mitomycin

mye-toe-MYE-sin

Therapeutic Classification: antineoplastics

Pharmacologic Classification: antitumor antibiotics

High Alert

Disseminated adenocarcinoma of the stomach or pancreas (in combination with other chemotherapy agents).

Jelmyto

Low-grade upper tract urothelial cancer.

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.

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.

(effects on blood counts)

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

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.

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 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.

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.

(Generic available)

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

Monitor vital signs periodically during administration.
Monitor for bone marrow depression. Assess for bleeding (bleeding gums; bruising; petechiae; guaiac stools, urine, and emesis) and avoid IM injections and taking rectal temperatures if platelet count is low. Apply pressure to venipuncture sites for 10 min. Assess for signs of infection during neutropenia. Anemia may occur. Monitor for ↑ fatigue, dyspnea, and orthostatic hypotension.
Monitor intake and output, appetite, and nutritional intake. Nausea and vomiting usually occur within 1–2 hr. Vomiting may stop within 3–4 hr; nausea may persist for 2–3 days. Antiemetics may be administered prophylactically. Adjust diet as tolerated to help maintain fluid and electrolyte balance and nutritional status.
Assess respiratory status and chest x-ray examination prior to and periodically during therapy. Cough, bronchospasm, hemoptysis, or dyspnea usually occurs after several doses and may be indicative of pulmonary toxicity, which may be life-threatening.
Monitor for potentially fatal hemolytic uremic syndrome in patients receiving long-term therapy. Symptoms include microangiopathic hemolytic anemia, thrombocytopenia, renal failure, and hypertension.
Pyelocalyceal: Monitor for signs and symptoms of ureteric obstruction (flank pain, fever, changes in renal function). May require transient or long-term ureteral stents or alternative procedures. Hold or permanently discontinue Jelmyto based on the severity of ureteric obstruction.

Lab Test Considerations:

Verify negative pregnancy test before starting therapy.Monitor CBC with differential, platelet count, and observation for fragmented RBCs on peripheral blood smears prior to and periodically during and for several mo following therapy.
- The nadirs of leukopenia and thrombocytopenia occur in 4–8 wk. Notify health care professional if leukocyte count <4000/mm³ or if platelet count <150,000/mm³ or is progressively declining. Recovery from leukopenia and thrombocytopenia occurs within 10 wk after cessation of therapy. Myelosuppression is cumulative and may be irreversible. Repeat courses of therapy are held until leukocyte count >4000/mm³ and platelet count >100,000/mm³.
- Monitor liver function (AST, ALT, LDH, bilirubin) and renal function (BUN, serum creatinine) prior to and periodically throughout therapy to detect hepatotoxicity and nephrotoxicity. Notify health care professional if serum creatinine >1.7 mg/dL.

High Alert: Do not confuse mitomycin with mitoxantrone. Wear gloves, gown, and mask while handling medication. Discard equipment in designated containers.
Pyelocalyceal: Jelmyto is not for IV, topical, or oral administration. Prior to each 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 procedure (total of 3.9 g). May use general anesthesia or sedation for instillation; if used, do not administer sodium bicarbonate 30 min before treatment. Consider holding diuretics 1 day before instillation until 4 hr postinstillation.
- Jelmyto must be prepared under chilled conditions. Admixture concentration is 4 mg of mitomycin per mL and will appear as a viscous liquid for instillation. Instill reconstituted Jelmytoas soon as possible after reconstitution. If immediate instillation is not possible, store reconstituted Jelmyto at 68°F–77°F for up to 8 hr. Jelmyto will appear as a semisolid gel when stored under these conditions. Protect reconstituted Jelmytofrom light. Must be instilled as a chilled solution using a Uroject12 Lever, a Luer Lock syringe, and a ureteral catheter with molded Luer Lock connector. Once chilled at 27°F–41°F, Jelmytowill convert to a viscous liquid for instillation and is stable for up to 1 additional hr. Reconstituted Jelmyto must be instilled within 1 hr after it is converted to a viscous liquid. When instilling Jelmyto, the entire syringe must be emptied within 1 min.

