Mitosol (mitomycin)

Common side effects of Mitosol include:

• local reactions such as eye inflammation
• hypotony
• hypotony maculopathy
• blebitis
• endophthalmitis
• vascular reactions
• corneal reactions, and
• cataract

Important Administration Instructions

• Mitosol is intended for topical application to the surgical site of glaucoma filtration surgery.
• Mitosol is a cytotoxic drug. It is not intended for intraocular administration.
•  If intraocular administration occurs, cell death leading to corneal infarction, retinal infarction, and ciliary body atrophy may result. Verify pregnancy status in females of reproductive potential prior to using Mitosol.

Method Of Reconstitution

• 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 dissolves into solution.

Method Of Use

• Sponges provided within the Mitosol Kit should be fully saturated with the entire reconstituted contents in the manner prescribed in the Instructions for Use.
• A treatment area approximating 10mm x 6mm +/- 2mm should be treated with the Mitosol.
• 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 in the Chemotherapy Waste Bag provided.

Stability

• Lyophilized Mitosol stored at 20°C to 25°C (68°F to 77°F) is stable for the shelf life indicated on the package. Avoid excessive heat. Protect from light.
• Reconstituted with 1 mL of Sterile Water for Injection at a concentration of 0.2 mg/mL, mitomycin is stable for one (1) hour at room temperature.

• Based on findings in animals and mechanism of action, Mitosol can cause fetal harm when administered to a pregnant woman.
• There are no available data on Mitosol use in pregnant women to inform the drug-associated risk.
• There are no data on the presence of mitomycin in human milk, the effects on the breastfed child, or the effects on milk production.
• Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during and for 1 week following administration of Mitosol.