Piqray is a brand-name prescription medication. It’s approved by the Food and Drug Administration (FDA) to treat breast cancer that has several factors. Specifically, the cancer must be:
- advanced (has spread into lymph glands or tissue near the breast) or metastatic (has spread to other parts of the body, such as the bones, liver, lungs, or brain)
- PIK3CA mutated (the cancer cells have a particular gene mutation, which is an abnormal change, that increases cancer growth)
- hormone receptor (HR) positive (its growth is stimulated by the hormones estrogen, progesterone, or both)
- human epidermal growth factor receptor 2 (HER2) negative (the cancer cells don’t have abnormally high levels of HER2, which is a protein that promotes cell growth)
- worsened during or after treatment with hormone therapy (treatment that stops estrogen, progesterone, or both from stimulating cancer growth)
Piqray is approved for use in adult females* after menopause and in adult males.* It is used in combination with a hormone therapy called fulvestrant (Faslodex).
For details about this condition and how the drug treats it, see the “Piqray: Uses” section below.
* Sex and gender exist on spectrums. In this article, use of the terms “male” and “female” refers to sex assigned at birth.
Key points
The following table provides key facts about Piqray.
Active drug | alpelisib |
Drug class | kinase inhibitors |
Form | oral tablet |
FDA approval | May 2019 |
Finding a healthcare professional
If you’re interested in taking this drug, search here to find a doctor who might prescribe it.
Piqray contains the active drug alpelisib. It comes only as a brand-name medication. It’s not available as a generic drug.
A generic is an identical copy of the active drug found in a brand-name medication. Generics typically cost less than brand-name drugs.
As with most drugs, it’s possible to have side effects with Piqray. These can include some mild side effects but also some serious ones.
To learn more about Piqray’s side effects, talk with your doctor or pharmacist. They may also provide information about managing certain side effects of this drug.
Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Piqray, you can do so through MedWatch.
Mild and serious side effects
Mild and serious side effects of Piqray are listed below. This article does not include all of Piqray’s possible side effects.
Mild side effects
Mild side effects* of Piqray may include:
- fatigue
- stomatitis (inflammation and sores in the mouth and throat)
- mild diarrhea
- nausea and vomiting
- abdominal pain
- headache
- change in the way foods taste
- reduced appetite
- weight loss
- hair loss
- increased blood sugar level
- dry mouth, lips, nose, or vagina
- dry or itchy skin
- mild skin rash
- mild allergic reaction†
Most times, mild side effects of a drug go away within a few days or a couple of weeks. Talk with your doctor or pharmacist if any side effects become severe or don’t go away.
* This is not a complete list of Piqray’s mild side effects. To learn about other mild side effects of this drug, ask your doctor or pharmacist. Or you can view the drug’s prescribing information.
† To learn more about allergic reaction, see below.
Serious side effects
Serious side effects of Piqray may include:
- severe hyperglycemia (very high blood sugar level)
- pneumonitis (inflammation in the lungs)
- colitis (inflammation in the bowel)
- severe diarrhea
- severe skin reactions, such as toxic epidermal necrolysis or Stevens-Johnson syndrome
- severe allergic reaction*
Serious side effects from Piqray aren’t common, but they are possible. If you have serious side effects, call your doctor right away. However, if you’re having a medical emergency or your symptoms feel life threatening, call 911 or a local emergency number.
* To learn more about allergic reaction, see below.
Allergic reaction
As with most drugs, some people can have an allergic reaction after taking Piqray. A more severe allergic reaction is rare but possible. In clinical studies, allergic reactions were reported with Piqray, although they were rare.
Possible symptoms of mild and serious allergic reactions are listed in the table below.
Mild allergic reaction symptoms | Serious allergic reaction symptoms |
flushing | swelling under your skin, possibly in your hands, feet, lips, or eyelids |
rash | swelling in your throat or mouth |
itching | trouble breathing |
If you have an allergic reaction to Piqray, call your doctor right away. This is important because the reaction could become severe.
However, if you’re having a medical emergency or your symptoms feel life threatening, call 911 or a local emergency number.
As with other medications, prices for Piqray may vary. The drug’s price will depend on factors such as:
Cost considerations for Piqray
Here are some things to consider when looking into the cost of Piqray.
