Names and pronunciation
(mye-toe-mye′sin) Jelmyto
PDF page 902
Drug reference
(mye-toe-mye′sin) Jelmyto
PDF page 902
Func. class.: Antineoplastic, antibiotic
PDF page 902
Do not confuse: mitoMYcin/mitoXANTRONE
PDF page 902
ACTION: Inhibits DNA synthesis, pri- marily; derived from Streptomyces caes- pitosus; appears to cause cross-linking of DNA; vesicant
PDF page 902
USES: Pancreatic, stomach, colorec- tal, bladder cancer
PDF page 902
Unlabeled uses: Palliative treatment of anal, bladder, head, neck, colon, biliary, cervical, lung malignancies
PDF page 902
CONTRAINDICATIONS: Preg- nancy, breastfeeding, hypersensitivity, as single agent, coagulation disorders, thrombocytopenia Precautions: Accidental exposure, acute bronchospasm, anemia, children, dental disease/work, extravasation, females, infection, radiation therapy, sur- gery, vaccines, renal/respiratory disease, leukopenia
PDF page 902
Black Box Warning: Bone marrow sup- pression, hemolytic uremic syndrome, requires an experienced clinician and specialized care setting Black Box Warning: Bone marrow sup- pression: monitor CBC, differential, platelet count weekly; withhold product if WBC is <4000/mm3, serum creatinine >1.7 mg/dL, or platelet count is <100,000/mm3, nadir of leukopenia, thrombocytopenia is 4-8 wk, recovering within 10 wk; notify prescriber; bleeding: hematuria, guaiac, bruising, pete- chiae, mucosa, or orifices, avoid IM injec- tions when platelets are low M Black Box Warning: Fatal hemolytic uremic syndrome: assess for hyper- tension, thrombocytopenia, microangio- pathic hemolytic anemia; occurs in those receiving long-term therapy; most cases are caused by doses ≥60 mg; transfusion may worsen syndrome • Nephrotoxicity: Renal studies: BUN, uric acid, urine CCr, before, during therapy; ad- just dose based on renal function; I&O ratio; report fall in urine output to <30 mL/hr • Monitor temperature; fever may indi- cate beginning infection • Hepatotoxicity: hepatic studies be- fore, during therapy: bilirubin, AST, ALT, alk phos as needed or monthly; check for jaundiced skin and sclera, dark urine, clay-colored stools, itchy skin, abdominal pain, fever, diarrhea • Pulmonary fibrosis: bronchospasm, dyspnea, crackles, unproductive cough; chest pain, tachypnea, fatigue, increased pulse, pallor, lethargy; pulmonary function tests; chest x-ray before, during therapy; chest x-ray should be obtained q2wk during treatment • Effects of alopecia on body image; discuss feelings about body changes • Buccal cavity q8hr for dryness, sores, ulceration, white patches, oral pain, bleeding, dysphagia • Local irritation, pain, burning at inj site • GI symptoms: frequency of stools, cramping • Adequate fluids (2-3 L/day) unless contraindicated • Rinsing of mouth tid-qid with water; brushing of teeth with baking soda bid-tid with soft brush or cotton-tipped applicators for stomatitis; use unwaxed dental floss • Cardiac toxicity (rare): HF may be treat- ed with diuretics, cardiac glycosides; most with this condition received doxorubicin • Pregnancy/breastfeeding: do not use in pregnancy or breastfeeding
PDF pages 902, 903, 904
SIDE EFFECTS CNS: Fever, headache, confusion, drows- iness, syncope, fatigue CV: Edema EENT: Blurred vision GI: Nausea, vomiting, anorexia, sto- matitis, hepatotoxicity, diarrhea GU: Urinary retention, renal failure, infertility HEMA: Thrombocytopenia, leukopenia, anemia INTEG: Rash, alopecia, extravasation, nail discoloration MISC: Hemolytic uremic syndrome RESP: Fibrosis, pulmonary infiltrate
PDF page 903
INTERACTIONS Increase: toxicity—other antineoplas- tics, radiation Increase: bleeding risk—NSAIDs, anticoagulants • Avoid use with vaccines Drug/Lab Test Increase: BUN, creatinine Decrease: platelets, WBCs
PDF page 903
DOSAGE AND ROUTES Disseminated adenocarcinoma of stomach/pancreas in combination • Adult: IV 20 mg/m2 q6-8wk Upper Tract Urothelial Cancer Adult: Instill Jelmyto 4 mg per mL via ureteral catheter or a nephrostomy tube, with total instillation volume based on pyelography, max 15 mL (60 mg of mitomycin). Instill weekly × 6 wk, those with a complete response after 3 mo may be used monthly for a max of 11 additional doses
PDF page 902
Available forms: Inj 5, 20, 40 mg/vial; powder for pyelocalyceal solution
PDF page 902
Administer: • Cytotoxic: use safe handling and dis- posal procedures • Vesicant: check for extravasation; do not give IM/subcut, may result in extreme tissue damage Direct IV route • Use port or central line if possible • Antiemetic 30-60 min before product to prevent vomiting • IV after reconstituting 5 mg/10 mL, 20 mg/40 mL, 40 mg/80 mL (0.5 mg/mL) sterile water for inj; shake, allow to stand, protect from light, give slow IV push or infuse over 15-30 min; color of reconstituted sol is gray • Avoid excessive heat; store unreconsti- tuted product at room temperature Y-site compatibilities: Amifostine, ampho- tericin B lipid complex, amphotericin B liposome, anidulafungin, argatroban, atenolol, bivalirudin, bleomycin, caspo- fungin, CISplatin, cyclophosphamide, DACTINomycin, dolasetron, DOXOrubicin, droperidol, epiRUBicin, ertapenem, fluo- rouracil, furosemide, granisetron, hepa- rin, leucovorin, melphalan, methotrexate, metoclopramide, nesiritide, octreotide, ondansetron, oxaliplatin, PACLitaxel, palo- nosetron, PEMEtrexed, riTUXimab, teni- poside, thiotepa, tigecycline, tirofiban, trastuzumab, vinBLAStine, vinCRIStine, voriconazole, zoledronic acid
PDF pages 902, 903
Assess:
PDF page 903
Evaluate: • Therapeutic response: decreased tu- mor size, spread of malignancy
PDF page 904
CLINICAL CONSIDERATIONS
PDF page 903
Patient and caregiver information: • That hair may be lost during treatment; that wig or hairpiece may make patient feel better; that new hair may be different in color, texture • To avoid foods with citric acid, hot temperature, or rough texture • To report any bleeding, white spots, ul- cerations in mouth; to examine mouth daily • To report sign of IV site reaction: red- ness, inflammation, burning, pain • To avoid crowds, persons with infec- tions if granulocyte count is low • Infection: to report fever, flulike symp- toms, sore throat • To immediately report urine retention, absence of urine, dyspnea, bleeding, jaundice, signs of pulmonary toxicity • Pregnancy/breastfeeding: to report if pregnancy is planned or suspected; not to breastfeed HIGH ALERT
PDF page 904
PHARMACOKINETICS Half-life 1 hr, metabolized in liver, 10% excreted in urine (unchanged)
PDF page 903
• Adult: IV 20 mg/m2 q6-8wk Upper Tract Urothelial Cancer Adult: Instill Jelmyto 4 mg per mL via ureteral catheter or a nephrostomy tube, with total instillation volume based on pyelography, max 15 mL (60 mg of mitomycin). Instill weekly × 6 wk, those with a complete response after 3 mo may be used monthly for a max of 11 additional doses
PDF page 902