【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)
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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)
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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)
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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
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Hypersensitivity to mitomycin. (4.1)
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Women who are or may become pregnant during therapy. (4.2)
WARNINGS AND PRECAUTIONS
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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)
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Hypotony. The use of mitomycin has been associated with an increased instance of post-operative hypotony. (5.2)
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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.
