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Mitosol Educational Articlesl

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

How to handle a Mitosol Spill?

April 30, 2017 by PINT Inc.

On the sterile field:

  1. Place a disposable towel or small stack of 4x4s onto the spill and allow it to be absorbed.
  2. Place in yellow chemotherapy disposal bag.
  3. Gloves must be changed after cleaning a spill.
  4. Place used gloves in yellow chemotherapy bag.

Off the sterile field:

  1. Don gloves.
  2. Place disposable towel onto the spill and allow it to be absorbed.
  3. Wipe area of spill with a bleach wipe.
  4. Place towel and bleach wipe into yellow chemotherapy disposal bag.
  5. Remove gloves and place in yellow bag.
  6. Wash hands.

WMI-039 Rev 01/2018

Filed Under: Handling Tagged With: Mitosol

Why is Mitosol used during a trabeculectomy procedure?

April 26, 2017 by PINT Inc.

Over time, the sclera and the conjunctiva eventually “scar up” and the bleb is no longer functional.

Mitosol and Trabeculectomy

Trabeculectomy is performed to treat glaucoma, a disease that causes blindness, often due to increased pressure on the optic nerve caused by compromised outflow of aqueous humor from the anterior chamber of the eye. A portion of the trabecular meshwork is removed by the surgeon to create a bypass drain for the aqueous humor. The surgeon cuts the conjunctiva and separates it from the sclera, then creates a scleral flap to access the trabecular meshwork underneath. Once the portion of the trabecular meshwork is removed, aqueous outflow is established. The aqueous collects in the space between the sclera and conjunctiva, creating a bleb, where it is reabsorbed by the body.

Why Mitosol?

Mitosol is Mitomycin C, an antimetabolite (a chemotherapy agent) that inhibits the growth of fibroblasts that cause scarring of those tissues. The surgeon applies Mitosol between the sclera and conjunctiva to target the fibroblasts and prevent bleb failure.

WMI-035 Rev 11/2019

Filed Under: Education Tagged With: glaucoma, Mitosol, trabeculectomy

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

What should I do if my skin or eyes come in contact with Mitosol?

April 23, 2017 by PINT Inc.

First aid measures listed in SDS

Eyes: Remove any contact lenses. Immediately flush eyes with water for 15 minutes keeping eyelids open. Cold water may be used. Do not use an eye ointment. Seek medical help

Skin: Gently wash thoroughly the contaminated skin with water and non-abrasive soap. Cold water may be used. Cover the irritated skin with an emollient. If irritation persists, seek medical attention. If the chemical gets on your clothing, remove the contaminated clothing carefully, using personal protective equipment, and wash areas of body. Wash clothing before reusing. For serious skin contact: Wash with a disinfectant soap and cover the contaminated skin with an anti-bacterial cream. Seek immediate medical attention.

Inhalation: Remove to fresh air, seek immediate medical attention. For serious inhalation: Remove to fresh air. Loosen clothing. If having difficulty breathing, administer oxygen. Giving mouth-to-mouth resuscitation may be dangerous. Seek immediate medical attention.

Ingestion: Have conscious person drink several glasses of water or milk. INDUCE VOMITING by sticking finger in throat or give Ipecac if ingestion has been less than 30 minutes. If greater than 30 minutes or unknown, activated charcoal may be administered if victim is alert and conscious (15-30g children; 50-100g adults). Seek immediate medical attention.

Accidental Injection: Seek prompt medical attention.

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Mitosol SDS

1 file(s) 1.09 MB
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WMI-037 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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Mobius Therapeutics (makers of Mitosol) is now a part of Glaukos corporation.