Criteria and precautions for discontinuing Alpelisib

Alpelisib - Piqray is a selective inhibitor of PI3Kα, and its medication management is closely related to the principles of targeted therapy for breast cancer and potential other indications. The discontinuation criteria are mainly judged based on the patient's treatment tolerance, disease control and changes in laboratory indicators. Overseas clinical guidelines and multi-center studies provide a reference framework.

First, drug discontinuation is usually considered when serious or intolerable adverse events occur, including severely uncontrolled hyperglycemia, significantly elevated liver function, or skin reactions. In these cases, doctors will comprehensively evaluate the drug's relevance, the patient's underlying condition, and alternative treatment options to decide whether to temporarily or permanently discontinue the drug. In some cases, short-term drug discontinuation or dose adjustment and then restart are used clinically to maintain disease control while improving patient tolerance.

Secondly, discontinuation of treatment may also be considered when the disease progresses significantly or when there is no obvious benefit in efficacy. Since Apelvis is a targeted therapy drug, its effect often depends on the molecular characteristics of the tumor and target compliance. If the patient still shows signs of disease progression or recurrence after continuous use of the drug for a period of time, the doctor will determine whether the drug needs to be discontinued and the treatment strategy needs to be adjusted based on the imaging evaluation and molecular testing results, such as switching to other targeted drugs or combination chemotherapy.

In addition, attention should be paid to potential rebound effects or worsening of symptoms during drug withdrawal. Overseas clinical experience shows that some patients may experience temporary disease activity or worsening discomfort in the early stages of drug withdrawal. Therefore, drug withdrawal should be carried out under the guidance of a professional doctor to avoid arbitrary interruption on your own. At the same time, it is necessary to ensure that the patient's basal blood sugar, liver and kidney function and other indicators are stable before discontinuing medication to reduce the risk of complications caused by discontinuation of medication.

In terms of specific operations, doctors usually develop individualized discontinuation plans based on factors such as the patient's age, comorbidities, previous treatment history, and medication compliance. Overseas guidelines recommend that drug withdrawal or dose adjustment should be gradual, and blood biochemistry and imaging indicators should be reviewed regularly after drug withdrawal to ensure that the condition is monitored within a safe range.

Reference materials:https://www.ema.europa.eu/en/documents/product-information/piqray-epar-product-information_en.pdf