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DAUNORUBICIN is a brand name for Daunorubicin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Daunorubicin is indicated for the following: - Inducing remissions of acute myelogenous and lymphocytic leukaemias. - For the treatment of acute lymphocytic leukaemia and acute myloid leukaemia in children, as part of a combination regimen.
Verbatim from this product's MHRA label. Tap a section to expand.
Adults: 40 - 60 mg/m² on alternate days for a course of up to three injections for the induction of remissions.
Acute myelogenous leukaemia:
The recommended dose is 45 mg/m² Acute lymphocytic leukaemia: The recommended dose is 45 mg/m² Paediatric population: Daunorubicin dosage for children (over 2 years) is usually calculated based on the body surface area and adjusted to meet the individual requirements of each patient, on the basis of clinical response and the patients’ haematological status.
Courses may be repeated after 3 to 6 weeks. Current specialised protocols and guidelines should be consulted for appropriate treatment regimen. For children over 2 years the maximal cumulative dose is 300 mg/m2. 5m2 body surface area), the maximum cumulative dose is 10mg/kg.
Elderly:
Daunorubicin should be used with care in patients with inadequate bone marrow reserves due to old age. A reduction of up to 50% in dosage is recommended. The number of injections required varies widely from patient to patient and must be determined in each case according to response and tolerance.
Daunorubicin should be administered with caution when the neutrophil count is <1,500/mm3. Daunorubicin dose reduction should be considered in case of severe neutropenia. The dosage should be reduced in patients with impaired hepatic or renal function.
A 25% reduction is recommended in patients with serum bilirubin concentrations of 20 - 50 μmol/l or creatinine of 105 - 265 μmol/l. A 50% reduction is recommended in cases with serum bilirubin concentrations of above 50 μmol/l or creatinine of above 265 μmol/l.
Daunorubicin is extremely irritating to tissues and may only be administered intravenously after dilution. Daunorubicin should be administered through a large vein and the infusion should be kept free flowing. When second or subsequent injections are given, the doses and time intervals depend on the effect of the previous doses and must be the subject of careful deliberation, examination of the peripheral blood and, under some circumstances, of the bone marrow.
The effect of Daunorubicin on the disease process and on normal blood precursors cannot be exactly predicted for any particular case. The difference between incomplete treatment, a satisfactory remission and overdosage with possible irreversible aplasia of the bone marrow depends on the correct choice of dosage, time intervals and total number of doses.
Blood and the lymphatic system disorders Bone marrow failure, leucopenia, anaemia, granulocytopenia (neutropenia), thrombocytopenia Frequency not known: febrile neutropenia, including with fatal outcomes, has been reported. Infections and infestations *Serious infections (including sepsis, septic shock and pneumonia) Immune system disorders Anaphylaxis and anaphylactoid reactions Metabolism and nutrition disorders Dehydration, tumor lysis syndrome, acute hyperuricaemia Nervous system disorders Frequency not known: Posterior Reversible Encephalopathy Syndrome (PRES, also known as Reversible Posterior Leukoencephalopathy Syndrome, RPLS), including with fatal outcomes, has been reported.
