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What is Jelmyto and what is it used for?

Jelmyto (mitomycin) for Pyelocalyceal Solution is a prescription medicine used to treat adults with a type of cancer of the lining of the upper urinary tract including the kidney called low-grade Upper Tract Urothelial Cancer (LG-UTUC).

It is not known if Jelmyto is safe and effective for use in children.

What are the possible side effects of Jelmyto?

Jelmyto may cause serious side effects, including:

• Swelling and narrowing of the tube that carries urine from the kidney to the bladder (ureteric obstruction). If you develop swelling and narrowing, and to protect your kidney from damage, your healthcare provider may recommend the placement of a small plastic tube (stent) in the ureter to help the kidney drain. Tell your healthcare provider right away if you develop side pain or fever during treatment with Jelmyto.
• Bone marrow problems. Jelmyto can affect your bone marrow and can cause a decrease in your white blood cell, red blood cell, and platelet counts. Your healthcare provider will do blood tests prior to each treatment to check your blood cell counts during treatment with Jelmyto. Your healthcare provider may need to temporarily or permanently stop Jelmyto if you develop bone marrow problems during treatment with Jelmyto.

The most common side effects of Jelmyto include:

• side pain
• vomiting
• urinary tract infection
• low red blood cell count
• blood in your urine
• frequent urination
• kidney problems
• itching
• tiredness
• chills
• nausea
• fever
• stomach pain
• trouble with urination

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

Mitomycin (also known as mitomycin-C) is an alkylating drug isolated from the broth of Streptomyces caespitosus. Mitomycin is a blue-violet crystalline powder with a molecular formula of C15H18N4O5, and a molecular weight of 334.33. Its chemical name is 7-amino-9α-methoxymitosane and it has the following structural formula:

Mitomycin is heat stable, has a high melting point, and is freely soluble in organic solvents.

Jelmyto is supplied in a single-dose carton containing two vials of sterile lyophilized mitomycin for pyelocalyceal solution, 40 mg each, and one vial of 20 mL of sterile hydrogel, to be used as a vehicle for reconstitution.

Mitomycin for pyelocalyceal solution is a sterile, lyophilized, grey to greyish-purple, cake or powder that contains mitomycin 40 mg and mannitol 80 mg in each vial.

Sterile hydrogel is a sterile, clear, colorless, gel with or without bubbles at room temperature or clear, colorless liquid at 2°C to 8°C (36°F to 46°F), which contains 0.04 g hydroxypropyl methylcellulose, 5.67 g poloxamer, 0.21 g polyethylene glycol, and water for injection in each vial.

Once reconstituted, Jelmyto is a clear, purple, viscous liquid at 2°C to 8°C (36°F to 46°F) or semisolid gel at room temperature with a concentration of 4 mg per mL of mitomycin, which may contain a few visible particles and have a pH between 6.0 and 8.0.