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Mitosol Disposal

May 1, 2017 by PINT Inc.

Do not disconnect the syringes from the sponge receptacle- the sponge receptacle with attached syringes is intended to remain intact for disposal. The used vial, the sponge receptacle with attached syringes and any other disposable items that have come in contact with Mitosol must be placed in a disposal bin designated for chemotherapy waste – usually they are yellow or black. (Your waste management provider will provide special bins for this purpose.) The yellow disposal bag provided in the kit is intended for disposal at the surgical field and to transport the used items to the chemotherapy bin. The yellow bag is not a substitute for the chemotherapy bin!

Chemotherapy is incinerated at a much higher temperature than other OR trash or the red bins. The goal is to break down the components of the drug to keep it out of our water supply. Your facility could be fined heavily if chemotherapy waste is found in bins or bags not designated for chemotherapy.

WMI-040 Rev 11/2019

Filed Under: Handling Tagged With: Mitosol

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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.

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.

Product Information

Please click here for full Product Information for Mitosol®

IMPORTANT SAFETY INFORMATION
Contraindications

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

Warnings & 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 sclera 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. 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.

Adverse Events & Reactions

The most frequent adverse reactions to Mitosol® occur locally and include hypotony, hypotony maculopathy, blebitis, endophthalmitis, vascular reactions, corneal reactions, and cataract. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch, or call 1-800-FDA-1088.

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Corporate Responsibility
Glaukos - Transforming Vision logo

Mobius Therapeutics (makers of Mitosol) is now a part of Glaukos corporation.