Mitomycin Ophthalmic

Mitomycin ophthalmic is used as an adjunct to ab externo glaucoma surgery.

Mitomycin ophthalmic is available under the following different brand names: Mitosol.

Dosages of Mitomycin Ophthalmic:

Dosage Forms and Strengths

Ophthalmic Solution

• 0.2mg/vial (contained within an entire kit)

Dosage Considerations – Should be Given as Follows:

Glaucoma Surgery

• Indicated for as an adjunct to ab externo glaucoma surgery
• Sponges provided within the kit should be fully saturated with the entire reconstituted contents
• 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 copiously 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 the product does not dissolve immediately, allow it to stand at room temperature until the product dissolves into a solution
• Following reconstitution, the resulting solution has a pH of 5.0-8.0
• Preparing sponges: See full prescribing information

Stability

• Unreconstituted vials: Store at controlled room temperature (i.e., 20-25°C [68-77°F]); avoid excessive heat and protect from light
• Reconstituted vials: When reconstituted to a concentration of 0.2 mg/mL, stable for 1 hour at room temperature
• Handling and disposal
• Procedures for proper handling and disposal of anticancer drugs should be followed
• Appropriate containment and disposal devices are included in each kit
• Safety and efficacy not established in pediatric patients

Side effects of mitomycin ophthalmic include:

• Blebitis (e.g., bleb ulceration, chronic bleb leak, encapsulated/cystic bleb, bleb-related infection, wound dehiscence, conjunctival necrosis, thin-walled bleb)
• Corneal reactions (e.g., corneal endothelial damage, epithelial defect, anterior synechiae, superficial punctuate keratitis, Descemet’s detachment, induced astigmatism)
• Endophthalmitis
• Hypotony that include choroidal reactions (e.g., choroidal detachment, choroidal effusion, serous choroidal detachment, suprachoroidal hemorrhage, hypotony maculopathy, presence of supraciliochoroidal fluid, hypoechogenic suprachoroidal effusion)
• Inflammation (e.g., 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 (e.g., 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)

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Mitomycin ophthalmic has no listed severe interactions with other drugs.
• Mitomycin ophthalmic has no listed serious interactions with other drugs.
• Mitomycin ophthalmic has no listed moderate interactions with other drugs.
• Mitomycin ophthalmic has no listed mild interactions with other drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

This medication contains mitomycin ophthalmic. Do not take Mitosol if you are allergic to mitomycin ophthalmic or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity
• Women who are or may become pregnant during therapy

Effects of Drug Abuse

• No information is available

Short-Term Effects

• See "What Are Side Effects Associated with Using Mitomycin Ophthalmic?”

Long-Term Effects

• See "What Are Side Effects Associated with Using Mitomycin Ophthalmic?”

Cautions

• Cytotoxic agent; use in concentrations greater than 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

• Do not use mitomycin ophthalmic in pregnancy. The risks involved outweigh the potential benefits. Safer alternatives exist.
• It is unknown whether mitomycin ophthalmic is distributed in breast milk. A decision should be made whether to discontinue nursing or to discontinue the mitomycin ophthalmic, taking into account the importance of the drug to the mother.