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IDARUBICIN is a brand name for Idarubicin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Cytotoxic and antimitotic agent. Adults - For the treatment of acute myeloid leukaemia (AML), for remission induction in untreated patients or for remission induction in relapsed or refractory patients. - For second line treatment of relapsed acute lymphoblastic leukaemia (ALL). Children - For first line treatment of…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Dosage is usually calculated on the basis of body surface area (mg/m2). For intravenous use.
Acute non-lymphocytic leukaemia (AML) Adults:
In acute non-lymphocytic leukaemia the recommended dose is 12 mg/m2 IV daily for 3 days in combination with cytarabine. Other dose schedule which could be used in acute non-lymphocytic leukaemia, as a single agent or in combination, is 8 mg/m2 IV daily for 5 days.
v. daily for 3 days in combination with cytarabine. v. daily for 3 days. v. daily for 3 days Note: These are only general guidelines. Refer to individual protocols for exact dosage. All of the dosage schedules should take into account the haematological status of the patient, and the dosages of other cytotoxic drugs when used in combination.
Method of administration Intravenous administration of idarubicin should be performed carefully. 9% sodium chloride injection taking 5 to 10 minutes over the injection. This technique minimises the risk of thrombosis or perivenous extravasation which can lead to severe cellulitis, vesication and tissue necrosis.
Direct injection is not recommended, due to the risk of extravasation, which may occur even with the adequate blood return by aspiration through the needle.
List of adverse reactions The frequencies of adverse events are ranked according to the following convention: Very common (≥ 1/10); common (≥ 1/100to <1/10); uncommon (≥ 1/1,000to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
, non-specific ST segment changes), myocardial infarction Very rare: Pericarditis, myocarditis, atrioventricular and bundle branch block Vascular disorders Common: Haemorrhages, local phlebitis, thrombophlebitis Uncommon: Shock Very rare: Thromboembolism, flush Gastrointestinal disorders Very common: Nausea, vomiting, mucositis/stomatitis, diarrhoea, abdominal pain or burning sensation Common: Gastrointestinal tract bleeding, bellyache Uncommon: Oesophagitis, colitis (including severe enterocolitis/neutropenic enterocolitis with perforation) Very rare: Gastric erosions or ulcerations Hepatobiliary disorders Common: Elevation of liver enzymes and bilirubin Skin and subcutaneous tissue disorders Very common: Alopecia Common: Rash, itch, hypersensitivity of irradiated skin (‘radiation recall reaction’) Uncommon: Skin and nail hyperpigmentation, urticaria, cellulitis (possibly severe), tissue necrosis Very rare: Acral erythema Not known: Local reaction Renal and urinary disorders Very common: Red colour to the urine for 1-2 days after treatment General disorders and administration site conditions Very common: Fever, headaches, chills Description of selected adverse reactions Haematopoietic system Pronounced myelosuppression is the most severe adverse effect of idarubicin treatment.
4). 4). Gastrointestinal Stomatitis and, in severe cases ulceration of mucosa, dehydration caused by severe diarrhoea and vomiting, risk of perforation of colon, etc. 2 of SPC; unintended paravenous infiltrates may cause pain, severe cellulites and tissue necrosis.
Other adverse reactions: hyperuricaemia Prevention of symptoms by hydration, urine alkalinisation, and prophylaxis with allopurinol may minimise potential complications of tumour lysis syndrome. 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
General Idarubicin should be administered only under the supervision of physicians experienced in the use of cytotoxic chemotherapy. Therapy with Idarubicin requires close observation of patient and laboratory monitoring. g. hemorrhage, overhelming infections) may be carried out.
Patients should recover from acute toxicities due to prior cytotoxic treatment (such as stomatitis, neutropenia, thrombocytopenia, and generalized infections) before beginning treatment with idarubicin. e. e. delayed) events.
Early (acute) events:
Early cardiotoxicity of idarubicin consists mainly of sinus tachycardia and/or electrocardiogram (ECG) abnormalities, such as non-specific ST-T wave changes. Tachyarrhythmia, including premature ventricular contractions and ventricular tachycardia, bradycardia as well as atrioventricular and bundle branch block have also been reported.
