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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag={{AV}}
|authorTag={{AV}}<!--Overview-->
 
 
<!--Overview-->
 
|genericName=mitomycin (topical)
|genericName=mitomycin (topical)
 
|aOrAn=a
 
|drugClass=[[Antibiotic]]
 
|indicationType=treatment
|aOrAn=
|indication=ab externo [[glaucoma]] surgery
 
|adverseReactions=[[loss of appetite]], [[nausea]] and [[vomiting]] and [[fever]]<!--Black Box Warning-->
a
|blackBoxWarningTitle=Title
 
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
|drugClass=
 
 
 
|indication=
 
 
 
|hasBlackBoxWarning=
 
 
|adverseReactions=
 
 
 
<!--Black Box Warning-->
 
|blackBoxWarningTitle=
Title
 
|blackBoxWarningBody=
<i><span style="color:#FF0000;">ConditionName: </span></i>


* Content
* Content
Line 41: Line 15:


<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
 
|fdaLIADAdult=*Mitomycin® is an [[antimetabolite]] indicated for use as an adjunct to ab externo [[glaucoma]] surgery.
|fdaLIADAdult=
*Mitosol® is an antimetabolite indicated for use as an adjunct to ab externo [[glaucoma]] surgery.
====Dosage====
====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.
*mitomycin® 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:
*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.
:*Each vial of mitomycin® 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:
*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.
:*Sponges provided within the mitomycin® 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 mitomycin®. 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 mitomycin® Tray for defined disposal in the Chemotherapy Waste Bag provided.
*Stability
*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.
:*Lyophilized mitomycin® 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.
:*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)-->
<!--Off-Label Use and Dosage (Adult)-->


<!--Guideline-Supported Use (Adult)-->
<!--Guideline-Supported Use (Adult)-->
 
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
|offLabelAdultGuideSupport=
 
 
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


<!--Non–Guideline-Supported Use (Adult)-->
<!--Non–Guideline-Supported Use (Adult)-->
 
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
|offLabelAdultNoGuideSupport=
 
 
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


<!--Pediatric Indications and Dosage-->
<!--Pediatric Indications and Dosage-->


<!--FDA-Labeled Indications and Dosage (Pediatric)-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
 
|fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
|fdaLIADPed=
 
 
 
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.


<!--Off-Label Use and Dosage (Pediatric)-->
<!--Off-Label Use and Dosage (Pediatric)-->


<!--Guideline-Supported Use (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
 
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
|offLabelPedGuideSupport=
 
 
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Non–Guideline-Supported Use (Pediatric)-->
<!--Non–Guideline-Supported Use (Pediatric)-->
 
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
|offLabelPedNoGuideSupport=
 
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Contraindications-->
<!--Contraindications-->
 
|contraindications=*[[Hypersensitivity]]
|contraindications=
:*Mitomycin® is contraindicated in patients that have demonstrated a hypersensitivity to mitomycin in the past.
 
* Hypersensitivity
 
:*Mitosol® is contraindicated in patients that have demonstrated a hypersensitivity to mitomycin in the past.


.<!--Warnings-->
.<!--Warnings-->
 
|warnings=* Cell Death
|warnings=
:*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.
 
* 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
*Hypotony
:*The use of mitomycin has been associated with an increased instance of post-operative hypotony.
:*The use of mitomycin has been associated with an increased instance of post-operative [[hypotony]].


*Cataract Formation
*Cataract Formation
:*Use in phakic patients has been correlated to a higher instance of lenticular change and cataract formation.
:*Use in phakic patients has been correlated to a higher instance of lenticular change and [[cataract]] formation.
<!--Adverse Reactions-->
<!--Adverse Reactions-->


<!--Clinical Trials Experience-->
<!--Clinical Trials Experience-->
|clinicalTrials=*Ophthalmic Adverse Reactions


|clinicalTrials=
*The most frequent adverse reactions to mitomycin® occur locally, as an extension of the pharmacological activity of the drug. These reactions include:


*Ophthalmic Adverse Reactions
:*Blebitis: [[bleb ulceration]], chronic bleb leak, encapsulated/cystic bleb, bleb-related infection, [[wound dehiscence]], [[conjunctivial necrosis]], thin-walled bleb


*The most frequent adverse reactions to Mitosol® occur locally, as an extension of the pharmacological activity of the drug. These reactions include:
:*Cornea: corneal endothelial damage, epithelial defect, anterior synechiae, superficial punctuate [[keratitis]], Descemet's detachment, induced [[astigmatism]]
 
