Piqray is a brand-name prescription medication that’s FDA-approved to treat a certain type of breast cancer. It’s used in adult females* who have gone through menopause, as well as in adult males.*

Specifically, Piqray is approved to treat breast cancer that’s all of the following:

Piqray is used for this type of breast cancer only if you’ve already tried hormone therapy and your cancer still got worse.

For more information on how Piqray is used to treat breast cancer, see the “Piqray uses” section below.

* Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth.

Drug details

The active drug in Piqray is alpelisib. It’s a targeted therapy that belongs to a drug class called PIK3 inhibitors. (A drug class is a group of medications that work in a similar way.) Piqray is not available as a generic drug.

Piqray comes as tablets that you swallow. They’re available in three strengths: 50 milligrams (mg), 150 mg, and 200 mg.

FDA approval

Piqray was approved by the Food and Drug Administration (FDA) in 2019 to treat a specific type of breast cancer.

Effectiveness

For information about the effectiveness of Piqray, see the “Piqray uses” section below.

Piqray is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. Generics usually cost less than brand-name drugs.

Piqray can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Piqray. These lists do not include all possible side effects.

For more information about the possible side effects of Piqray, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

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 side effects

Mild side effects* of Piqray can include:

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Piqray. To learn about other mild side effects, talk with your doctor or pharmacist, or view Piqray’s patient information.
† For more information about this side effect, see “Side effect details

Serious side effects

Serious side effects from Piqray aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

* For more information about this side effect, see “Side effect details” below.

Side effect details

Here’s some detail on certain side effects this drug may cause.

Skin rash

Some people may develop a rash from taking Piqray. Mild rash was a common side effect reported by people taking the drug in clinical studies.

Most people who developed a rash in these studies had a mild rash. But in rare cases, Piqray can cause a serious rash. A few people have stopped taking the drug due to this side effect.

If you develop a rash while taking Piqray, talk with your doctor right away. This is because a rash may be a sign of a more serious side effect from the drug, including a serious skin reaction or allergic reaction.

Symptoms that your rash may be a sign of a more serious side effect can include:

  • fever
  • flu-like symptoms, such as chills or headache
  • a rash that continues to get worse
  • swollen lymph nodes

Your doctor can determine how serious your rash is by checking how much of your body it covers. If your rash is mild, you likely won’t have to stop taking Piqray. Your doctor will likely recommend using a topical corticosteroid to treat the rash. They may also prescribe an antihistamine medication for itching if you have this side effect as well.

If your reaction is serious, your doctor may have you temporarily stop taking Piqray and treat the rash. They may then have you take the drug again but at a lower dose. Or if your reaction is severe, they may have you permanently stop taking Piqray.

Hair loss

Hair loss is a possible side effect of Piqray. This was a common side effect in the drug’s clinical studies.

If you experience hair loss that concerns you while taking Piqray, talk with your doctor. They may suggest a treatment to help. Or they may suggest that you stop Piqray treatment and try another drug for your breast cancer.

Hyperglycemia

Taking Piqray may cause hyperglycemia (high blood sugar). Mild hyperglycemia was a common side effect in clinical studies. This condition can also be serious in some cases.

In rare cases, people taking Piqray have developed diabetic ketoacidosis or hyperglycemia hyperosmolar nonketotic syndrome. These are both severe forms of hyperglycemia, and these conditions can be life threatening.

Hyperglycemia doesn’t always cause symptoms, especially if it’s mild. But you may have symptoms such as:

  • fruity-smelling breath
  • confusion
  • dry mouth
  • feeling excessively thirsty
  • increased appetite combined with weight loss
  • nausea or vomiting
  • needing to urinate more often than usual
  • producing more urine than usual

Before you start taking Piqray, your doctor will order lab tests to check your blood sugar. Then, they’ll have you continue monitoring your blood sugar at home.

If you have a high risk of hyperglycemia, your doctor may have you monitor your blood sugar more often. People with a higher risk of this side effect include adults ages 75 years or older, people with obesity, and people using a corticosteroid (such as prednisone).

If you develop hyperglycemia while taking Piqray, your doctor may have you temporarily or permanently stop taking Piqray. If your doctor advises that you stop using the drug temporarily, they may restart your Piqray treatment at a lower dose after treating your hyperglycemia. You may also need to take a diabetes drug, such as metformin, to treat this side effect.

If you have diabetes, talk with your doctor before taking Piqray. See the “Piqray precautions” section to learn more.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Piqray.

Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (temporary warmth, redness, or deepening of skin color)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have an allergic reaction to Piqray, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

As with all medications, the cost of Piqray can vary. To find current prices for Piqray in your area, check out GoodRx.com.


The cost you find on GoodRx.com is what you may pay without insurance. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Keep in mind that you may be able to get a 90-day supply of Piqray. If approved by your insurance company, getting a 90-day supply of the drug could reduce your number of trips to the pharmacy and help lower the cost. If you’re interested in this option, check with your doctor or your insurance company.

It’s important to note that you may have to get Piqray at a specialty pharmacy. This type of pharmacy is authorized to carry specialty medications. These are drugs that may be expensive or may require help from healthcare professionals to be used safely and effectively.

Before approving coverage for Piqray, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure if you’ll need to get prior authorization for Piqray, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Piqray, or if you need help understanding your insurance coverage, help is available.

Novartis Pharmaceuticals Corporation, the manufacturer of Piqray, offers savings programs for its drug. For more information, and to find out if you’re eligible for support, call 800-282-7630 or visit the manufacturer’s website.

Mail-order pharmacies

Piqray may be available through a mail-order pharmacy. Using this service may help lower the drug’s cost and allow you to get your medication without leaving home.

If recommended by your doctor, you may be able to receive a 90-day supply of Piqray, so there’s less concern about running out of the medication. If you’re interested in this option, check with your doctor and your insurance company. Some Medicare plans may help cover the cost of mail-order medications.

If you don’t have insurance, you can ask your doctor or pharmacist about online pharmacy options.

Generic version

Piqray is not available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

The Piqray dosage your doctor prescribes will depend on several factors. These include:

  • side effects you may have from taking Piqray
  • other medical conditions you may have

The following information describes dosages that are commonly used or recommended. But be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Piqray comes as tablets that you swallow. They’re available in three strengths: 50 milligrams (mg), 150 mg, and 200 mg.

Dosage for breast cancer

For treating breast cancer, the recommended Piqray dosage is 300 mg (two 150-mg tablets) taken once per day with food.

What if I vomit after I take a dose of Piqray?

If you vomit after taking your Piqray dose, you should not take an additional dose afterward. Just wait and take your next scheduled dose the following day at its regular time.

What if I miss a dose?

If you miss a dose and it’s been 9 hours or less since you were supposed to take it, take your dose with food as soon as you remember. If it’s more than 9 hours after you were supposed to take your dose, just skip the missed dose. Then, take your next dose the following day at its regular time.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.

Will I need to take this drug long term?

Piqray is meant to be taken as a long-term treatment. If you and your doctor determine that Piqray is safe and effective for you, you’ll likely take it long term.

Other drugs are available that can treat breast cancer. Some may be a better fit for you than others. If you’re interested in finding an alternative to Piqray, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are prescribed off-label to treat these specific conditions. Off-label drug use is when a drug approved by the Food and Drug Administration (FDA) is used for a purpose other than what it’s approved for.

Examples of other drugs that may be prescribed to treat certain types of breast cancer include:

Here are answers to some frequently asked questions about Piqray.

Is Piqray a chemotherapy drug?

No, Piqray isn’t a chemotherapy drug. Chemotherapy drugs affect cells in your body that are quickly multiplying. This includes cancer cells, but it also includes healthy cells. This is why chemotherapy drugs can cause so many side effects.

Piqray is a kinase inhibitor, which is a type of targeted therapy. These are treatments that attack specific cancer cells without affecting other, healthy cells. Specifically, Piqray is the first kind of targeted therapy in a drug class called PIK3 inhibitors. (A drug class is a group of medications that work in a similar way.)

If you have other questions about how Piqray differs from chemotherapy, talk with your doctor.

Does Piqray treat triple-negative breast cancer?

Piqray isn’t approved to treat triple-negative breast cancer, but it may be prescribed off-label to treat this condition. (Off-label drug use is when a drug approved by the Food and Drug Administration (FDA) is used for a purpose other than what it’s approved for.)

If you have questions about off-label uses for Piqray, including for treating triple-negative breast cancer, talk with your doctor.

Why do I have to undergo genetic testing before starting Piqray?

You’ll need to have genetic testing done before taking Piqray because the drug is only approved to treat breast cancer that is PIK3CA-mutated. This means the cancer cells have a mutation (genetic change) in a protein called PIK3CA. This mutation causes PIK3CA to tell your cells to keep multiplying and dividing without stopping, which can lead to a tumor.

So before you start taking Piqray, your doctor will order a genetic test to see if your cancer cells have this mutation. If you have questions about this testing, talk with your doctor.

