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These highlights do not include all the information needed to use Mitosol safely and effectively. See full prescribing information for Mitosol. Mitosol (mitomycin for solution) for ophthalmic useInitial U.S. Approval: 1974 | Mitosol [Mobius Therapeutics LLC] | BioPortfolio

12:25 EST 27th January 2019 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

Mitosol is an antimetabolite indicated for use as an adjunct to ab externo glaucoma surgery.

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

Endophthalmitis

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.

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/m), 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.

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).

Storage

Store kits at 20° - 25° C (68° - 77° F).

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.

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

A. Outer Pack
     (Figure A)

     One   Sterile Chemotherapy Waste Bag      One   Instructions for Use      One   Package Insert      One   Inner Tray      Two  Patient Chart Labels

The Outer Pack is to be handled, opened, and its STERILE contents dispensed by the non-sterile circulating nurse.
B. STERILE Inner Tray
     (Figure B)

     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

The Sterile Inner Tray is to be handled, opened, and its contents assembled and dispensed by the sterile scrub technician.
This tray and its contents are STERILE.
1. Getting Started

Non-Sterile Circulating Nurse: Open outer pack. Affect sterile transfer of ALL contents to the sterile field.

Sterile Surgical Technician: Open sterile inner tray.
2. Reconstituting Mitosol®

a.  Remove vial and vial adapter from blue foam pouch.

b.   Screw clear plunger rod to rubber plunger of pre-filled syringe. (Fig. 1)

c.  Rock syringe cap sideways (do not twist) until it breaks free from syringe collar. (Fig. 2)

d.  Attach threaded end of connector to syringe. (Fig. 3)



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.
e.  Firmly attach the smaller (threaded) end of vial adapter to the safety connector. (Fig. 4)

f.  Stand vial upright on a sturdy, flat surface and push on the vial lid until seated and secure. (Fig. 5)
g.  Inject entire contents of sterile water (1 ml) into vial. (Fig. 6) Do not force syringe plunger. See note at step 2.

h.   IMPORTANT: INVERT VIAL REPEATEDLY to saturate ALL drug product, including that adhering to stopper, then shake until complete reconstitution of Mitosol®. If product does not dissolve immediately, allow to stand at room temperature until the product has dissolved into solution.
3. Preparing sponges

a.   Invert vial and syringe and draw full volume of medication into syringe. (Fig. 7)

b.  Remove all sponges from sponge tray.

c.  Return to sponge tray only those sponges to be saturated with Mitosol®.
d. Unscrew the syringe with safety connector from vial and vial adapter. (Fig. 8) Note: DO NOT remove safety connector from syringe.

e.  Place vial and vial adaptor in chemotherapy waste disposal bag (yellow bag), and set bag aside, within sterile field, for additional use.

f.  Take sponge container from sterile inner tray.

g.  Screw both syringes into sponge container; the TB syringe to one end, the syringe with reconstituted Mitosol® to the other.
h.   Mitosol® must be used within 1 hour of reconstitution:

•  Inject medication into sponge container, saturating sponges. Reconstituted Mitosol® should remain undisturbed in sponge container for 60 seconds . (Fig. 9) Do not force syringe plunger. See note at step 2.

•  If any excess fluid remains, withdraw plunger of TB syringe, drawing excess fluid/air into syringe.
4. Using Mitosol®

a.  With both syringes connected, the TB syringe to one end, the pre-filled syringe to the other, open sponge container, offering contents to surgeon for placement on surgical site. (Fig. 10)

b.  Apply saturated sponges to surgical site for two minutes. Remove sponges from eye and copiously irrigate surgical site.

c.  As used sponges are removed from surgical site, accept used sponges back into sponge container for disposal. Close container lid.

d.  With syringes still connected to sponge container, remove entire assembly from surgical field in chemotherapy waste disposal bag.

NDC 49771-002-02

Mitosol (mitomycin for solution)

0.2 mg/vial

Lyophilized Mitomycin forreconstitutionProtect from light.Single Use VialDose: See Package Insert.

Rx Only

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)

Rx ONLY

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

mobius therapeutics™

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.

Manufacturer

Mobius Therapeutics LLC

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