose of Piqray (alpelisib) , or have you stop taking Piqray (alpelisib) (either temporarily or permanently, depending on your blood sugar levels). Let your provider know if you experience any symptoms of seriously high blood sugar, such as feeling more thirsty, urinating more often, or experiencing weight loss despite feeling more hungry.
Lung problems
Some people taking Piqray (alpelisib) developed lung problems, like inflammation of the lungs or interstitial lung disease (IDL). If you experience trouble breathing, your provider will have you stop taking Piqray (alpelisib) while they figure out what is causing the problem. If you do have IDL or inflammation in your lungs, then your provider will ask you to stop taking Piqray (alpelisib). Let your provider know if you develop any new or worsening breathing problems, like cough, chest pain, or trouble breathing.
Diarrhea or serious gut problems
Piqray (alpelisib) commonly causes diarrhea. This can occur as soon as you start treatment, but some people don't experience this side effect until they’ve been taking this medication for over a year. Diarrhea can be dangerous because you might lose too much body fluids and electrolytes. Let your provider know if you experience diarrhea and they can let you know if you need more immediate medication attention. Depending on how serious your condition is, your provider might ask you to temporarily stop taking Piqray (alpelisib), lower your dose, or have you stop the medication permanently. They might also recommend that you take a medication to help stop the diarrhea, like loperamide (Imodium A-D). If you develop diarrhea, be sure to drink water or sports drink to stay hydrated and replace the fluids you've lost.
Taking Piqray (alpelisib) might also cause inflammation of the large intestines (colitis). If this occurs, your provider might delay your Piqray (alpelisib) dose, lower your dose, or have you stop taking the medication. They might also prescribe you steroids to ease the symptoms. Let your provider know if you experience symptoms of colitis, like stomach pain, or mucus or blood in your stool.
Harm to unborn baby
Piqray (alpelisib) hasn’t been studied in human pregnancies, but animal studies show that it can cause harm to unborn babies. If you're able to become pregnant, your provider might check to see if you are pregnant before you start treatment. You should use birth control while you’re receiving Piqray (alpelisib) and for at least 1 week after your last dose. If you’re a male receiving Piqray (alpelisib) and your partner is able to become pregnant, you should also use birth control while receiving Piqray (alpelisib) and for at least 1 week after your last dose. Let your provider know right away if you or your partner become pregnant during this time.
Piqray (alpelisib) dosage
Typical dosage for Piqray (alpelisib)
The typical dose is to take 300 mg by mouth once daily.
