MITOSOL (MITOMYCIN) KIT [MOBIUS THERAPEUTICS LLC]

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MITOSOL (MITOMYCIN) KIT [MOBIUS THERAPEUTICS LLC]
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NDC 49771-002-01, 49771-002-03
Set ID 244002c6-c61d-43fe-9326-072797113979
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Mobius Therapeutics LLC
Generic Name
Product Class Alkylating Drug
Product Number
Application Number NDA022572
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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    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 use
    Initial U.S. Approval: 1974

    INDICATIONS AND USAGE

    Mitosol® is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery. (1)

    DOSAGE AND ADMINISTRATION

    Mitosol® is intended for topical application to the surgical site of glaucoma filtration surgery. It is not intended for intraocular administration. (2)

    •
    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 has dissolved into solution. (2.1)
    •
    Fully saturate sponges provided within the Mitosol® Kit utilizing the entire reconstituted contents of the vial in the manner prescribed in the Instructions for Use. (2.2)
    •
    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. (2.2)

    DOSAGE FORMS AND STRENGTHS

    Each vial contains a sterile lyophilized mixture of 0.2 mg mitomycin and 0.4 mg mannitol; when reconstituted with Sterile Water for Injection, the solution contains 0.2 mg/mL mitomycin. (3)

    CONTRAINDICATIONS

    •
    Hypersensitivity to mitomycin. (4.1)
    •
    Women who are or may become pregnant during therapy. (4.2)

    WARNINGS AND PRECAUTIONS

    •
    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. (5.1)
    •
    Hypotony: The use of mitomycin has been associated with an increased incidence of post-operative hypotony. (5.2)
    •
    Cataract Development: Use in phakic patients has been correlated to a higher incidence of lenticular change and cataract formation. (5.3)

    ADVERSE REACTIONS

    The most frequent adverse reactions to Mitosol® occur locally and include hypotony, hypotony maculopathy, blebitis, endophthalmitis, vascular reactions, corneal reactions, and cataract. (6.1)

    To report SUSPECTED ADVERSE REACTIONS, contact Mobius Therapeutics LLC at 1-877-393-6486 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

    See 17 for PATIENT COUNSELING INFORMATION.

    Revised: 8/2020

  • Table of Contents

    FULL PRESCRIBING INFORMATION: CONTENTS*

    1 INDICATIONS AND USAGE

    2 DOSAGE AND ADMINISTRATION

    2.1 Method of Reconstitution

    2.2 Method of Use

    2.3 Stability

    3 DOSAGE FORMS AND STRENGTHS

    4 CONTRAINDICATIONS

    4.1 Hypersensitivity

    4.2 Pregnant women

    5 WARNINGS AND PRECAUTIONS

    5.1 Cell Death

    5.2 Hypotony

    5.3 Cataract Formation

    6 ADVERSE REACTIONS

    6.1 Ophthalmic Adverse Reactions

    8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    8.3 Nursing Mothers

    8.4 Pediatric Use

    8.5 Geriatric Use

    11 DESCRIPTION

    12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    12.3 Pharmacokinetics

    13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

    14 CLINICAL STUDIES

    16 HOW SUPPLIED/STORAGE AND HANDLING

    16.1 How Supplied

    16.2 Storage and Handling

    17 PATIENT COUNSELING INFORMATION

    *
    Sections or subsections omitted from the full prescribing information are not listed.
  • 1 INDICATIONS AND USAGE

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

  • 2 DOSAGE AND ADMINISTRATION

    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.

    2.1 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.

    2.2 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.

    2.3 Stability

    Lyophilized Mitosol® stored at controlled room temperature (i.e., 20°C - 25°C or 68°F - 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.

  • 3 DOSAGE FORMS AND STRENGTHS

    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.

  • 4 CONTRAINDICATIONS

    4.1 Hypersensitivity

    Mitosol® is contraindicated in patients that have demonstrated a hypersensitivity to mitomycin in the past.

    4.2 Pregnant women

    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.

  • 5 WARNINGS AND PRECAUTIONS

    5.1 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.

    5.2 Hypotony

    The use of mitomycin has been associated with an increased incidence of post-operative hypotony.

    5.3 Cataract Formation

    Use in phakic patients has been correlated to a higher incidence of lenticular change and cataract formation.

  • 6 ADVERSE REACTIONS

    6.1 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:

    Blebitis: bleb ulceration, chronic bleb leak, encapsulated/cystic bleb, bleb-related infection, wound dehiscence, conjunctival 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.

  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    Teratogenic Effects: Pregnancy Category X [see Contraindications, (4.2)].

    8.3 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.

    8.4 Pediatric Use

    Safety and effectiveness in pediatric patients have not been established.

    8.5 Geriatric Use

    No overall differences in safety and effectiveness have been observed between elderly and younger patients.

  • 11 DESCRIPTION

    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 C15H18N4O5 and a molecular weight of 334.33. Its chemical name is 7-amino-9α-methoxymitosane and it has the following structural formula:

    Structural Formula

    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.