Option for a 90-day supply. For some drugs, it’s possible to get a 90-day supply. If this option is approved by your insurance company, it can help lower the cost of the drug. It can also help you avoid frequent trips to your pharmacy. If you’d like to learn more about this option, ask your doctor, pharmacist, or insurance company.
Need for prior authorization. Before insurance coverage for Piqray is approved, your insurance company may require prior authorization. In this case, your doctor and insurance company will communicate about your prescription for Piqray. Then, the insurance company will decide whether the drug will be covered. To find out whether you need prior authorization for Piqray, contact your insurance company.
Possible cost assistance options. Financial assistance to help lower the cost of Piqray is available. The manufacturer of Piqray offers savings programs that may help reduce its cost. To learn more and see whether you’re eligible for support, call 800-282-7630 or visit the manufacturer’s website. Also, check out this article to learn about ways to save on prescription drugs.
Use of a specialty pharmacy. Piqray is dispensed only from specialty pharmacies. These pharmacies are authorized to handle certain drugs considered specialty medications. These medications may be expensive or require help from healthcare professionals to be used safely and effectively. Ask your doctor which specialty pharmacy they’ll prescribe Piqray through.
Use of a mail-order pharmacy. Piqray may be dispensed through mail-order pharmacies. Getting your prescription through a mail-order pharmacy could lower its cost. It can also allow you to get the drug without leaving home. To find out more about this option, check with your doctor, pharmacist, or insurance company.
Availability of a generic form. Piqray doesn’t come in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Typically, generics cost less than brand-name drugs.
Below, you’ll find dosages that are commonly recommended for Piqray. However, you should take the dosage your doctor prescribes for you. They’ll recommend the dosage that’s best for your needs.
The dosage of Piqray that your doctor prescribes will depend on factors such as:
- any health conditions you have
- side effects you may have with Piqray
Piqray’s forms and strengths
Piqray is available as follows.
- Form: oral tablet
- Strengths: 50 milligrams (mg), 150 mg, and 200 mg
Piqray’s recommended dosage
The recommended dosage for Piqray is described below.
Adult dosage
The recommended dosage for Piqray in adults is as follows.
- Dose: 300 mg
- Frequency: once per day
Dosage considerations
Below are some things to consider about Piqray’s dosage.
Missing a dose. You should take Piqray with food at the same time each day. If you miss a dose, check when it was due. If it was due 9 hours ago or less, take the missed dose with food as soon as possible. Then take the next dose at your usual time the following day.
If it was due more than 9 hours ago, skip the missed dose. Then take the next dose at your usual time the following day. Do not take two doses together or take extra doses to make up for a missing dose.
Try these medication reminder options to help you avoid missing doses. You could also set an alarm, use a timer, or download a reminder app on your phone.
Vomiting after a dose. If you vomit after taking a dose, don’t take an extra dose that day. However, take the next dose at your usual time the following day.
Length of treatment. Doctors typically prescribe Piqray as a long-term treatment. You’ll likely take it long term if you and your doctor feel it’s safe and effective for your condition.
Prescription drugs, such as Piqray, are approved by the Food and Drug Administration (FDA) to treat certain conditions.
Using Piqray for breast cancer
Piqray is FDA approved to treat breast cancer that has several factors. Specifically, the cancer must be:
- advanced (has spread into lymph glands or tissue near the breast) or metastatic (has spread to other parts of the body, such as the bones, liver, lungs, or brain)
- PIK3CA mutated (the cancer cells have a particular gene mutation, which is an abnormal change, that increases cancer growth)
- hormone receptor (HR) positive (its growth is stimulated by the hormones estrogen, progesterone, or both)
- human epidermal growth factor receptor 2 (HER2) negative (the cancer cells don’t have abnormally high levels of HER2, which is a protein that promotes cell growth)
- worsened during or after treatment with hormone therapy (treatment that stops estrogen, progesterone, or both from stimulating cancer growth)
Piqray is approved for use in adult females* after menopause and in adult males.* It is used in combination with the hormone therapy called fulvestrant (Faslodex).
Piqray will not work to treat breast cancer that doesn’t have the PIK3CA mutation. It’s a therapy that targets this type of breast cancer. Targeted therapies (drugs) block specific proteins or processes that make cancer cells grow and multiply quickly.
Your doctor will order various tests before prescribing Piqray. These tests will check your cancer for the PIK3CA gene mutation and its HR and HER2 status. The tests examine a tissue sample from a biopsy (sample of cells usually removed with a needle). They also may examine tumor tissue removed by surgery. Once your doctor knows the features of your cancer, they can prescribe the most appropriate treatment.