Neoplasms benign, malignant and unspecified (including cysts and polyps) Secondary malignancies, including leukemia have been reported in association with daunorubicin when used in combination with other antineoplastic treatments known to be associated with secondary malignancies Cardiac disorders Cardiomyopathy (clinically manifested by dyspnea, cyanosis, dependent oedema [peripheral, cardiac], hepatomegaly, ascites, pleural effusion and overt congestive heart failure), endomyocardial fibrosis, myocardial ischemia (angina) and myocardial infarction, pericarditis/myocarditis, supraventricular tachyarrhythmias (such as sinus tachycardia, premature ventricular contractions, heart block) Vascular disorders Shock, haemorrhage, flushes Respiratory, thoracic and mediastinal disorders Tissue hypoxia Gastrointestinal disorders Mucositis/stomatitis (pain, or burning sensation, erythema, erosions-ulcerations, bleeding, infections), esophagitis, diarrhoea, nausea, vomiting, abdominal pain, colitis including neutropenic enterocolitis (typhlitis), enterocolitis Skin and subcutaneous tissue disorders Alopecia (reversible), contact dermatitis, erythema, hypersensitivity to irradiated skin (‘radiation recall reaction’), pruritus, skin rash, skin and nail hyperpigmentation, urticaria Renal and urinary disorders Nephrotic syndrome, uric acid nephropathy, red color of urine for 1 to 2 days after administration Reproductive system and breast disorders Amenorrhea, azoospermia Congenital, familial and genetic disorders Aplasia General disorders and administration site conditions Death, fulminant hyperpyrexia, perivenous extravasation (immediate local pain/burning sensation, severe cellulitis, painful ulceration and tissue necrosis), venous sclerosis/phlebosclerosis, thrombophlebitis, local phlebitis, pain, fever, chills Investigations ECG abnormalities (such as non-specific ST- T wave changes, low voltage QRS complex, T waves), transient elevations in serum bilirubin, aspartate aminotransferase (AST) and alkaline phosphatase concentrations *which sometimes can be fatal Bone marrow depression In every patient bone marrow function will be depressed by treatment with daunorubicin and in a variable proportion of cases, severe aplasia will develop.
Special warnings When handling daunorubicin hydrochloride all contact with the skin and mucous membranes must be avoided. Increased safety precautions for doctors and nursing staff should be observed because of the potentially mutagenic and carcinogenic action of daunorubicin hydrochloride.
Special caution is also advisable for the contact with patients’ excrement and vomit as they may contain daunorubicin or an active metabolite. Pregnant personnel must not be allowed to come into contact with cytostatics. Precautions for use Daunorubicin should be used under the direction of a clinician conversant with the management of acute leukaemia and cytotoxic chemotherapy.
The haematological status of patients should be monitored regularly. Relative contraindications are high-grade pancytopenia or isolated leuko-/thrombo-cytopenia. Further relative contraindications are severe cardiac arrhythmias in particular ventricular tachycardias or arrhythmias with clinically relevant hemodynamic effects and clinically manifest heart failure – even in the history, myocardial infarction, severe disorders of the kidneys and liver, pregnancy and a poor general condition of the patient.
The treating physician should weigh the benefits and risks and decide, in each individual case, on the treatment. Uncontrolled infections, especially viral diseases (Herpes zoster) can develop into life- threatening exacerbations after daunorubicin hydrochloride administration because of its immunosuppressive effect.
Special caution should be exercised in patients with preceding, concurrent or planned radiotherapy. These patients have an increased risk of local reactions in the radiation area (recall phenomena) during treatment with daunorubicin hydrochloride.
A preceding radiation of the mediastinum increases the cardiotoxicity of daunorubicin hydrochloride. Patients should recover from acute toxicities of prior cytotoxic treatment (such as stomatitis, neutropenia, thrombocytopenia, and generalized infections) before beginning treatment with daunorubicin.
1. Daunorubicin should not be used in patients: • recently exposed to, or with existing, chicken pox or herpes zoster. • with persistent myelosuppression • with severe infection • with severe hepatic or renal function impairment • with myocardial insufficiency • having had recent myocardial infarction • with severe arrhythmias Do not administer by the intramuscular route.
Daunorubicin hydrochloride must not be used if the cumulative highest dose of daunorubicin hydrochloride (500-600 mg/m2 in adults, 300 mg/m2 in children of 2 years and older, 10mg/kg body weight in children under 2 years) or another cardiotoxic anthracycline has already been previously administered, as otherwise the danger of life-threatening cardiac damage markedly increases.
Women must not breastfeed during treatment.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The consequence may include severe infection and opportunistic infection. Leucopenia is usually more significant than thrombocytopenia. The nadir for leucopenia usually occurs between 10 - 14 days and recovery occurs gradually over the next 1 - 2 weeks.
Bone marrow depression must be anticipated in every case by eliminating infection before treatment, by isolating the patient from infection during treatment and by means of supportive therapy. This includes the continuous administration of anti-infective agents, the administration of platelet-rich plasma or fresh whole blood transfusion and, under some circumstances, the transfusion of white cell concentrates.
