doxorubicin (Rx)

Brand and Other Names:Adriamycin, Caelyx, more...Rubex
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 2mg/mL

powder for injection

  • 10mg
  • 20mg
  • 50mg

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

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

and doxorubicin

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    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

            Myocardial damage, including acute left ventricular failure, can occur with doxorubicin hydrochloride; the risk of cardiomyopathy is proportional to cumulative exposure with incidence rates from 1- 20% for cumulative doses ranging from 300 mg/m2 to 500 mg/m2 when doxorubicin hydrochloride is administered every 3 weeks; the risk of cardiomyopathy is further increased with concomitant cardiotoxic therapy; assess left ventricular ejection fraction (LVEF) before and regularly during and after treatment with doxorubicin hydrochloride

            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

            Extravasation of doxorubicin hydrochloride can result in severe local tissue injury and necrosis requiring wide excision of affected area and skin grafting; immediately terminate drug and apply ice to affected area; do not administer IM or SC

            Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including doxorubicin hydrochloride

            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

            Pericarditis and myocarditis reported during or following treatment; assess left ventricular cardiac function (eg, MUGA or echocardiogram) prior to initiation of doxorubicin; discontinue in patients who develop signs or symptoms of cardiomyopathy; consider use of dexrazoxane to reduce incidence and severity of cardiomyopathy due to administration in patients who have received a cumulative doxorubicin hydrochloride dose of 300 mg/m2 and who will continue to receive doxorubicin hydrochloride

            The risk of developing secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) is increased following treatment with doxorubicin hydrochloride. Cumulative incidences ranged from 0.2% at five years to 1.5% at 10 years in two separate trials involving the adjuvant treatment of women with breast cancer. These leukemias generally occur within 1 to 3 years of treatment

            Drug clearance of doxorubicin is decreased in patients with elevated serum bilirubin with increased risk of toxicity; reduce dose in patients with serum bilirubin levels of 1.2 to 5 mg/dL; obtain liver tests including ALT, AST, alkaline phosphatase, and bilirubin prior to and during therapy

            Doxorubicin hydrochloride can induce tumor lysis syndrome in patients with rapidly growing tumors; evaluate blood uric acid levels, potassium, calcium, phosphate, and creatinine after initial treatment; hydration, urine alkalinization, and prophylaxis with allopurinol to prevent hyperuricemia may minimize potential complications of tumor lysis syndrome

            Therapy can increase radiation-induced toxicity to myocardium, mucosa, skin, and liver; radiation recall, including but not limited to cutaneous and pulmonary toxicity, can occur in patients who receive drug after prior radiation therapy

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

            Use caution in the elderly, liver impairment, and concomitant radiotherapy

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

            Therapy can cause myelosuppression; a dose-dependent, reversible neutropenia is predominant manifestation of myelosuppression from therapy; obtain complete blood counts prior to each treatment and carefully monitor patients during treatment for possible clinical complications due to myelosuppression; delay next dose if severe myelosuppression has not improved; consider dose reduction for patients with prolonged myelosuppression based on severity of reaction

            Extravasation

            • Extravasation of doxorubicin hydrochloride can cause severe local tissue injury manifesting as blistering, ulceration, and necrosis requiring wide excision of the affected area and skin grafting
            • Extravasation should be considered if a patient experiences a burning or stinging sensation or shows other evidence indicating peri-venous infiltration or extravasation; however, extravasation may be present in patients who do not experience a stinging or burning sensation or when blood return is present on aspiration of the infusion needle
            • When given via a peripheral venous line, infuse over 10 minutes or less to minimize risk of thrombosis or perivenous extravasation
            • If extravasation is suspected, immediately discontinue intravenous injection or continuous intravenous infusion; apply ice to site intermittently for 15 minutes, 4 times a day for 3 days; in adults, if appropriate, administer dexrazoxane at site of extravasation as soon as possible and within the first 6 hours after extravasation

            Arrhythmias

            • Therapy can result in arrhythmias, including life-threatening arrhythmias, during or within a few hours after treatment and at any time point during treatment; tachyarrhythmias, including sinus tachycardia, premature ventricular contractions, and ventricular tachycardia, as well as bradycardia, can occur
            • Electrocardiographic changes, including non-specific ST-T wave changes, atrioventricular and bundle-branch block can also occur; these electrocardiographic changes may be transient and self-limited and may not require a dosage modification of doxorubicin hydrochloride

            Pediatric patients

            • Based on postmarketing reports, pediatric patients are at risk for developing late cardiovascular dysfunction
            • Risk factors include young age at treatment (especially < 5 years), high cumulative doses and receipt of combined modality therapy; long-term periodic cardiovascular monitoring recommended for all pediatric patients
            • Drug, as a component of intensive chemotherapy regimens administered to pediatric patients, may contribute to prepubertal growth failure and may also contribute to gonadal impairment, which is usually temporary

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            Pregnancy & Lactation

            Pregnancy

            Based on findings in animals and its mechanism of action, drug can cause fetal harm when administered to a pregnant woman; avoid use during 1st trimester; available human data do not establish presence or absence of major birth defects and miscarriage related to use during 2nd and 3rd trimesters; drug was teratogenic and embryotoxic in rats and embryotoxic in rabbits when administered during organogenesis at doses approximately 0.07 times (based on body surface area) recommended human dose of 60 mg/m2; advise pregnant women of potential risk to a fetus

            Verify pregnancy status of females of reproductive potential prior to initiating therapy

            In females of reproductive potential, drug may cause infertility and result in amenorrhea; premature menopause can occur; recovery of menses and ovulation is related to age at treatment

            Contraception

            • Females: Treatment can cause fetal harm when administered to pregnant women; advise female patients of reproductive potential to use highly effective contraception during treatment and for 6 months after treatment
            • Males: Treatment may damage spermatozoa and testicular tissue, resulting in possible genetic fetal abnormalities; due to potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after treatment; males with pregnant partners should use condoms during treatment and for at least 10 days after final dose

            Lactation

            Data are not available regarding effects on breastfed children or milk production

            Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for 10 days after the final dose

            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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            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.