  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    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.

    12.3 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.

  • 13 NONCLINICAL TOXICOLOGY

    13.1 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.

  • 14 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.

  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    16.1 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 Safety Connector

    One             Plunger Rod

    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

    One             Label, MMC (mitomycin)

    Three kits are supplied in each carton (NDC 49771-002-03).

    16.2 Storage and Handling

    Storage

    Store kits at 20°C to 25°C (68°F to 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.

  • 17 PATIENT COUNSELING INFORMATION

    •
    Instruct patients to discuss with their physician if they are pregnant or if they might become pregnant [see Contraindications (4.2)].
    •
    Instruct patients to discuss with their physician if they have demonstrated a hypersensitivity to mitomycin in the past [see Contraindications (4.1)].
    •
    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 [see Use in Specific Populations (8.3)].
    •
    Patients should be advised of the toxicity of Mitosol® and potential complications.

    Manufactured for:
    Mobius Therapeutics, LLC
    1000 Executive Parkway
    Suite 224
    St. Louis, MO 63141

  •  

    Mitosol®
    (mitomycin for solution)
    0.2 mg/vial
    Kit for Ophthalmic Use

    Read INSTRUCTIONS FOR USE Before Proceeding

    Instructions for Use

    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.

    		Figure A: Outer Pack

    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) with Safety Connector

         One   Plunger Rod

         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 (mitomycin)



    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.

    		Figure B: Sterile Inner Tray

    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.

    		Figure 1

    2. Reconstituting Mitosol®

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

    b.  Screw white plunger rod to rubber plunger of pre‑filled syringe. (Fig. 1)

    c.  Press firmly and screw the blue end of the vial adapter into the blue end of the syringe connector. (Fig. 2)

    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.

    		Figure 2

    d.  Stand vial upright on a sturdy, flat surface and push on the vial lid until seated and secure. (Fig. 3)

    e.  Inject entire contents of sterile water (1 ml) into vial. (Fig. 4) Do not force syringe plunger. See note at step 2.

    f.  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.

    		Figure 3Figure 4

    3. Preparing sponges

    a.  Invert vial and syringe and draw full volume of medication into syringe. (Fig. 5)

    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. 6) 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.

    		Figure 5Figure 6

    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. 7) 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.

    		Figure 7

    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. 8)

    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.

    		Figure 8

    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 issued and pending.

    A4807998-2
    Rev. 07/20

  • PRINCIPAL DISPLAY PANEL - VIAL LABEL

    Principal Display Panel - Vial Label

    Vial Label

    NDC 49771-002-02

    Mitosol®
    (mitomycin for solution)

    0.2 mg/vial

    Lyophilized Mitomycin for
    reconstitution
    Protect from light.
    Single Use Vial
    Dose: See Package Insert.

    Rx Only

    Store at 20°-25°C (68°-77°F).

    Manufactured for:
    Mobius Therapeutics, LLC
    1000 Executive Parkway
    Suite 224
    St. Louis, MO 63141

    Manufactured by:
    Intas Pharmaceuticals Ltd.
    Ahmedabad-382 210, INDIA.

    Mfg. Lic. No.: G/1026

    10 9750 2 658376 INL5021

  • PRINCIPAL DISPLAY PANEL - OUTER KIT PACKAGE

    Principal Display Panel - Outer Kit Package

    Outer Kit Package

    Mitosol®
    (mitomycin for solution)
    0.2 mg/vial

    Kit for Ophthalmic Use

    Manufactured for:
    Mobius Therapeutics, LLC
    1000 Executive Parkway
    Suite 224
    St. Louis, MO 63141 USA
    +1 314-615-6930
    1-877-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 issued and pending.

    ©2019 Mobius Therapeutics, LLC

    mobius
    therapeutics™

    A1426418-1
    Rev. 8/19

    NDC #49771-002-01
    Re-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)
                 with Safety Connector
       One   Plunger Rod
       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.

    HD CAUTION: HAZARDOUS DRUG
    OBSERVE SPECIAL HANDLING, ADMINISTRATION
    AND DISPOSAL REQUIREMENTS

  • INGREDIENTS AND APPEARANCE
    MITOSOL 
    mitomycin kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49771-002
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49771-002-033 in 1 CARTON02/08/2012
    1NDC:49771-002-011 in 1 TRAY; Type 0: Not a Combination Product
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 VIAL, SINGLE-USE 1 mL
    Part 21 SYRINGE 1 mL
    Part 1 of 2
    MITOSOL 
    mitomycin injection, powder, lyophilized, for solution
    Product Information
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Mitomycin (UNII: 50SG953SK6) (Mitomycin - UNII:50SG953SK6) Mitomycin0.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    mannitol (UNII: 3OWL53L36A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02257202/08/2012
    Part 2 of 2
    STERILE WATER 
    water injection, solution
    Product Information
    Route of AdministrationOPHTHALMIC
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 mL in 1 SYRINGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02257202/08/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02257202/08/2012
    Labeler - Mobius Therapeutics LLC (805642118)
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