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BLEOMYCIN VENUS PHARMA is a brand name for Bleomycin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Bleomycin can be used in the treatment of: • Squamous cell carcinoma (SCC) of the head and neck, cervix and external genitalia • Hodgkin's lymphoma • Non-Hodgkin’s lymphoma of intermediate and high malignancy in adults • Testicular carcinoma (seminoma and non-seminoma) • Intrapleural therapy of malignant pleural…
Verbatim from this product's MHRA label. Tap a section to expand.
Warning:
Posology for all therapeutic indications is provided in IU and not in mg. Some hospital protocols may state use “mg” instead of Units (U or IU). This mg value refers to mg-activity and not to mg-dry material as these reflect different values.
Our recommendation is to ignore this posology in mg and actually use the posology in International Units (IU) as described in this SmPC for the relevant therapeutic indications. Please note that 1 mg dry substance is equivalent to at least 1500 IU.
Yet we strongly recommend not to use this conversion as this may result in overdosage because of the differences between mg-activity and mg-dry material. This product should therefore only be prescribed in international units (IU). Bleomycin should only be used under the strictest supervision of a physician specialised in the use of oncolytic medicinal products, preferably in a hospital with experience in such therapies Bleomycin may be administered intravenously, intramuscularly, intra-arterially, subcutaneously or by intrapleural instillation.
Local injection directly into the tumour may occasionally be indicated. Posology Adults 1) Squamous cell carcinoma Intramuscular or intravenous injection of 10-15 x 103 IU/m2 body surface area (BSA), once or twice a week, at intervals of 3-4 weeks up to a lifetime cumulative dose of 360 x 103 IU.
Intravenous infusion of 10-15 x 103 IU/m2/day for 6-24 hours on 4 to 7 consecutive days, at intervals of 3-4 weeks. 2) Hodgkin's disease and non-Hodgkin's lymphoma When used alone, intramuscular or intravenous injection of 5-15 x103 IU/m2 BSA, once or twice a week, up to a cumulative total dose of 225 x103 IU.
Because of the possibility of anaphylactoid reactions, lymphoma patients should be treated with lower doses (for instance 2 x103 IU) for the first two applications. If there are no acute reactions after 4 hours of observation, the normal dose schedule can be followed.
3) Testicular tumours Intramuscular or intravenous injection of 10-15 x103 IU/m2 BSA once or twice a week, at intervals of 3-4 weeks up to a total cumulative dose of 400 x 103 IU. The intravenous infusion of the dose of 10-15 x 103 IU/m2 BSA/day is performed for 6-24 hours on 5-6 consecutive days, at intervals of 3-4 weeks.
a. Summary of the safety profile Like most cytotoxic agents, bleomycin can cause immediate and delayed toxic effects. Fever on the day of injection is the earliest reaction. 2%). Pain at the injection site and in the tumour area has also been observed on occasion.
Other sporadic side effects include hypotension and local thrombophlebitis following intravenous injection. There have also been reports of Raynaud's phenomena, both when using bleomycin as monotherapy and in combination therapy b.
Tabulated list of adverse reactions:
The following undesirable effects can occur during treatment with bleomycin: Frequencies are defined as follows: 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).
v. m. or local administration) c. Description of selected adverse reactions Fever and chills may develop with a lag time of 45 hours or more after the administration of this drug. Because a dose response relation exists between the fever and dose at a given time, if the fever is severe, appropriate measures should be taken such as administering a reduced dose at shorter intervals, or antihistaminic and antipyretic agents before and/or after administration of this drug.
If cutaneous side effects occur in AIDS patients, the treatment should be discontinued and not resumed. Skin and mucosal lesions are the most common undesirable effects and are observed in up to 50% of the patients treated. They comprise induration, oedema, erythema, pruritus, rashes, striae, ulceration, blistering, hyperpigmentation, tenderness, swelling of the fingertips, hyperkeratosis, nail changes, bulla formation at pressure points such as the elbows, hair loss and stomatitis.
Patients receiving Bleomycin chemotherapy must be carefully monitored by experienced oncologists. A highly rigorous risk/benefit assessment should be performed following lung or mediastinal radiotherapy. Bleomycin should only be used with caution and at a reduced dose in the event of impaired renal function.
Because of the possible mutagenic effects of bleomycin on male and female germ cells, reliable contraception must be ensured during therapy and for up to 6 months after the end thereof. Pulmonary reactions Patients should be carefully monitored for any signs of pulmonary dysfunction during treatment with bleomycin Pulmonary reactions are the most serious side effects, occurring in roughly 10% of patients treated, during or after the end of a course of treatment.
The most common form is interstitial pneumonitis. If this condition is not recognised and treated promptly, it can develop into pulmonary fibrosis. Approximately 1% of patients treated have died from the consequences of pulmonary fibrosis.
Patients undergoing treatment with bleomycin should have chest X-rays weekly. These should continue to be taken for up to 4 weeks after completion of the course and patients should be kept under clinical review for approximately 2 months.
With concomitant radiation therapy of the thorax, a study or an X-ray of the thorax should possibly be done more frequently. Lung function tests with 100% oxygen should not be used in patients who have been treated with bleomycin. Lung function tests using less than 21% oxygen are recommended as an alternative.
