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doxorubicin liposomal (Rx)Brand and Other Names:Doxil, Lipodox, more...Myocet

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 2mg/mL
more...

Kaposi's Sarcoma

Indicated for AIDS-related Kaposi’s sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy

20 mg/m² IV q3Weeks 

Ovarian Cancer

Indicated for ovarian cancer in patients whose disease has progressed or recurred after platinum-based chemotherapy

50 mg/m² IV q4Weeks x 4 courses minimum 

Multiple Myeloma

Indicated in combination with bortezomib for multiple myeloma in patients who have not previously received bortezomib and have received at least 1 prior therapy

30 mg/m² IV on day 4 following bortezomib 1.3 mg/m² on days 1, 4, 8 & 11 q3Weeks 

Dosage Modifications

Hepatic impairment: Reduce dose if serum bilirubin ≥1.2 mg/dL

Hand-foot syndrome or stomatitis

  • Grade 1: If no previous grade 3 or 4 toxicity, no dose adjustment required; if previous grade 3 or 4 toxicity, delay up to 2 wk then decrease dose by 25%
  • Grade 2: Delay dose up to 2 wk or until resolved to grade 0-1; discontinue if not resolved after 2 wk; if resolve (no previous grades 3-4 toxicity), continue at previous dose; if resolve (hx of previous grades 3-4 toxicity), decrease dose by 25%
  • Grade 3: Delay dose up to 2 wk or until resolved to grade 0-1, then decrease dose by 25%; discontinue if no resolution after 2 wk
  • Grade 4: Delay dose up to 2 wk or until resolved to grade 0-1, then decrease dose by 25% and return to original dose interval; discontinue if no resolution after 2 wk

Neutropenia or thrombocytopenia

  • Grade 1: No dose reduction
  • Grade 2 or 3: Delay until ANC ≥1,500 and platelets ≥75,000; resume treatment at previous dose
  • Grade 4: Delay until ANC ≥1,500 and platelets ≥75,000; resume at 25% dose reduction or continue previous dose with prophylactic granulocyte growth factor

Other toxicities

  • Fever ≥38°C and ANC <1,000/mm³: Withhold dose for this cycle if before Day 4; decrease dose by 25%, if after Day 4 of previous cycle
  • On any day of drug administration after Day 1 of each cycle (platelet count <25,000/mm³, Hgb <8 g/dL, ANC <500/mm³): Withhold dose for this cycle if before Day 4; cecrease dose by 25%, if after Day 4 of previous cycle AND if bortezomib is reduced for hematologic toxicity
  • Grade 3 or 4 nonhematologic toxicity: Hold dose until recovered to <grade 2, then reduce dose by 25%

Sarcomas (Orphan)

Treatment of soft tissue sarcomas

Orphan indication sponsor

  • GP-Pharm SA; Pol. Ind. Els Vinyets els Fogars n 2, Quinti de Mediona; Barcelona, Spain

Hepatocellular Carcinoma (Orphan)

Lyso-thermosensitive liposomal doxorubicin

Orphan indication sponsor

  • Celsion Corporation; 10220-L Old Columbia Road; Columbia, MD 21046

Safety and efficacy not established

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Interactions

Interaction Checker

doxorubicin liposomal 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%

            Kaposi's Sarcoma

            • Anemia (>50%)
            • Thrombocytopenia (>50%)
            • Neutropenia (10-50%)
            • Anemia (18.2%)
            • Nausea (17%)

            Ovarian cancer >25%

            • Hand-foot syndrome (50%)
            • Nausea (46%)
            • Stomatitis (41%)
            • Asthenia (40.2%)
            • Vomiting (32.6%)
            • Rash (28%)
            • Constipation (>25%)
            • Abdominal pain (>25%)

            Ovarian cancer 10-25%

            • Fever (21.3%)
            • Anorexia (20%)
            • Diarrhea (20%)
            • Peripheral edema
            • Dyspepsia
            • Pharyngitis
            • Dyspnea
            • Alopecia

            1-10%

            Kaposi's Sarcoma 5-10%

            • Asthenia (9.9%)
            • Fever (9.1%)
            • Diarrhea (7.8%)
            • Vomiting (7.8%)
            • Stomatitis (6.8%)
            • Rash (1-5%)
            • Alopecia (1-5%)
            • Increased alkaline phosphatase

            Kaposi's Sarcoma 1-5%

            • Hand-foot syndrome (3.4%)
            • Hypotension
            • Tachycardia
            • Dyspnea
            • Hemolysis
            • Rash

