Dosing and uses of Mitosol (mitomycin ophthalmic)
Adult dosage forms and strengths
ophthalmic solution
- 0.2mg/vial (contained within entire kit)
Glaucoma Surgery
Indicated for as adjunct to ab externo glaucoma surgery
Sponges provided within the kit should be fully saturated with the entire reconstituted contents (see Administration)
A treatment area approximating 10mm x 6mm +/- 2mm should be treated with mitomycin ophthalmic
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 2 minutes, and then remove and copious irrigate surgical site
Administration
Intended for topical application to the surgical site of glaucoma filtration surgery
Not for intraocular administration; if intraocular administration occurs, cell death may lead to corneal infarction, retinal infarction, and ciliary body atrophy
Reconstitution
- Each vial contains a lyophilized mixture of mitomycin 0.2 mg and mannitol 0.4 mg
- 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
- Following reconstitution, resulting solution has a pH of 5.0-8.0
- Preparing sponges: See full prescribing information
Stability
- Unreconstituted vials: Store at controlled room temperature (ie, 20-25°C [68-77°F]); avoid excessive heat and protect form light
- Reconstituted vials: When reconstituted to concentration of 0.2 mg/mL, stable for 1 hr at room temperature
Handling & disposaL
- Procedures for proper handling and disposal of anticancer drugs should be followed
- Appropriate containment and disposal devices are included in each kit
Pterygium (Orphan)
Prevention of recurrence of pterygium after its surgical excision
Orphan designation sponsor
- Mobius Therapeutics, Inc; 1141 South 7th Street; St. Louis, MO 63104
Corneal Subepithelial Haze (Orphan)
Prevention of corneal subepithelial haze formation following surface ablation laser keratectomy
Orphan designation sponsor
- Mobius Therapeutics, Inc; 1141 South 7th Street; St. Louis, MO 63104
Pediatric dosage forms and strengths
Safety and efficacy not established
Mitosol (mitomycin ophthalmic) adverse (side) effects
Frequency not defined
Blebitis (eg, bleb ulceration, chronic bleb leak, encapsulated/cystic bleb, bleb-related infection, wound dehiscence, conjunctival necrosis, thin-walled bleb)
Corneal reactions (eg, corneal endothelial damage, epithelial defect, anterior synechiae, superficial punctuate keratitis, Descemet’s detachment, induced astigmatism)
Endophthalmitis
Hypotony that include choroidal reactions (eg, choroidal detachment, choroidal effusion, serous choroidal detachment, suprachoroidal hemorrhage, hypotony maculopathy, presence of supraciliochoroidal fluid, hypoechogenic suprachoroidal effusion)
Inflammation (eg, iritis, fibrin reaction)
Cataract development, cataract progression, capsule opacification, capsular constriction and/or capsulotomy rupture, posterior synechiae
Retinal pigment epithelial tear, retinal detachment (serous and rhegmatogenous)
Wound dehiscence
Vascular (eg, hyphema, central retinal vein occlusion, hemiretinal vein occlusion, retinal hemorrhage, vitreal hemorrhage and blood clot, subconjunctival hemorrhage, disk hemorrhage)
Other reactions (macular edema, sclera thinning or ulceration, intraocular lens capture, disk swelling, malignant glaucoma, lacrimal drainage system obstruction, ciliary block, corneal vascularization, visual acuity decrease, cystic conjunctival degeneration, upper eyelid retraction, dislocated implants, severe loss of vision)
Warnings
Contraindications
Hypersensitivity
Women who are or may become pregnant during therapy
Cautions
Cytotoxic agent; use in concentrations >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
Associated with an increased instance of postoperative hypotony
Use in phakic patients has been correlated to a higher instance of lenticular change and cataract formation
Pregnancy and lactation
Pregnancy category: X
Lactation: Unknown whether distributed in breast milk; a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Mitosol (mitomycin ophthalmic)
Mechanism of action
Inhibits synthesis of deoxyribonucleic acid (DNA); guanine and cytosine content correlates with the degree of mitomycin-induced cross-linking
Cellular RNA and protein synthesis may also be suppressed
Absorption
Systemic exposure following ocular administration is unknown, but is expected to be multiple orders of magnitude lower than those achieved by IV administration
Metabolism
Cleared from ophthalmic tissue after intraoperative topical application and irrigation, as metabolism occurs in other affected tissues; systemic clearance is affected primarily by metabolism in the liver
Elimination
Excretion: Urine 10% (as unchanged)
