Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Kit, Ophthalmic:
Mitosol: 0.2 mg
Pharmacology
Mechanism of Action
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).
Pharmacokinetics/Pharmacodynamics
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
Use: Labeled Indications
Glaucoma surgery: Adjunct to ab externo glaucoma surgery
Contraindications
Hypersensitivity to mitomycin or any component of the formulation; pregnancy
Dosage and Administration
Dosing: Adult
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
Dosing: Geriatric
Refer to adult dosing.
Reconstitution
Kit should only be opened and reconstituted by sterile surgical scrub technician. To reconstitute, add 1 mL of SWFI; shake/swirl to dissolve (detailed instructions are available in the kit). If powder does not dissolve immediately, allow to stand at room temperature until it dissolves completely into solution.
Administration
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.
Storage
Store at 20°C to 25°C (68°F to 77°F). Avoid excessive heat. Protect from light.
Reconstituted solution is stable for 1 hour at room temperature.
Drug Interactions
There are no known significant interactions.
Adverse Reactions
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
Warnings/Precautions
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.
Pregnancy
Pregnancy Risk Factor
X
Pregnancy Considerations
Adverse events were observed in animal reproduction studies. Use is contraindicated in pregnant women or women who may become pregnant during therapy.
Patient Education
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Have patient report immediately to prescriber sudden vision changes, eye pain, or severe eye irritation (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.
