every person [750/mm:<1,000 cells/mm 3 : 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) ALERT: U.S. 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. 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/m 2 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/m 2 and every 160 mg/m 2 thereafter or every 160 mg/m 2 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. Concurrent drug therapy issues: Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Other warnings/precautions: Experienced physician: [US Boxed Warning]: Should be administered under the supervision of an experienced cancer chemotherapy physician. 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/m 2 , and every 160 mg/m 2 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/m 2 thereafter); signs and symptoms of infection or disease progression; monitor closely for infusion reactions Pregnancy Risk Factor D Pregnancy Considerations Adverse events were observed in animal reproduction studies. May cause fetal harm if administered during pregnancy. Women of childbearing potential should avoid becoming pregnant while receiving treatment. Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience flu-like symptoms, urine discoloration, abdominal pain, lack of appetite, hair loss, headache, cough, back pain, mouth irritation, lip irritation, or rhinorrhea. Have patient report immediately to prescriber signs of heart problems (cough or shortness of breath that is new or worse, swelling of the ankles or legs, abnormal heartbeat, weight gain of more than five pounds in 24 hours, dizziness, or passing out), signs of infection, angina, passing out, burning or numbness feeling, severe nausea, vomiting, excessive weight loss, severe diarrhea, bruising, bleeding, loss of strength and energy, vision changes, depression, or injection site pain or irritation (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients. Next Interactions Print this page Add to My Med List More about daunorubicin liposomal Side Effects During Pregnancy Dosage Information Drug Interactions Support Group En Español 0 Reviews Add your own review/rating Drug class: antibiotics/antineoplastics Consumer resources Daunorubicin liposomal Daunorubicin (Liposomal) Daunorubicin citrate liposome Intravenous (Advanced Reading) Related treatment guides Kaposi's Sarcoma ] Drug Status Availability Discontinued D Pregnancy Category Positive evidence of risk N/A CSA Schedule Not a controlled drug Daunorubicin liposomal Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! 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