Daunorubicin liposomal Side Effects

Not all side effects for daunorubicin liposomal may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to daunorubicin liposomal: intravenous solution

In addition to its needed effects, some unwanted effects may be caused by daunorubicin liposomal. In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking daunorubicin liposomal, check with your doctor or nurse as soon as possible:

More common
  • Cough or hoarseness
  • fever or chills
  • lower back or side pain
  • painful or difficult urination
  • shortness of breath
  • sore throat
  • troubled breathing
  • weakness or numbness in arms or legs
Less common
  • Black, tarry stools
  • blood in urine or stools
  • bloody vomit
  • chest pain
  • coughing up blood
  • fainting
  • fast heartbeat
  • irregular heartbeat
  • pinpoint red spots on skin
  • producing large amounts of pale, dilute urine
  • sores in mouth and on lips
  • swelling of abdomen, face, fingers, hands, feet, or lower legs
  • unusual bleeding or bruising
  • unusual nighttime urination
  • unusual tiredness or weakness
  • weight gain

Some of the side effects that can occur with daunorubicin liposomal may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Abdominal pain
  • back pain
  • chest tightness
  • diarrhea
  • feeling unusually cold
  • flushing
  • headache
  • nausea and vomiting
  • shivering
  • skin rash or itching
Less common
  • Bleeding after defecation
  • bleeding gums
  • constipation
  • difficulty swallowing
  • dizziness
  • dry mouth
  • dry, irritated, itching, or red eyes
  • extreme feeling of sleepiness
  • eye pain
  • frequent urge to defecate
  • pain in joints or muscles
  • pain at site of injection
  • painful, red, hot, or irritated hair follicles
  • red, hot, or irritated skin at site of injection
  • ringing sound in ears
  • sleeplessness
  • swelling or lump under skin at site of injection
  • tooth pain
  • uncomfortable swelling around anus
  • uncontrollable movement of body
Symptoms of overdose
  • Black, tarry stools
  • blood in urine or stools
  • cough or hoarseness
  • fever or chills
  • lower back or side pain
  • painful or difficult urination
  • pinpoint red spots on skin
  • sore throat
  • sores in mouth and on lips
  • unusual bleeding or bruising

Liposomal daunorubicin causes the urine to turn reddish in color, which may stain clothes. This is not blood. It is to be expected and only lasts for 1 or 2 days after each dose is given.

This medicine often causes a temporary and total loss of hair. After treatment with liposomal daunorubicin has ended, normal hair growth should return.

For Healthcare Professionals

Applies to daunorubicin liposomal: intravenous dispersion

General

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

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.

Cardiovascular

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

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

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

Local side effects have included thrombophlebitis and necrosis following extravasation, and injection site inflammation (<=5%).

Hepatic

Hepatic serum transaminase and bilirubin concentration elevations have been transiently observed.

Renal

Renal side effects have rarely included new or worsened renal insufficiency, probably associated with hyperuricemia and/or dehydration.

Other

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

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

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

Metabolic side effects have included dehydration and thirst in 5% or fewer patients (n=116).

Respiratory

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

Ocular side effects have included abnormal vision (3% mild./moderate, 2% severe), conjunctivitis (<=5%), and eye pain (<=5%).

Genitourinary

Genitourinary side effects have included dysuria, nocturia and polyuria in 5% or fewer patients (n=116).

Endocrine

Endocrine side effects have included increased sweating (12% mild/moderate, 2% severe).

Other

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

Musculoskeletal side effects have included rigors (19% mild/moderate), back pain (16% mild/moderate), arthralgia (7% mild/moderate), and myalgia (7% mild/moderate).

Hypersensitivity

Hypersensitivity reactions have been reported (21% mild/moderate, 3% severe) (n=116).

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