• Skip to primary navigation
  • Skip to main content
  • Skip to footer
Mitosol Logo

Mitosol®

Mitosol Has It All

  • HOME
  • CONTACT
  • ORDER
  • RESOURCES
    • Mitosol Resource Center
    • The Mitosol Kit
    • What is Mitosol?
    • Getting Started with Mitosol
  • ABOUT US

Mitosol Inservice Video


Introducing Mitosol®, a convenient and safer way to use Mitomycin-C for Ophthalmic Surgery. This video will demonstrate how to safely and efficiently use the Mitosol Kit.

The video includes the following 6 short video segments, which breaks down the entire process:

  1. Mitosol Kit Contents
  2. Getting Started
  3. Reconstituting Mitosol
  4. Soaking the Sponges
  5. Using Mitosol
  6. Assembly Disposal

Additional information can be found on the RESOURCES page.


Mitosol In-Service Video Transcript


Mitosol Kit Contents

The Mitosol Kit is made up of two main components: The White Outer Pack and the Sterile Inner Tray.

The contents of the white outer pack are sterile and include:

  • The package insert
  • Instructions for use which should be read prior to use
  • A zip closure chemotherapy waste bag
  • 2 patient chart labels
  • A Sterile Inner Tray

The sterile inner tray contains the components needed to reconstitute and use Mitosol. Its contents include:

  • The Mitosol vial and a vial adapter with spike, both within a blue foam pouch
  • A pre-filled syringe containing 1ml Sterile Water for Injection, with safety connector attached
  • A white plunger rod
  • A sponge container with pre-cut sponges
  • A 1ml Luer Lock TB syringe
  • A MMC label to label the drug on the sterile field

Getting Started

The Mitosol Kit contains everything needed to safely deliver the desired concentration of Mitomycin-C. Let’s get started with opening and dispensing the contents of your Mitosol Kit for ophthalmic surgery.

The contents inside the white outer pack are sterile. This pack should be handled, opened and its contents dispensed by a circulating nurse.

The sterile inner tray and its contents are also sterile and must be handled, opened and its contents assembled and dispensed by a sterile scrub person.

  • Before the reconstitution of Mitosol, it is recommended that you prepare the sponge tray. To do so:
  • Remove the sponge container with precut sponges and TB syringe from the inner tray.
  • Dump the pre-cut sponges back into the inner tray.
  • Select the surgeon-preferred sponges and place them back into the sponge tray.
  • Close the lid, attach the luer lock TB syringe to one side of the sponge tray and set aside while you reconstitute the Mitosol.

Reconstituting Mitosol

Next, we’ll show you how to safely reconstitute Mitosol.

Please note that double gloving is specified by USP 800.

A sterile scrub technician shall perform the following steps.

Remove the Mitosol vial and vial adapter from the blue foam pouch. (DO NOT attach vial adapter with spike to vial at this point.)

Next, screw the white plunger rod into the plunger of the pre-filled syringe.

Push and twist the vial adapter with spike onto the safety connector until firmly seated.

Place the vial on a firm, flat surface.

Push the syringe down and spike the vial, then inject the sterile water down into the vial.

Invert and shake well to insure complete drug reconstitution. Once the Mitosol is reconstituted, it is time to soak the sponges.

Soaking the Sponges

Now, we’ll demonstrate how to prepare the sponges.

A sterile scrub technician shall perform the following steps.

First, invert the vial and draw the full volume of medication into the syringe.

Next, unscrew the vial adapter from the safety connector.

Make sure that the vial adapter remains fully seated to the stopper on the vial.

Screw the syringe that contains the Mitosol into the sponge tray on the opposite end of the tray where the TB syringe is already attached.

Next, inject the full volume of the medication into the sponge container to saturate the sponges. Please allow 60 seconds for the Mitosol to be fully absorbed by the sponges.

After waiting 60 seconds, any excess fluid within the container can be removed by withdrawing the plunger of the TB syringe.

The Mitosol is now ready for use by the surgeon. It must be used within 1 hour of reconstitution.

Using Mitosol

Next, we’ll show you how to properly use the Mitosol during ophthalmic surgery.

The surgeon will now apply the saturated sponges to the surgical site.

After the allotted time has passed, the surgeon will remove the sponges and place them back into the sponge container and close its lid.

Assembly Disposal

Let’s review the final steps.

The entire assembly, the vial with vial adapter attached and gloves used at the surgical field will be placed into the chemotherapy waste disposal bag. Do not disconnect the syringes from the sponge tray. Do not forget to place your surgical gloves into the chemotherapy waste bag.

The chemotherapy waste bag must be disposed of in an appropriate chemotherapy waste bin.

Additionally, the forceps used to handle Mitosol sponges should only be used for this purpose. These forceps should be isolated from the other instruments and hand washed before returning to tray for processing.

WMI-031 Rev 02/2021

Footer

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.

This site is intended only for US residents.
Use of website is governed by the Terms of Use and Privacy Policy
Corporate Responsibility