:*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
:*Endophthalmitis


:*Hypotony: choroidal reactions (choroidal detachment, choroidal effusion, serous choroidal detachment, suprachoroidal hemorrhage, hypotony maculopathy, presence of supraciliochoroidal fluid, hypoechogenic suprachoroidal effusion)
:*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
:*Inflammation: [[iritis]], fibrin reaction


:*Lens: cataract development, cataract progression, capsule opacification, capsular constriction and/or capsulotomy rupture, posterior synechiae
:*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)
:*Retina: retinal pigment epithelial tear, retinal detachment (serous and rhegatogenous)
Line 147: Line 85:
:*Scleritis: wound dehiscence
:*Scleritis: wound dehiscence


:*Vascular: hyphema, central retinal vein occlusion, hemiretinal vein occlusion, retinal hemorrhage, vitreal hemorrhage and blood clot, subconjunctival hemorrhage, disk hemorrhage
:*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.
:*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.


<!--Postmarketing Experience-->
<!--Postmarketing Experience-->
 
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|postmarketing=
 
There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
 


<!--Drug Interactions-->
<!--Drug Interactions-->
|drugInteractions=
|drugInteractions=
*


<!--Use in Specific Populations-->
<!--Use in Specific Populations-->
 
|FDAPregCat=X
|useInPregnancyFDA=
|useInPregnancyFDA=*Pregnancy Category X  
* Teratogenic Effects: Pregnancy Category X  
*Pregnant women
*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
:*Mitomycin® 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. Mitomycin® 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
|useInPregnancyAUS=
|useInPregnancyAUS=There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
 
|useInNursing=*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 mitomycin®, 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 mitomycin® not breast feed because of the potential for serious adverse reactions in nursing infants.
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInPed=*Safety and effectiveness in pediatric patients have not been established.
 
|useInGeri=*No overall differences in safety and effectiveness have been observed between elderly and younger patients.
|useInLaborDelivery=
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
 
|useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with [[renal impairment]].
|useInNursing=
|useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with [[hepatic impairment]].
*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.
|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInPed=
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are [[immunocompromised]].
*Safety and effectiveness in pediatric patients have not been established.
|useInGeri=
*No overall differences in safety and effectiveness have been observed between elderly and younger patients.
|useInGender=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
 
|useInRace=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
 
|useInRenalImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
 
|useInHepaticImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
 
|useInReproPotential=
There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
 
|useInImmunocomp=
There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.


<!--Administration and Monitoring-->
<!--Administration and Monitoring-->
 
|administration=* Topical
|administration=
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
 
* Topical
 
|monitoring=
 
There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
 


<!--IV Compatibility-->
<!--IV Compatibility-->
 
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
|IVCompat=
 
There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.


<!--Overdosage-->
<!--Overdosage-->
 
|overdose=There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
|overdose=
 
 
 
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.


<!--Pharmacology-->
<!--Pharmacology-->


<!--Drug box 2-->
<!--Drug box 2-->
|drugBox={{Chembox2
|drugBox={{Chembox2
| Watchedfields = changed
| Watchedfields = changed
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|  AdminRoutes = Eye drops Intravenous}}
|  AdminRoutes = Eye drops Intravenous}}
}}
}}


<!--Mechanism of Action-->
<!--Mechanism of Action-->
 
|mechAction=*Mitomycin® 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.
|mechAction=
 
* 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-->
<!--Structure-->
 
|structure=* Mitomycin is an antibiotic isolated from the broth of Streptomyces verticillus Yingtanensis which has been shown to have antimetabolic activity.
|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:
*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:


: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
[[File:Mitomycin chemical structure.png|none|400px]]
*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.
*Mitomycin® 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. Mitomycin® 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-->
<!--Pharmacodynamics-->
 
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
|PD=
 
There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.


<!--Pharmacokinetics-->
<!--Pharmacokinetics-->
|PK=*Absorption


|PK=
:*The systemic exposure of mitomycin following ocular administration of mitomycin® 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.
*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
*Metabolism
Line 338: Line 219:
:*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.
:*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-->
<!--Nonclinical Toxicology-->
 
|nonClinToxic=*Carcinogenesis, Mutagenesis, Impairment of Fertility
|nonClinToxic=
:*Adequate long-term studies in animals to evaluate carcinogenic potential have not been conducted with mitomycin®. 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 mitomycin® on [[fertility]] is unknown.
 
