阿茲海默症 (Alzheimer's Disease, AD)：適用於治療具有類澱粉蛋白病理確認的早期患者，包括輕度認知障礙或輕度失智階段之阿茲海默症。

Kisunla is indicated for the treatment of Alzheimer’s disease (AD) in patients with mild cognitive impairment or mild dementia stage of disease, with confirmed presence of amyloid pathology in the brain.

類澱粉蛋白乙型單株抗體。

Amyloid beta-directed antibody.

分佈容積約 3.3 公升。半衰期約 10 天。主要透過蛋白質分解路徑清除，不涉及CYP450 酵素系統。

The volume of distribution is approximately 3.3 L. The elimination half-life is approximately 10 days. Clearance is primarily via proteolytic catabolism and does not involve cytochrome P450 enzymes.

對 donanemab 或其成分有嚴重過敏反應病史者。

Known serious hypersensitivity to donanemab-azbt or any of its excipients.

目前尚無孕婦使用的足夠資料。僅在潛在益處大於對胎兒的潛在風險時方可考慮使用。

There are no adequate data on use in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus.

尚不清楚 donanemab 是否分泌至人類乳汁。哺乳期間應評估對嬰兒的益處與母親的臨床需求。

It is unknown whether donanemab is excreted in human milk. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug.

常見副作用包括類澱粉蛋白相關影像異常 (ARIA-E 腦水腫、ARIA-H 微出血)、輸注相關反應及頭痛。

Common side effects include amyloid-related imaging abnormalities (ARIA-E edema, ARIA-H microhemorrhage), infusion-related reactions, and headache.

透過靜脈輸注給藥，每 4 週一次。前三次劑量為 700 mg，隨後劑量增加至 1400 mg。醫療人員應根據類澱粉蛋白斑塊清除狀況考慮停止治療。

Administered via intravenous infusion every 4 weeks. The dose for the first three infusions is 700 mg, followed by 1400 mg for subsequent infusions. Prescribers may consider discontinuing treatment based on the reduction of amyloid plaques.

儲存於 2°C 至 8°C 避光冷藏。不可冷凍或劇烈搖晃。稀釋後於室溫下可保存 4 小時，或於冷藏下保存 24 小時。

Store at 2°C to 8°C and protect from light. Do not freeze or shake. After dilution, the solution is stable for 4 hours at room temperature or 24 hours under refrigeration.平衡於室溫後再行輸注。Allow to reach room temperature before infusion.