Other cytotoxic antibiotics

Mitosol

Approved 7 Feb 2012TopicalFor solution

Indications

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

Contraindications

Hypersensitivity to mitomycin. ( 4.1 )

4.1Hypersensitivity

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

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 )
Embryo-Fetal Toxicity : Can cause fetal harm. Advise of potential risk to a fetus. Verify pregnancy status in females of reproductive potential prior to use. ( 5.4 , 8.1 , 8.3 )

5.1Cell 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.

5.2Hypotony

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

5.3Cataract Formation Use

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

5.4

At a glance

Brand name: Mitosol
Active substance: mitomycin
Drug class: Other cytotoxic antibiotics
Route: Topical
Dosage form: For solution
Applicant: Glaukos
Status: Prescription
FDA approval: 7 Feb 2012
Application: NDA022572-001
RxCUI: 1244554

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 )
Embryo-Fetal Toxicity : Can cause fetal harm. Advise of potential risk to a fetus. Verify pregnancy status in females of reproductive potential prior to use. ( 5.4 , 8.1 , 8.3 )

5.1Cell Death

5.2Hypotony

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

5.3Cataract Formation Use

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

5.4

Adverse reactions

The following clinically significant adverse reactions are described elsewhere in the labeling:

Cell Death [see Warnings and Precautions ( 5.1 )]
Hypotony [see Warnings and Precautions ( 5.2 )]
Cataract Formation [see Warnings and Precautions ( 5.3 )] 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

6.1Ophthalmic Adverse Reactions

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. 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.

Mitosol

Indications

Contraindications

4.1Hypersensitivity

Warnings and precautions

5.1Cell Death

5.2Hypotony

5.3Cataract Formation Use

5.4

At a glance

Two medicines in one question?

Mitosol

Indications

Contraindications

4.1Hypersensitivity

Warnings and precautions

5.1Cell Death

5.2Hypotony

5.3Cataract Formation Use

5.4

At a glance

Two medicines in one question?

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary Based

Adverse reactions

6.1Ophthalmic Adverse Reactions

Composition

Official product information