* Sex and gender exist on spectrums. In this article, use of the terms “male” and “female” refers to sex assigned at birth.
Taking Piqray with other drugs
Piqray is used with a hormone therapy called fulvestrant (Faslodex). Combining these drugs slows the cancer’s growth and spread more effectively than taking just one or the other.
Fulvestrant is taken by intramuscular injection (into a muscle). You’ll typically receive fulvestrant injections once every month at your doctor’s office or clinic.
Using Piqray in children
Piqray is not approved for any uses in children.
Finding a healthcare professional for Piqray
If you’re interested in taking Piqray, you can find a doctor who may prescribe it by searching here. To prepare for your appointment, you may find it helpful to use the appointment guide for breast cancer.
Doctors may prescribe drugs other than Piqray for your condition. Certain drugs may work better for you than others.
Piqray is used to treat breast cancer. Here’s a summary of other drugs that doctors sometimes prescribe for this condition.
For additional information about alternatives to Piqray, ask your doctor. They can tell you about other medications that could be prescribed for your condition. One example is palbociclib (Ibrance).
Piqray treats breast cancer that has a particular gene mutation (abnormal change). Through its mechanism of action, it treats breast cancer that has a mutation in the PIK3CA gene. Your doctor will order tests to check your breast cancer cells for this mutation.
To learn about other criteria for using Piqray in breast cancer, see the “Piqray: Uses” section above.
What PIK3CA does
The PIK3CA gene is found in all cells of the body. It carries instructions that tell cells how to make a protein called PI3K. The PI3K protein sends signals for making cells grow and multiply.
What happens with breast cancer that has a PIK3CA mutation
Sometimes, a mutation develops in the PIK3CA gene. When this occurs, cells make the PI3K protein, but it’s faulty. The faulty protein sends more signals than usual, which makes the cells grow and multiply more quickly. This action can lead to cancer.
Breast cancer cells that have a PIK3CA mutation also grow and multiply quickly. This causes the breast cancer to grow and spread.
What Piqray does
Piqray belongs to a drug class known as kinase inhibitors. Specifically, it’s a PI3K inhibitor, which is a type of kinase inhibitor. Piqray targets a kinase (a type of protein) called PI3K.
It works by blocking the signals sent by the PI3K protein. This slows the rate at which the breast cancer cells grow and multiply. In turn, it reduces the growth and spread of the cancer.
How long does Piqray take to start working?
Piqray starts working soon after you start taking it, although it’s unlikely you’ll notice this. Your doctor will order tests from time to time to check that Piqray is working for you.
Here are some common questions about Piqray and brief answers to them. If you’d like to know more about these topics, ask your doctor.
Is Piqray a chemotherapy drug?
No, Piqray isn’t a chemotherapy drug. Chemotherapy drugs are traditional cancer treatments. They work by destroying any cells in your body that are multiplying quickly. This includes healthy cells and not just cancer cells. As a result, chemotherapy drugs can cause significant side effects.
Instead, Piqray is a targeted therapy, which is a newer type of cancer treatment. It blocks specific proteins or processes that make cancer cells grow and multiply faster than healthy cells. Targeted therapies have fewer side effects than chemotherapy. However, they can still affect healthy cells, which can cause some serious side effects.
To learn how Piqray works, see the “Piqray: How it works” section above.
Will I need to have certain genetic tests before I can take Piqray?
Yes, you will need some genetic tests. Piqray treats only breast cancer that’s caused by a particular gene mutation (abnormal change). Specifically, it treats breast cancer that has a mutation in the PIK3CA gene.
Your doctor will order genetic tests that check your breast cancer cells for the PIK3CA mutation. This allows your doctor to make sure Piqray is right for you.
Do doctors prescribe Piqray for cancer other than breast cancer?
Sometimes they do, but Piqray is approved only for a particular type of breast cancer. Specifically, the cancer must have a mutation (abnormal change) in the PIK3CA gene.
With off-label use, doctors prescribe a drug for a purpose other than what it’s approved to treat. Doctors sometimes prescribe Piqray off-label for certain cancers that have the PIK3CA mutation.
For example, the drug is being studied for the treatment of cancers other than breast cancer. These include head and neck, ovarian, and stomach cancers. However, further research is needed to establish if Piqray is effective for these and other cancers.
