Version May 2024
Glaucoma surgery (adjunctive therapy): Topical ophthalmic: 0.2 mg solution is aseptically applied via saturated sponges to surgical site of glaucoma filtration surgery for 2 minutes.
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Frequency not defined.
Hematologic & oncologic: Hemorrhage (retinal, subconjunctival, suprachoroidal, vitreal)
Infection: Infection (bleb)
Local: Local tissue necrosis (conjunctiva)
Ophthalmic: Anterior chamber eye hemorrhage, astigmatism, bleb ulceration, blebitis, capsulotomy rupture, cataract, choroidal detachment, choroidal effusion (may include suprachoroidal effusion), chronic bleb leak, conjunctival abnormalities (degeneration), corneal changes (damage, vascularization) decreased intraocular pressure, decreased visual acuity, disk hemorrhage, endophthalmitis, epithelial keratopathy, iritis, lacrimal duct obstruction, macular edema, maculopathy, malignant glaucoma, papilledema, posterior capsule opacification, progression of cataract, retinal detachment, retinal pigment epithelial detachment, retinal vein occlusion, scleral ulceration, superficial punctate keratitis, synechiae of iris, vision loss
Miscellaneous: Encapsulated/cystic bleb, wound dehiscence, wound healing impairment
Hypersensitivity to mitomycin or any component of the formulation.
Concerns related to adverse effects:
• Cataract formation: An increased incidence of lenticular change and cataract formation has been correlated with mitomycin (ophthalmic) use in phakic patients.
• Corneal/scleral damage: Inadvertent corneal and/or scleral damage, including thinning or perforation, may occur with use of mitomycin (ophthalmic) solution in concentrations >0.2 mg/mL or for time periods >2 minutes. In addition, direct contact of the solution with the corneal endothelium will result in cell death.
• Hypotony: Increased incidence of postoperative hypotony has been observed with use.
Other warnings/precautions:
• Appropriate administration: Mitomycin (ophthalmic) is only intended for topical application to the surgical site of glaucoma filtration surgery. Do not administer intraocularly; intraocular administration may result in cell death, potentially causing corneal and retinal infarction, and ciliary body atrophy.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Kit, Ophthalmic:
Mitosol: 0.2 mg
No
Kit (Mitosol Ophthalmic)
0.2 mg (per each): $516.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
For aseptic topical administration to surgical site of glaucoma filtration surgery; not for intraocular administration. The inner tray and the contents of the kit are sterile and should only be handled, opened and assembled by a sterile surgical scrub technician. Use within 1 hour of reconstitution. Technician should fully saturate sponges provided in the kit with the entire reconstituted solution (0.2 mg). Allow saturated sponges to remain undisturbed in kit for 60 seconds. Saturated sponges should be applied aseptically with the use of surgical forceps in a single layer to a treatment area ~10 mm × 6 mm (± 2 mm); sponges should be removed from the treatment area after 2 minutes. Following removal of sponges from eye, the surgical site should be copiously irrigated. Saturated sponges should be returned to the provided tray for disposal into chemotherapy waste bag. Consult product labeling for additional details.
Hazardous agent (NIOSH 2016 [group 1]).
Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2016; USP-NF 2020).
Glaucoma surgery: Adjunct to ab externo glaucoma surgery
MitoMYcin (Ophthalmic) may be confused with MitoMYcin (Systemic), mitotane, mitoXANTRONE
This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes that have a heightened risk of causing significant patient harm when used in error.
Mitosol is not intended for intraocular administration; intraocular administration may result in cell death and lead to corneal and retinal infarction, and ciliary body atrophy.
Mitosol is only intended for topical application to the surgical site of glaucoma filtration surgery.
None known.
There are no known significant interactions.
Evaluate pregnancy status prior to administration.
Based on the mechanism of action and data from animal reproduction studies, in utero exposure to mitomycin may cause fetal harm.
It is not known if mitomycin is present in breast milk following ophthalmic application.
Due to the potential for serious adverse reactions in the breastfeeding infant, breastfeeding is not recommended for 1 week following ophthalmic administration of mitomycin.
Verify pregnancy status prior to use.
Mitomycin alkylates DNA to produce DNA cross-linking (primarily with guanine and cytosine pairs) and inhibits DNA and RNA synthesis. Mitomycin is not cell cycle specific but has its maximum effect against cells in late G and early S phases (Perry 2012). During use in trabeculectomy (filtration surgery) for glaucoma, mitomycin topical ophthalmic application alters conjunctival vascular endothelium and inhibits fibroblast proliferation (Bindlish 2002).
Absorption: Systemic absorption following ocular administration is unknown; however, systemic concentrations are expected to be of multiple orders of magnitude lower than concentrations produced following parenteral administration.
Metabolism: Cleared from ophthalmic tissue following topical administration and irrigation; systemic metabolism primarily occurs in the liver
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