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idarubicin (Rx)Brand and Other Names:Idamycin

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 1mg/mL
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Acute Myeloid Leukemia

Induction: 12 mg/m² IV qDay over 10-15 min for 3 day with concomitant cytarabine 

Consolidation: 10-12 mg/m²/day IV for 2 days

Renal Impairment

Children

  • CrCl < 50 mL/min: 75% of dose
  • Peritoneal dialysis: 75% of dose
  • Hemodialysis: 75% of dose
  • Renal replacement therapy: 75% of dose

Adults

  • CrCl 10-50 mL/min: 75% of dose
  • CrCl <10 mL/min: 50% of dose
  • Hemodialysis: Supplemental dose not necessary
  • Peritoneal dialysis: Supplemental dose not necessary

Hepatic Impairment

Bilirubin 2.6-5 mg/dL: 50% of dose

Bilirubin >5 mg/dL: Avoid use

Monitor

CBC, LFTs, cardiac & renal function

Administration

Mucositis Development: Discontinue if severe mucositis after 1st course, after resolution continue w/ 25% dose reduction

Dosage Forms & Strengths

injectable solution 

  • 1mg/mL
more...

Acute Myeloid Leukemia

10-12 mg/m² IV qDay for 3 days q3weeks

Acute Lymphoblastic Leukemia (Orphan)

Treatment of acute lymphoblastic leukemia in pediatric patients.

Orphan indication sponsor

  • Pharmacia & Upjohn; 7000 Portage Road, Unit 0633-298-113; Kalamazoo, MI 49001-0199
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Interactions

Interaction Checker

idarubicin and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Infection (95%)

            Nausea (30-60%)

            Vomiting (30-60%)

            Alopecia (25-30%)

            Hemorrhage (63%)

            Stomatitis (11%)

            Fever (26%)

            Elevated bilirubin and transaminases (20-30%)

            Myelosuppression: > 10%

            1-10%

            Seizure (4%)

            CHF (2%)

            Peripheral neuropathy (8%)

            Frequency Not Defined

            Fever

            Chills

            Headache

            Flushing

            Myocardial infarction

            Cardiac dysrhythmia

            Chest pain

            Diarrhea

            Inflammatory disease of mucous membrane

            Hyperuricemia

            Red discoloration of urine

            Rash

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            Warnings

            Black Box Warnings

            The drug should be administered under the supervision of a cancer chemotherapy physician experienced in acute leukemia treatment in a facility with appropriate equipment to monitor patients compromised by drug toxicity. Severe hemorrhagic conditions or overwhelming infection resulting from the therapy should also be able to be treated at the facility.

            Only administer intravenously into a freely flowing IV infusion. Do not administer intramuscularly or subcutaneously. Severe local tissue damage can occur with extravasation.

            Myocardial toxicity leading to CHF may occur. Toxicity is more common with prior anthracycline use or preexisting cardiac disease.

            Myelosuppression can be severe at therapeutic doses

            Reduce dose in renal or hepatic impairment

            Contraindications

            Hypersensitivity

            Serum bilirubin >5 mg/dL [>85.5 umol/L]

            Cautions

            Vesicant-avoid extravasation

            Risk of myocardiac toxicity leading to potentially fatal CHF

            Prior radiation treatment to mediastinal-pericardial area & prior anthracyclines increases cardiotoxic risk

            Cumulative doses >150 mg/m² associated with decreased ejection fraction

            Possibility of injection site reactions

            Hepatic/renal impairment

            Avoid pregnancy

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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

            Anthracycline; intercalates between DNA base pairs, inhibits topoisomerase II, which in turn inhibits DNA and RNA synthesis

            Pharmacokinetics

            Half-Life: 14-35 hr (PO); 12-27 hr (IV)

            Bioavailability: 30%

            Protein Bound: 94-97%

            Vd: 64 L/kg

            Peak plasma time: 1-5 hr

            Metabolism: Liver

            Metabolites: Idarubicinol

            Clearance: 122.8 L/hr

            Excretion: Urine (5-13%)

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            Administration

            IV Incompatibilities

            Additive: heparin

            Syringe: heparin

            Y-site: acyclovir, allopurinol, ampicillin/sulbactam, cefazolin, cefepime, ceftazidime, clindamycin, dexamethasone Na-phosphate, etoposide, fluorouracil, furosemide, gentamicin, heparin, hydrocortisone Na-succinate, lorazepam, meperidine, methotrexate, piperacillin/tazobactam, Na-bicarb, teniposide, vancomycin, vincristine

            IV Compatibilities

            Solution: with most common diluents

            Y-site (partial list): cimetidine, diphenhydramine, etoposide PO4, granisetron, MgSO4, metoclopramide, KCl

            IV Preparation

            Vials: reconstitute with NS to a concentration of 1 mg/mL

            Standard dilution

            • IV push: dose/syringe (concentration is 1 mg/mL); maximum syringe size for IVP is 30 mL syringe & syringe should be <75% full
            • IVPB: dose/100 mL D5W or NS

            IV Administration

            Vesicant

            Administer by intermittent infusion over 10-15 min

            Administer into a free flowing IV solution of NS or D5W

            Local erythematous streaking along the vein may indicate rapid administration

            Extravasation Management

            Topical cooling may be achieved using ice packs or cooling pad with circulating ice water

            Cooling of site for 25 hr as tolerated by pt.

            Elevate & rest extremity 24-48 hr, then resume normal activity as tolerated

            Cold inhibits vesicant's cytotoxicity

            Heat can be harmful & is contraindicated

            If pain, erythema, &/or swelling persist beyond 48 hr, refer pt immediately to plastic surgeon for consultation & possible debridement

            See also Totect

            Storage

            Store intact vials of lyophilized powder at room temp

            Protect from light

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            Images

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            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            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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