daunorubicin liposomal (Discontinued)

Brand and Other Names:DaunoXome
  • Print

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 2mg/mL
more...

Advanced HIV-Associated Kaposi Sarcoma

July 20, 2016: FDA notice of discontinuation; no other daunorubicin liposome product available

40 mg/m² IV (infuse over 1 hr) q2Weeks 

Withold treatment if ANC <750/cu.mm

Continue treatment until evidence of progressive disease

Acute Myeloid Leukemia (Orphan)

Orphan indication sponsor

  • Diatos USA, LLC; 15310 Amberly Drive; Tampa, FL 33647

Hepatic Impairment

Serum bilirubin 1.2-3 mg/dL [20.5-51.3 micromoles/L]: Give 75% normal dose

Serum bilirubin or creatinine >3 mg/dL [bili >51.3 micromoles/L; Cr >265 micromoles/L]: Give 50% normal dose

Monitor

CBC prior to each administration

LVEF prior to & at every cumulative 160 mg/sq.meter

Renal & hepatic function

Safety & efficacy not established

Next:

Interactions

Interaction Checker

and daunorubicin liposomal

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 
            Previous
            Next:

            Adverse Effects

            >10%

            Nausea (54%)

            Fatigue (49%)

            Fever (47%)

            Diarrhea (38%)

            Cough (28%)

            Dyspnea (26%)

            Headache (25%)

            Neuropathy

            Increased sweating

            Depression

            Back pain

            Malaise

            Rigors

            Triad of back pain, flushing and chest tightness

            Chest pain

            Edema

            Rhinitis

            Abdominal pain

            Anorexia

            Stomatitis

            Vomiting

            Allergic reactions

            1-10%

            Abnormal vision

            Dizziness

            Insomnia

            Sinusitis

            Constipation

            Flu-like Symptoms

            Myalgia

            Arthralgia

            Alopecia

            Pruritus

            Tenesmus

            Frequency Not Defined

            Cardiotoxicity

            Myelosuppression

            Previous
            Next:

            Warnings

            Black Box Warnings

            Monitor cardiac function, especially in patients who have received prior anthracyclines, have had preexisting cardiac disease, or who have had prior radiotherapy encompassing the heart. Severe myelosuppression may occur.

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

            Reduce dose in patients with impaired hepatic function

            A triad of back pain, flushing, and chest tightness may occur during the first 5 minutes of the infusion. It subsides with interruption of the infusion and generally does not recur when resumed at a slower rate.

            Contraindications

            Hypersensitivity

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

            Not recommended for less than advanced Kaposi's sarcoma

            Cautions

            Risk of myelosuppression & cardiotoxicity with CHF

            Irritant

            Safety not established for pts with renal/hepatic impairment

            Avoid pregnancy

            Previous
            Next:

            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: excretion in milk unknown/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.

            more...
            Previous
            Next:

            Pharmacology

            Half-Life: 4.4±2.3 hr

            Vd: 6.4 L

            Clearance: 17 mL/min

            Metabolism: to daunorubicinol

            Excretion: N/A

            Mechanism of Action

            Anthracycline; intercalates between DNA base pairs, impairs topo II function & DNA replication

            Previous
            Next:

            Administration

            IV Incompatibilities

            Do not mix with other drugs

            IV Preparation

            Use strict aseptic technique-contains no preservatives or antibacterials

            Solution in vial is a red translucent dispersion

            Dilute ONLY in D5W; do not mix with any other fluid or bacteriostatic agent

            Withdraw required amount from vial (containing 50 mg at 2 mg/mL) & add to an infusion bag containing an equal amount of D5W for a 1:1 dilution (final conc 1 mg/mL)

            Administer immediately although diluted soln may be refrigerated at 2-8°C for 6 hr

            IV Administration

            Infuse over 1 hr

            Extravasation Management

            Stop infusion immediately, aspirate back as much as possible, & restart in another vein

            Apply ice for 30 min over extravasation site

            May produce redness/edema, low ulceration potential

            If ulceration begins or pain/redness/edema persists, treat like daunorubicin extravasation

            See also Totect

            Storage

            Refrigerate vials at 2-8°C; do not freeze

            Protect from light

            Previous
            Next:

            Images

            Previous
            Next: