mitomycin (Rx)

Brand and Other Names:Mitomycin C, Mutamycin
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • 5mg
  • 20mg
  • 40mg

Stomach Cancer, Pancreas Cancer

20 mg/m² IV q6-8Weeks  

Anal Carcinoma (Off-label)

10 mg/m² as IV bolus days 1-29; not to exceed 20 mg/dose

Dosage Modification

for SI units: count in US units x10^6/L

Full dose if

  • Leukocytes >3000/mm³
  • Platelets >75 x 10^3/mm³

Give 70% if

  • Leukocytes: 2000-2999/mm³
  • Platelets: 25-74.999 x 10^3/mm³

Give 50% if

  • Leukocytes <2000/mm³
  • Platelets <25 x 10^3/mm³

Renal Impairment

Serum creatinine >1.7 mg/dL: Avoid use

CrCl <10 mL/min: Decrease dose by 25%

CAPD: Decrease dose by 25%

Monitor

CBC, LFTs, renal function

Do not repeat dose until WBC >4000/mm³ and Plts >100,000/mm³

Dosing Considerations

Always use in combination with other antineoplastics

Discontinue if progression continues after 2 courses

Safety and efficacy not established

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Interactions

Interaction Checker

and mitomycin

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Hemolytic uremic syndrome (≤15%)

            Myelosuppression (64%)

            Nausea/vomiting (14%)

            Fever (14%)

            1-10%

            Stomatitis (4%)

            Increased serum creatinine (2%)

            Mucous membrane toxicity (4%)

            Frequency Not Defined

            Fatigue

            Pulmonary toxicity

            Dyspnea

            Cystitis

            Interstitial fibrosis

            Nephrotoxicity

            Amenorrhea

            Alopecia

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            Warnings

            Black Box Warnings

            The drug should be administered under the supervision of an experienced cancer chemotherapy physician in a facility equipped to manage complications

            Bone marrow suppression, notably thrombocytopenia and leucopenia, may contribute to overwhelming infections in an already compromised patient

            Hemolytic uremic syndrome may occur with monotherapy or combination therapy and usually occurs with doses >60 mg. Blood product transfusion may exacerbate symptoms

            Contraindications

            Hypersensitivity

            Thrombocytopenia, coagulation disorders, bleeding diathesis

            Cautions

            Vesicant

            Avoid use in renal impairment (SCr >1.7 mg/dL [150.3 umol/L])

            Chicken pox, recent

            Bladder fibrosis/contraction reported

            Herpes zoster

            Acute respiratory distress syndrome reported when used in combination with other types of chemotherapy maintained at FIO2 concentrations >50% preoperatively

            Avoid pregnancy

            Increased prevalence of Heart Failure observed when used in conjunction with anthracyclines

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            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: Not known if excreted in breast milk, do not nurse

            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

            Crosslinks DNA, preventing replication and transcription

            Pharmacokinetics

            Half-life: 48 min

            Vd: 16-56 L/m²

            Metabolism: Liver

            Clearance: 201-810 mL/min/m²

            Excretion: Urine (10%)

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            Administration

            IV Incompatibilities

            Solution: D5W

            Additive: bleomycin

            Y-site: aztreonam, cefepime, etoposide PO4, filgrastim, gemcitabine, piperacillin/tazobactam, sargramostim, topotecan, vinorelbine

            IV Compatibilities

            Solution: LR, NS

            Additive: dexamethasone Na-phosphate, heparin, hydrocortisone Na-succinate

            Syringe: bleomycin, cisplatin, cyclophosphamide, doxorubicin, droperidol, fluorouracil, furosemide, heparin, leucovorin, methotrexate, metoclopramide, vinblastine, vincristine

            Y-site: amifostine, bleomycin, cisplatin, cyclophosphamide, doxorubicin, droperidol, fluorouracil, furosemide, granisetron, heparin, leucovorin, melphalan, methotrexate, metoclopramide, ondansetron, teniposide, thiotepa, vinblastine, vincristine

            IV Preparation

            Reconstitute with SWI to a concentration of 0.5 mg/mL

            Standard dilution

            • IV push: dose/syringe (concentration is 0.5 mg/mL); maximum syringe size for IVP is a 30 mL syringe & syringe should be <75% full
            • IVPB: dose/100 mL NS

            IV Administration

            Vesicant

            Administer slow IV push by central line only

            Flush with 5-10 mL of IV solution before & after drug administration

            IVPB infusion should be closely monitored for adequate vein patency

            Extravasation Management

            Frequently causes necrosis

            Plastic surgeon may be required

            Storage

            Store intact vials of lyophilized powder at RT

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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.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            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.