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Piqray Side Effects

Generic Name: alpelisib

Note: This document contains side effect information about alpelisib. Some of the dosage forms listed on this page may not apply to the brand name Piqray.

For the Consumer

Applies to alpelisib: oral tablet

Side effects requiring immediate medical attention

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

  • 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
  • troubled breathing
  • unexplained weight loss
  • unusual tiredness of weakness
  • unusual weight gain or loss
  • vomiting

Less common

  • Pale skin
  • troubled breathing with exertion
  • unusual bleeding or bruising

Side effects not requiring immediate medical attention

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

For Healthcare Professionals

Applies to alpelisib: oral tablet

Hematologic

Very common (10% or more): Lymphocyte count decreased (52%), hemoglobin decreased (42%), activated partial thromboplastin time (aPTT) prolonged (21%), platelet count decreased (14%)[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Severe hypersensitivity (e.g., anaphylaxis, anaphylactic shock, dyspnea, flushing, rash, fever, tachycardia)[Ref]

Musculoskeletal

Common (1% to 10%): Osteonecrosis of the jaw (ONJ)[Ref]

Metabolic

Very common (10% or more): Glucose increased (79%), hyperglycemia (65%), weight loss (27%), calcium (corrected) decreased (27%), glucose decreased (26%), potassium decreased (14%), albumin decreased (14%), magnesium decreased (11%)[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (10%)[Ref]

Hepatic

Very common (10% or more): Gamma glutamyl transferase (GGT) increased (52%), alanine aminotransferase (ALT) increased (44%)[Ref]

Respiratory

Common (1% to 10%): Pneumonitis (including acute interstitial pneumonitis and interstitial lung disease)[Ref]

Other

Very common (10% or more): Fatigue (42%), lipase increased (42%), edema peripheral (15%), pyrexia (14%)[Ref]

General

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]

Nervous system

Very common (10% or more): Headache (18%), dysgeusia/ageusia/hypogeusia (18%)[Ref]

Renal

Very common (10% or more): Creatinine increased (79%)[Ref]

Dermatologic

Very common (10% or more): Rash (e.g., maculopapular, macular, generalized, papular, pruritic) (52%), alopecia (20%), pruritus (18%), dry skin/skin fissures/xerosis/xeroderma (18%)

Uncommon (0.1% to 1%): Stevens-Johnson syndrome (SJS), erythema multiforme (EM)[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (58%), nausea (45%), stomatitis/aphthous ulcer/mouth ulceration (30%), vomiting (27%), mucosal inflammation (19%), abdominal pain/abdominal pain upper/abdominal pain lower (17%), mucosal dryness (12%), dyspepsia (11%)[Ref]

References

1. "Product Information. Piqray (alpelisib)." Novartis Pharmaceuticals, East Hanover, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.