PIQRAY® (alpelisib) tablets is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
Important Safety Information PIQRAY is contraindicated in patients with severe hypersensitivity to it or any of its components.
Severe Hypersensitivity: Severe hypersensitivity reactions, including anaphylaxis and anaphylactic shock, were reported in patients treated with PIQRAY. Severe hypersensitivity reactions were manifested by symptoms including, but not limited to, dyspnea, flushing, rash, fever, or tachycardia. Advise patients of the signs and symptoms of severe hypersensitivity reactions. Permanently discontinue PIQRAY in the event of severe hypersensitivity.
Severe Cutaneous Reactions: Severe cutaneous reactions, including Stevens-Johnson syndrome (SJS) and erythema multiforme (EM) were reported. Do not initiate PIQRAY treatment in patients with a history of SJS, EM, or toxic epidermal necrolysis (TEN). Interrupt PIQRAY if signs or symptoms of severe cutaneous reactions are present (eg, a prodrome of fever, flu-like symptoms, mucosal lesions or progressive skin rash), until etiology of the reaction has been determined. Advise patients of the signs and symptoms of severe cutaneous reactions. Consider consultation with a dermatologist. Permanently discontinue PIQRAY if SJS, EM, or TEN is confirmed.
Hyperglycemia: Severe hyperglycemia, including ketoacidosis, was reported. Before initiating treatment with PIQRAY, test fasting plasma glucose (FPG), HbA1c, and optimize blood glucose. After initiating treatment, monitor blood glucose and/or FPG at least once every week for the first 2 weeks, then at least once every 4 weeks, and as clinically indicated. Monitor HbA1c every 3 months and as clinically indicated. Initiate or optimize antihyperglycemic medications as clinically indicated. Interrupt, reduce dose, or discontinue PIQRAY if severe hyperglycemia occurs. The safety of PIQRAY in patients with type 1 and uncontrolled type 2 diabetes has not been established as these patients were excluded from the SOLAR-1 trial. Patients with a history of diabetes mellitus may require intensified diabetic treatment. Closely monitor patients with diabetes.
Advise patients of the signs and symptoms of hyperglycemia (eg, excessive thirst, urinating more often than usual or higher amount of urine than usual, or increased appetite with weight loss).
Pneumonitis: Severe pneumonitis, including acute interstitial pneumonitis and interstitial lung disease, has been reported in patients treated with PIQRAY. Monitor for clinical symptoms or radiological changes. Consider a diagnosis of non-infectious pneumonitis in patients presenting with non-specific respiratory signs and symptoms such as hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams and in whom infectious, neoplastic, and other causes have been excluded by means of appropriate investigations. Interrupt or discontinue PIQRAY if severe pneumonitis occurs. Advise patients to immediately report new or worsening respiratory symptoms.
Diarrhea: Severe cases of diarrhea, including dehydration and acute kidney injury, have been reported. Based on the severity of the diarrhea, PIQRAY may require dose interruption, reduction, or discontinuation. Advise patients to start antidiarrheal treatment, increase oral fluids, and notify their health care provider if diarrhea occurs while taking PIQRAY.
Embryo-Fetal Toxicity: PIQRAY and fulvestrant can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. Also, refer to Full Prescribing Information of fulvestrant for pregnancy and contraception information.
Please click here for full Prescribing Information.
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