【商品名】Mitosol
【英文通用名】Mitomycin-c
【中文通用名】丝裂霉素C （别名：自力霉素、丝裂霉素、丝裂霉素协和MMC）
【中文化学名】（1aS，8R，8aR，8bS）-6- 氨基-4,7-二氧-1,1a,2,8,8a,8b-6H-8a-甲氧基-5-甲基连氮 [2`,3`,3,4]吡咯[1,2-α]吲哚-8-基甲基氨基甲酸盐
【英文化学名】;[(1aS,8S,8aR,8bS)-6-amino-8a-methoxy-5-methyl-4,7-dioxo-1,1a,2,4,7,8,8a,8b-octahydroazireno[2',3':3,4]pyrrolo[1,2-a]indol-8-yl]methyl carbamate
【分子式】C15H18N4O5
【相对分子量】334.33

【化学性质】蓝紫色有光泽的结晶。360℃以上分解。溶于水、甲醇、丙醇、乙酸丁酯和环已酮，微溶于苯、四氯化碳和醚，几乎不溶于石油醚。其水溶液对酸、碱均不稳定。
【剂型】外用溶液
【适应证】用于青光眼手术中，特别是难治性青光眼患者。
【一般描述】
美国眼科药品公司Mobius于 2月9日收到美国FDA对其Mitosol的最终批准决定。Mitosol用于青光眼手术。Mobius治疗剂公司可立即启动Mitosol的生产和营销工作。Mitosol的获准是该公司5年努力的结果，这将为青光眼手术治疗增加便利性、安全性和恒定性。
青光眼在美国为导致失明的第二大原因。Mitosol采用一种新的给药系统即：外用溶液，递送精确剂量的活性成分丝裂霉素C（mitomycin-c），眼科医师在使用过程中无需改变他们目前的手术技术。

HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Mitosol® (mitomycin for solution) safely and effectively. See full prescribing information for Mitosol® (mitomycin for solution).
Mitosol® (mitomycin for solution)
Initial U.S. Approval: 1974
 
INDICATIONS AND USAGE
Mitosol® is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery. (1)

DOSAGE AND ADMINISTRATION
Mitosol® is intended for topical application to the surgical site of glaucoma filtration surgery. It is not intended for intraocular administration. (2)

Each vial of Mitosol® contains 0.2 mg of mitomycin and mannitol in a 1:2 concentration ratio. To reconstitute, add 1 mL of Sterile Water for Injection, then shake to dissolve. If product does not dissolve immediately, allow to stand at room temperature until the product has dissolved into solution. (2.1)
Fully saturate sponges provided within the Mitosol® Kit utilizing the entire reconstituted contents of the vial in the manner prescribed in the Instructions for Use. (2.2)
Apply fully saturated sponges equally to the treatment area, in a single layer, with the use of a surgical forceps. Keep the sponges on the treatment area for two (2) minutes, then remove and return to the Mitosol® Tray for defined disposal. (2.2)
 
DOSAGE FORMS AND STRENGTHS
Each vial contains a sterile lyophilized mixture of 0.2 mg mitomycin and 0.4 mg mannitol; when reconstituted with Sterile Water for Injection, the solution contains 0.2 mg/mL mitomycin. (3)

CONTRAINDICATIONS
Hypersensitivity to mitomycin. (4.1)
Women who are or may become pregnant during therapy. (4.2)
 
WARNINGS AND PRECAUTIONS
Cell Death. Mitomycin is cytotoxic. Use of mitomycin in concentrations higher than 0.2 mg/mL or use for longer than 2 minutes may lead to unintended corneal and/or scleral damage including thinning or perforation. Direct contact with the corneal endothelium will result in cell death. (5.1)
Hypotony. The use of mitomycin has been associated with an increased instance of post-operative hypotony. (5.2)
Cataract Development. Use in phakic patients has been correlated to a higher instance of lenticular change and cataract formation. (5.3)
 
ADVERSE REACTIONS
The most frequent adverse reactions to Mitosol® occur locally and include hypotony, hypotony maculopathy, blebitis, endophthalmitis, vascular reactions, corneal reactions, and cataract. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Mobius Therapeutics LLC at 1-877-393-6486 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.