Piqray

Generic name: Alpelisib
Dosage form: tablets (50mg, 150mg, and 200mg)
Drug class: PI3K inhibitors

Usage of Piqray

Piqray (alpelisib) is used to treat breast cancer in men and postmenopausal women, that is HR-positive, HER2-negative, and is advanced or has spread to other parts of the body (metastatic). Piqray is a targeted therapy from a class of medicines called PI3K inhibitors (phosphoinositide 3-kinase inhibitors) and is sometimes called a kinase inhibitor.

Piqray is only used for breast cancer if it has a specific PIK3CA mutation (an abnormal "PIK3CA" gene) which your doctor will test you for. Piqray is given in combination with fulvestrant (Faslodex).

Piqray became an FDA-approved medicine on May 24, 2019, as the first PI3K Inhibitor for specific breast cancers. Another brand, alpelisib called Vijoice became an FDA-approved medicine on April 5, 2022, to treat specific patients with PIK3CA-Related Overgrowth Spectrum (PROS).

Piqray side effects

Common Piqray side effects may include:

nausea, vomiting;

loss of appetite, weight loss;

feeling weak or tired;

mouth sores;

rash;

hair loss; or

abnormal blood tests.

Serious side effects:

Get emergency medical help if you have signs of an allergic reaction (hives, warmth or tingling, difficulty breathing, fast heartbeats, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Piqray may cause other serious side effects. Call your doctor at once if you have:

chest pain, cough, feeling short of breath;

severe or ongoing diarrhea;

blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;

pale skin, unusual tiredness, cold hands and feet;

little or no urination; or

high blood sugar with symptoms of increased thirst, increased urination, dry mouth, fruity breath odor, confusion, hunger, weight loss;

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Piqray

You should not use alpelisib if you are allergic to it or any of the inactive ingredients.

Tell your doctor if you have ever had:

diabetes; or

a severe skin rash (skin pain, redness, peeling, burning eyes, blistering of your lips or mouth).

Pregnancy

Piqray can cause fetal harm when administered to a pregnant woman, you may need to have a negative pregnancy test before starting this treatment. Tell your doctor if you think you may be pregnant.

Male patients with female partners of reproductive potential should be advised to use condoms and effective contraception during treatment with Alpelisib and for 1 week after the last dose.

Piqray and fulvestrant both can harm an unborn baby or cause birth defects if the mother or the father is using these medicines.

If you are a woman, do not use alpelisib if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 1 week after your last dose.

If you are a man, use condoms and effective birth control if your sex partner is pregnant or is able to get pregnant. Keep using condoms and birth control for at least 1 week after your last dose.

Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Piqray.

Women who also take fulvestrant may need to prevent pregnancy for at least 1 year after treatment ends. Ask your doctor about how long to keep using birth control.

Piqray and fulvestrant may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because these medicines can harm an unborn baby.

Breastfeeding

Do not breastfeed while using this medicine, and for at least 1 week after your last dose. If you are also using fulvestrant, you may not be able to breastfeed for 1 year after your last dose of fulvestrant. Ask your doctor.

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How to use Piqray

Usual Adult Piqray Dose for Breast Cancer:

Usual dose: 300 mg (two 150 mg tablets) orally once a day with food at approximately the same time each day.

Comments: Treatment is usually until disease progression or unacceptable toxicity. When fulvestrant is prescribed with Piqray the recommended dose of fulvestrant is 500 mg orally on Days 1, 15, and 29, and once monthly thereafter. The alpelisib dose may be changed due to adverse reactions. Use: In combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.

Warnings

Do not take Piqray if you have had a severe allergic reaction to alpelisib or are allergic to any of the ingredients in this medicine.

Call your doctor right away if you have severe diarrhea.

What other drugs will affect Piqray

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may interact with alpelisib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Disclaimer

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