Applies to alpelisib: oral tablet.

Serious side effects of Alpelisib

Along with its needed effects, alpelisib 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
• trouble breathing
• unexplained weight loss
• unusual tiredness of weakness
• unusual weight gain or loss
• vomiting

Less common

• 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 Alpelisib

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

• 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 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]