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DOXORUBICIN HYDROCHLORIDE is a brand name for Doxorubicin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Doxorubicin is a cytotoxic medicinal product that is indicated in the following neoplastic conditions: • Small-cell lung cancer (SCLC) • Breast cancer • Recurrent ovarian carcinoma • Systemic treatment of local advanced or metastasized bladder carcinoma • Intravesical prophylaxis of recurrences of superficial bladder…
Verbatim from this product's MHRA label. Tap a section to expand.
Treatment with Doxorubicin should be started by or after consultation with a doctor with extensive experience from cytostatic treatment. Due to the risk of a lethal cardiomyopathy, the risks and benefits to the individual patient should be weighted before each application.
Doxorubicin must not be used orally, subcutaneously, intramuscularly or intrathecally.
Note:
The dosages of S-liposomal doxorubicin and (conventional) doxorubicin are different. The two formulations cannot be interchanged. Posology For intravenous use The dosage of doxorubicin depends on dosage regimen, general status and previous treatment of the patient.
In order to avoid cardiomyopathy, it is recommended that the cumulative total lifetime dose of doxorubicin (including related medicinal products such as daunorubicin) should not exceed 450 - 550 mg/m² body surface area. 4). Dosage is usually calculated on the basis of body surface area.
On this basis, a dose of 60 - 75 mg/m² body surface area is recommended every three weeks when doxorubicin is used alone. If it is used in combination with other antitumour agents the dosage of doxorubicin should be reduced to 30 - 40 mg/m² every three weeks.
g. in case of immunosuppression, old age), an alternative dosage is 15 - 20 mg/m² body surface area per week. Patients with prior radiotherapy Patients who have received prior radiotherapy to the mediastinal/pericardial area should not receive doxorubicin greater than a total cumulative dose of 400 mg/m².
Elderly patients Dosage may need to be reduced in the elderly. Paediatric population In view of the substantial risk of doxorubicin induced cardiotoxicity during childhood certain maximum cumulative dosages that depend on the youth of patients should be applied.
In children (under 12 years of age) the maximal cumulative dose is usually considered 300 mg/m², whereas in adolescents (over 12 years of age) the maximal cumulative dose is set to 450 mg/m². For infants the maximal cumulative dosages are still indecisive, but even lower tolerability is assumed.
Dosage for children should be reduced, since they have an increased risk for cardiac toxicity, especially late toxicity. Myelotoxicity should be anticipated, with nadirs at 10 to 14 days after start of treatment. 3). Renal impairment In cases of renal insufficiency with a GFR less than 10 ml/min, 75 % of the calculated dose should be administered.
Treatment with doxorubicin often causes undesirable effects, and some of these effects are serious enough to entail careful monitoring of the patient. The frequency and kind of undesirable effects are influenced by the speed of administration and the dosage.
Bone-marrow suppression is an acute dose limiting adverse effect, but is mostly transient. Clinical consequences of doxorubicin bone marrow/haematological toxicity may be fever, infections, sepsis/septicaemia, haemorrhages, tissue hypoxia or death.
Nausea and vomiting as well as alopecia are seen in almost all patients. Within each system organ class, the adverse events have been ranked under the headings of frequency, most frequent reactions first. For the evaluation of adverse effects the following frequency specification will be used: Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Not known (cannot be estimated from the available data) Infections and infestations Very common: Common: Uncommon: Infection Sepsis, septicaemia Septic shock Neoplasms benign, malignant and unspecified (incl.
e. g. e. 4) Investigations Very common: Asymptomatic decrease in LVEF, abnormal ECG, abnormal transaminase levels, weight gaina Surgical and medical procedures Not known: Extravasation can lead to severe cellulitis, vesication and local tissue necrosis which may require surgical measures (including skin grafts) aIn patients with early breast cancer who received adjuvant therapy with doxorubicin (NSABP B-15 study).
The described side effects of doxorubicin therapy are mostly reversible. 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.
Like all chemotherapy, therapy with Doxorubicin hydrochloride should be carried out only under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available.
Patients should recover from the acute toxicities of prior cytotoxic treatment (such as stomatitis, neutropenia, thrombocytopenia, and generalized infections) before beginning treatment with doxorubicin. g. ECG, UCG and MUGA scan) • daily inspection of the oral cavity and pharynx for mucosal changes • blood tests: haematocrit, platelets, differential white cell count, AST, ALT, LDH, bilirubin, uric acid.
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 symptoms generally indicate acute transient toxicity. Flattening and widening of the QRS-complex beyond normal limits may indicate doxorubicin hydrochloride-induced cardiomyopathy. As a rule, in patients with a normal LVEF baseline value (= 50 %), a 10 % decrease of absolute value or dropping below the 50 % threshold indicates cardiac dysfunction and in such situation treatment with doxorubicin hydrochloride should be carefully considered.
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.
1, or to other anthracyclines or anthracenediones. g. urethral stenosis • haematuria • breast-feeding Dosage should not be repeated in the presence or development of bone marrow depression or buccal ulceration. The latter may be preceded by premonitory buccal burning sensations and repetition in the presence of this symptom is not advised.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4). R). The recommended dose for intravesical treatment of superficial cancer of the bladder is 30 - 50 mg in 25 - 50 ml of physiological saline per instillation. The optimal concentration is about 1 mg/ml. 9 % or dextrose 5 % into a large vein using a Butterfly needle, taking 2 to 3 minutes over the injection.
This technique minimises the risk of thrombosis or perivenous extravasation, which can lead to severe local cellulitis and necrosis. Intravesical administration The solution should remain in the bladder for 1 - 2 hours. During this period the patient should be turned 90° every 15 minutes.
To avoid undesired dilution with urine the patient should be informed not to drink anything for a period of 12 hours before the instillation (this should reduce the production of urine to about 50 ml/h). The instillation may be repeated with an interval of 1 week to 1 month, dependent on whether the treatment is therapeutic or prophylactic.
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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 medicinal product.
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. 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. If the patient has other potential risk factors of cardiotoxicity (history of cardiovascular disease, previous therapy with other anthracyclines or anthracenediones, prior or concomitant radiotherapy to the mediastinal/pericardial area, and concomitant use of medicinal products with the ability to suppress cardiac contractility, including cyclophosphamide and 5-fluoruracil), cardiotoxicity with doxorubicin may occur at lower cumulative doses and cardiac function should be carefully monitored.
Children and adolescents are at an increased risk for developing delayed cardiotoxicity following doxorubicin administration. There may be a greater risk for females than males for cardiotoxicity. Follow-up cardiac evaluations are recommended periodically to monitor the effect.
It is probable that the toxicity of doxorubicin and other anthracyclines or anthracenediones is additive. Pre-treatment with digoxin (250 μg daily starting 7 days before doxorubicin) showed a protective effect against cardiotoxicity.
Myelosuppression There is a high incidence of bone marrow depression, primarily of leucocytes, requiring careful haematological monitoring. With the recommended dosage schedule, leukopenia is usually transient, reaching its nadir at 10 - 14 days after treatment, with recovery usually occurring by the 21st day.
White blood cell counts as low as 1,000/mm³ are to be expected during treatment with appropriate doses of doxorubicin. Red blood cell and platelet levels should also be monitored, since they may also be depressed. Clinical consequences of severe myelosuppression include fever, infections, sepsis/septicaemia, septic shock, haemorrhage, tissue hypoxia or death.
Myelosuppression is more common in patients who have had extensive radiotherapy, bone infiltration by tumour, impaired liver function (when appropriate dosage reduction has not been adopted) and simultaneous treatment with other myelosuppressive agents.
Haematological toxicity may require dose reduction or […]