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Liposomal daunorubicin (United States: Not available): Drug information

Liposomal daunorubicin (United States: Not available): Drug information
(For additional information see "Liposomal daunorubicin (United States: Not available): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Experienced physician:

Administer liposomal daunorubicin only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents.

Myocardial toxicity:

Monitor cardiac function regularly in patients receiving liposomal daunorubicin because of the potential risk for cardiac toxicity and heart failure (HF). Cardiac monitoring is especially advised in those patients who have received prior anthracyclines, have had preexisting cardiac disease, or who have had prior radiotherapy encompassing the heart.

Hepatic impairment:

Reduce dosage in patients with impaired hepatic function.

Bone marrow suppression:

Severe myelosuppression may occur.

Infusion reactions:

A triad of back pain, flushing, and chest tightness has been reported in 13.8% of the patients (16/116) treated with liposomal daunorubicin in the phase 3 clinical trial, and in 2.7% of treatment cycles (27/994). This triad generally occurs during the first 5 minutes of the infusion, subsides with interruption of the infusion, and generally does not recur if the infusion is then resumed at a slower rate.

Pharmacologic Category
  • Antineoplastic Agent, Anthracycline;
  • Antineoplastic Agent, Topoisomerase II Inhibitor
Dosing: Adult

Note: DaunoXome has been discontinued in the US for more than 1 year.

Note: DAUNOrubicin (liposomal) is different from the conventional DAUNOrubicin formulation; do NOT substitute (indications and doses are different).

Kaposi sarcoma

Kaposi sarcoma: IV: 40 mg/m2 once every 2 weeks; continue until disease progression.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

Serum creatinine >3 mg/dL: Administer 50% of normal dose.

Dosing: Hepatic Impairment: Adult

Bilirubin 1.2 to 3 mg/dL: Administer 75% of normal dose.

Bilirubin >3 mg/dL: Administer 50% of normal dose.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Obesity: Adult

American Society of Clinical Oncology guidelines for appropriate systemic therapy dosing in adults with cancer with a BMI ≥30 kg/m2: Utilize patient's actual body weight for calculation of BSA- or weight-based dosing; manage regimen-related toxicities in the same manner as for patients with a BMI <30 kg/m2; if a dose reduction is utilized due to toxicity, may consider resumption of full weight-based dosing (or previously tolerated dose level) with subsequent cycles only if dose escalations are allowed in the prescribing information, if contributing underlying factors (eg, hepatic or kidney impairment) are sufficiently resolved, AND if performance status has markedly improved or is considered adequate (ASCO [Griggs 2021]).

Dosing: Adjustment for Toxicity: Adult

ANC <750/mm3: Withhold treatment.

Infusion reactions (back pain, flushing, chest tightness): Temporarily interrupt infusion; may resume at a slower rate.

Generic Equivalent Available: US

No

Dosage Forms Considerations

Daunorubicin (liposomal) injection contains sucrose 2,125 mg/25 mL

Product Availability

DaunoXome has been discontinued in the US for more than 1 year.

Administration: Adult

IV: Infuse over 1 hour; do not mix with other drugs. Do NOT administer with an in-line filter. Avoid extravasation.

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2016 [group1]).

Use appropriate precautions for receiving, handling, administration, and disposal. Gloves (single) should be worn during receiving, unpacking, and placing in storage.

NIOSH recommends double gloving, a protective gown, ventilated engineering controls (a class II biological safety cabinet or a compounding aseptic containment isolator), and closed system transfer devices (CSTDs) for preparation. Double gloving, a gown, and (if dosage form allows) CSTDs are required during administration (NIOSH 2016).

Use: Labeled Indications

Kaposi sarcoma: First-line treatment of advanced HIV-associated Kaposi sarcoma

Limitation of use: Daunorubicin (liposomal) is not recommended in HIV-related Kaposi sarcoma which is less than advanced.

Medication Safety Issues
Sound-alike/look-alike issues:

DAUNOrubicin liposomal may be confused with DACTINomycin, DAUNOrubicin (Conventional), DOXOrubicin, DOXOrubicin liposomal, epiRUBicin, IDArubicin, valrubicin

Liposomal formulation (DaunoXome) may be confused with the conventional DAUNOrubicin formulation

High alert medication:

This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes which have a heightened risk of causing significant patient harm when used in error.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not always defined.