The Food and Drug Administration (FDA) approves prescription drugs such as Piqray to treat certain conditions.

Piqray for breast cancer

Piqray is approved to treat breast cancer that’s all of the following:

  • Hormone receptor (HR)-positive. This means that growth of the cancer cells is fueled by certain hormones, including estrogen and progesterone.
  • Human epidermal growth factor 2 (HER2)-negative. This means that your cancer cells don’t have higher levels of a protein called HER2. When HER2 is present, it causes the cancer to grow faster and more aggressively.
  • PIK3CA-mutated. This means your cancer cells contain a mutation (genetic change) in a protein called PIK3CA. This mutation causes PIK3CA to tell your cells to keep multiplying and dividing without stopping, which can lead to a tumor.
  • Advanced or metastatic. This means the cancer has spread beyond your breast and to other parts of the body, such as your bones or liver.

For this use, Piqray may be prescribed for adult females* who have gone through menopause, as well as for adult males.* Piqray is prescribed for this type of breast cancer only if you’ve already tried hormone therapy and your cancer still got worse.

About breast cancer

With cancer, cells in your body develop a genetic change that makes them start to grow and multiply uncontrollably. (Cells that multiply are making more cells.) When these cells are in the breast, it’s called breast cancer.

To learn more, check out Medical News Today’s cancer hub.

Effectiveness for breast cancer

Clinical studies have shown Piqray to be effective for treating breast cancer.

National Comprehensive Cancer Network guidelines recommend Piqray as a treatment option for males and postmenopausal females with breast cancer that meets the criteria listed above.

If you have questions about how Piqray is used to treat breast cancer, talk with your doctor.

* Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth.

Piqray and children

Piqray is not approved for use in children. The drug hasn’t been studied in this population.

If you’d like more information about treating childhood breast cancer, talk with your child’s pediatrician or oncologist.

To treat breast cancer, you’ll take Piqray with the drug fulvestrant (Faslodex).

You’ll start by taking a 500-milligram (mg) dose of fulvestrant on days 1, 15, and 29 of Piqray treatment. Then, you’ll take a 500-mg dose of fulvestrant once per month for as long as you continue taking Piqray.

Fulvestrant comes as a solution given by intramuscular injection (an injection into your muscle).

If you have questions about fulvestrant and how it’s used with Piqray, talk with your doctor or pharmacist.

Piqray is approved to treat breast cancer that’s all of the following:

For more information on this type of breast cancer, see the “Piqray uses” section above.

With cancer, cells in your body develop a genetic change that makes them start to grow and multiply uncontrollably. (Cells that multiply are making more cells.) When these cells are in the breast, it’s called breast cancer.

“PIK3CA-mutated” means that your cancer cells contain a mutation (genetic change) in a protein called PIK3CA. This mutation causes PIK3CA to tell your cells to keep multiplying and dividing without stopping, which can lead to a tumor.

Piqray’s mechanism of action (how the drug works) is to block the PIK3 protein. This blocks signals that tell the cancer cells to grow and spread.

How long does it take to work?

Piqray begins working after you take your first dose. But you may not notice any difference right away. In fact, it’s not likely you’ll feel the drug working in your body.

Instead, your doctor will periodically have you get scans (such as X-rays) to see if your cancer is getting worse. Your doctor can give you more information on how they’ll use these tests to monitor whether Piqray is effective in treating your breast cancer.

You should take Piqray according to the administration instructions your doctor or other healthcare professional gives you.

Piqray comes as tablets that you swallow.

When to take

You can take your dose with food at any time of day, but you should try to take it at the same time every day. This helps make sure you have a consistent amount of the drug in your body.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.

Taking Piqray with food

You should take your Piqray dose with food. This helps your body absorb the drug better.

Can Piqray be crushed, split, or chewed?

No, Piqray shouldn’t be crushed, split, or chewed. You should swallow the tablets whole.

If you’re having problems swallowing Piqray tablets, talk with your doctor. They can suggest other treatments for your breast cancer.

Before taking Piqray, talk with your doctor about your health history. Piqray may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Diabetes. Piqray can cause hyperglycemia (high blood sugar). This increase in blood sugar may be dangerous in people who already have diabetes. In addition, Piqray hasn’t been studied in people with diabetes, so it isn’t known whether the drug is safe to take if you have this condition. Your doctor can help determine whether it’s safe for you to take Piqray if you have type 1 or type 2 diabetes. They can also recommend other breast cancer treatments that may be safer for you to take.
  • Allergic reaction. If you’ve had an allergic reaction to Piqray or any of its ingredients, you shouldn’t take Piqray. Ask your doctor what other medications are better options for you.
  • Pregnancy. It’s not safe to take Piqray while pregnant. For more information, see the “Piqray and pregnancy” section below.
  • Breastfeeding. You shouldn’t breastfeed while taking Piqray. For more information, see the “Piqray and breastfeeding” section below.