If you’re interested in taking Piqray to treat cancer other than breast cancer, talk with your doctor.
Your doctor will recommend how you should take Piqray. It’s important to administer the drug exactly as your doctor instructs.
Piqray comes as an oral tablet that you swallow.
Questions about taking Piqray
Here’s a list of common questions related to taking Piqray.
When should I take Piqray? You should take Piqray once per day, at the same time each day. Taking Piqray around the same time each day helps keep a steady level of it in your body. This helps the medication work effectively.
Try these medication reminder options to help avoid missing doses of Piqray. You could also set an alarm, use a timer, or download a reminder app on your phone.
Do I need to take Piqray with food? Yes, you should take Piqray with food. Food helps the medication get absorbed properly into your body.
Can Piqray be chewed, split, or crushed? No, Piqray should be swallowed whole with water. Don’t chew, split, or crush Piqray tablets. If you have trouble swallowing Piqray, talk with your doctor.
Don’t take Piqray tablets that are broken or cracked. If you have a damaged tablet, dispose of it safely. See “Piqray: Expiration, storage, and disposal” below for more information about safe disposal of medications.
Is there a best time of day to take Piqray? No, there’s no best time to take Piqray. You can take it at any time, but consistently take it at the same time each day.
Tell your doctor about your health history before starting treatment with Piqray. Your doctor may not recommend this medication if you have certain factors affecting your health or specific medical conditions. These situations are considered drug-condition interactions.
These factors and conditions include those listed below.
Diabetes. Piqray commonly causes hyperglycemia (high blood sugar level), which can be severe. It’s not known whether Piqray is safe for people with diabetes. This includes people who have type 1 diabetes or people with type 2 diabetes that isn’t well managed.
If you have diabetes, ask your doctor whether Piqray is right for you. Other treatments may be better suited to your condition. If you do take Piqray, your doctor should monitor your blood sugar levels closely. If your blood sugar levels rise too high, they may adjust your diabetes medications. They also might recommend switching to a treatment other than Piqray.
Allergic reaction. Your doctor will likely not prescribe Piqray if you’ve had an allergic reaction to it or any of its ingredients. Also, your doctor likely will not prescribe Piqray if you’ve had a severe skin reaction to Piqray before. To find out about other treatment options, talk with your doctor.
Pregnancy. Piqray isn’t safe to take during pregnancy. If you’d like additional information about taking Piqray while pregnant, view the “Piqray: Taking while pregnant” section below.
Breastfeeding. You shouldn’t breastfeed while taking Piqray and for 1 week after your final dose. If you’d like additional information about taking Piqray while breastfeeding, view the “Piqray: Taking while breastfeeding” section below.
To learn more about the effects of Piqray that could be harmful, see the “Piqray: Side effects” section above.
Consuming alcohol while you’re taking Piqray isn’t known to affect the way the medication works. However, if you experience certain side effects with Piqray, drinking alcohol may make them worse. Examples of these side effects include:
- nausea and vomiting
- diarrhea
- headache
- hyperglycemia (high blood sugar level), if you consume alcoholic drinks with a high sugar content
In addition, if you have mouth or throat sores with Piqray, it may be painful to drink alcohol.
If you drink alcohol, talk with your doctor about how much is safe for you to consume while you’re taking Piqray.
Piqray may interact with other medications, certain supplements, and certain foods.
Different interactions can cause different effects. Some interactions can interfere with a drug’s effectiveness. Others can increase a drug’s side effects or cause them to be severe.
Before you start Piqray, be sure to tell your doctor about any medications, herbs, vitamins, or supplements you take. They can check for any possible interactions between these products and Piqray.
If any of the interactions listed below might pertain to you, talk with your doctor. (This isn’t a complete list of drug interactions that may occur with Piqray.) They can tell you what you need to do to avoid the interaction.
- Piqray and certain other medications. Because Piqray may interact with the following drugs, your doctor may recommend you do not take it with these drugs. Examples include:
- the seizure drugs phenytoin (Dilantin) and carbamazepine (Tegretol, Carbatrol, Equetro)
- the antibiotic rifampin (Rifadin)
- the immunosuppressant cyclosporine (Neoral, Gengraf, Sandimmune)
- the gout treatment febuxostat (Uloric)
- the nausea drug rolapitant (Varubi)
- the blood thinner warfarin (Jantoven)
- the nonsteroidal anti-inflammatory drug celecoxib (Celebrex)
- the diabetes medication glimepiride (Amaryl)
- corticosteroids, such as prednisone (Rayos), methylprednisolone (Medrol), and dexamethasone
- Piqray and herbs and supplements. Certain herbs and supplements may interact with Piqray. Examples include:
- St. John’s wort
- curcumin (turmeric)
- Piqray and foods. Piqray and foods don’t have any known interactions.