*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-->
<!--Clinical Studies-->
 
|clinicalStudies=*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.
|clinicalStudies=
 
*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-->
<!--How Supplied-->
 
|howSupplied=* mitomycin® (mitomycin for solution) is available in a kit containing:
|howSupplied=
 
* Mitosol® (mitomycin for solution) is available in a kit containing:


:*One            Vial containing 0.2 mg mitomycin
:*One            Vial containing 0.2 mg mitomycin
Line 379: Line 251:


*Three kits are supplied in each carton (NDC49771-002-03).
*Three kits are supplied in each carton (NDC49771-002-03).


*Storage
*Storage
Line 387: Line 258:
*Handling Procedures
*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.
:*Procedures for Proper Handling and Disposal of anti-cancer drugs should be followed. Appropriate containment and disposal devices are included within the mitomycin® (mitomycin for solution) Kit for Ophthalmic Use.
<!--Patient Counseling Information-->
<!--Patient Counseling Information-->
 
|fdaPatientInfo=*Instruct patients to discuss with their physician if they are pregnant or if they might become pregnant  
|fdaPatientInfo=
 
*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 .
*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 .
*Nursing mothers should be advised that it is not known if mitomycin® 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 mitomycin® 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.
*Patients should be advised of the toxicity of mitomycin® and potential complications.
<!--Precautions with Alcohol-->
<!--Precautions with Alcohol-->
 
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|alcohol=
 
* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.


<!--Brand Names-->
<!--Brand Names-->
 
|brandNames=MITOSOL<!--Look-Alike Drug Names-->
|brandNames=
|lookAlike=<!--Drug Shortage Status-->
 
 
 
<!--Look-Alike Drug Names-->
 
|lookAlike=
 
 
 
<!--Drug Shortage Status-->
 
|drugShortage=
|drugShortage=
}}
}}
<!--Pill Image-->
<!--Pill Image-->


<!--Label Display Image-->
<!--Label Display Image-->


{{LabelImage
|fileName={{PAGENAME}}04.png|This image is provided by the National Library of Medicine.
}}
{{LabelImage
{{LabelImage
|fileName={{PAGENAME}}05.png|This image is provided by the National Library of Medicine.
|fileName={{PAGENAME}}05.png|This image is provided by the National Library of Medicine.

Latest revision as of 16:44, 20 August 2015

Mitomycin (topical)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Aparna Vuppala, M.B.B.S. [2]

Disclaimer

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Overview

Mitomycin (topical) is a Antibiotic that is FDA approved for the treatment of ab externo glaucoma surgery. Common adverse reactions include loss of appetite, nausea and vomiting and fever.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Dosage

  • mitomycin® 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 mitomycin® 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 mitomycin® 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 mitomycin®. 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 mitomycin® Tray for defined disposal in the Chemotherapy Waste Bag provided.
  • Stability
  • Lyophilized mitomycin® 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

  • Mitomycin® 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 mitomycin® occur locally, as an extension of the pharmacological activity of the drug. These reactions include:
  • Cornea: corneal endothelial damage, epithelial defect, anterior synechiae, superficial punctuate keratitis, Descemet's detachment, induced astigmatism
  • Endophthalmitis
  • 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
  • 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.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Mitomycin (topical) in the drug label.

Drug Interactions

There is limited information regarding Mitomycin (topical) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): X

  • Pregnancy Category X
  • Pregnant women
  • Mitomycin® 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. Mitomycin® 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


Pregnancy Category (AUS): 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 mitomycin®, 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 mitomycin® 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.

Pharmacology

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Template:Chembox header2 | Mitomycin (topical)
Identifiers
3D model (JSmol)
ChEBI
ChEMBL
ChemSpider
DrugBank
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KEGG
UNII
Properties
C15H18N4O5
Molar mass 334.33 g·mol−1
Template:Chembox header2 | Except where noted otherwise, data are given for
materials in their standard state
(at 25 °C, 100 kPa)
Infobox disclaimer and references

Mechanism of Action

  • Mitomycin® 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:
  • Mitomycin® 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. Mitomycin® 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 mitomycin® 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 mitomycin®. 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 mitomycin® 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

  • mitomycin® (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 mitomycin® (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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Package and Label Display Panel

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Patient Counseling Information

  • 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 mitomycin® 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 mitomycin® not breast feed because of the potential for serious adverse reactions in nursing infants .
  • Patients should be advised of the toxicity of mitomycin® 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

MITOSOL

Look-Alike Drug Names

There is limited information regarding Mitomycin (topical) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.


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