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Piqray Side Effects

Generic name: alpelisib

Medically reviewed by Drugs.com. Last updated on May 13, 2024.

Note: This document provides detailed information about Piqray.

Applies to alpelisib: oral tablet Side Effects associated with alpelisib. Some dosage forms listed on this page may not apply specifically to the brand name Piqray.

Applies to alpelisib: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

It is unlikely that a postmenopausal woman may become pregnant. But, using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control to keep from getting pregnant during treatment and for 1 week after your last dose. Male patients who have female partners should use effective birth control during treatment and for 1 week after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, and anaphylactic shock, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

This medicine may cause serious skin reactions, including Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness with this medicine.

This medicine may affect your blood sugar levels. Check with your doctor right away if you have increased thirst or increased urination. If you notice a change in the results of your urine or blood sugar tests, or if you have any questions, check with your doctor.

This medicine may cause swelling of the lungs (pneumonitis) or interstitial lung disease. These are life-threatening conditions and require immediate medical attention. The symptoms may be similar to the symptoms from lung cancer. Check with your doctor right away if you have new or worsening cough, fever, or trouble breathing.

This medicine may cause diarrhea (colitis), and in some cases it can be severe. Your doctor may give you medicine to treat diarrhea. Drink plenty of fluids to prevent dehydration and kidney problems. If you have any questions about this or if mild diarrhea continues, or gets worse, check with your doctor. Call your doctor right away if you have stomach pain, or mucus or blood in your stool.

If you plan to have children, talk with your doctor before using this medicine. Some men and women using this medicine have become infertile (unable to have children).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Piqray

Along with its needed effects, alpelisib (the active ingredient contained in Piqray) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking alpelisib:

More common side effects

  • bladder pain
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody or cloudy urine
  • blurred vision
  • diarrhea
  • difficult, burning, or painful urination
  • dry mouth
  • fever
  • flushed, dry skin
  • frequent urge to urinate
  • fruit-like breath odor
  • increased hunger
  • increased thirst
  • increased urination
  • lower back or side pain
  • nausea
  • rapid weight gain
  • stomach pain
  • sweating
  • tingling of the hands or feet
  • trouble breathing
  • unexplained weight loss
  • unusual tiredness of weakness
  • unusual weight gain or loss
  • vomiting

Less common side effects

  • pale skin
  • unusual bleeding or bruising

Incidence not known

  • black, tarry stools
  • blistering, peeling, or loosening of the skin
  • chest pain
  • chills
  • cough
  • itching
  • joint or muscle pain
  • large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • painful or difficult urination
  • red irritated eyes
  • red skin lesions, often with a purple center
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • swollen glands
  • unusual bleeding or bruising

Other side effects of Piqray

Some side effects of alpelisib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common side effects

  • belching
  • decreased weight
  • dry skin or mouth
  • hair loss or thinning of hair
  • headache
  • heartburn
  • indigestion
  • loss or change in taste
  • stomach discomfort or upset
  • swelling or inflammation of the mouth

For healthcare professionals

Applies to alpelisib: oral granule, oral tablet.

General adverse events

The most common adverse reactions including laboratory abnormalities (all Grades, incidence 20% or greater) were glucose increased, creatinine increased, diarrhea, rash, lymphocyte count decreased, GGT increased, nausea, ALT increased, fatigue, hemoglobin decreased, lipase increased, decreased appetite, stomatitis, vomiting, weight decreased, calcium decreased, glucose decreased, activated partial thromboplastin time (aPTT) prolonged, and alopecia.[Ref]

Hypersensitivity

Musculoskeletal

Metabolic

Genitourinary

Hepatic

Respiratory

Other

Hematologic

Nervous system

Renal

Dermatologic

Gastrointestinal

See also:

References

1. (2019) "Product Information. Piqray (alpelisib)." Novartis Pharmaceuticals

Frequently asked questions

Further information

Piqray side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.