Daunorubicin liposomal Side Effects
Some side effects of daunorubicin liposomal may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to daunorubicin liposomal: intravenous dispersion
Get emergency medical help if you have any of these signs of an allergic reaction while taking daunorubicin liposomal: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, or have back pain and chest tightness.
Call your doctor at once if you have:
chest pain, shortness of breath (even with mild exertion), swelling, rapid weight gain;
fever, chills, body aches, flu symptoms, sores in your mouth and throat;
easy bruising, unusual bleeding (nose, mouth, vagina, or rectum);
nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
pain, burning, irritation, or skin changes where the injection was given.
Common side effects may include:
mild nausea, vomiting, diarrhea, stomach pain;
temporary hair loss, mild itching or rash; or
red colored urine for 1 or 2 days following a dose.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to daunorubicin liposomal: intravenous dispersion
In general the two main dose-limiting toxicities are myelosuppression and cumulative cardiotoxicity. Acute febrile drug reactions have occurred in up to 50% of patients (probably represent reactions to histamine release), but are not generally observed with steroid and other premedications. The main metabolite, daunorubicinol, has only approximately 1/10th the toxicity of the parent compound.
Hematologic toxicity can be expected after therapeutic doses and is a dose-limiting toxicity of daunorubicin. Daunorubicin is a potent bone marrow suppressant, and can cause significant reductions in all bone marrow cell lines for one to two weeks after therapy. Persistent, severe myelosuppression may result in superinfection, hemorrhage, and/or death.
In a study with HIV-related Kaposi's sarcoma patients (n=116), neutropenia of 1000 cells/mm3 or less was reported in 36% of patients and neutropenia of less than 500 cells/mm3 was reported in 15%. Causality was difficult to establish due to concurrent medications and disease complications.
In one patient with Kaposi's sarcoma, congestive heart failure has been reported at a cumulative dose of 340 mg/m2. In eight Kaposi's sarcoma patients, left ventricular ejection fraction (LVEF) decreases have been reported at cumulative doses ranging from 200 mg/m2 to 2100 mg/m2 (median dose of 320 mg/m2) of daunorubicin liposomal. Congestive heart failure has been reported at a cumulative dose as low as 200 mg/m2 in clinical studies in malignancies other than Kaposi's sarcoma and treated with greater than the recommend dose of 40 mg/m2 of daunorubicin liposomal.
Patients who have received prior therapy with anthracyclines (doxorubicin >300 mg/m2 or equivalent), have preexisting cardiac disease, or have received previous radiotherapy encompassing the heart may be more susceptible to cardiac adverse events. It is recommended that monitoring of LVEF occur prior to therapy and every 160 mg/m2 for these patients.
Cardiovascular toxicity has included congestive heart failure, pericardial effusion, pericardial tamponade, ventricular extrasystoles, cardiac arrest, sinus tachycardia, atrial fibrillation, pulmonary hypertension, myocardial infarction, supraventricular tachycardia, angina pectoris, hot flushes, hypertension, palpitation, syncope, and tachycardia in 5% or fewer patients (n=116). Additionally, edema (9% mild/moderate, 2% severe) and chest pain (9% mild/moderate, 1% severe) have been reported.
Dermatologic side effects have included reversible alopecia (6% mild, 2% moderate) and pruritus (7% mild/moderate). Urticaria , folliculitis, dry skin, seborrhea have been reported in 5% or fewer patients (n=116). Chemical thrombophlebitis and local necrosis have occurred in cases of extravasation.
Cases of palmar-plantar erythrodysesthesia syndrome (hand-foot syndrome) have been reported in 2 patients receiving high dose daunorubicin liposomal therapy (100 to 125 mg/m2 daily for 3 days) in combination with cytarabine, and in one patient receiving recommended doses (40 mg/m2).
Gastrointestinal side effects have included nausea (35% mild, 16% moderate, 3% severe), diarrhea (34% mild/moderate, 4% severe), abdominal pain (20% mild/moderate, 3% severe), vomiting (10% mild, 10% moderate, 3% severe), anorexia (21% mild/moderate, 2% severe), stomatitis (9% mild/moderate, 1% severe), constipation (7% mild/moderate), and tenesmus (4% mild/moderate, 1% severe). Increase appetite, dysphagia, GI hemorrhage, gastritis, gingival bleeding, hemorrhoids, hepatomegaly, melena, dry mouth, and tooth caries have been reported in 5% or fewer patients (n=116).
Local side effects have included thrombophlebitis and necrosis following extravasation, and injection site inflammation (<=5%).
Hepatic serum transaminase and bilirubin concentration elevations have been transiently observed.
Renal side effects have rarely included new or worsened renal insufficiency, probably associated with hyperuricemia and/or dehydration.
Back pain, flushing, and chest tightness (generally occurring during the first five minutes of therapy) have been reported in 13.8% of patients treated in Phase III clinical trials and in 2.7% of treatment cycles.
One case report describes chest and back pain in a patient receiving a 6-hour infusion of high dose daunorubicin liposomal (125 mg/m2).
Immunologic side effects have included reports of opportunistic infections in 40% of patients with HIV-related Kaposi's sarcoma (n=116). The median time to the first opportunistic illness was 214 days. Causality was difficult to determine due to disease complications and multiple concurrent medications.
Nervous system side effects have included fatigue (43% mild/moderate, 6% severe), headache (22% mild/moderate, 3% severe), neuropathy (12% mild/moderate, 1% severe), and dizziness (8% mild/moderate), depression (7% mild/moderate, 3% severe) insomnia (6% mild/moderate). Amnesia, anxiety, ataxia, confusion, convulsions, emotional lability, abnormal gait, hallucination, hyperkinesia, hypertonia, meningitis, somnolence, abnormal thinking, tremor, taste perversion, deafness, earache, and tinnitus have been reported in 5% or fewer patients (n=116).
Metabolic side effects have included dehydration and thirst in 5% or fewer patients (n=116).
Respiratory side effects have included dyspnea (23% mild/moderate, 3% severe), cough (26% mild/moderate, 2% severe), rhinitis (12% mild/moderate), and sinusitis (8% mild/moderate). Hemoptysis, hiccups, pulmonary infiltration, and increased sputum have been reported in 5% or fewer patients (n=116).
Ocular side effects have included abnormal vision (3% mild./moderate, 2% severe), conjunctivitis (<=5%), and eye pain (<=5%).
Genitourinary side effects have included dysuria, nocturia and polyuria in 5% or fewer patients (n=116).
Endocrine side effects have included increased sweating (12% mild/moderate, 2% severe).
Other side effects have included malaise (9% mild/moderate, 1% severe), influenza-like symptoms (5% mild/moderate), lymphadenopathy (<=5%), and splenomegaly (<=5%) (n=116).
Musculoskeletal side effects have included rigors (19% mild/moderate), back pain (16% mild/moderate), arthralgia (7% mild/moderate), and myalgia (7% mild/moderate).
Hypersensitivity reactions have been reported (21% mild/moderate, 3% severe) (n=116).
More daunorubicin liposomal resources
- daunorubicin liposomal Concise Consumer Information (Cerner Multum)
- daunorubicin liposomal MedFacts Consumer Leaflet (Wolters Kluwer)
- DaunoXome Prescribing Information (FDA)
- Daunoxome Advanced Consumer (Micromedex) - Includes Dosage Information
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