Cardiovascular: Edema (11%), chest pain (10%), angina pectoris (≤5%), atrial fibrillation (≤5%), cardiac arrest (≤5%), cardiac tamponade (≤5%), hypertension (≤5%), myocardial infarction (≤5%), palpitations (≤5%), pericardial effusion (≤5%), pulmonary hypertension (≤5%), sinus tachycardia (≤5%), supraventricular tachycardia (≤5%), syncope (≤5%), tachycardia (≤5%), ventricular premature contractions (≤5%), decreased left ventricular ejection fraction (3%; reduction of 20% to 25%), cardiomyopathy (cumulative, dose-related; total dose above 300 mg/m2)

Central nervous system: Fatigue (49%), headache (25%), rigors (19%), neuropathy (13%), depression (10%), malaise (10%), dizziness (8%), insomnia (6%), abnormality in thinking (≤5%), amnesia (≤5%), anxiety (≤5%), ataxia (≤5%), confusion (≤5%), drowsiness (≤5%), emotional lability (≤5%), hallucination (≤5%), hypertonia (≤5%), meningitis (≤5%), seizure (≤5%)

Dermatologic: Diaphoresis (14%), alopecia (8%), pruritus (7%), folliculitis (≤5%), seborrhea (≤5%), xeroderma (≤5%)

Endocrine & metabolic: Dehydration (≤5%), hot flash (≤5%), increased thirst (≤5%)

Gastrointestinal: Nausea (54%), diarrhea (38%), abdominal pain (23%), anorexia (23%), vomiting (23%), stomatitis (10%), constipation (7%), tenesmus (5%), dental caries (≤5%), dysgeusia (≤5%), dysphagia (≤5%), gastritis (≤5%), gastrointestinal hemorrhage (≤5%), gingival hemorrhage (≤5%), hemorrhoids (≤5%), hiccups (≤5%), increased appetite (≤5%), melena (≤5%), xerostomia (≤5%)

Genitourinary: Dysuria (≤5%), nocturia (≤5%)

Hematologic & oncologic: Neutropenia (<1,000 cells/mm3: 36%; grade 4: 15%), lymphadenopathy (≤5%), splenomegaly (≤5%), bone marrow depression (especially granulocytes; platelets and erythrocytes less effected), severe granulocytopenia (may be associated with fever and result in infection)

Hepatic: Hepatomegaly (≤5%)

Hypersensitivity: Hypersensitivity reaction (24%)

Infection: Opportunistic infection (40%; median time to first infection/illness: 214 days)

Local: Inflammation at injection site (≤5%)

Neuromuscular & skeletal: Back pain (16%), arthralgia (7%), myalgia (7%), abnormal gait (≤5%), hyperkinesia (≤5%), tremor (≤5%)

Ophthalmic: Visual disturbance (5%), conjunctivitis (≤5%), eye pain (≤5%)

Otic: Deafness (≤5%), otalgia (≤5%), tinnitus (≤5%)

Renal: Polyuria (≤5%)

Respiratory: Cough (28%), dyspnea (26%), rhinitis (12%), sinusitis (8%), flu-like symptoms (5%), hemoptysis (≤5%), increased bronchial secretions (≤5%), pulmonary infiltrates (≤5%)

Miscellaneous: Fever (47%), infusion-related reaction (14%; includes back pain, flushing, chest tightness)

Contraindications

Hypersensitivity to daunorubicin (liposomal) or any component of the formulation

Documentation of allergenic cross-reactivity for drugs in this class is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Warnings/Precautions

Concerns related to adverse effects:

• Bone marrow suppression: [US Boxed Warning]: May cause bone marrow suppression, particularly neutropenia (may be severe). Monitor blood counts. Monitor closely for infections (including opportunistic infections).

• Extravasation: Avoid extravasation. Although not reported with daunorubicin (liposomal), daunorubicin (conventional) is associated with local tissue necrosis if extravasated.

• Infusion reactions: [US Boxed Warning]: The lipid component is associated with infusion-related reactions (back pain, flushing, chest tightness) usually within the first 5 minutes of infusion, and subsides with interruption of the infusion, and generally does not recur if the infusion is resumed at a lower rate. Monitor for infusion reactions; interrupt infusion if reaction occurs, and resume at reduced infusion rate.

• Myocardial toxicity: [US Boxed Warning]: Due to the potential for cardiac toxicity and heart failure, monitor cardiac function regularly, especially in patients with previous therapy with anthracyclines, thoracic radiation, or who have preexisting cardiac disease. Cardiomyopathy is usually associated with a decrease left in ventricular ejection fraction (LVEF). Although the risk increases with cumulative dose, irreversible cardiotoxicity may occur with anthracycline treatment at any dose level. Patients who have received prior anthracycline therapy (DOXOrubicin >300 mg/m2 or equivalent), with preexisting heart disease, hypertension, concurrent administration of other antineoplastic agents, prior or concurrent chest irradiation, and advanced age are at increased risk. Evaluate LVEF prior to treatment and periodically during treatment (at cumulative doses of daunorubicin liposomal 320 mg/m2 and every 160 mg/m2 thereafter or every 160 mg/m2 in patients at higher risk).