Rapid destruction of a large number of leukaemia cells may cause a rise in blood uric acid or urea and so it is a wise precaution to check these concentrations three or four times a week during the first week of treatment. Fluids should be administered and allopurinol used in severe cases to prevent the development of hyperuricaemia.
Patients with heart disease should not be treated with this potentially cardiotoxic drug. Cardiotoxicity, if it occurs, is likely to be heralded by either a persistent tachycardia, shortness of breath, swelling of feet and lower limbs or by minor changes in the electrocardiogram and for this reason an electrocardiographic examination should be made at regular intervals during the treatment.
Cardiotoxicity usually appears within 1 to 6 months after initiation of therapy. It may develop suddenly and not be detected by routine ECG. It may be irreversible and fatal but responds to treatment if detected early. The risk of congestive heart failure increases significantly when the total cumulative dosage exceeds 600mg/m² in adults, 300mg/m² in children over 2 years or 10mg/kg in children under 2 years.
Cardiotoxicity may be more frequent in children and the elderly. The dosage should be modified if previous or concomitant cardiotoxic drug therapy is used. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Haematopoietic system After administration of a therapeutic dose, myelosuppression will occur in all patients. Reversible bone marrow suppression develops dose-dependently and consists primarily of leukopenia, granulocytopenia (neutropenia) and thrombocytopenia.
Anaemia occurs more rarely. The nadir is achieved 8 to 10 days after starting therapy. Recovery generally occurs 2 to 3 weeks after the last injection. To avoid myelotoxic complications, careful monitoring of the blood count before and during treatment with special attention to the leukocytes, granulocytes, platelets and erythrocytes is necessary.
Fever, infections, sepsis, septic shock, hemorrhages and tissue hypoxia may occur as sequelae of the myelosuppression and these may even lead to death. It must be guaranteed that a severe infection and/or bleeding episode can be treated quickly and effectively.
Myelosuppression may require intensive supportive treatment. Secondary Leukaemia Secondary leukaemia, with or without a pre-leukaemic phase, has been reported in patients treated with anthracyclines, including daunorubicin. Secondary leukaemia is more common when such drugs are given in combination with DNA-damaging antineoplastic agents, in combination with radiotherapy, when patients have been heavily pre-treated with cytotoxic drugs, or when doses of the anthracyclines have been escalated.
These leukaemias can have a 1- to 3-year latency period. Cardiotoxicity Damage to the myocardium is one of the major risks of treatment with daunorubicin hydrochloride. Toxic myocardial damage by daunorubicin hydrochloride can occur in two forms.
The dose-independent “acute type” is manifested by supraventricular arrhythmias (sinus tachycardia, premature ventricular contractions, AV-block) and/or non-specific ECG abnormalities (ST-T wave changes, low voltage QRS complex, T waves).
Angina pectoris, myocardial infarction, endomyocardial fibrosis, pericarditis/myocarditis have also been reported. In the “delayed type”, congestive cardiomyopathy may develop, especially after high cumulative doses of daunorubicin hydrochloride.
Sometimes this occurs during therapy, but frequently also only months to years after completing treatment and is clinically manifested by global heart failure, which occasionally leads to death through acute heart failure. The severity and frequency of these side effects depend on the cumulative daunorubicin hydrochloride dose.
Careful monitoring of the cardiac function before, during and after treatment is therefore recommended in order to identify the risk of cardiac complications as early as possible. For routine monitoring the most suitable means are ECG and the determination of the left ventricular ejection fraction (UCG, MUGA scan).
The threshold dose for adults is about 550 mg/m², for children over two years of age about 300 mg/m² and for children under 2 years about 10 mg/kg body weight. , trastuzumab). Anthracyclines including daunorubicin should not be administered in combination with other cardiotoxic agents unless the patient’s cardiac function is closely monitored.
Patients receiving anthracyclines after stopping treatment with other cardiotoxic agents, especially those with long half-lives such as trastuzumab, may also be at an increased risk of developing cardiotoxicity. Under these conditions, a total cumulative dose of 400 mg/m2 in adults should be exceeded only with extreme caution.
Elderly patients, patients with a history of cardiac disease or manifest arterial hypertension and thoracic irradiation are endangered to a greater degree, as are also children. Under these […]