mitomycin

Contraindicated in:

Hypersensitivity;
Perforation of the bladder or upper urinary tract (Jelmyto only);
Severe renal impairment (CCr <30 mL/min) (Jelmyto only);
OB: Pregnancy (may cause fetal harm);
Lactation: Lactation.

Use Cautiously in:

Active infections;
↓bone marrow reserve;
Hepatic impairment;
History of pulmonary problems;
Rep: Women of reproductive potential and men with female partners of reproductive potential;
Pedi: Safety and effectiveness not established in children;
Geri: Older adults may have ↑ sensitivity to drug effects.

Adv. Reactions/Side Effects ⬆ ⬇

CV: edema (IV only)

Derm: pruritus (Jelmyto only), alopecia (IV only), desquamation (IV only)

F and E: hyperkalemia (Jelmyto only), hypocalcemia (Jelmyto only)

GI: abdominal pain (Jelmyto only), hypoalbuminemia (Jelmyto only), nausea, vomiting, anorexia, stomatitis (IV only)

GU: dysuria (Jelmyto only), flank pain (Jelmyto only), hematuria (Jelmyto only), pollakiuria (Jelmyto only), renal impairment, ureteric obstruction (Jelmyto only), urinary tract infection (Jelmyto only), infertility (IV only), UROSEPSIS (JELMYTO ONLY)

Hemat: anemia, leukopenia, lymphopenia (Jelmyto only), thrombocytopenia, HEMOLYTIC UREMIC SYNDROME(IV ONLY), NEUTROPENIA

Local: phlebitis at IV site

Metab: hyperuricemia (Jelmyto only)

Resp: PULMONARY TOXICITY(IV ONLY)

Misc: chills (Jelmyto only), fatigue, fever

Interactions ⬆ ⬇

Interactions noted are for IV therapy only.

Drug-drug:

Additive bone marrow depression with other antineoplastics or radiation therapy.
May ↓ antibody response to live-virus vaccines and ↑ risk of adverse reactions.
Concurrent or sequential use with vinca alkaloids may result in respiratory toxicity.

Availability ⬆ ⬇

(Generic available)

Powder for injection: 5 mg/vial; 20 mg/vial; 40 mg/vial
Powder for pyelocalyceal (ureteral) solution: 40 mg/vial

Route/Dosage ⬆ ⬇

IV and pyelocalceal (ureteral) formulations are not interchangeable.

IV (Adults ): 20 mg/m² every 6–8 wk.
Pyelocalyceal (ureteral)(Adults ): Instill 4 mg per 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]). Instill once weekly for a total of 6 wk. If complete response demonstrated 3 mo after initiation of therapy, continue instillations once monthly for a maximum of 11 additional instillations.

US Brand Names ⬆ ⬇

Jelmyto, ~~Mutamycin~~

Action ⬆ ⬇

Primarily inhibits DNA synthesis by causing cross-linking; also inhibits RNA and protein synthesis (cell-cycle phase-nonspecific but is most active in S and G phases).

Therapeutic effects:

Death of rapidly replicating cells, particularly malignant ones.

Classifications ⬆ ⬇

Therapeutic Classification: antineoplastics

Pharmacologic Classification: antitumor antibiotics

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability. Bioavailability following pyelocalyceal administration unknown.

Distribution: Widely distributed, concentrates in tumor tissue. Does not enter CSF.

Metabolism/Excretion: Mostly metabolized by the liver. Small amounts (<10%) excreted unchanged by the kidneys and in bile.

Half-Life: IV: 50 min.

Time/Action Profile ⬆ ⬇

(effects on blood counts)

ROUTE	ONSET	PEAK	DURATION
IV	3–8 wk	4–8 wk	up to 3 mo

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy. Emphasize need for periodic lab tests to monitor for side effects.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Instruct patient to notify health care professional promptly if fever; chills; cough; hoarseness; sore throat; signs of infection; lower back or side pain; painful or difficult urination; bleeding gums; bruising; petechiae; blood in stools, urine, or emesis; ↑ fatigue; dyspnea; or orthostatic hypotension occurs. Caution patient to avoid crowds and persons with known infections. Instruct patient to use soft toothbrush and electric razor and to avoid falls. Caution patient not to drink alcoholic beverages or take medication containing aspirin or NSAIDs; may precipitate gastric bleeding.
Instruct patient to notify health care professional if ↓ urine output, edema in lower extremities, shortness of breath, skin ulceration, or persistent nausea occurs.
Instruct patient to inspect oral mucosa for redness and ulceration. If ulceration occurs, advise patient to use sponge brush and rinse mouth with water after eating and drinking. Topical agents may be used if pain interferes with eating. Stomatitis pain may require treatment with opioid analgesics.
Discuss with patient the possibility of hair loss. Explore coping strategies.
Instruct patient not to receive any vaccinations without advice of health care professional.
Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception during and for 6 mo after last dose and males with female partners of reproductive potential to use effective contraception during and for 3 mo after last dose. Advise patient to avoid breastfeeding for 1 wk after last dose.
Jelmyto: Advise patients that solution is violet to blue color and may discolor urine following instillation. Advise patient to avoid contact with urine for ≥6 hr postinstillation. Advise patients to void sitting on a toilet; flush the toilet several times after use; and to wash hands, perineum, or glans with soap and water after each instillation procedure. Advise patients to wash clothing soiled with urine promptly and separately from other clothing.

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Indications ⬇

Contraind./Precautions ⬆ ⬇