Disease-related concerns:

• Hepatic impairment: [US Boxed Warning]: Reduce dosage in patients with hepatic impairment.

• Renal impairment: Use with caution in patients with renal impairment; may require dosage reduction.

Other warnings/precautions:

• Experienced physician: [US Boxed Warning]: Should be administered under the supervision of an experienced cancer chemotherapy physician.

Metabolism/Transport Effects

Substrate of P-glycoprotein/ABCB1 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Ado-Trastuzumab Emtansine: May enhance the cardiotoxic effect of Anthracyclines. Management: When possible, patients treated with ado-trastuzumab emtansine should avoid anthracycline-based therapy for up to 7 months after stopping ado-trastuzumab emtansine. Monitor closely for cardiac dysfunction in patients receiving this combination. Risk D: Consider therapy modification

Baricitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination

BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

BCG Products: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination

Bevacizumab: May enhance the cardiotoxic effect of Anthracyclines. Risk X: Avoid combination

Brincidofovir: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy

Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy

Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk X: Avoid combination

Cladribine: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination

CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor therapy

Coccidioides immitis Skin Test: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing cytotoxic chemotherapy several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification

COVID-19 Vaccine (Adenovirus Vector): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification

COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy

COVID-19 Vaccine (mRNA): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider therapy modification

COVID-19 Vaccine (Subunit): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy

COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy

Cyclophosphamide: May enhance the cardiotoxic effect of Anthracyclines. Risk C: Monitor therapy

Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider therapy modification

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination

Denosumab: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and cytotoxic chemotherapy. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider therapy modification

Deucravacitinib: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination

Fam-Trastuzumab Deruxtecan: May enhance the cardiotoxic effect of Anthracyclines. Management: When possible, patients treated with fam-trastuzumab deruxtecan should avoid anthracycline-based therapy for up to 7 months after stopping fam-trastuzumab deruxtecan. Monitor closely for cardiac dysfunction in patients receiving this combination. Risk D: Consider therapy modification

Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination

Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Inebilizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy

Influenza Virus Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating chemotherapy if possible. If vaccination occurs less than 2 weeks prior to or during chemotherapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification

Leflunomide: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents, such as cytotoxic chemotherapy. Risk D: Consider therapy modification

Lenograstim: Antineoplastic Agents may diminish the therapeutic effect of Lenograstim. Management: Avoid the use of lenograstim 24 hours before until 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Risk D: Consider therapy modification

Lipegfilgrastim: Antineoplastic Agents may diminish the therapeutic effect of Lipegfilgrastim. Management: Avoid concomitant use of lipegfilgrastim and myelosuppressive cytotoxic chemotherapy. Lipegfilgrastim should be administered at least 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Risk D: Consider therapy modification

Margetuximab: Anthracyclines may enhance the adverse/toxic effect of Margetuximab. Specifically, the risk of cardiac dysfunction may be increased. Management: Avoid anthracycline-based therapy for up to 4 months after discontinuing margetuximab due to an increased risk of cardiac dysfunction. If anthracyclines must be used with margetuximab monitor cardiac function closely. Risk D: Consider therapy modification

Natalizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination

Ocrelizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy

Ofatumumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy

Olaparib: Myelosuppressive Agents may enhance the myelosuppressive effect of Olaparib. Risk C: Monitor therapy

Palifermin: May enhance the adverse/toxic effect of Antineoplastic Agents. Specifically, the duration and severity of oral mucositis may be increased. Management: Do not administer palifermin within 24 hours before, during infusion of, or within 24 hours after administration of myelotoxic chemotherapy. Risk D: Consider therapy modification

Pidotimod: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy

Pimecrolimus: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Pneumococcal Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination

Polymethylmethacrylate: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification

Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

Rabies Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification

Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider therapy modification

Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination

Ruxolitinib (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination

Sipuleucel-T: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants, such as cytotoxic chemotherapy, prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification

Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk C: Monitor therapy

Tacrolimus (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination

Talimogene Laherparepvec: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination

Taxane Derivatives: May enhance the adverse/toxic effect of Anthracyclines. Taxane Derivatives may increase the serum concentration of Anthracyclines. Taxane Derivatives may also increase the formation of toxic anthracycline metabolites in heart tissue. Management: Consider separating doxorubicin and paclitaxel administration by as much time as possible, using liposomal doxorubicin or epirubicin instead of doxorubicin, or using docetaxel instead of paclitaxel. Monitor closely for cardiovascular and other toxicities. Risk D: Consider therapy modification

