Daunoxome Side Effects
Please note - some side effects for Daunoxome may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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Side Effects of Daunoxome - for the consumer
DaunoXome
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using DaunoXome:
Seek medical attention right away if any of these SEVERE side effects occur when using DaunoXome:Diarrhea; hair loss; loss of appetite; mouth pain; nausea; sore throat; stomach pain; tiredness; weakness.
TopSevere allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain; black, tarry stools; blood in the stools; chest pain; chills; cough or sore throat; excessive bleeding; fever; flushing; irregular heartbeat; pain, redness, or swelling at the injection site; shortness of breath; sores on the mouth or lips; unusual bruising or bleeding.
For the professional
DaunoXome
DaunoXome contains daunorubicin, encapsulated within a liposome. Conventional daunorubicin has acute myelosuppression as its dose limiting side effect, with the greatest effect on the granulocytic series. In addition, daunorubicin causes alopecia, and nausea and vomiting in a significant number of patients treated. Extravasation of conventional daunorubicin can cause severe local tissue necrosis. Chronic therapy at total doses above 300 mg/m2 causes a cumulative-dose-related cardiomyopathy with congestive heart failure.
Administered as DaunoXome, daunorubicin has substantially altered pharmacokinetics and some differences in toxicity. The most important acute toxicity of DaunoXome remains myelosuppression, principally of the granulocytic series, with much less marked effects on the platelets and erythroid series.
In an open-label, randomized, controlled clinical trial conducted in 13 centers in the U.S.A. and Canada in advanced HIV-related Kaposi's sarcoma, two treatment regimens were compared as first line cytotoxic therapy: DaunoXome and ABV (doxorubicin (Adriamycin®), bleomycin, and vincristine). All drugs were administered intravenously every 2 weeks. The safety data presented below include all reported or observed adverse experiences, including those not considered to be drug related. Patients with advanced HIV-associated Kaposi's sarcoma are seriously ill due to their underlying infection and are receiving several concomitant medications including potentially toxic antiviral and antiretroviral agents. The contribution of the study drugs to the adverse experience profile is therefore difficult to establish.
Table III summarizes the important safety data.
| SUMMARY OF IMPORTANT SAFETY DATA | ||
|---|---|---|
| DaunoXome (N = 116) % of patients |
ABV (N = 111) % of patients |
|
| Neutropenia (< 1000 cells/mm3) | 36% | 35% |
| Neutropenia (< 500 cells/mm3) | 15% | 5% |
| Opportunistic Infections/Illnesses,% of patients | 40% | 27% |
| Median time to first Opportunistic Infections/Illnesses | 214 days | 412 days* |
| Number of cases with absolute reduction in ejection fraction of 20 – 25%† | 3 | 1 |
| Number of cases removed from therapy due to cardiac causes† | 2 | 0 |
| Alopecia All grades % of patients |
8% | 36%‡ |
| Neuropathy All grades % of patients |
13% | 41%‡ |
A triad of back pain, flushing and chest tightness was reported in 13.8% of the patients (16/116) treated with DaunoXome in the Phase III clinical trial and in 2.7% of treatment cycles (27/994). Most of the episodes were mild to moderate in severity (12% of patients and 2.5% of treatment cycles).
Mild alopecia was reported in 6% of patients treated with DaunoXome and moderate alopecia in 2% of patients. Mild nausea was reported in 35% of DaunoXome patients, moderate nausea in 16% of patients and severe nausea in 3% of patients. For patients treated with DaunoXome, mild vomiting was reported in 10%, moderate in 10%, and severe in 3% of patients. Although grade 3 – 4 injection site inflammation was reported in 2 patients treated with DaunoXome, no instances of local tissue necrosis were observed with extravasation.
Table IV is a listing of all the mild-moderate and severe adverse events reported on both treatment arms in Protocol 103-09 in ≥ 5% of DaunoXome patients.
| ADVERSE EXPERIENCES: PROTOCOL 103-09 | ||||
|---|---|---|---|---|
| DaunoXome (N = 116) |
ABV (N = 111) |
|||
| Mild Moderate |
Severe | Mild Moderate |
Severe | |
| Nausea | 51% | 3% | 45% | 5% |
| Fatigue | 43% | 6% | 44% | 7% |
| Fever | 42% | 5% | 49% | 5% |
| Diarrhea | 34% | 4% | 29% | 6% |
| Cough | 26% | 2% | 19% | 0% |
| Dyspnea | 23% | 3% | 17% | 3% |
| Headache | 22% | 3% | 23% | 2% |
| Allergic Reactions | 21% | 3% | 19% | 2% |
| Abdominal Pain | 20% | 3% | 23% | 4% |
| Anorexia | 21% | 2% | 26% | 2% |
| Vomiting | 20% | 3% | 26% | 2% |
| Rigors | 19% | 0% | 23% | 0% |
| Back Pain | 16% | 0% | 8% | 0% |
| Increased Sweating | 12% | 2% | 12% | 0% |
| Neuropathy | 12% | 1% | 38% | 3% |
| Rhinitis | 12% | 0% | 6% | 0% |
| Edema | 9% | 2% | 8% | 1% |
| Chest Pain | 9% | 1% | 7% | 0% |
| Depression | 7% | 3% | 6% | 0% |
| Malaise | 9% | 1% | 11% | 1% |
| Stomatitis | 9% | 1% | 8% | 0% |
| Alopecia | 8% | 0% | 36% | 0% |
| Dizziness | 8% | 0% | 9% | 0% |
| Sinusitis | 8% | 0% | 5% | 1% |
| Arthralgia | 7% | 0% | 6% | 0% |
| Constipation | 7% | 0% | 18% | 0% |
| Myalgia | 7% | 0% | 12% | 0% |
| Pruritus | 7% | 0% | 14% | 0% |
| Insomnia | 6% | 0% | 14% | 0% |
| Influenza-like symptoms | 5% | 0% | 5% | 0% |
| Tenesmus | 4% | 1% | 1% | 0% |
| Abnormal vision | 3% | 2% | 3% | 0% |
The following adverse events were reported in ≤ 5% of patients treated with DaunoXome, tabulated by body system.
Body As A Whole: Injection site inflammation
Cardiovascular: Hot flushes, hypertension, palpitation, syncope, tachycardia. In other follow-up clinical trials of DaunoXome (daunorubicin citrate liposome injection) use in treatment of Kaposi's sarcoma or other malignancies, the following serious cardiac events were reported: Pericardial effusion, pericardial tamponade, ventricular extrasystoles, cardiac arrest, sinus tachycardia, atrial fibrillation, pulmonary hypertension, myocardial infarction, supraventricular tachycardia, angina pectoris.
Digestive: Increased appetite, dysphagia, GI hemorrhage, gastritis, gingival bleeding, hemorrhoids, hepatomegaly, melena, dry mouth, tooth caries
Hemic and Lymphatic: Lymphadenopathy, splenomegaly
Metabolic and Nutritional: Dehydration, thirst
Nervous: Amnesia, anxiety, ataxia, confusion, convulsions, emotional lability, abnormal gait, hallucination, hyperkinesia, hypertonia, meningitis, somnolence, abnormal thinking, tremor
Respiratory: Hemoptysis, hiccups, pulmonary infiltration, increased sputum
Skin: Folliculitis, seborrhea, dry skin
Special Senses: Conjunctivitis, deafness, earache, eye pain, taste perversion, tinnitus
Urogenital: Dysuria, nocturia, polyuria
TopMore resources:
DaunoXome - Includes detailed dosage instructions.
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