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. |
| Molecular Weight | 334.33 |
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 | Contraindicated due to risk of fetal harm based on animal data and its mechanism of action. |
| 2nd trimester | Contraindicated due to risk of fetal harm. |
| 3rd trimester | Contraindicated due to risk of fetal harm. |
Clinical note
Comprehensive clinical and safety monograph for JELMYTO (JELMYTO).
| Placental transfer | Mitomycin is known to cross the placenta in animals; human data are not available, but transfer is expected based on molecular weight. |
| Breastfeeding | It is unknown if JELMYTO (mitomycin) is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants, breastfeeding is not recommended during treatment and for 2 weeks after the last dose. |
| Lactation Rating |
■ 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 the formulationPregnancyKnown bleeding diathesis (for intravesical use)
| 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 |
| Food/Dietary | No known food interactions. Maintain adequate hydration unless otherwise instructed. Grapefruit does not interact with mitomycin. |
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| L5 (Contraindicated) |
| 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. |
| 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. |
| Clinical Pearls | JELMYTO (mitomycin) is a reverse thermal gel containing mitomycin for intravesical use in low-grade upper tract urothelial carcinoma (UTUC). Administer via ureteral catheter; gel transitions from liquid to gel at body temperature. Ensure adequate dwell time (4-6 hours) for efficacy. Premedicate with antiemetics and consider anticholinergics for bladder spasms. Contraindicated in patients with perforation of the urinary tract or known hypersensitivity. Monitor for myelosuppression, hemolytic uremic syndrome, and renal toxicity. |
| Patient Advice | JELMYTO is a gel placed directly into the kidney through a small tube (catheter) during a procedure. · You will need to lie still for about 4-6 hours after administration to allow the gel to work. · Common side effects include nausea, vomiting, urinary tract infection, and blood in urine. Report fever, chills, or severe pain immediately. · Avoid pregnancy while on this drug; use effective contraception. Notify your doctor if you become pregnant. · Do not drive or operate machinery for 24 hours after the procedure due to possible sedation from premedication. |