Tertomotide: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination

Tofacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Tofacitinib. Risk X: Avoid combination

Trastuzumab: May enhance the cardiotoxic effect of Anthracyclines. Management: When possible, patients treated with trastuzumab should avoid anthracycline-based therapy for up to 7 months after stopping trastuzumab. Monitor closely for cardiac dysfunction in patients receiving anthracyclines with trastuzumab. Risk D: Consider therapy modification

Typhoid Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination

Upadacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination

Vaccines (Inactivated/Non-Replicating): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of chemotherapy when possible. Patients vaccinated less than 14 days before initiating or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification

Vaccines (Live): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Vaccines (Live) may diminish the therapeutic effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Yellow Fever Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination

Pregnancy Considerations

Adverse events were observed in animal reproduction studies.

Breastfeeding Considerations

Daunorubicin (liposomal) is indicated for advanced HIV-associated Kaposi sarcoma.

The Health and Human Services perinatal HIV guidelines do not recommend breastfeeding for patients in the United States with HIV infection when safer infant feeding options are available (HHS [perinatal] 2021).

Monitoring Parameters

CBC with differential and platelets (prior to each dose), liver function tests, renal function tests; evaluate cardiac function (baseline left ventricular ejection fraction [LVEF] prior to treatment initiation; repeat LVEF at total cumulative doses of 320 mg/m2, and every 160 mg/m2 thereafter; patients with preexisting cardiac disease, history of prior chest irradiation, or history of prior anthracycline treatment should have baseline LVEF and every 160 mg/m2 thereafter); signs and symptoms of infection or disease progression; monitor closely for infusion reactions

Mechanism of Action

Liposomal preparation of daunorubicin; liposomes have been shown to penetrate solid tumors more effectively, possibly because of their small size and longer circulation time. Once in tissues, daunorubicin is released (over time). Daunorubicin inhibits DNA and RNA synthesis by intercalation between DNA base pairs and by steric obstruction; and intercalates at points of local uncoiling of the double helix. Although the exact mechanism is unclear, it appears that direct binding to DNA (intercalation) and inhibition of DNA repair (topoisomerase II inhibition) result in blockade of DNA and RNA synthesis and fragmentation of DNA.

Pharmacokinetics

Distribution: Vd: ~5 to 8 L

Metabolism: Daunorubicinol (major active metabolite) is detected at low levels in plasma

Half-life elimination: Distribution: 4.4 hours

Excretion: Primarily feces; some urine

Pricing: US

Injection (DaunoXome Intravenous)

2 mg/mL (25 mL): $1380.00

Disclaimer: The pricing data provide a representative AWP and/or AAWP price from a single manufacturer of the brand and/or generic product, respectively. The pricing data should be used for benchmarking purposes only, and as such should not be used to set or adjudicate any prices for reimbursement or purchasing functions. Pricing data is updated monthly.

Brand Names: International
  • DaunoXome (AT, DK, FI, FR, GB, IT, PT);
  • Daunoxome (BB)


For country code abbreviations (show table)
  1. DaunoXome (daunorubicin liposomal) [prescribing information]. Souderton, PA: Galen US Inc; December 2011.
  2. Gill PS, Espina BM, Muggia F, et al. Phase I/II Clinical and Pharmacokinetic Evaluation of Liposomal Daunorubicin. J Clin Oncol. 1995;13(4):996-1003. [PubMed 7707129]
  3. Gill PS, Wernz J, Scadden DT, et al. Randomized Phase III Trial of Liposomal Daunorubicin Versus Doxorubicin, Bleomycin, and Vincristine in AIDS-Related Kaposi's Sarcoma. J Clin Oncol. 1996;14(8):2353-2364. [PubMed 8708728]
  4. Griggs JJ, Bohlke K, Balaban EP, et al. Appropriate systemic therapy dosing for obese adult patients with cancer: ASCO guideline update. J Clin Oncol. 2021;39(18):2037-2048. doi:10.1200/JCO.21.00471 [PubMed 33939491]
  5. US Department of Health and Human Services; Centers for Disease Control and Prevention; National Institute for Occupational Safety and Health. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2016. http://www.cdc.gov/niosh/topics/antineoplastic/pdf/hazardous-drugs-list_2016-161.pdf. Updated September 2016. Accessed October 5, 2016.
  6. US Department of Health and Human Services (HHS) Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission. Recommendations for the use of antiretroviral drugs during pregnancy and interventions to reduce perinatal HIV transmission in the United States. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/Perinatal_GL.pdf. Updated December 30, 2021. Accessed January 3, 2022.
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