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Does the contraindication for pregnancy include pregnant health care workers who work with Mitosol?

April 24, 2017 by PINT Inc.

Unfortunately, safe use during pregnancy has not been established.  The following is a statement from the American Academy of Ophthalmology regarding use of MMC in pregnant/lactating patients.

“Mitomycin C is an antifibrotic agent which is frequently applied in glaucoma surgery. A decrease of mean litter size and body weight and an increase of exencephaly in second gestation mice were associated with mitomycin use.29 There are no studies reporting the teratogenic effect of this drug in the human fetus, though the mechanism of action of the drug strongly suggests a possible teratogenic risk.” -EyeWiki

Although this addresses use in pregnant patients, the issue is exposure to the drug.  The Mitosol kit is designed to make the use of MMC in the operating room as safe as possible, however, there is always a potential for exposure, either by contact or inhalation.  Therefore, we recommend that pregnant or nursing health care workers avoid working with it if possible.  Due to the lack of information on chemotherapy and pregnant healthcare workers, our advice is it’s better to be safe than sorry.

WMI-038 Rev 01/2018

Filed Under: Education 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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Mobius Therapeutics (makers of Mitosol) is now a part of Glaukos corporation.