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Overview
Mitomycin (topical) is a that is FDA approved for the {{{indicationType}}} of . Common adverse reactions include .
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Mitosol® is an antimetabolite indicated for use as an adjunct to ab externo glaucoma surgery.
Dosage
Mitosol® is intended for topical application to the surgical site of glaucoma filtration surgery. It is not intended for intraocular administration. If intraocular administration occurs, cell death leading to corneal infarction, retinal infarction, and ciliary body atrophy may result.
Method of Reconstitution:
Each vial of Mitosol® contains 0.2 mg of mitomycin and mannitol in a 1:2 concentration ratio. 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.
Method of Use:
Sponges provided within the Mitosol® Kit should be fully saturated with the entire reconstituted contents in the manner prescribed in the Instructions for Use. A treatment area approximating 10mm x 6mm +/-2mm should be treated with the Mitosol®. 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 two (2) minutes, then remove and return to the Mitosol® Tray for defined disposal in the Chemotherapy Waste Bag provided.
Stability
Lyophilized Mitosol® stored at controlled room temperature (i.e., 20 - 25°C or 68° - 77° F) is stable for the shelf life indicated on the package. Avoid excessive heat. Protect from light.
Reconstituted with Sterile Water for Injection at a concentration of 0.2 mg/ml, mitomycin is stable for one (1) hour at room temperature.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Mitomycin (topical) in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Mitomycin (topical) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Mitomycin (topical) in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Mitomycin (topical) in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Mitomycin (topical) in pediatric patients.
Contraindications
Hypersensitivity
Mitosol® is contraindicated in patients that have demonstrated a hypersensitivity to mitomycin in the past.
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Warnings
Cell Death
Mitomycin is cytotoxic. Use of mitomycin in concentrations higher 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.
Hypotony
The use of mitomycin has been associated with an increased instance of post-operative hypotony.
Cataract Formation
Use in phakic patients has been correlated to a higher instance of lenticular change and cataract formation.
Adverse Reactions
Clinical Trials Experience
Ophthalmic Adverse Reactions
The most frequent adverse reactions to Mitosol® occur locally, as an extension of the pharmacological activity of the drug. These reactions include:
Mitosol® may cause fetal harm when administered to a pregnant woman. Mitomycin administered parenterally has been shown to be teratogenic in mice and rats when given at doses equivalent to the usual human intravenous dose. Mitosol® is contraindicated in women who are or may become pregnant during therapy. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus
Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Mitomycin (topical) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Mitomycin (topical) during labor and delivery.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from Mitosol®, 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. It is recommended that women receiving Mitosol® not breast feed because of the potential for serious adverse reactions in nursing infants.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatic Use
No overall differences in safety and effectiveness have been observed between elderly and younger patients.
Gender
There is no FDA guidance on the use of Mitomycin (topical) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Mitomycin (topical) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Mitomycin (topical) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Mitomycin (topical) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Mitomycin (topical) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Mitomycin (topical) in patients who are immunocompromised.
Administration and Monitoring
Administration
Topical
Monitoring
There is limited information regarding Monitoring of Mitomycin (topical) in the drug label.
IV Compatibility
There is limited information regarding IV Compatibility of Mitomycin (topical) in the drug label.
Overdosage
There is limited information regarding Chronic Overdose of Mitomycin (topical) in the drug label.
Mitosol® inhibits the synthesis of deoxyribonucleic acid (DNA). The guanine and cytosine content correlates with the degree of mitomycin-induced cross-linking. Cellular RNA and protein synthesis may also be suppressed.
Structure
Mitomycin is an antibiotic isolated from the broth of Streptomyces verticillus Yingtanensis which has been shown to have antimetabolic activity.
