Key facts
- Active ingredient
- Mitomycin
- Drug class
- Alkylating Drug
- Form
- Kit
- Strength
- Mitomycin 0.2MG/VIAL
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Glaukos
- FDA application
- NDA022572
What is Mitosol?
From the FDA label:Mitomycin is an antibiotic isolated from the broth of Streptomyces verticillus Yingtanensis which has been shown to have antimetabolic activity. Mitomycin is a blue-violet crystalline powder with the molecular formula of C 15 H 18 N 4 O 5 and a molecular weight of 334.33. Its chemical name is 7-amino-9α-methoxymitosane and it has the following structural formula: 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. Structural Formula
How to use
Mitosol ® is intended for topical application to the surgical site of glaucoma filtration surgery. It is not intended for intraocular administration. ( 2 ) • 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 ) • 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 ) • 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 ) 2.1 Important Administration Instructions Mitosol ® is intended for topical application to the surgical site of glaucoma filtration surgery. Mitosol ® is a cytotoxic drug. It is not intended for intraocular administration. If intraocular administration occurs, cell death leading to corneal infarction, retinal infarction, and ciliary body atrophy may result. Verify pregnancy status in females of reproductive potential prior to using Mitosol ® . 2.2 Method of Reconstitution Each vial of Mitosol ®…
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: • Cell Death [see Warnings and Precautions ( 5.1 )] • Hypotony [see Warnings and Precautions ( 5.2 )] • Cataract Formation [see Warnings and Precautions ( 5.3 )] The most frequent adverse reactions to Mitosol ® occur locally and include hypotony, hypotony maculopathy, blebitis, endophthalmitis, vascular reactions, corneal reactions, and cataract. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mobius Therapeutics LLC at 1-877-393-6486 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Ophthalmic Adverse Reactions Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most frequent adverse reactions to Mitosol ® occur locally, as an extension of the pharmacological activity of the drug. These reactions include: Blebitis: bleb ulceration, chronic bleb leak, encapsulated/cystic bleb, bleb-related infection, wound dehiscence, conjunctival necrosis, thin-walled bleb Cornea: corneal endothelial damage, epithelial defect, anterior synechiae, superficial punctuate keratitis, Descemet's detachment, induced astigmatism Endophthalmitis Hypotony: choroidal reactions (choroidal…
Warnings
Important safety information
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 ) • Hypotony : The use of mitomycin has been associated with an increased incidence of post-operative hypotony. ( 5.2 ) • Cataract Development : Use in phakic patients has been correlated to a higher incidence of lenticular change and cataract formation. ( 5.3 ) • 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 , 8.1 , 8.3 ) 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. 5.2 Hypotony The use of mitomycin has been associated with an increased incidence of post-operative hypotony. 5.3 Cataract Formation Use in phakic patients has been correlated to a higher incidence of lenticular change and cataract formation. 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 ( 8.1 , 8.3 ) and Clinical Pharmacology ( 12.1 )] .
Who should not take Mitosol
Hypersensitivity to mitomycin. ( 4.1 ) 4.1 Hypersensitivity Mitosol ® is contraindicated in patients that have demonstrated a hypersensitivity to mitomycin in the past.
Drug class
How this class works, per Cyclophosphamide — StatPearls, NCBI Bookshelf (NIH).
May treat (source: NIH RxClass)
See how Mitosol ranks — best-rated alkylating drug for:
Dosage forms
Kit
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
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Request a 90-day supply
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Use copay cards
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Frequently asked questions
- What does Mitosol treat?
- Mitosol (Mitomycin) may be used to treat adenocarcinoma, urinary bladder neoplasms, pancreatic neoplasms, stomach neoplasms, colorectal neoplasms, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Mitosol work?
- Mitosol is a alkylating drug. Alkylating chemotherapy drugs attach chemical groups to a cell's DNA, forming cross-links that lock the two DNA strands together. This damage stops the cell from copying its DNA and dividing, which triggers it to die; because they are not limited to one phase of the cell cycle, they can act on cells whether or not they are actively dividing.
- Is there a coupon or discount for Mitosol?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Mitosol. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Mitosol?
- Mitosol is marketed by Glaukos. You can see Glaukos's full profile, rating, and other products on pharmaranks.
- Is Mitosol a brand-name or generic drug?
- Mitosol is a brand-name product with the active ingredient Mitomycin. Lower-cost generic equivalents containing Mitomycin are available — ask your pharmacist.
- Is Mitosol available over the counter?
- No. Mitosol is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Mitosol come in?
- Mitosol is currently marketed as kit, per the FDA's National Drug Code Directory.
- What class of drug is Mitosol?
- Mitosol is classified as alkylating drug, per the FDA's Established Pharmacologic Class.
- Is Mitosol FDA-registered?
- Mitosol is on record with the U.S. FDA under application number NDA022572. You can verify this on its official FDA label.
- Is Mitosol safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Mitosol. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Mitosol?
- Mitosol's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are described elsewhere in the labeling: • Cell Death [see Warnings and Precautions ( 5.1 )] • Hypotony [see Warnings and Precautions ( 5.2 )] • Cataract Formation [see Warnings and Precautions ( 5.3 )] The most frequent adverse reactions to Mit… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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