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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: Whenever intravenous idarubicin hydrochloride cannot be employed e.g. for medical, psychological or social reasons, oral idarubicin can be used for remission induction in patients with previously untreated, relapsed or refractory acute non-lymphocytic leukaemia. Zavedos may be used in combination chemotherapy regimens…
Verbatim from this product's MHRA label. Tap a section to expand.
Route of Administration:
Oral Dosage is usually calculated on the basis of body surface area. In adult acute non-lymphocytic leukaemia (ANLL) also referred to as acute myelogenous leukaemia (AML), the recommended dose schedule suggested is 30mg/m2 orally given daily for 3 days as a single agent, or between 15 and 30mg/m2 orally daily for 3 days in combination with other anti-leukemic agents.
In advanced breast cancer the recommended dose schedule as single agent is 45mg/m2 orally given either on a single day or divided over 3 consecutive days, to be repeated every 3 or 4 weeks based on the haematological recovery. A maximum cumulative dose of 400mg/m2 is recommended.
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. In patients with hepatic impairment a dose reduction of Zavedos should be considered.
4). The capsules should be swallowed whole with some water and should not be sucked, bitten or chewed. Zavedos Capsules may also be taken with a light meal.
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 Renal and urinary disorders Very common Red colouration 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. Other adverse reactions: hyperuricaemia Prevention of symptoms by hydration, urine alkalinisation, and prophylaxis with allopurinol may minimise potential complications of tumour lysis syndrome.
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.
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. 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. Available data on patients treated with oral idarubicin hydrochloride total cumulative doses up to 400 mg/m2 suggest a low probability of cardiotoxicity.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 the 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 probable that the toxicity of idarubicin and other anthracyclines or anthracenediones is additive.
Haematologic Toxicity Idarubicin is a potent bone marrow suppressant. Severe myelosuppression will occur in all patients given a therapeutic dose of this agent. Haematologic 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 hematologic toxicity and is the most common acute doselimiting 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, infections, sepsis/septicaemia, septic shock, haemorrhage, tissue hypoxia, or death. If febrile neutropenia occurs, treatment with an IV antibiotic is […]