Uses
Mitosol ® is an antimetabolite indicated for use as an adjunct to ab externo glaucoma surgery. Mitosol ® is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery.
Source: US FDA prescribing information
Molecule
Mitomycin
Alkylating Drug
Available on requestOrphanCold chain
- Presentations
- 7
- Brands
- 4
- Manufacturers
- 3
- Available from stock
- 0
Mitomycin is an alkylating drug indicated as an adjunct to ab externo glaucoma surgery. It is available as powder for injection and kits for intravenous use. MedsAcross supplies Mitomycin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- Pharmacological class
- Alkylating Drug, Alkylating Activity
- US FDA first approval
- 14 November 2002
- EU status
- Not recorded
- Orphan designation
- Yes
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Intravenous
- Dosage forms
- Powder for injection, Kit
- Identifiers
- UNII 50SG953SK6RxCUI 632CAS 50-07-7DrugBank DB00305Q19856779
Clinical information
From the regulator-approved product information. Each section names its source.
How it works
Mitosol ® inhibits the synthesis of deoxyribonucleic acid (DNA). The guanine and cytosine content correlates with the degree of mitomycin-induced cross-linking. Cellular RNA and protein synthesis may also be suppressed.
Source: US FDA prescribing information
Dosing overview
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. • 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. • 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 minutes, then remove and return to the Mitosol ® Tray for defined disposal.
Source: US FDA prescribing information
Contraindications
• Hypersensitivity to mitomycin. Hypersensitivity Mitosol ® is contraindicated in patients that have demonstrated a hypersensitivity to mitomycin in the past.
Source: US FDA prescribing information
Warnings and 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 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. • Cataract Development: 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.
Source: US FDA prescribing information
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: • Cell Death • Hypotony • Cataract Formation The most frequent adverse reactions to Mitosol ® occur locally and include hypotony, hypotony maculopathy, blebitis, endophthalmitis, vascular reactions, corneal reactions, and cataract.
Source: US FDA prescribing information
Storage
Storage Store kits at 20°C to 25°C (68°F to 77°F). Protect from light.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
All presentations
7 presentations of Mitomycin, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Mitomycin 5 mg/10 mL powder for injectionIntravenous Cold chainGeneric name | — | US FDA | Available on request |
| Mutamycin 40 mg/80 mL powder for injectionIntravenous Cold chain | Accord BioPharmaIndia | US FDA | Available on request |
| Jelmyto kit | UroGen Pharma | US FDA | Available on request |
| Mitomycin 20 mg powder for injectionIntravenousGeneric name | — | US FDA | Available on request |
| Mitomycin 40 mg powder for injectionIntravenousGeneric name | — | US FDA | Available on request |
| Mitosol kit | Mobius Therapeutics | US FDA | Available on request |
| Zusduri kit | UroGen Pharma | US FDA | Available on request |
Brands by market
4 brand names across 1 markets.
Manufacturers
Indian manufacturers are highlighted.
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 14 November 2002 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions
Conditions linked to Mitomycin in public data. This is not a list of approved uses, see the clinical information.
Questions and answers
Is Mitomycin available for export from India?
Yes, on request. MedsAcross lists 7 presentations of Mitomycin and sources them for licensed hospitals, importers and physicians against valid import documents. Indian manufacturers include Accord BioPharma.
What brand names does Mitomycin have?
The catalogue lists 4 brand names for Mitomycin, including Jelmyto, Mitosol, Mutamycin, Zusduri.
Is Mitomycin approved by the US FDA?
Yes. The US FDA first approved Mitomycin on 14 November 2002, according to Drugs@FDA.
Does Mitomycin need cold chain shipping?
At least one listed presentation of Mitomycin must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
References
- Mitosol prescribing information (Mobius Therapeutics). U.S. National Library of Medicine, DailyMed. Retrieved 23 April 2025
Request Mitomycin for export supply
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