These effects are not usually predictors of subsequent development of delayed cardiotoxicity, are rarely of clinical importance and are generally not a reason for discontinuation of Idarubicin treatment.
Late (delayed) events:
Delayed cardiotoxicity usually develops late in the course of therapy or within 2 to 3 months after treatment termination, but later events, several months to years after completion of treatment, have also been reported. Delayed cardiomyopathy is manifested by reduced left ventricular ejection fraction (LVEF) and/or signs and symptoms of congestive heart failure (CHF), such as dyspnoea, pulmonary oedema, dependent oedema, cardiomegaly, hepatomegaly, oliguria, ascites, pleural effusion and gallop rhythm.
Subacute effects such as pericarditis/myocarditis have also been reported. Life-threatening congestive heart failure is the most severe form of anthracycline-induced cardiomyopathy and represents the cumulative dose-limiting toxicity of the drug.
6)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The cumulative dose limits for IV or oral idarubicin hydrochloride have not been defined. However, idarubicin-related cardiomyopathy was reported in 5% of patients who received cumulative IV doses of 150 to 290 mg/m2. The available data on patients treated with oral idarubicin hydrochloride total cumulative doses of up to 400 mg/m2 suggest a low probability of cardiotoxicity.
Cardiac function should be assessed before patients undergo treatment with idarubicin and must be monitored throughout therapy to minimise the risk of incurring severe cardiac impairment. The risk may be decreased through regular monitoring of LVEF during the course of treatment, with prompt discontinuation of idarubicin at the first sign of impaired function.
The appropriate quantitative method for repeated assessment of cardiac function (evaluation of LVEF) includes Multiple Gated Acquisition (MUGA) scan or echocardiography (ECHO). A baseline cardiac evaluation consisting of an ECG and either a MUGA scan, or an ECHO, is recommended, especially in patients with risk factors for increased cardiotoxicity.
Repeated MUGA or ECHO determinations of LVEF should be performed, particularly with higher cumulative doses of anthracyclines. The technique used for assessment should be consistent throughout follow-up. Risk factors for cardiac toxicity include active or dormant cardiovascular disease, prior or concomitant radiotherapy to the mediastinal/pericardial area, previous therapy with other anthracyclines or anthracenedione agents, and concomitant use of drugs capable of suppressing cardiac contractility or cardiotoxic drugs (for example trastuzumab).
5). 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. The reported half-life of trastuzumab is variable.
The substance may persist in circulation for up to 7 months. Therefore, physicians should avoid anthracycline-based therapy for up to 7 months after stopping trastuzumab when possible. If this is not possible the patient’s cardiac function should be monitored carefully.
Cardiac function monitoring must be particularly strict in patients receiving high cumulative doses and in those with risk factors, however, cardiotoxicity with idarubicin may occur at lower cumulative doses whether or not cardiac risk factors are present.
In infants and children there appears to be a greater susceptibility to anthracycline induced cardiac toxicity and a long-term periodic evaluation of cardiac function has to be performed. It is possible that the toxicity of idarubicin and other anthracyclines or anthracenediones is additive.
Haematological toxicity Idarubicin is a potent bone marrow suppressant. Severe myelosuppression will occur in all patients given a therapeutic dose of this drug. Haematological profiles should be assessed before and during each cycle of therapy with idarubicin, including a differential white blood cell (WBC) counts.
A dose-dependent reversible leukopenia and/or granulocytopenia (neutropenia) is the predominant manifestation of idarubicin haematologic toxicity and is the most common acute dose-limiting toxicity of this drug. Leukopenia and neutropenia are usually severe; thrombocytopenia and anaemia may also occur.
Neutrophil and platelet counts usually reach their nadir 10 to 14 days after drug administration; however, cell counts generally return to normal levels during the third week. During the phase of severe myelosuppression, deaths due to infections and/or haemorrhages have been reported.
Clinical consequences of severe myelosuppression include fever, […]