Things to note when taking Osimertinib

Osimertinib is an anti-tumor drug. Osimertinib is suitable for patients with epidermal growth factor receptor (EGFR) exon19 deletion or exon21 Adjuvant therapy after tumor resection for patients with L858Rmutated non-small cell lung cancer (NSCLC), suitable for EGFRexon19 deletion or exon21 First-line treatment of patients with L858Rmutated metastatic non-small cell lung cancer. It is suitable for patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer whose disease has progressed during or after treatment with EGFRtyrosine kinase inhibitors (TKI).

What should I pay attention to when taking osimertinib?

1.Interstitial lung disease/Pneumonia. If a patient develops worsening of respiratory symptoms (e.g., dyspnea, cough, and fever) that may indicateILD, osimertinib should be discontinued and promptly investigated for ILD. If ILD/pneumonitis is confirmed, permanently discontinue osimertinib.

2. QTcinterval prolongation. Patients receivingosimertinibhave experienced a prolongation of the heart rate correctedQT (QTc) interval. Perform periodic ECG and electrolyte monitoring in patients with congenital longQTc syndrome, congestive heart failure, electrolyte abnormalities, or who are taking drugs known to prolong the QTc interval. Osimertinib should be permanently discontinued in patients who develop QTc prolongation and signs of life-threatening arrhythmias.

3.Cardiomyopathy. Perform cardiac monitoring in patients with cardiac risk factors, including baseline and during treatmentLVEFassessments. Evaluate patients who develop relevant cardiac signs or symptoms during treatmentLVEF. For symptomatic congestive heart failure, permanently discontinue osimertinib.

4.Keratitis. In clinical trials, 0.7%of 1479patients who receivedosimertinib reported keratitis. If a patient develops signs and symptoms suggestive of keratitis (such as eye inflammation, watery eyes, light sensitivity, blurred vision, eye pain, or red eyes), see an ophthalmologist immediately.

5.Erythema multiforme severe, Stevens-Johnson syndrome and toxic epidermal necrolysis. Erythema multiforme (EMM), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). If EMM, SJS or TEN is suspected, discontinue osimertinib, and if osimertinib is confirmed, permanently discontinue osimertinib.

6.Cutaneous vasculitis. Postmarketing cases of cutaneous vasculitis, including leukocytoclastic vasculitis, urticarial vasculitis, and IgAvasculitis, have been reported in patients receivingosimertinib. If cutaneous vasculitis is suspected, osimertinib should be discontinued, systemic involvement evaluated, and dermatologic consultation considered. If no other cause can be identified, consider permanently discontinuing osimertinib based on severity.

7.Aplastic anemia. Aplastic anemia has been reported in patients during clinical trials (0.07% of 1479 cases ) and post-marketing therapy. Some cases have had fatal outcomes. Inform patients of the signs and symptoms of aplastic anemia, including but not limited to new or persistent fever, bruising, bleeding, and paleness. If aplastic anemia is suspected, osimertinib should be discontinued and hematology consultation should be obtained. If aplastic anemia is confirmed, permanently discontinue osimertinib. Perform a complete blood count and differential count before initiatingosimertiniband periodically throughout treatment, or more frequently if necessary.

8.Embryo-Fetal Toxicity. Based on animal study data and its mechanism of action, osimertinib taken by pregnant women can cause harm to the fetus. In animal reproduction studies, during early developmental stages at the recommended clinical dose1.5Taking osimertinib at twice the dose may result in post-implantation fetal loss. When males were treated prior to mating with untreated females, the preimplantation embryo loss increase in plasma exposure was approximately 0.5 times the recommended once daily dose of 80 mg once daily. Verify pregnancy status in females of reproductive potential before initiating osimertinib. Inform pregnant women of potential risks to the fetus. Advise females of childbearing potential to use effective contraception during treatment with osimertinib and for 6 weeks after the last dose. Advise men with female partners of childbearing potential to use effective contraception for 4months after the last dose. Generic medicines cost several hundred yuan per box, and prices vary depending on the version. If you want to get more high-quality information, you can contact Yaode, and Yaode will do its best to learn more about high-quality overseas drugs for you.

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