            Ovarian cancer (selected)

            • Neutropenia (13.3%)
            • Anemia (0.4-5.4%)
            • Thrombocytopenia (1.3%)

            <1%

            Abscess

            Acute myeloid leukemia

            Cardiomegaly

            Cardiomyopathy

            Erythema nodosum

            Hyperkalemia

            Hyperuricemia

            Ketosis

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            Warnings

            Black Box Warnings

            Myocardial toxicity

            • Can cause myocardial damage, including congestive heart failure, as the total cumulative dose of doxorubicin HCl approaches 550 mg/m²
            • In a clinical study of 250 patients with advanced cancer who were treated with liposomal doxorubicin, the risk of cardiotoxicity was 11% when the cumulative anthracycline dose was between 450-550 mg/m²
            • Prior use of other anthracyclines or anthracenediones should be included in calculations of total cumulative dosage
            • The risk of cardiomyopathy may be increased at lower cumulative doses in patients with prior mediastinal irradiation

            Infusion-related reactions

            • May include flushing, shortness of breath, facial swelling, headache, chills, back pain, tightness in the chest or throat
            • Hypotension occurred in 11% of patients with solid tumors treated with liposomal doxorubicin
            • Serious, life-threatening and fatal infusion reactions have been reported

            Contraindications

            History of severe hypersensitivity to doxorubicin, including anaphylaxis

            Cautions

            Can result in myocardial damage, including acute left ventricular failure; risk of cardiomyopathy is generally proportional to the cumulative exposure (see Black Box Warnings)

            Serious and sometimes life-threatening infusion-related reactions reported; ensure that medications to treat infusion-related reactions and cardiopulmonary resuscitative equipment are available for immediate use prior to initiation (see Black Box Warnings)

            Incidence of hand-foot syndrome in 1 trial was 51%, including 24% grade 3 or 4 toxicity (see Dosage Modifications)

            Secondary oral cancers, primarily squamous cell carcinoma, have been reported

            Based on animal data, can cause fetal harm when administered to pregnant women

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            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: Unknown whether distributed in breast milk; because many drugs, including anthracyclines, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, discontinue breast feeding during treatment

            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 subsequently inhibits DNA and RNA replication

            Doxorubicin is a strong chelator; doxorubicin-iron complex binds to cell membranes and DNA and produces free hydroxyl radicals that cleaves them

            Pharmacokinetics

            Peak Plasma: (20 mg/m²): 8.34±0.49 mcg/mL

            Half-life: 44-55 hr

            AUC (20 mg/m²): 590±59 mcg.hr/mL

            Protein binding: 70%

            Vd: 2.8 L/m²

            Metabolism: Low

            Clearance (20 mg/m²): 41 mL/hr/m²

            Excretion: Urine (5%)

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            Administration

            IV Incompatibilities

            Y-site: ampho B, amphotericin B cholesteryl sulfate, buprenorphine, ceftazidime, cefoperazone, docetaxel, hydroxyzine, mannitol, meperidine, metoclopramide, mitoxantrone, morphine sulfate, ofloxacin, paclitaxel, piperacillin/tazobactam, promethazine, Na-bicarb

            IV Compatibilities

            Y-site: acyclovir, allopurinol, ampicillin, carboplatin, cimetidine, ciprofloxacin, cisplatin, clindamycin, cyclophosphamide, dexamethasone, diphenhydramine, dobutamine, dopamine, fluconazole, fluorouracil, furosemide, granisetron, heparin, lorazepam, MgSO4, KCl, prochlorperazine, TMP/SMX, vancomycin, zidovudine

            IV Preparation

            Dilute aseptically <90 mg doses in 250 mL & >90 mg doses in 500 mL D5W (do NOT use other IV fluids)

            Refrigerate at 2-8°C & administer within 24 hr

            Red translucent dispersion (will not be a clear solution)

            IV Administration

            Initial infusion at 1 mg/min, if no infusion reaction may increase rate to complete infusion in 1 hr

            Do not administer as bolus injection or undiluted suspension

            Do not use in-line filter

            Use cytotoxic precautions for handling, administration, and disposal

            Extravasation Management

            Stop infusion immediately

            Do not remove the needle until attempts are made to aspirate extravasated fluid

            Do not flush the line

            Avoid applying pressure to the site

            Apply ice to the site intermittently for 15 minutes 4 x/day for 3 days

            If the extravasation is in an extremity, elevate the extremity

            Storage

            Store vials refrigerated at 2-8°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.
            • 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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