Osimertinib detailed instructions

1. Indications and Usage

Osimertinib is a kinase inhibitor suitable for:

•As adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer, the patient's tumor has an epidermal growth factor receptor ( EGFR (span)

•A test approved by the U.S. Food and Drug Administration (FDA) has found the presence of EGFR< in the tumors of adults with metastatic non-small cell lung cancer. span>The 19 exon deletion or the 21 exon L858R mutation can be used as first-line treatment.

•A U.S. Food and Drug Administration (FDA)-approved test found that adult patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer progressed during or after treatment with an EGFR·TKI.

2. Dosage and usage

Adjuvant treatment for early-stage non-small cell lung cancer:80 mg orally administered once daily, with or without food, until disease relapse or toxicity is unacceptable, or for up to 3 years.

Metastatic non-small cell lung cancer:80 mg orally once daily, with or without food, until disease progression or unacceptable toxicity.

Three. Dosage form and strength

Tablets: 80mg and 40mg.

Four. Contraindications

No.

Five. Warnings and Precautions

•Interstitial lung disease (ILD)/Pneumonia:occurs in 3.8% of patients. Osimertinib should be permanently discontinued in patients diagnosed with ILD/pneumonitis.

•QTcInterval prolongation:Monitor if you have a history ofQTc interval prolongation or ECG and electrolytes in patients who are susceptible to prolongation of the QTc interval or who are taking drugs known to prolong the QTc interval. Discontinue and restart at a reduced dose or permanently discontinue osimertinib.

•Cardiomyopathy:occurs in 3% of patients. Cardiac monitoring, including left ventricular ejection fraction (LVEF) assessment, is performed in patients with cardiac risk factors.

•Keratitis:Promptly refer patients with signs and symptoms of keratitis to an ophthalmologist for evaluation.

•Erythema multiforme severe, Stevens-Johnson syndrome, and toxic epidermal necrolysis:If erythema multiforme (EMM is suspected) ), Stevens-Johnson syndrome (SJS), or toxic epidermal necrolysis (TEN), this product should be discontinued, and if confirmed, this product should be permanently discontinued.

•Cutaneous vasculitis:If cutaneous vasculitis is suspected, teglisol should be discontinued, systemic involvement evaluated, and dermatology consultation considered. If no other cause can be identified, consider permanent discontinuation based on severity.

•Aplastic anemia:If aplastic anemia is suspected, teglisol should be discontinued; if confirmed, osimertinib should be permanently discontinued. Osimertinib should be discontinued.

•Embryo-Fetotoxicity:Osimertinibcan cause harm to the fetus. Advise women to be aware of the potential risk to the fetus and to use effective contraception during treatment with osimertinib and for 6 weeks after the final dose. It is recommended that men use effective contraception for 4 months after taking the last dose of osimertinib.

Five. Adverse reactions

The most common (》20%) adverse reactions (including laboratory abnormalities) include leukopenia, lymphopenia, thrombocytopenia, diarrhea, anemia, rash, musculoskeletal pain, nail toxicity, neutropenia, dry skin, stomatitis, fatigue, and cough.

6. Drug interactions

StrongCYP3AInducers:Avoid if possible. If not possible, increase osimertinib to 160 mg daily in patients receiving strong CYP3A4 inducers.

6. Use among specific groups of people

Lactation period:Do not breastfeed.

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