IV Administration:

Ensure patency of IV. Extravasation may cause severe tissue necrosis. If patient complains of discomfort at IV site, discontinue immediately and restart infusion at another site. Promptly notify health care professional of extravasation.
IV Push: Reconstitution: Reconstitute 5-mg vial with 10 mL and 10-mg vial with 40 mL of sterile water for injection. Shake the vial; may need to stand at room temperature for additional time to dissolve. Final solution is blue-gray. Reconstituted solution is stable for 7 days at room temperature, 14 days if refrigerated. Diluent: 0.9% NaCl.Concentration: 20–40 mcg/mL for administration.
Rate: May be administered IV push over 5–10 min through free-flowing IV of 0.9% NaCl or D5W.
Y-Site Compatibility:
- amifostine
- amphotericin B lipid complex
- amphotericin B liposomal
- ampicillin
- ampicillin/sulbactam
- anidulafungin
- argatroban
- bivalirudin
- bleomycin
- bumetamide
- buprenorphine
- butorphanol
- calcium chloride
- calcium gluconate
- carboplatin
- caspofungin
- cefoxitin
- ceftazidime
- ceftriaxone
- chloramphenicol
- chlorpromazine
- ciprofloxacin
- cisplatin
- cyclophosphamide
- cyclosporine
- dactinomycin
- daunorubicin
- dexamethasone
- dexmedetomidine
- digoxin
- diphenhydramine
- doxorubicin hydrochloride
- enalaprilat
- ephedrine
- epinephrine
- epirubicin
- ertapenem
- erythromycin
- fentanyl
- fluconazole
- fludarabine
- fluorouracil
- foscarnet
- fosphenytoin
- furosemide
- granisetron
- heparin
- hetastarch
- hydralazine
- hydrocortisone
- hydromorphone
- ifosfamide
- imipenem/cilastatin
- ketorolac
- leucovorin calcium
- levofloxacin
- lidocaine
- linezolid
- magnesium sulfate
- mannitol
- melphalan
- meperidine
- meropenem
- mesna
- methadone
- methotrexate
- methylprednisolone
- metoclopramide
- metoprolol
- metronidazole
- moxifloxacin
- nafcillin
- nitroglycerin
- octreotide
- ondansetron
- oxaliplatin
- paclitaxel
- palonosetron
- pemetrexed
- pentamidine
- phentolamine
- potassium acetate
- potassium chloride
- potassium phosphates
- procainamide
- rituximab
- sodium acetate
- sodium bicarbonate
- sodium phosphates
- sufentanil
- tacrolimus
- theophylline
- thiotepa
- tigecycline
- tirofiban
- tobramycin
- trastuzumab
- trimethoprim/sulfamethoxazole
- vasopressin
- verapamil
- vinblastine
- vincristine
- voriconazole
- zidovudine
- zoledronic acid
Y-Site Incompatibility:
- acyclovir
- allopurinol
- amikacin
- aminophylline
- amiodarone
- amphotericin B deoxycholate
- aztreonam
- cefazolin
- cefepime
- cefotaxime
- cefotetan
- cefuroxime
- clindamycin
- dacarbazine
- dantrolene
- daptomycin
- dexrazoxane
- diazepam
- diltiazem
- dobutamine
- docetaxel
- dopamine
- doxycycline
- esmolol
- etoposide
- etoposide phosphate
- famotidine
- filgrastim
- ganciclovir
- gemcitabine
- gentamicin
- glycopyrrolate
- haloperidol
- idarubicin
- insulin, regular
- irinotecan
- isoproterenol
- labetalol
- lorazepam
- methohexital
- midazolam
- milrinone
- minocycline
- morphine
- nalbuphine
- naloxone
- nitroprusside
- norepinephrine
- pantoprazole
- pentobarbital
- phenobarbital
- phenylephrine
- phenytoin
- piperacillin/tazobactam
- prochlorperazine
- promethazine
- propranolol
- remifentanil
- sargramostim
- succinylcholine
- thiopental
- topotecan
- vancomycin
- vecuronium
- vinorelbine

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.

