What does the official instructions for use of Osimertinib contain?

Osimertinib (trade name: Tagrisso) is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, mainly used to treat patients with specific EGFR mutation-positive non-small cell lung cancer (NSCLC). According to the official instructions for use approved by the U.S. Food and Drug Administration (FDA), the main contents of osimertinib include the following aspects:

Indications and usage

Osimertinib is approved for the following situations: (1) As postoperative adjuvant therapy, suitable for patients with tumor presenceEGFRexon19deletion or exon21 L858RmutatedNSCLCadult patients; (2) first-line treatment for locally advanced or metastatic disease< /span>NSCLCPatients whose tumors have the above-mentioned EGFR mutations; (3) in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of patients with locally advanced or metastatic NSCLC whose tumors have the above EGFRMutation; (4) patients with EGFR who have progressed after treatment with EGFRtyrosine kinase inhibitors T790Mmutated metastaticNSCLCadult patients.

Dosage and usage

The recommended dose of osimertinib is 80 mg once daily, taken orally with or without food. Before starting treatment, the presence of the corresponding EGFR mutation in the patient's tumor should be confirmed through an FDA-approved testing method. Treatment should be continued until disease progression or unacceptable toxicity occurs. For patients who are unable to swallow tablets, the tablets may be dissolved in water and taken. If adverse reactions occur, dose adjustment or treatment suspension may be necessary based on specific circumstances.

Warnings and Precautions

Osimertinib may cause serious adverse reactions, including interstitial lung disease/pneumonitis, QT prolongation, cardiomyopathy, and embryonic -fetotoxicity. During treatment, patients' cardiac function and electrolyte levels should be monitored regularly. In patients with a history of heart disease, cardiac function should be assessed before starting treatment. In addition, osimertinib may cause hematological abnormalities, such as leukopenia and thrombocytopenia, and routine blood tests need to be performed regularly.

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Adverse reactions and drug interactions

Common adverse reactions include diarrhea, rash, dry skin, stomatitis, fatigue and cough. Osimertinib is mainly metabolized by CYP3A enzyme, so its plasma concentration may be affected when it is combined with CYP3A inhibitors or inducers. It is recommended to avoid concurrent use with strong CYP3A inhibitors (such as ketoconazole) or inducers (such as rifampicin). In addition, osimertinib may affect the metabolism of other drugs, and attention should be paid to potential drug interactions when using it.

Reference materials:https://go.drugbank.com/drugs/DB09330