PIQRAY (alpelisib)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Lactation

There are 7 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Colitis
Dehydration
Hyperglycemia
Interstitial lung disease
Interstitial pneumonitis
Pregnancy
Severe diarrhea

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Diabetes mellitus

There are 19 severe adverse reactions.

More Frequent	Less Frequent
Anemia Dehydration Hyperglycemia Hypocalcemia Increased alanine transaminase Lymphopenia	Abnormal hepatic function tests Kidney disease with reduction in glomerular filtration rate (GFr)

Rare/Very Rare
Anaphylaxis Angioedema Colitis DRESS syndrome Erythema multiforme Hyperosmolar hyperglycemic state Hypersensitivity drug reaction Interstitial pneumonitis Ketoacidosis Stevens-johnson syndrome Toxic epidermal necrolysis

There are 22 less severe adverse reactions.

More Frequent	Less Frequent
Alopecia Anorexia Diarrhea Elevated serum lipase Fatigue Nausea Prolonged activated partial thromboplastin time Skin rash Stomatitis Vomiting Weight loss	Acute abdominal pain Dry skin Dysgeusia Headache disorder Peripheral edema Pruritus of skin Urinary tract infection Vulvovaginal dryness Xerostomia

Rare/Very Rare
Skin inflammation Uveitis

Alpelisib may cause fetal harm if administered to pregnant females based on its mechanism of action and animal findings.

It is not known whether alpelisib is distributed into milk. Because of the potential for serious adverse reactions to alpelisib in breast-fed infants, females should be advised to discontinue breast-feeding during alpelisib therapy and for one week after discontinuance of the drug. The effects of the drug on breast-fed infants or on milk production are unknown.

No adults >=65 years of age were enrolled in the EPIK-P1 study evaluating alpelisib in patients with PROS. In the SOLAR-1 study evaluating alpelisib in patients with breast cancer, 41% of patients receiving alpelisib were 65 years of age or older, while 12% were 75 years of age or older. No overall differences in efficacy were observed between geriatric patients 65 years of age or older and younger adults; however, grade 3 or 4 hyperglycemia occurred more frequently in geriatric patients (44 versus 32%).

Experience with alpelisib in patients 75 years of age or older is insufficient to determine whether efficacy and safety of the drug in this age group are similar to those in younger adults. However, in the SOLAR-1 study, hyperglycemia (74 versus 66%) and grade 3-4 hyperglycemia (56 versus 36%) occurred more frequently in patients 75 years of age or older compared to patients younger than 75 years of age, respectively.