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DOXORUBICIN is a brand name for Doxorubicin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Antimitotic and cytotoxic. Doxorubicin has been used successfully to produce regression in a wide range of neoplastic conditions including acute leukaemia, lymphomas, soft-tissue and osteogenic sarcomas, paediatric malignancies and adult solid tumours; in particular breast and lung carcinomas. Doxorubicin is…
Verbatim from this product's MHRA label. Tap a section to expand.
g. given as a single agent or in combination with other cytotoxic drugs) and according to the indication. The solution is given via the tubing of a freely running intravenous infusion, taking not less than 3 minutes and not more than 10 minutes over the injection.
This technique minimises the risk of thrombosis or perivenous extravasation which can lead to severe cellulitis, vesication and necrosis. 4). Dosage is usually calculated on the basis of body surface area. As a single agent, the recommended standard starting dose of doxorubicin per cycle in adults is 60-75mg/m2 of body surface area.
The total starting dose per cycle may be given as a single dose or divided over 3 successive days or in divided doses given on days 1 and 8. Under conditions of normal recovery from drug- induced toxicity (particularly bone marrow depression and stomatitis), each treatment cycle can be repeated every 3 to 4 weeks.
If it is used in combination with other antitumour agents having overlapping toxicity, the dosage of doxorubicin may need to be reduced to 30-60mg/m2 every three weeks. If dosage is calculated on the basis of body weight, it has been shown that giving doxorubicin as a single dose every three weeks greatly reduces the distressing toxic effect, mucositis.
8mg/kg or 20- 25mg/m2 on each day) gives greater effectiveness though at the cost of higher toxicity. 4 mg/kg should be given as a single dose every three weeks. Administration of doxorubicin in a weekly regimen has been shown to be as effective as the 3-weekly regimen.
The recommended dosage is 20mg/m2 weekly, although, objective responses have been seen at 16mg/m2. Weekly administration leads to a reduction in cardiotoxicity. Dosage may also need to be reduced in children, obese patients and the elderly.
4). 3).
Adverse reactions reported in association with doxorubicin therapy are listed below by MedDRA System Organ Class and by frequency. 01%), and Not known (cannot be estimated from available data). Adverse Reactions Table Infections and Infestations Very common Infection Common Sepsis Neoplasms Benign, Malignant and Unspecified (including cysts and polyps) Not known Acute lymphocytic leukaemia, Acute myeloid leukaemia Blood and Lymphatic System Disorders Very common Leukopenia, Neutropenia, Anaemia, Thrombocytopenia Immune System Disorders Not known Anaphylactic reaction Metabolism and Nutrition Disorders Very common Decreased appetite Not known Dehydration, Hyperuricaemia Eye Disorders Common Conjunctivitis Not known Keratitis, Lacrimation increased Cardiac Disorders Common Cardiac failure congestive, Sinus tachycardia Not known Atrioventricular block, Tachyarrhythmia, Bundle branch block Vascular Disorders Uncommon Embolism Not known Shock, Haemorrhage, Thrombophlebitis, Phlebitis, Hot flush Gastrointestinal Disorders Very common Mucosal inflammation/Stomatitis, Diarrhoea, Vomiting, Nausea Common Oesophagitis, Abdominal pain Not known Gastrointestinal haemorrhage, Gastritis erosive, Colitis, Mucosal discolouration Skin and Subcutaneous Tissue Disorders Very common Palmar-plantar erythrodysaesthesia syndrome, Alopecia Common Urticaria, Rash, Skin hyperpigmentation, Nail hyperpigmentation Not known Photosensitivity reaction, Recall phenomenon, Pruritus, Skin disorder Renal and Urinary Disorders Not known Chromaturiaa Reproductive System and Breast Disorders Not known Amenorrhoea, Azoospermia, Oligospermia General Disorders and Administration Site Conditions Very common Pyrexia, Asthenia, Chills Common Infusion site reaction Not known Malaise Investigations Very common Ejection fraction decreased, Electrocardiogram abnormal, Transaminases abnormal, Weight increasedb aFor one to two days after administration bReported in patients with early breast cancer receiving doxorubicin-containing adjuvant therapy (NSABP B-15 trial) Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Doxorubicin should be administered only under the supervision of physicians experienced in the use of cytotoxic therapy. Patients should recover from the acute toxicities of prior cytotoxic treatment (such as stomatitis, neutropenia, thrombocytopenia, and generalized infections) before beginning treatment with doxorubicin.
e. 2). e. e. delayed) events. e.
Acute) Events:
Early cardiotoxicity of doxorubicin consists mainly of sinus tachycardia and/or 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, and are generally not a consideration for discontinuation of doxorubicin treatment. e.
Delayed) Events:
Delayed cardiotoxicity usually develops late in the course of therapy with doxorubicin 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 and 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. Cardiac function should be assessed before patients undergo treatment with doxorubicin and must be monitored throughout therapy to minimize the risk of incurring severe cardiac impairment.
1, other anthracyclines or anthracenediones. 4).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Doxorubicin in United Kingdom.
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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.
The risk may be decreased through regular monitoring of LVEF during the course of treatment with prompt discontinuation of doxorubicin at the first sign of impaired function. The appropriate quantitative method for repeated assessment of cardiac function (evaluation of LVEF) includes multi-gated radionuclide angiography (MUGA) 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. The probability of developing CHF, estimated around 1% to 2% at a cumulative dose of 300 mg/m2 slowly increases up to the total cumulative dose of 450-550 mg/m2.
Thereafter, the risk of developing CHF increases steeply and it is recommended not to exceed a maximum cumulative dose of 550 mg/m2. g. trastuzumab) and age over 70 years. 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. Trastuzumab 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 must be carefully monitored in patients receiving high cumulative doses and in those with risk factors. However, cardiotoxicity with doxorubicin may occur at lower cumulative doses whether or not cardiac risk factors are present.
Children and adolescents are at an increased risk for developing delayed cardiotoxicity following doxorubicin administration. Females may be at greater risk than males. Follow-up cardiac evaluations are recommended periodically to monitor for this effect.
It is probable that the toxicity of doxorubicin and other anthracyclines or anthracenediones is additive. Haematologic Toxicity Doxorubicin may produce myelosuppression. Haematologic profiles should be assessed before and during each cycle of therapy with doxorubicin, including differential white blood cell (WBC) counts.
A dose-dependent, reversible leucopenia and/or granulocytopenia (neutropenia) is the predominant manifestation of doxorubicin haematologic toxicity and is the most common acute dose-limiting toxicity of this drug. Leucopenia and neutropenia generally reach the nadir between days 10 and 14 after drug administration; the WBC/neutrophil counts return to normal values in most cases by day 21.
Thrombocytopenia and anaemia may also occur. Clinical consequences of severe myelosuppression include fever, infections, sepsis/septicaemia, septic shock, haemorrhage, tissue hypoxia or death. Secondary Leukaemia Secondary leukaemia, with or without a preleukaemic phase, has been reported in patients treated with anthracyclines.
Secondary leukaemia is more common when such drugs are given in combination with DNA-damaging antineoplastic agents, when patients have been heavily pretreated with cytotoxic drugs or when doses of the anthracyclines have been escalated.
These leukaemias can have a 1 to 3 year latency period. Carcinogenesis, Mutagenesis and Impairment of Fertility Doxorubicin was genotoxic and mutagenic in vitro and in vivo tests. In women, doxorubicin may cause […]