治療下列眼部疾病:
1. 血管新生型(濕性)年齡相關性黃斑部退化病變 (nAMD)
2. 糖尿病黃斑部水腫 (DME)
3. 視網膜靜脈阻塞(RVO)續發的黃斑部水腫
Indicated for the treatment of:
1. Neovascular (wet) age-related macular degeneration (nAMD)
2. Diabetic macular edema (DME)
3. Macular edema secondary to retinal vein occlusion (RVO)
Faricimab 是一種人源化雙特異性 IgG1 抗體,同時中和血管內皮生長因子 A (VEGF-A) 和 angiopoietin-2 (Ang-2),降低血管通透性與發炎,抑制病理性血管新生並恢復血管穩定性。
Faricimab is a humanized bispecific IgG1 antibody that neutralizes both VEGF-A and Ang-2, reducing vascular permeability and inflammation, inhibiting pathological angiogenesis, and restoring vascular stability.
玻璃體內注射後約 2 天達到血漿中最大濃度(Cmax),平均為 0.22–0.23 g/mL。平均全身半衰期為約 7.5 天,血漿中無明顯累積。主要代謝途徑為蛋白白分解,無需經肝臟代謝。
After intravitreal injection, peak plasma concentration (Cmax) is reached in approximately 2 days (mean 0.22–0.23 g/mL). The apparent systemic half-life is about 7.5 days with no significant accumulation. It is primarily metabolized by proteolytic degradation, not hepatic enzymes.
禁用於眼部或眼周感染、有活動性眼內發炎或對 faricimab 或其任何成分過敏的病人。
Contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or hypersensitivity to faricimab or any of its excipients.
懷孕期間使用 Vabysmo 的資料有限。除非潛在效益大於對胎兒的風險,否則不建議使用。動物試驗未顯示生殖毒性。
There are limited data on the use of Vabysmo during pregnancy. Use is not recommended unless the potential benefit outweighs the potential risk to the fetus. Animal studies have shown no reproductive toxicity.
尚不清楚 Vabysmo 是否分泌至人乳中,應評估母親的臨床需求與哺乳對嬰兒的潛在風險。
It is unknown whether Vabysmo is excreted in human milk. The benefits of breastfeeding should be weighed against the potential risks to the infant and the mother's clinical need for treatment.
常見副作用包括白內障 (9.7%)、結膜出血 (6.7%)、玻璃體剝離 (4.2%)、眼壓升高 (3.5%)、玻璃體漂浮物 (3.5%)、眼痛 (2.5%)。
Common adverse reactions include cataract (9.7%), conjunctival hemorrhage (6.7%), vitreous detachment (4.2%), increased intraocular pressure (3.5%), vitreous floaters (3.5%), and eye pain (2.5%).
Vabysmo 僅供玻璃體內注射使用,應由具備玻璃體內注射經驗的醫師操作,每瓶僅用於單眼治療。
Vabysmo is for intravitreal injection only and must be administered by a qualified physician. Each vial should be used for treatment of a single eye only.
血管新生型濕性年齡相關性黃斑部退化病變 (nAMD):建議 6 mg (0.05 mL) 每月一次,連續 4 劑後,依解剖學或視力結果調整治療間隔至每 8、12 或 16 週。
Neovascular Age-Related Macular Degeneration (nAMD): Recommended dose is 6 mg (0.05 mL) monthly for 4 doses, then adjust to every 8, 12, or 16 weeks based on anatomical or visual outcomes.
糖尿病黃斑部水腫 (DME):建議 6 mg (0.05 mL) 每月一次,連續 4 劑後,逐步延長注射間隔,每次延長不超過 4 週,最長至每 16 週一次。
Diabetic Macular Edema (DME): Recommended dose is 6 mg (0.05 mL) monthly for 4 doses, then progressively extend intervals by no more than 4 weeks at a time, up to every 16 weeks.
視網膜靜脈阻塞續發黃斑水腫(RVO):建議 6 mg (0.05 mL) 每月一次,連續 3 次或更多後,可考慮逐步延長至每 16 週一次。
Macular Edema Secondary to Retinal Vein Occlusion (RVO): Recommended dose is 6 mg (0.05 mL) monthly, at least 3 consecutive doses, then consider extension up to every 16 weeks.
給藥方式:注射前應檢查有無微粒或變色。注射後需監測眼壓與視神經灌流。病人應警覺眼內炎症狀如視力惡化或眼痛等。
Administration: Inspect for particulates or discoloration before injection. After injection, monitor intraocular pressure and optic nerve perfusion. Advise patients to promptly report symptoms of endophthalmitis such as vision loss or eye pain.
尚未確立小兒使用 Vabysmo 的安全性與療效。
Safety and efficacy of Vabysmo in pediatric patients have not been established.
臨床試驗顯示腎功能不全病人與正常者藥物動力學無顯著差異,無需調整劑量。
No dose adjustment is required for patients with renal impairment as pharmacokinetics are not significantly different.
因為代謝不依賴肝臟功能,肝功能不全病人無需調整劑量。
No dose adjustment is necessary in patients with hepatic impairment as faricimab metabolism is independent of liver function.