Mitomycin is a blue-violet crystalline powder with the molecular formula of C15H18N405 and a molecular weight of 334.33. Its chemical name is 7-amino-9α-methoxymitosane and it has the following structural formula:
Mitosol® is a sterile lyophiliized mixture of mitomycin and mannitol, which, when reconstituted with Sterile Water for Injection, provides a solution for application in glaucoma filtration surgery. Mitosol® is supplied in vials containing 0.2 mg of mitomycin. Each vial also contains mannitol 0.4 mg, at a 1:2 ratio of mitomycin to mannitol. Each mL of reconstituted solution contains 0.2 mg mitomycin and has a pH between 5.0 and 8.0.
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Mitomycin (topical) in the drug label.
Pharmacokinetics
Absorption
The systemic exposure of mitomycin following ocular administration of Mitosol® in humans is unknown. Based on a comparison of the proposed dose of up to 0.2 mg to intravenous (IV) doses of mitomycin used clinically for treatment of oncologic indications (up to 20 mg/m2), systemic concentrations in humans upon ocular administration are expected to be multiple orders of magnitude lower than those achieved by IV administration.
Metabolism
In humans, mitomycin is 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. The rate of clearance is inversely proportional to the maximal serum concentration because of saturation of the degradative pathways.
Excretion
Approximately 10% of an injectable dose of mitomycin is excreted unchanged in the urine. Since metabolic pathways are saturated at relatively low doses, the percent of a dose excreted in urine increases.
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment of Fertility
Adequate long-term studies in animals to evaluate carcinogenic potential have not been conducted with Mitosol®. Intravenous administration of mitomycin has been found to be carcinogenic in rats and mice. At doses approximating the recommended clinical injectable dose in humans, mitomycin produces a greater than 100 percent increase in tumor incidence in male Sprague-Dawley rats, and a greater than 50 percent increase in tumor incidence in female Swiss mice. The effect of Mitosol® on fertility is unknown.
Clinical Studies
In placebo-controlled studies reported in the medical literature, mitomycin reduced intraocular pressure (IOP) by 3 mmHg in patients with open-angle glaucoma when used as an adjunct to ab externo glaucoma surgery by Month 12. In studies with a historical control reported in the medical literature, mitomycin reduced intraocular pressure (IOP) by 5 mmHg in patients with open-angle glaucoma when used as an adjunct to ab externo glaucoma surgery by Month 12.
How Supplied
Mitosol® (mitomycin for solution) is available in a kit containing:
One Vial containing 0.2 mg mitomycin
One 1 mL syringe (Sterile Water For Injection) with Connector
One Plunger Rod
One Vial Adapter with Spike
One 1 mLTB Syringe, Luer Lock
One Sponge Container
Six 3 mm Absorbent Sponges
Six 6 mm Absorbent Sponges
Six Half Moon Sponges
One Instrument Wedge Sponge
One Alcohol Prep Pad, Sterile
One Chemotherapy Waste Bag
Three kits are supplied in each carton (NDC49771-002-03).
Storage
Store kits at 20° - 25° C (68° - 77° F). Protect from light.
Handling Procedures
Procedures for Proper Handling and Disposal of anti-cancer drugs should be followed. Appropriate containment and disposal devices are included within the Mitosol® (mitomycin for solution) Kit for Ophthalmic Use.
Storage
There is limited information regarding Mitomycin (topical) Storage in the drug label.
Images
Drug Images
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Instruct patients to discuss with their physician if they are pregnant or if they might become pregnant
Instruct patients to discuss with their physician if they have demonstrated a hypersensitivity to mitomycin in the past .
Nursing mothers should be advised that it is not known if Mitosol® is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue use of the drug, taking into account the importance of the drug to the mother. It is recommended that women receiving Mitosol® not breast feed because of the potential for serious adverse reactions in nursing infants .
Patients should be advised of the toxicity of Mitosol® and potential complications.
Precautions with Alcohol
Alcohol-Mitomycin (topical) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Mitomycin (topical) Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Mitomycin (topical) Look-Alike Drug Names in the drug label.
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