Piqray Disease Interactions

Severe cutaneous reactions, including Stevens-Johnson Syndrome (SJS) and Erythema Multiforme (EM) were reported in patients treated with alpelisib. Do not initiate alpelisib treatment in patients with a history of SJS, EM, or Toxic Epidermal Necrolysis (TEN). If signs or symptoms of severe cutaneous reactions occur, interrupt treatment until the etiology of the reaction has been determined. Consultation with a dermatologist is recommended. If SJS, TEN, or EM is confirmed, permanently discontinue alpelisib. Do not reintroduce alpelisib in patients who have experienced previous severe cutaneous reactions during treatment.

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Severe hyperglycemia, including ketoacidosis, has been reported in patients treated with alpelisib. Before initiating treatment with alpelisib it is recommend to test, optimize and monitor blood glucose as clinically indicated. Care should be exercised when using this agent in diabetic patients. Patients with a history of diabetes mellitus may require intensified diabetic treatment. Based on the severity of the hyperglycemia, alpelisib may require dose interruption, reduction, or discontinuation. Advise patients of the signs and symptoms of hyperglycemia. Closely monitor patients with diabetes.

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Severe diarrhea, including dehydration and acute kidney injury, occurred in patients treated with alpelisib. Based on the severity of the diarrhea, alpelisib may require dose interruption, reduction, or discontinuation. Care should be exercised when using this agent in patients with diarrhea. Advise patients to start antidiarrheal treatment, increase oral fluids, and notify their healthcare provider if diarrhea occurs while taking alpelisib.

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Osteonecrosis of the jaw (ONJ) has been reported in patients using alpelisib. Caution is advised when this drug and bisphosphonates or denosumab are used either simultaneously or sequentially. Do not initiate treatment with alpelisib in patients with ongoing osteonecrosis of the jaw from previous or concurrent treatment with bisphosphonates or denosumab. Patients experiencing ONJ should be managed according to clinical practice.

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Severe pneumonitis, including acute interstitial pneumonitis and interstitial lung disease, has been reported in patients treated with alpelisib. It is recommended to interrupt alpelisib immediately and evaluate the patient for pneumonitis in patients who have new or worsening respiratory symptoms or are suspected to have developed pneumonitis. Advise patients to immediately report new or worsening respiratory symptoms. Permanently discontinue alpelisib in all patients with confirmed pneumonitis.

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No dose adjustment is recommended for patients with mild to moderate renal impairment (CrCl 30 to < 90 mL/min). Close monitoring is recommended when using alpelisib in patients with severe renal impairment (CrCl < 30 mL/min) as its effect on the pharmacokinetics is unknown.

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