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Jelmyto
Mitomycin
$52030.00
4mg/ml · 1 vial
BrandBranded medicine· By UroGen Pharma
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FDA boxed warning
WARNINGS
Mitomycin should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available.
Hemolytic Uremic Syndrome (HUS) a serious complication of chemotherapy, consisting primarily of microangiopathic hemolytic anemia, thrombocytopenia, and irreversible renal failure, has been reported in patients receiving systemic mitomycin. The syndrome may occur at any time during systemic therapy with mitomycin as a single agent or in combination with other cytotoxic drugs; however, most cases occur at doses ≥ 60 mg of mitomycin. Blood product transfusion may exacerbate the symptoms associated with this syndrome.
The incidence of the syndrome has not been defined.
About Jelmyto
What it treats
Stomach or pancreatic adenocarcinoma that has spread, treated in combination with other approved chemotherapy medicines and as palliative treatment when other treatments have failed. Mitomycin is not recommended as the sole initial treatment or as a replacement for appropriate surgery or radiotherapy.
Safety information
FDA boxed warning
WARNINGS
Mitomycin should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available.
Hemolytic Uremic Syndrome (HUS) a serious complication of chemotherapy, consisting primarily of microangiopathic hemolytic anemia, thrombocytopenia, and irreversible renal failure, has been reported in patients receiving systemic mitomycin. The syndrome may occur at any time during systemic therapy with mitomycin as a single agent or in combination with other cytotoxic drugs; however, most cases occur at doses ≥ 60 mg of mitomycin. Blood product transfusion may exacerbate the symptoms associated with this syndrome.
The incidence of the syndrome has not been defined.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
Before taking this medicine
Do not use mitomycin if you have previously had an allergic or other unusual reaction to it, have a low platelet count (thrombocytopenia), have a blood-clotting disorder, or have an increased tendency to bleed for any other reason.
Using Jelmyto
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store in the original carton below 25°C, protected from light, unless the pack states refrigeration. Do not freeze. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label MITOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] (DailyMed, retrieved 19 September 2026).
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