MITOSOL

AbsorptionThe systemic exposure of mitomycin following ocular administration of Mitosol ® in humans is unknown. Based on a comparison of the proposed dose of up to 0.2 mg to intravenous (IV) doses of mitomycin used clinically for treatment of oncologic indications (up to 20 mg/m 2 ), systemic concentrations in humans upon ocular administration are expected to be multiple orders of magnitude lower than those achieved by IV administration.

Elimination

MetabolismIn humans, mitomycin is cleared fr...

In placebo-controlled studies reported in the medical literature, mitomycin reduced intraocular pressure (IOP) by 3 mmHg in patients with open-angle glaucoma when used as an adjunct to ab externo glaucoma surgery by Month 12. In studies with a historical control reported in the medical literature, mitomycin reduced intraocular pressure (IOP) by 5 mmHg in patients with open-angle glaucoma when used as an adjunct to ab externo glaucoma surgery by Month 12.

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Cell Death [see Warnings and Precautions ( 5.1 )]
• Hypotony [see Warnings and Precautions ( 5.2 )]
• Cataract Formation [see Warnings and Precautions ( 5.3 )] 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 ...

• Hypersensitivity to mitomycin. ( 4.1 ) 4.1 Hypersensitivity Mitosol ® is contraindicated in patients that have demonstrated a hypersensitivity to mitomycin in the past.

• 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 incidence of post-operative hypotony. ( 5.2 )
• Cataract Development : Use in phakic patients has been correlated to a higher incide...