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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.
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.
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.
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.
Mitosol is a sterile lyophilized 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.
Mitosol is contraindicated in patients that have demonstrated a hypersensitivity to mitomycin in the past.
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.
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.
The use of mitomycin has been associated with an increased incidence of post-operative hypotony.
Use in phakic patients has been correlated to a higher incidence of lenticular change and cataract formation.
The most frequent adverse reactions to Mitosol occur locally, as an extension of the pharmacological activity of the drug. These reactions include:
Blebitis: bleb ulceration, chronic bleb leak, encapsulated/cystic bleb, bleb-related infection, wound dehiscence, conjunctivial necrosis, thin-walled bleb
Cornea: corneal endothelial damage, epithelial defect, anterior synechiae, superficial punctuate keratitis, Descemet's detachment, induced astigmatism
Hypotony: choroidal reactions (choroidal detachment, choroidal effusion, serous choroidal detachment, suprachoroidal hemorrhage, hypotony maculopathy, presence of supraciliochoroidal fluid, hypoechogenic suprachoroidal effusion)
Inflammation: iritis, fibrin reaction
Lens: cataract development, cataract progression, capsule opacification, capsular constriction and/or capsulotomy rupture, posterior synechiae
Retina: retinal pigment epithelial tear, retinal detachment (serous and rhegatogenous)
Scleritis: wound dehiscence
Vascular: hyphema, central retinal vein occlusion, hemiretinal vein occlusion, retinal hemorrhage, vitreal hemorrhage and blood clot, subconjunctival hemorrhage, disk hemorrhage
Additional 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.
Teratogenic Effects: Pregnancy Category X (see Contraindications, 4.2).
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.
Safety and effectiveness in pediatric patients have not been established.
No overall differences in safety and effectiveness have been observed between elderly and younger patients.
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 CHNO 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.
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.
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/m), systemic concentrations in humans upon ocular administration are expected to be multiple orders of magnitude lower than those achieved by IV administration.
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.
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.
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.
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.
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)
One Plunger Rod
One Safety Connector
One Vial Adapter with Spike
One 1 mL TB 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 Protective Foam Pouch
One Chemotherapy Waste Bag
Three kits are supplied in each carton (NDC49771-002-03).
Store kits at 20° - 25° C (68° - 77° F).
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.
Manufactured for:Mobius Therapeutics, LLC1000 Executive ParkwaySuite 224St. Louis, MO 63141
Mitosol (mitomycin for solution)0.2 mg/vial Kit for Ophthalmic Use
Read INSTRUCTIONS FOR USE Before Proceeding
Instructions for Use
DISPOSE OF CHEMOTHERAPY WASTE BAG AND ITS CONTENTS AS CHEMOTHERAPY WASTE
US Patents #7,806,265, #8,186,511, #D685,962, #D685,963, #9,205,075, #9,539,241 and #9,649,428; other international patents pending.
A4805347-2 Rev. 12/17
The Outer Pack is to be handled, opened, and its STERILE contents dispensed by the non-sterile circulating nurse.
The Sterile Inner Tray is to be handled, opened, and its contents assembled and dispensed by the sterile scrub technician.
NOTE: Do not force plunger. Syringe will not operate if vial adapter and syringe connector are not properly connected. Forcing plunger may result in syringe leakage and Mitosol® exposure.
Mitosol (mitomycin for solution)
Lyophilized Mitomycin forreconstitutionProtect from light.Single Use VialDose: See Package Insert.
Store at 20°-25°C (68°-77°F).
Manufactured for: Mobius Therapeutics, LLC1000 Executive ParkwaySuite 224St. Louis, MO 63141
Manufactured by:Intas Pharmaceuticals Ltd.Ahmedabad-382 210, INDIA.
Mfg. Lic. No.: G/1026
10 9750 2 658376 INL5021
Mitosol (mitomycin for solution)0.2 mg/vial
Kit for Ophthalmic Use
Manufactured for:Mobius Therapeutics, LLC1000 Executive ParkwaySuite 224St. Louis, MO 63141 USA+1 314-615-69301-877-EYE-MITO (1-877-393-6486)
US Patents #7,806,265, #8,186,511, #D685,962,#D685,963, #9,205,075, #9,539,241 and #9,649,428;other international patents pending.
©2017 Mobius Therapeutics, LLC
A1426362-2 Rev. 12/17
NDC #49771-002-01Re-Order #MOB.2
Each Mitosol Kit Contains: One Chemotherapy Waste Bag One Instructions for Use One Package Insert One Inner Tray Two Patient Chart Labels
Inner Tray Contains: One Vial Containing 0.2 mg mitomycin (inside protective foam pouch) One 1 mL Syringe (Sterile Water for Injection) One Plunger Rod One Safety Connector One Vial Adaptor with Spike (inside protective foam pouch) One 1 mL TB Syringe, Luer Lock One Sponge Container Containing: Six 3 mm Absorbent Sponges Six 6 mm Absorbent Sponges Six Half Moon Sponges One Instrument Wedge Sponge One Label, MMC
Contents STERILE in unopened undamaged package.
Storage: Store kits at 20° - 25° C (68° - 77° F). Protect from light.
Mobius Therapeutics LLC
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