Decrease in size and spread of malignant cells.

Jelmyto, ~~Mutamycin~~

NDC Code

0143- West-Ward Pharmaceuticals Corp
- 0143-9279- Mitomycin
  - 0143-9279-01- 1 VIAL in 1 BOX, UNIT-DOSE (0143-9279-01) > 40 mL in 1 VIAL

0143- West-Ward Pharmaceuticals Corp
- 0143-9280- Mitomycin
  - 0143-9280-01- 1 VIAL in 1 BOX, UNIT-DOSE (0143-9280-01) > 80 mL in 1 VIAL

16729- Accord Healthcare Inc
- 16729-108- Mitomycin
  - 16729-108-11- 1 VIAL in 1 BOX, UNIT-DOSE (16729-108-11) > 40 mL in 1 VIAL

16729- Accord Healthcare Inc
- 16729-115- Mitomycin
  - 16729-115-05- 1 VIAL in 1 CARTON (16729-115-05) > 10 mL in 1 VIAL

16729- Accord Healthcare Inc
- 16729-116- Mitomycin
  - 16729-116-38- 1 VIAL in 1 BOX, UNIT-DOSE (16729-116-38) > 80 mL in 1 VIAL

16729- Accord Healthcare Inc
- 16729-246- Mitomycin
  - 16729-246-05- 1 VIAL in 1 CARTON (16729-246-05) > 10 mL in 1 VIAL

16729- Accord Healthcare Inc
- 16729-247- Mitomycin
  - 16729-247-11- 1 VIAL in 1 CARTON (16729-247-11) > 10 mL in 1 VIAL

16729- Accord Healthcare Inc
- 16729-248- Mitomycin
  - 16729-248-38- 1 VIAL in 1 CARTON (16729-248-38) > 10 mL in 1 VIAL

49771- Mobius Therapeutics LLC
- 49771-002- Mitosol
  - 49771-002-03- 3 TRAY in 1 CARTON (49771-002-03) > 1 KIT in 1 TRAY (49771-002-01) * 1 mL in 1 VIAL, SINGLE-USE * 1 mL in 1 SYRINGE

67457- Mylan Institutional LLC
- 67457-518- Mitomycin
  - 67457-518-05- 1 VIAL in 1 CARTON (67457-518-05) > 10 mL in 1 VIAL

67457- Mylan Institutional LLC
- 67457-519- Mitomycin
  - 67457-519-20- 1 VIAL in 1 CARTON (67457-519-20) > 40 mL in 1 VIAL

67457- Mylan Institutional LLC
- 67457-520- Mitomycin
  - 67457-520-40- 1 VIAL in 1 CARTON (67457-520-40) > 80 mL in 1 VIAL

68001- BluePoint Laboratories
- 68001-389- Mitomycin
  - 68001-389-36- 1 VIAL in 1 CARTON (68001-389-36) > 10 mL in 1 VIAL (68001-389-28)

68001- BluePoint Laboratories
- 68001-390- Mitomycin
  - 68001-390-77- 1 VIAL in 1 BOX, UNIT-DOSE (68001-390-77) > 40 mL in 1 VIAL (68001-390-78)

68001- BluePoint Laboratories
- 68001-391- Mitomycin
  - 68001-391-79- 1 VIAL in 1 BOX, UNIT-DOSE (68001-391-79) > 80 mL in 1 VIAL (68001-391-80)

69448- Accord BioPharma Inc.
- 69448-001- MUTAMYCIN
  - 69448-001-05- 1 VIAL in 1 CARTON (69448-001-05) > 10 mL in 1 VIAL

69448- Accord BioPharma Inc.
- 69448-002- MUTAMYCIN
  - 69448-002-11- 1 VIAL in 1 BOX, UNIT-DOSE (69448-002-11) > 40 mL in 1 VIAL

69448- Accord BioPharma Inc.
- 69448-003- MUTAMYCIN
  - 69448-003-38- 1 VIAL in 1 BOX, UNIT-DOSE (69448-003-38) > 80 mL in 1 VIAL

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