mitomycin ophthalmic (Rx)

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)

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

Based on findings in animals and mechanism of action; drug can cause fetal harm when administered to a pregnant woman

There are no available data on use in pregnant women to inform drug-associated risk

Verify pregnancy status in females of reproductive potential prior to using Mitosol

Animal data

• In animal reproduction studies, parenteral administration of mitomycin resulted in teratogenicity; advise pregnant women of potential risk to fetus
• Verify pregnancy status in females of reproductive potential prior to initiating therapy

Lactation

There are no data on the presence of mitomycin in human milk, effects on breastfed child, or on milk production; because of potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during and for 1 week following administration of drug

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.

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)