阿培利斯片Alpelisib 50mg

Alpelisib is a kinase inhibitor indicated for adult and pediatric patients aged 2 years and older with severe manifestations of PIK3CA-related overgrowth spectrum (PROS) who require systemic therapy.

Adult Patients: The recommended dose of alpelisib is 250 mg orally once daily, administered as recommended until disease progression or unacceptable toxicity occurs. Pediatric Patients (Aged 2 to Under 18 Years): The recommended initial dose of alpelisib is 50 mg orally once daily, administered as recommended until disease progression or unacceptable toxicity occurs.

Patients with severe hypersensitivity to alpelisib or any of its components.

Severe Hypersensitivity Reactions: Permanently discontinue alpelisib and promptly initiate appropriate treatment if a severe hypersensitivity reaction occurs. Hyperglycemia: Alpelisib may cause severe hyperglycemia associated with hyperosmolar hyperglycemic nonketotic syndrome (HHNKS) or ketoacidosis. Prior to initiation of treatment, test fasting plasma glucose (FPG) and glycated hemoglobin (HbA1c), and optimize blood glucose control. Monitor blood glucose regularly after treatment initiation. Pneumonia and Interstitial Lung Disease: Alpelisib may cause severe pneumonia and interstitial lung disease. Monitor for clinical symptoms or radiological changes. Permanently discontinue alpelisib if pneumonia occurs. Diarrhea and Colitis: Alpelisib may cause severe diarrhea, which can lead to dehydration and acute kidney injury in some cases, as well as colitis. Monitor for diarrhea and other symptoms of colitis, including abdominal pain and mucoid or bloody stools. Interrupt treatment, reduce dose, or permanently discontinue alpelisib based on the severity of diarrhea or colitis. Embryo-Fetal Toxicity: Alpelisib can cause fetal harm. Advise patients of the potential risk to the fetus and recommend effective contraceptive measures. Drug Interactions Avoid concomitant use of alpelisib with potent CYP3A4 inducers. Avoid use of BCRP inhibitors in patients receiving alpelisib. If no alternative medication is available, closely monitor for increased adverse reactions. Closely monitor patients when alpelisib is used concomitantly with CYP2C9 substrates, as decreased plasma concentrations of these drugs may reduce their efficacy.

Severe hypersensitivity reactions, severe cutaneous adverse reactions, hyperglycemia, pneumonia, diarrhea, colitis, etc.

28 tablets per bottle.

Store at room temperature between 20°C and 25°C. Keep out of the reach of children.