For information about drug-condition interactions, see the “Piqray: Precautions” section above.
Piqray isn’t safe to take during pregnancy. Animal studies reported harm in offspring of animals given Piqray, which doesn’t necessarily predict what would happen in people. However, knowing these findings and how Piqray works, it could harm a fetus if used during pregnancy.
If you could become pregnant, your doctor may order a pregnancy test for you before you start Piqray. If you become pregnant during treatment, talk with your doctor right away.
If you’re pregnant or planning to become pregnant, talk with your doctor about alternative treatment options for your cancer.
Piqray and fertility
Based on findings from animal studies, Piqray may affect fertility in males and females. If you’re concerned about your future ability to have children, talk with your doctor.
Note: Sex and gender exist on spectrums. In this article, use of the terms “male” and “female” refers to sex assigned at birth.
Piqray isn’t safe to take during pregnancy. Talk with your doctor about birth control needs with Piqray if you’re sexually active and you or your partner could become pregnant. Your doctor can recommend whether you should use birth control with this medication.
If you’d like to learn more about taking Piqray during pregnancy, see the “Piqray: Taking while pregnant” section above.
Note: Sex and gender exist on spectrums. In this article, use of the terms “male” and “female” refers to sex assigned at birth.
For females taking Piqray
If you could become pregnant, you should use birth control during treatment with Piqray. You should continue using it for 1 week after your final dose.
For males taking Piqray
If you have a sexual partner who could become pregnant, you should use condoms during treatment with Piqray. You should continue using them for 1 week after your final dose. Your sexual partner should also use a different form of birth control.
Doctors don’t know whether Piqray passes into breast milk. However, if it did, it could cause serious side effects in a child who’s breastfed.
You should not breastfeed while taking Piqray and for 1 week after your final dose.
Serious effects can occur if you use more than the recommended dosage of Piqray. Do not use more Piqray than your doctor recommends.
If you vomit after taking a dose, don’t take an extra dose that day. Taking another dose after vomiting could increase the risk of overdose. Instead, take the next dose at your usual time the following day.
Symptoms of overdose
Symptoms that an overdose could cause include:
- hyperglycemia (high blood sugar level)
- nausea
- weakness
- rash
What to do in case of overdose
Call your doctor if you think you’ve taken too much of this drug. Also, you can call the American Association of Poison Control Centers at 800-222-1222 or use its online tool. However, if your symptoms are severe, call 911 or a local emergency number. Or go to the nearest emergency room right away.
Here’s some information about Piqray’s expiration date, as well as how to store and dispose of the drug.
Expiration. Your pharmacist will add an expiration date to the label on Piqray’s packaging. This date is usually 1 year from the date the medication was dispensed to you. Expiration dates help ensure that a medication is effective during a period of time.
The Food and Drug Administration (FDA)
Storage. Many factors determine how long a medication remains good to use. These factors include how and where you store the drug. Piqray tablets should be stored at room temperature. Avoid storing it in areas where it could get damp or wet, such as bathrooms. The medication should be kept in a tightly sealed container.
Disposal. It’s important to safely dispose of Piqray if you no longer need to take it and have unused medication. Doing so helps prevent others, including children and pets, from accidentally taking the drug. It also helps avoid causing harm to the environment.
Ask your pharmacist for information about disposing of Piqray. Also, check out this page for several tips on safe medication disposal.
If you have questions about Piqray, talk with your doctor. They can help advise you on whether Piqray could be a good treatment option for you.
Here’s a list of questions you may want to ask your doctor:
- Will Piqray interact with my other medications?
- Will Piqray affect any of my other medical conditions?
- How effective is Piqray compared with other treatment options?
- Am I likely to have serious side effects with Piqray?
- Do Piqray side effects improve with continued treatment?
Your doctor may also tell you about other treatment options for your condition. You may find this article helpful in learning about alternative drugs. And view our selection of videos on breast cancer.
Disclaimer: Healthgrades has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.