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ZAVEDOS is a brand name for Idarubicin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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). Paediatric population For first line treatment of acute myeloid-leukaemia…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Dosage is calculated on the basis of body surface area. v. daily for 3 days in combination with cytarabine. v. daily for 5 days with/without combination. v. daily for 3 days in combination with cytarabine. v. daily for 3 days. v. daily for 3 days, as a single agent.
NOTE:
These are general guidelines. Refer to individual protocols for exact dosage. All of these dosage schedules should, however, take into account the haematological status of the patient and the dosages of other cytotoxic drugs when used in combination.
Administration of a second course should be delayed in patients who develop severe mucositis until recovery from this toxicity has occurred and a dose reduction of 25% is recommended. Method of administration For intravenous use only.
Not for intrathecal use.
g. nonspecific ST segment changes), myocardial infarction Very rare Pericarditis, myocarditis, atrioventricular and bundle branch block Vascular disorders Common Local phlebitis, thrombophlebitis, haemorrhages 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 the 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 (this event can be severe), tissue necrosis Very rare Acral erythema Not known Local reaction Renal and urinary disorders Very common Red coloration of the urine for 1-2 days after the treatment General disorders and administration site conditions Very common Fever, headache, 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 vomiting and diarrhoea; risk of perforation of colon etc. 2; 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.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.
General Idarubicin should be administered only under the supervision of physicians experienced in the use of cytotoxic chemotherapy. g. haemorrhage, overwhelming infections) may be carried out. Patients should recover from acute toxicities of prior cytotoxic treatment (such as stomatitis, neutropenia, thrombocytopenia, and generalized infections) before beginning treatment with idarubicin hydrochloride.
Haematological toxicity Idarubicin is a potent bone marrow suppressant. Severe myelosuppression will occur in all patients given a therapeutic dose of this agent. Haematological profiles should be assessed before and during each cycle of therapy with idarubicin, including 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 the 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, infections, sepsis/septicaemia, septic shock, haemorrhage, tissue hypoxia or death. v. antibiotic is recommended. Secondary leukaemia Secondary leukaemia, with or without a preleukaemic phase, has been reported in patients treated with anthracyclines, including idarubicin.
Secondary leukaemia is more common when such drugs are given in combination with DNA-damaging antineoplastic agents, when patients have been heavily pre-treated with cytotoxic drugs, or when doses of the anthracyclines have been escalated.
6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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These leukaemias can have a 1 to 3 year latency period. e. e. delayed) events. e. acute) events Early cardiotoxicity of idarubicin consists mainly of sinus tachycardia and/or electrocardiogram (ECG) abnormalities, such as non-specific ST-T wave changes.
Tachyarrhythmias, including premature ventricular contractions and ventricular tachycardia, bradycardia, as well as atrioventricular and bundle-branch block have also been reported. These effects do not usually predict subsequent development of delayed cardiotoxicity, are rarely of clinical importance, and are generally not a reason for the discontinuation of idarubicin treatment.
e. 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 CHF is the most severe form of anthracycline-induced cardiomyopathy and represents the cumulative dose-limiting toxicity of the drug. v. or oral idarubicin hydrochloride have not been defined.
v. doses of 150 to 290 mg/m2. Available data on patients treated with oral idarubicin hydrochloride total cumulative doses 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 minimize 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 with 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 anthracycline doses.
The technique used for assessment should be consistent throughout follow-up. g. 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 […]