mitomycin pyelocalyceal (Rx)

Brand and Other Names:Jelmyto
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

pyelocalyceal solution

  • Kit contains: Two 40-mg single-dose vials plus 20-mL vial sterile hydrogel for reconstitution

Urothelial Cancer

Indicated for low-grade upper tract urothelial cancer (LG-UTUC)

Instill 4 mg/mL via ureteral catheter or a nephrostomy tube, with total instillation volume based on volumetric measurements using pyelography; not to exceed 15 mL (60 mg of mitomycin)

Instill qWeek x6 weeks

Patient achieving complete response 3 months after initial 6 weeks: May continue administration once monthly for maximum of 11 additional instillations

Dosage Modifications

Renal impairment

  • GFR <30 mL/min: Avoid use; data are not available with severe renal impairment

Dosing Considerations

Verify pregnancy status in females of reproductive potential before initiating

Laboratory tests obtained before each treatment

  • Platelet count
  • WBC count (with differential)
  • Hemoglobin

Safety and efficacy not established

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Adverse Effects

>10% All Grades

Ureter stenosis (44%)

Flank pain (39%)

Urinary tract infection (34%)

Hematuria (32%)

Renal dysfunction (25%)

Nausea (24%)

Fatigue (24%)

Abdominal pain (23%)

Dysuria (21%)

Vomiting (20%)

Hydronephrosis (18%)

Pollakiuria (13%)

Anemia (13%)

Pruritus (13%)

Chills (11%)

Pyrexia (11%)

Laboratory abnormalities worsening from baseline

  • Anemia (37%)
  • eGFR (37%)
  • Increased creatinine (32%)
  • Hypoalbuminemia (30%)
  • Lymphopenia (21%)
  • Thrombocytopenia (21%)
  • Hypocalcemia (17%)
  • Hyperuricemia (16%)
  • Hyperkalemia (13%)

>10% Grades 3-4

Laboratory abnormalities worsening from baseline

  • Hyperuricemia (16%)
  • 1-10% All Grades H3
  • Ureteropelvic obstruction (6%)
  • Urinary tract obstruction (6%)
  • Ureteric obstruction (2.8%)
  • Obstructive uropathy (1.4%)

1-10% Grades 3-4

Ureteric stenosis (8%)

Hydronephrosis (6%)

Urinary tract infection (4.2%)

Vomiting (4.2%)

Flank pain (2.8%)

Hematuria (2.8%)

Renal dysfunction (2.8%)

Ureteropelvic obstruction (1.4%)

Urinary tract obstruction (1.4%)

Ureteric obstruction (1.4%)

Nausea (1.4%)

Abdominal pain (1.4%)

Fatigue (1.4%)

Laboratory abnormalities worsening from baseline

  • eGFR (10%)
  • Lymphopenia (2.9%)
  • Thrombocytopenia (2.8%)
  • Hypoalbuminemia (2.8%)
  • Hyperkalemia (1.4%)
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Warnings

Contraindications

Perforation of bladder or upper urinary tract

Cautions

Ureteric obstruction, including ureteral stenosis, and hydronephrosis reported; monitor for signs and symptoms of ureteric obstruction, including flank pain, fever, and renal function changes; withhold or permanently discontinue mitomycin pyelocalyceal based on severity of ureteric obstruction

May cause bone marrow suppression, particularly thrombocytopenia and neutropenia; monitor laboratory tests before each dose; withhold mitomycin pyelocalyceal for Grade 2 thrombocytopenia or neutropenia; permanently discontinue for ≥Grade 3

Can cause fetal harm

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Pregnancy & Lactation

Pregnancy

Based on animal studies and mechanism of action, can cause fetal harm

Advise pregnant females of potential risk to fetus

Animal studies

  • Teratological changes observed in animal studies

Contraception

  • Females of reproductive potential: Use effective contraception during treatment and for 6 months after last dose
  • Males with female partners of reproductive potential: Use effective contraception during treatment and for 3 months after last dose

Lactation

Data are not available on presence in human milk, effects on breastfed children, or effects on milk production

Advise women not to breastfeed during treatment and for 1 week following the last dose

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Inhibits DNA synthesis; guanine and cytosine content correlates with the degree of mitomycin-induced cross-linking; at high drug concentrations, cellular RNA and protein synthesis are also suppressed

Absorption

Peak plasma concentration: 6.24 ng/mL (range: 2.43-12.8 ng/mL)

Metabolism

Metabolized primarily in the liver

Elimination

Forms semisolid gel, which dissolves from normal kidney urine flow over 4-6 hr

Excretion: Urine (10%, unchanged)

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Administration

Pyelocalyceal Preparation

Follow applicable special handling and disposal procedures

Prepared only under chilled conditions

Once reconstituted, admixture is 4 mg/mL and appears as a viscous liquid for instillation

Reconstituted mitomycin pyelocalyceal has reverse thermal properties with a gelation point of ~19ºC (66ºF)

Instill as soon as possible after reconstitution; if immediate instillation not possible, may store at controlled room temperature for up to 8 hr

Pyelocalyceal Administration

Not for IV, topical, or oral administration

Before every instillation, instruct patient to take 1.3 g of sodium bicarbonate orally the evening prior to, the morning of, and 30 min prior to instillation

Instill as a chilled solution using an Uroject12 Lever, a Luer lock syringe, and a ureteral catheter with molded Luer lock connector

Once chilled at -3ºC to 5C (27-41ºF), it will convert to a viscous liquid for instillation and is stable for up to 1 additional hr

Instill within 1 hr after it is converted to a viscous liquid

Storage

Unopened vials

Store in carton at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)

Avoid excessive heat over 40ºC (104ºF)

After reconstitution

If immediate instillation is not possible, store at 20-25ºC (68-77ºF) for up to 8 hr

Appears as a semisolid gel when stored under these conditions

Protect from light

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Images

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.