Alpelisib

Generic name: Alpelisib
Dosage form: Piqray tablets (50mg, 150mg, 200mg), Vijoice tablets (50mg, 125mg, 200mg)
Drug class: PI3K inhibitors

Usage of Alpelisib

Alpelisib (Piqray brand) is used to treat types of breast cancer in men and postmenopausal women, and Vijoice brand of alpelisib is used to treat a condition called PROS (PIK3CA-Related Overgrowth Spectrum) in certain patients. Alpelisib is a targeted therapy from a class of medicines called PI3K inhibitors (phosphoinositide 3-kinase inhibitors) and is sometimes called a kinase inhibitor. Alpelisib is only used for PIK3CA-mutated tumors as detected by an FDA-approved test.

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

Alpelisib side effects

Common alpelisib 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 alpelisib 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.

Alpelisib 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 Alpelisib

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

Alpelisib 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.

Alpelisib 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 alpelisib 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 alpelisib.

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.

Alpelisib 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 alpelisib, and for at least 1 week after your last dose. If you are also using fulvestrant then 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 Alpelisib

Usual Piqray Adult Dose for Breast Cancer:

Recommended dose: 300 mg (two 150 mg film-coated 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 alpelisib 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.

Usual Vijoice Adult Dose for PIK3CA-Related Overgrowth Spectrum:

Recommended dose: 250 mg orally once a day. Comments: Treatment is usually until disease progression or unacceptable toxicity.

Usual Vijoice Pediatric Dose for PIK3CA-Related Overgrowth Spectrum:

Initial dose: 50 mg orally once a day. Maintenance dose: Patients younger than 6 years old: 50 mg orally once a day. Patients 6 years and older: Increase to 125 mg orally once a day after 24 weeks of 50 mg/day. Maximum dose: 125 mg/day oral Duration of therapy: Until disease progression or unacceptable toxicity. Comment: When the pediatric patient turns 18 years old, consider a gradual dose increase up to 250 mg/day.

Warnings

Call your doctor right away if you have severe diarrhea.

What other drugs will affect Alpelisib

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 affect 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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