Note: For more information about the potential negative effects of Piqray, see the “Piqray side effects” section above.

There aren’t known interactions between alcohol and Piqray. But alcohol could worsen certain side effects of Piqray, including:

If you drink alcohol, talk with your doctor about how much (if any) may be safe for you to drink while you’re taking Piqray.

Piqray can interact with several other medications. It may also interact with an over-the-counter (OTC) supplement some people use to treat symptoms of depression.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Piqray and other medications

Below is a list of medications that can interact with Piqray. This list does not contain all drugs that may interact with Piqray.

Before taking Piqray, talk with your doctor and pharmacist. Tell them about all prescription, OTC, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Medications that should not be used with Piqray include:

  • Strong CYP3A4 inducers. Your body uses an enzyme (protein) called CYP3A4 to break down Piqray after you take a dose. Taking Piqray with these drugs can cause Piqray to be less effective. Examples of strong CYP3A4 inducers include:
    • the antiepileptic drugs phenytoin (Dilantin) and carbamazepine (Tegretol)

Other medications that could interact with Piqray include:

  • Breast cancer resistance protein (BCRP) inhibitors. Taking Piqray with these drugs can raise your risk of side effects from Piqray. Examples of BCRP inhibitors include:
    • the HIV drugs nelfinavir and ritonavir
    • the cancer drugs gefitinib (Iressa) and imatinib (Gleevec)

Piqray and herbs and supplements

You shouldn’t use St. John’s wort during Piqray treatment. Like some prescription medications discussed above, St. John’s wort is a CYP3A4 inducer. This means it may make Piqray less effective.

Check with your doctor or pharmacist before using any OTC products while taking Piqray.

Piqray and foods

There aren’t any foods that have been specifically reported to interact with Piqray. If you have any questions about eating certain foods with Piqray, talk with your doctor.

Piqray is not safe to use while pregnant. Based on the results of animal studies, it’s thought that Piqray could cause harm to a fetus.

If you can become pregnant, your doctor will order a pregnancy test to confirm it’s negative before you begin taking Piqray. You’ll need to use birth control while taking the drug and for at least 1 week after your last dose.

If you become pregnant while taking Piqray, talk with your doctor right away.

Piqray and fertility

It’s possible that taking Piqray can affect your fertility (the ability to conceive a child). If this is a concern for you, talk with your doctor before starting treatment with Piqray.

Piqray isn’t safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Piqray.

For more information about taking Piqray during pregnancy, see the “Piqray and pregnancy” section above.

For females using Piqray

If you’re a female* who can become pregnant, your doctor will order a pregnancy test to confirm it’s negative before you begin taking Piqray. You’ll need to use birth control while taking the drug and for at least 1 week after your last dose.

For males using Piqray

If you’re a male* with a sexual partner who can become pregnant, you’ll need to use condoms and have your partner use birth control while you’re taking Piqray and for at least 1 week after your last dose.

* Sex and gender exist on spectrums. Use of the terms “female” and “male” in this article refers to sex assigned at birth.

You shouldn’t breastfeed while taking Piqray or for at least 1 week after your last dose. It’s not known whether Piqray passes into human breast milk. But it has the potential to cause serious side effects in a child who is breastfed if they’re exposed to the drug.

If you’re breastfeeding or planning to breastfeed, talk with your doctor about your options.

Using more than the recommended dosage of Piqray can lead to serious side effects. Do not take more Piqray than your doctor recommends.

Overdose symptoms

Symptoms of an overdose can include:

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use its online tool. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

When you get Piqray from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk with your pharmacist about whether you might still be able to take it.

Storage

How long a medication remains good to take can depend on many factors, including how and where you store the medication.

Piqray tablets should be stored at room temperature, 68°F to 77°F (20°C to 25°C) in a tightly sealed container away from light. For a short period of time, such as when traveling, you may store Piqray at temperatures of 59°F to 86°F (15°C to 30°C).

Avoid storing this medication in areas where it could get damp or wet, such as bathrooms.

Disposal

If you no longer need to take Piqray and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

This article provides several useful tips on medication disposal. You can also ask your pharmacist for information about how to dispose of your medication.

Disclaimer: Medical News Today 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.