Pivikto Tablet

Alpelisib is indicated for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Alpelisib is a kinase inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Severe Hypersensitivity: Permanently discontinue Alpelisib. Promptly initiate appropriate treatment. Severe Cutaneous Adverse Reactions (SCARs): Alpelisib can cause SCARs, including Stevens-Johnson syndrome (SJS), erythema multiforme (EM), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). Interrupt Alpelisib for signs or symptoms of SCARs. Permanently discontinue Alpelisib if SCARs are confirmed. Hyperglycemia: Alpelisib can cause severe hyperglycemia, in some cases associated with hyperglycemic hyperosmolar non-ketotic syndrome (HHNKS) or ketoacidosis. The safety of Alpelisib in patients with Type 1 or uncontrolled Type 2 diabetes has not been established. Before initiating treatment with Alpelisib, test fasting plasma glucose (FPG), HbA1c, and optimize blood glucose. After initiating treatment, monitor periodically. Initiate or optimize anti-hyperglycemic medications as clinically indicated. Interrupt, reduce dose, or discontinue Alpelisib if severe hyperglycemia occurs. Pneumonitis: Alpelisib can cause severe pneumonitis and interstitial lung disease. Monitor for clinical symptoms or radiological changes. Permanently discontinue Alpelisib if pneumonitis occurs. Diarrhea or Colitis: Alpelisib can cause severe diarrhea, resulting in dehydration and in some cases in acute kidney injury, as well as colitis. Monitor for diarrhea and additional symptoms of colitis, including abdominal pain and mucus or blood in stool. Interrupt, reduce dose, or permanently discontinue Alpelisib based on severity of diarrhea or colitis. Patients with colitis may require additional treatment, such as enteric-acting and/or systemic steroids. Embryo-Fetal Toxicity: Alpelisib can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. Severe Hypersensitivity Severe hypersensitivity reactions, including anaphylaxis, anaphylactic shock, and angioedema, have occurred in adult patients treated with alpelisib in the oncology setting and in patients treated with Alpelisib. Alpelisib is not approved for use in the oncology setting. Permanently discontinue Alpelisib in the event of severe hypersensitivity. Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), erythema multiforme (EM), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have occurred in adult patients treated with alpelisib in the oncology setting and may occur in patients treated with Alpelisib. If signs or symptoms of SCARs occur, interrupt Alpelisib until the etiology of the reaction has been determined. Consultation with a dermatologist is recommended. If a SCAR is confirmed, permanently discontinue Alpelisib. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following clinically significant adverse reactions are discussed elsewhere in the labeling: Severe Hypersensitivity Severe Cutaneous Adverse Reactions Hyperglycemia Pneumonitis Diarrhea or Colitis Most common adverse reactions (Grades 1 to 4, incidence ≥ 10%) were diarrhea, stomatitis, and hyperglycemia.. Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Alpelisib was evaluated in EPIK-P1 (NCT04285723), a single-arm clinical study in patients who were treated as part of an expanded access program for compassionate use. Fifty-seven patients 2 years of age and older with severe or life-threatening PIK3CA-Related Overgrowth Spectrum (PROS) received Alpelisib based on age at dosages ranging from 50 mg to 250 mg orally once daily. Among patients who received Alpelisib, 95% were exposed for 6 months or longer and 79% were exposed for greater than one year. The median age of patients who received Alpelisib was 14 years (range, 2 to 50); 58% were female; 12% were White and race was not reported for 88%. Serious adverse reactions occurred in 12% of patients who received Alpelisib. Serious adverse reactions occurring in two or more patients included dehydration (n = 2) and cellulitis (n = 2). Dosage interruption of Alpelisib due to an adverse reaction occurred in 11% of patients. Adverse reactions which required dosage interruption in two or more patients included dizziness (n = 2) and vomiting (n = 2). Dose reductions of Alpelisib due to an adverse reaction occurred in 5% of patients. Adverse reactions which required dose reduction included alopecia, memory impairment, and soft tissue infection. The most common adverse reactions (≥ 10%) were diarrhea, stomatitis, and hyperglycemia. The most common Grade 3 or 4 laboratory abnormalities (≥ 2%) were increased glucose, decreased hemoglobin, decreased phosphate, increased bilirubin, decreased sodium, and decreased platelets. Adverse reactions and laboratory abnormalities are listed in Table 10 and Table 11, respectively. Table 10: Adverse Reactions (≥ 5%) in Patients with PROS Who Received Alpelisib in EPIK-P1 Grading according to CTCAE Version 4.03. a Stomatitis: including stomatitis and aphthous ulcer. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.