doxorubicin (Rx)Brand and Other Names:Adriamycin, Caelyx, more...Rubex

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 2mg/mL

powder for injection

  • 10mg
  • 20mg
  • 50mg
more...

Cancers

Cancer of breast, ovary, prostate, stomach, thyroid; small cell cancer of lung, liver; squamous cell cancer of head and neck; multiple myeloma, Hodgkin's disease, lymphomas, ALL, AML

60-75 mg/m² IV q21Days OR 

60 mg/m² IV q14Days OR

40-60 mg/m² IV q21-28Days OR

20 mg/m²/dose qweek

Hepatocellular Carcinoma (Orphan)

Orphan indication sponsor

  • Delcath Systems, Inc; Rockefeller Center, 23rd Floor; New York, NY 10020

Renal Impairment

Dose adjustment not necessary

Hepatic Impairment

Serum bilirubin <1.2 mg/dL: Dose adjustment not necessary

Serum bilirubin 1.2-3 mg/dL [20.5-51.3 micromoles/L]: Give 50% dose

Serum bilirubin: 3.1-5 mg/dL [53-85.5 micromoles/L]: Give 25% dose

Severe hepatic impairment: Contraindicated

Administration

Limit lifetime cumulative dose to <550 mg/m² to reduce risk of cardiotox

Monitor: CBC, cardiac function, LFTs

Dosage Forms & Strengths

injectable solution

  • 2mg/mL

powder for injection

  • 10mg
  • 20mg
  • 50mg
more...

Cancers

Cancer of stomach, neuroblastoma, thyroid; liver; squamous cell cancer of head and neck; multiple myeloma, Hodgkin's disease, lymphomas, ALL, AML

35-75 mg/m² IV q21Days OR 

20-30 mg/m²/dose qweek

60-90 mg/m² IV over 96 hr q3-4weeks OR

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Interactions

Interaction Checker

doxorubicin 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%

            Neutropenia (52%)

            Anemia (52%)

            Leukopenia (42%)

            Pruritus (37%)

            Nausea (37%)

            Stomatitis (37%)

            Fatigue (33%)

            CHF (30%)

            Thrombocytopenia (24%)

            Vomiting (22%)

            Rash (21%)

            Alopecia (15%)

            Anorexia (12%)

            Constipation (12%)

            Diarrhea (10%)

            1-10%

            Cardiomyopathy (0.5-9%)

            Frequency Not Defined

            Photosensitivity

            Cardiac dysrhythmia

            Necrotizing colitis

            Myelosuppression

            Hyperuricemia

            Red urine

            Hyperpigmentation of previously radiated areas

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            Warnings

            Black Box Warnings

            The drug should be administered under the supervision of an experienced cancer chemotherapy physician

            Cumulative dose-related cardiotoxicity may occur. Potentially fatal CHF may occur months to years after completion of therapy. The risk of developing CHF increases with increasing total cumulative doses of doxorubicin in excess of 450 mg/m².

            Delayed cardiotoxicity may occur in patients with prior mediastinal irradiation, in those on concurrent cyclophosphamide therapy, or in those with preexisting heart disease. Toxicity may also occur at a lower cumulative dose in patients

            For IV administration only. Severe local tissue damage will occur in extravasation. Do not administer IM or SC

            Development of secondary acute myelogenous leukemia and myelodysplastic syndrome reported

            Severe myelosuppression may occur

            Reduce dose in hepatic dysfunction

            Contraindications

            Hypersensitivity

            Active infection

            Severe hepatic impairment

            Baseline neutrophil count <1500/mm³

            Recent MI or severe myocardial insufficiency

            Prior treatment max dose of doxorubicin, daunorubicin, idarubicin, or other anthracyclines

            Cardiomyopathy, CHF, impaired cardiac function

            IM/SC administration

            Cautions

            Vesicant

            Risk of cardiotoxicity (cardiomyopathy, CHF)- may manifest months or even years after discontinuation

            Risk of infusion reactions, myelosuppression

            May cause tumor lysis syndrome and hyperuricemia

            Secondary oral cancers, primarily squamous cell carcinoma, reported with long-term (ie, >1 yr)

            Pediatric patients, elderly, liver impairment, concomitant radiotherapy

            Not effective in malignant melanoma, kidney CA, bowel CA, brain tumors, CNS metastasis

            Avoid pregnancy

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            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: Enters breast milk/not recommended

            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, impairs topoisomerase II function and inhibits replication & transcription

            Distribution

            Protein Bound: 75%

            Vd: 20-30 L/kg (700-1214 L/m²)

            Metabolism

            Predominantly liver

            Metabolites: Doxorubicinol

            Elimination

            Half-Life: 1-3 hr

            Clearance: 8-20 mL/min/kg

            Excretion: Feces (40-50%); urine (5-12%)

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            Administration

            IV Incompatibilities

            Additive: aminophylline, dacarbazine/ondansetron(?), diazepam, fluorouracil

            Syringe: cisplatin/mitomycin(?), fluorouracil (at high concs of both), furosemide, heparin

            Y-site: allopurinol, amphotericin B cholesteryl sulfate, cefepime, furosemide(?), ganciclovir, heparin(?), piperacillin/tazobactam, propofol

            IV Preparation

            Reconstitute with NS to a final concentration of 2 mg/mL

            Protect from light

            Reconstituted soln stable for 7 d at room temp if protected from light & 15 d at 2-8°C

            IV Administration

            Administered into the tubing of a freely running intravenous infusion of NS or D5W

            Administer over 3-5 min with frequent checks of IV patency via visible blood return

            Monitor for local erythematous streaking (flare rxn) along vein &/or facial flushing (may indicate too rapid administration)

            Extravasation Management

            Terminate injection or infusion immediately & aspirate back as much as possible

            Apply cold pack w/ circulating ice water, ice pack or cryogel pack to extravasation site for 15-20 min QID x 24-48 hr

            Elevate site for 48 hr, then resume normal activity

            Extravasation of <1-2 mL often heal spontaneously. If >3 mL, ulceration may occur.

            Protect site from heat & sunlight

            Varied results in studies using 99% DMSO to treat extravasation, follow institutional policy

            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 solution under refrigeration at 2-8°C

            Protect from light

            Store intact vials of lyophilized powder at room temp(15-30°C)

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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.
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            • Compare formulary status to other drugs in the same class.
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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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