What is Mitosol®?


Mitosol® is the only FDA approved ophthalmic formulation of mitomycin. The Mitosol® Kit permits room temperature storage and an extended shelf life. Assured sterility, potency, and dosing along with closed transfer and qualified disposal reinvents mitomycin for ophthalmology.

 

 
FDA Approved for Ophthalmology Yes
Reimbursed by CMS Yes
Assured Sterility, Potency, Dosing Yes
AORN Compliant Sterile Transfer Yes
Closed Fluid Transfer Yes
Room Temp Storage Yes
cGMP Manufacturing Controls Yes
Detailed Instructions for Use Yes
NIOSH Compliant Disposal Yes
No “Black Box Warning” Yes
Shelf Life up to 24 months

 

INDICATION
Mitosol® (mitomycin for solution) 0.2 mg/vial Kit for Ophthalmic Use is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery.

Dosage & Administration
Mitosol® is intended for topical application to the surgical site of glaucoma filtration surgery and must be reconstituted prior to application. Sponges provided within the Mitosol®  Kit should be fully saturated with the entire reconstituted contents in a manner prescribed in the Instructions For Use. The sponge(s) should be applied to the treatment area for two minutes.
Reconstituted Mitosol® should be used within one hour of reconstitution.


IMPORTANT SAFETY INFORMATION
Contraindications

Hypersensitivity to mitomycin.
Women who are or may become pregnant during therapy.

Warnings & Precautions
Cell Death, mitomycin is cytotoxic. Use of mitomycin in concentrations higher than 0.2mg/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 Development. Use in phakic patients has been correlated to a higher instance of lenticular change and cataract formation.


Adverse events and reactions
The most frequent adverse reactions to Mitosol® occur locally and include hypotony, hypotony maculophathy, blebitis, endophthalmitis, vascular reactions, corneal reactions, and cataract.

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