JELMYTO
Clinical safety rating: caution
Comprehensive clinical and safety monograph for JELMYTO (JELMYTO).
JELMYTO (mitomycin) is a mitomycin-containing gel that induces apoptosis by cross-linking DNA, inhibiting DNA synthesis, and producing reactive oxygen species, with additional local tumoricidal effects via thermal ablation of the mitomycin-containing hydrogel.
| Metabolism | Primarily undergoes reductive metabolism by NAD(P)H:quinone oxidoreductase (NQO1) and other cellular reductases; minimal hepatic metabolism. |
| Excretion | JELMYTO (mitomycin) is not absorbed systemically after intravesical administration; urinary excretion is the primary route of elimination of the administered dose. Less than 1% of the dose is absorbed and undergoes hepatic metabolism and biliary/fecal excretion. |
| Half-life | Following intravesical administration, systemic absorption is negligible, so terminal half-life is not clinically relevant. Mitomycin given intravenously has a terminal half-life of 23-78 minutes (triphasic); this is not applicable for intravesical JELMYTO. |
| Protein binding | Mitomycin is <70% bound to plasma proteins (albumin). However, due to negligible systemic absorption after intravesical administration, plasma protein binding is clinically irrelevant. |
| Volume of Distribution | Following intravenous administration, Vd is approximately 0.5-0.8 L/kg, indicating distribution into total body water. Not relevant for intravesical use. |
| Bioavailability | Systemic bioavailability after intravesical administration is <1%, as the drug is primarily retained in the bladder and excreted in urine. |
| Onset of Action | After intravesical instillation, the alkylating effect on urothelial cells occurs within minutes to hours; clinical effect (tumor response) is typically assessed after 3 months. |
| Duration of Action | The cytotoxic effect is limited to the bladder mucosa during the 2-hour dwell time; systemic effects are negligible. Duration of action is confined to the treatment cycle. |
Instill 4 mg (1 vial) into the renal pelvis via ureteral catheter or nephrostomy tube, once weekly for 6 weeks, followed by monthly maintenance for up to 11 months. Administer 2 mL of sterile water for irrigation through the catheter to ensure delivery; clamp for 1 hour.
| Dosage form | POWDER |
| Renal impairment | No dose adjustment required for GFR ≥30 mL/min. Not studied in GFR <30 mL/min or dialysis; avoid use due to potential systemic accumulation. |
| Liver impairment | No dose adjustment required for Child-Pugh A or B. Not studied in Child-Pugh C; avoid use. |
| Pediatric use | Safety and efficacy not established in pediatric patients; no recommended dose. |
| Geriatric use | No specific dose adjustment recommended; use standard dosing with caution due to potential age-related renal function decline. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for JELMYTO (JELMYTO).
| Breastfeeding | It is not known whether mitomycin is excreted in human milk. However, many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from JELMYTO, advise patients that breastfeeding is not recommended during treatment and for at least 2 weeks after the final dose. |
| Teratogenic Risk | JELMYTO (mitomycin) is contraindicated in pregnancy. Based on its mechanism of action and animal studies, it can cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus. In animal reproduction studies, mitomycin was teratogenic and embryotoxic in rats and mice at doses below the clinical dose. |
■ FDA Black Box Warning
JELMYTO is for pyelocalyceal use only via ureteral catheter. Administration into tissue or bloodstream can cause serious tissue damage, hemolytic uremic syndrome, or death.
| Serious Effects |
["Hypersensitivity to mitomycin or any component of JELMYTO","Active urinary tract infection","Pregnancy (based on mechanism of action)"]
| Precautions | ["Risk of hemolytic uremic syndrome, especially with systemic exposure; monitor renal function and blood counts","Local tissue damage from extravasation; administer only via ureteral catheter","Hypersensitivity reactions including anaphylaxis","Myelosuppression, nausea, vomiting, and abdominal pain have been reported"] |
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| Fetal Monitoring | For women of childbearing potential, verify pregnancy status prior to initiating JELMYTO. Monitor for signs of myelosuppression, including anemia, leukopenia, and thrombocytopenia, which may affect pregnancy outcome. If used during pregnancy, perform fetal monitoring as per standard obstetrical care and consider consultation with a maternal-fetal medicine specialist. |
| Fertility Effects | JELMYTO may impair fertility in males and females. Based on animal studies, mitomycin may cause reduced fertility and gonadal toxicity. Advise patients of the potential for reduced fertility. |