Mitosol

Mitosol^® is an antimetabolite indicated for use as an adjunct to ab externo glaucoma surgery.

Mitosol^® is intended for topical application to the surgical site of glaucoma filtration surgery. It is not intended for intraocular administration. (

• •Each vial of Mitosol^® contains 0.2 mg of mitomycin and mannitol in a 1:2 concentration ratio. To reconstitute, add 1 mL of Sterile Water for Injection, then shake to dissolve. If product does not dissolve immediately, allow to stand at room temperature until the product has dissolved into solution. (
  2.2 Method of Reconstitution

  Each vial of Mitosol^®contains 0.2 mg of mitomycin and mannitol in a 1:2 concentration ratio. To reconstitute, add 1 mL of Sterile Water for Injection, then shake to dissolve. If product does not dissolve immediately, allow to stand at room temperature until the product dissolves into solution.
  )
• •Fully saturate sponges provided within the Mitosol^® Kit utilizing the entire reconstituted contents of the vial in the manner prescribed in the Instructions for Use. (
  2.3 Method of Use

  Sponges provided within the Mitosol^®Kit should be fully saturated with the entire reconstituted contents in the manner prescribed in the Instructions for Use. A treatment area approximating 10mm x 6mm +/- 2mm should be treated with the Mitosol^®. Apply fully saturated sponges equally to the treatment area, in a single layer, with the use of a surgical forceps. Keep the sponges on the treatment area for two (2) minutes, then remove and return to the Mitosol^®Tray for defined disposal in the Chemotherapy Waste Bag provided.
  )
• •Apply fully saturated sponges equally to the treatment area, in a single layer, with the use of a surgical forceps. Keep the sponges on the treatment area for two (2) minutes, then remove and return to the Mitosol^® Tray for defined disposal. (
  2.3 Method of Use

  Sponges provided within the Mitosol^®Kit should be fully saturated with the entire reconstituted contents in the manner prescribed in the Instructions for Use. A treatment area approximating 10mm x 6mm +/- 2mm should be treated with the Mitosol^®. Apply fully saturated sponges equally to the treatment area, in a single layer, with the use of a surgical forceps. Keep the sponges on the treatment area for two (2) minutes, then remove and return to the Mitosol^®Tray for defined disposal in the Chemotherapy Waste Bag provided.
  )

Mitosol^® is a sterile lyophilized mixture of mitomycin and mannitol, which, when reconstituted with Sterile Water for Injection, provides a solution for application in glaucoma filtration surgery. Mitosol^® is supplied in vials containing 0.2 mg of mitomycin. Each vial also contains mannitol 0.4 mg, at a 1:2 ratio of mitomycin to mannitol. Each mL of reconstituted solution contains 0.2 mg mitomycin and has a pH between 5.0 and 8.0.

Based on findings in animals and mechanism of action

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% - 4% and 15% - 20%, respectively.

• •
  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 scleral damage including thinning or perforation. Direct contact with the corneal endothelium will result in cell death. (
  5.1 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 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 incidence of post-operative hypotony. (
  5.2 Hypotony

  The use of mitomycin has been associated with an increased incidence of post-operative hypotony.
  )
• •
  Cataract Development
  : Use in phakic patients has been correlated to a higher incidence of lenticular change and cataract formation. (
  5.3 Cataract Formation

  Use in phakic patients has been correlated to a higher incidence 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. (
  5.4 Embryo-Fetal Toxicity

  Based on findings in animals and mechanism of action, Mitosol^®can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, parenteral administration of mitomycin resulted in teratogenicity

  [see Use in Specific Populations and Clinical Pharmacology ]

  .
  ,
  8.1 Pregnancy

  Risk Summary

  Based on findings in animals and mechanism of action

  [see Clinical Pharmacology ]

  , Mitosol^®can cause fetal harm when administered to a pregnant woman. There are no available data on Mitosol^®use in pregnant women to inform the drug-associated risk. In animal reproduction studies, parenteral administration of mitomycin resulted in teratogenicity (

  see Data

  ). Advise pregnant women of the potential risk to a fetus.

  The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% - 4% and 15% - 20%, respectively.

  Data

  Animal Data

  Parenteral administration of mitomycin in animal reproduction studies produced fetal malformations and embryofetal lethality.
  ,
  8.3 Females and Males of Reproductive Potential

  Mitosol^®can cause fetal harm when administered to pregnant women

  [see Use in Specific Populations ]

  .

  Pregnancy Testing

  Verify pregnancy status in females of reproductive potential prior to using Mitosol^®.
  )