Monthly analysis of pulmonary diffusion capacity for carbon monoxide could be planned. A study of lung function, in particular the measuring of the carbon monoxide diffusion and vital capacity, often makes an early diagnosis of lung toxicity possible.
Pulmonary toxicity is both dose-related and age-related, occurring more frequently in those over the age of 70 and in patients who have received a total dose of more than 400 units. It is significantly increased by thoracic irradiation and by hyperoxia during surgical anaesthesia.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4) Malignant pleural effusions 60 x 103 IU in 100 mL physiological saline solution intrapleurally, as a single dose, which can be repeated after 2-4 weeks, depending on the response. Since approximately 45% of bleomycin is absorbed, this should be taken into account for the lifetime cumulative dose (body surface area, kidney function and lung function).
The development of stomatitis is the most useful guide to the determination of individual tolerance with respect to the maximum dose. A total cumulative dose of 400 x103 IU (corresponding to 225 x 103IU/m2 BSA) should not be exceeded in patients under 60, because of the increased risk of pulmonary toxicity in all indications.
In lymphoma patients, the total dose should not be more than 225 x103 IU. In cases of Hodgkin's disease and testicular tumours, improvement occurs rapidly and can be observed within two weeks. If no improvement is observed by then, an improvement is unlikely.
Squamous cell carcinomas respond more slowly. In some cases it can take up to three weeks before an improvement is observed. Elderly population (from the age of 60) The total dose of bleomycin in elderly patients should be reduced according to the following table: Age in years Total dose Dose per week 80 and over 100 x 103 IU 15 x 103 IU 70-79 150-200 x 103 IU 30 x 103 IU 60-69 200-300 x 103 IU 30-60 x 103 IU Under 60 400 x 103 IU 30-60 x 103IU Paediatric population There is insufficient experience with regard to the administration of bleomycin in paediatric patients.
Until more information is available, bleomycin should only be administered in children in exceptional circumstances and at special facilities. If administration is indicated as part of a combination regimen the dosage is usually calculated based on the body surface area and adjusted to meet the individual requirements of each patient.
Current specialised protocols and guidelines should be consulted for the appropriate treatment regimen. Renal impairment In case of renal failure, especially if creatinine clearance <35 ml / min, elimination of bleomycin is delayed.
There are no specific guidelines for dose adjustment in these patients, but it is recommended that patients with moderate renal impairment (GFR 10-50 ml / min) should receive 75% of the usual dose administered at the usual dosing intervals and patients severe renal failure (GFR below 10 ml / minute) should receive 50 % of the usual dose, given at the normal dosing interval.
No dose adjustment is required in patients with a GFR greater than 50 ml / minute. Combination therapy The dose might require adjustment when bleomycin is used in combination therapy. The bleomycin dosage should be reduced in conjunction with radiotherapy since the risk of mucosal damage is increased.
Dose adjustment may also be required when bleomycin is used in combination chemotherapy. Details regarding treatment regimens applied for certain indications can be found in the current literature. : The entire contents of a vial (15,000 IU) should be dissolved in the appropriate quantity of solvent for preparation of the solution.
The quantity of units required for the treatment is then taken from this solution. Intramuscular injection Dissolve the contents of a vial in 1-5 mL physiological saline solution. m. injections at the same site can cause local discomfort, it is recommended to change the injection site regularly.
g. 5-2 mL lidocaine HCl 1%. Intravenous injection Dissolve the contents of a vial in […]
Mucosal ulcers appear to be aggravated by the combination of bleomycin with radiotherapy or other medication toxic to mucous membranes. Skin toxicity occurs at a relatively late stage and is correlated with the total dose; it usually develops in the second and third week after administration of 150 to 200 units of bleomycin.
Gastrointestinal side effects such as nausea and vomiting are possible, but are observed more frequently in high-dose regimens. Antiemetics may be helpful. Loss of appetite and weight loss are common and may continue for a long time after the end of the treatment.
Bone marrow Bleomycin does not appear to have any significant bone marrow depressant properties. Thrombocytopaenia occurring in connection with bleomycin treatment has not been attributed to decreased production of platelets, but rather to increased destruction of platelets.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
Pulmonary toxicity has also been observed on occasion in young patients receiving low doses. Vascular changes occur in the lungs, leading to partial destruction of the elasticity of the vessel wall. The earliest symptom of pulmonary damage caused by bleomycin is dyspnoea.
Fine rales are the earliest sign. If pulmonary changes are noticed, bleomycin treatment should be discontinued until it is determined whether they are caused by the medication. The patients should be treated with broad spectrum antibiotics and corticosteroids.
In the event of dyspnoea, cough, basal crepitations or lung infiltrates not clearly attributable to the neoplasm or a concomitant pulmonary disease, administration of bleomycin must be discontinued immediately and the patient should be treated with a corticosteroid and broad spectrum antibiotics.
High oxygen concentrations should be used with caution. 3). Although the pulmonary toxicity of bleomycin appears to be dose-related upon exceeding a total dose of 400 units (corresponding to approx. 225 units/m2 BSA), it can also be observed at lower doses, in particular in elderly patients, patients with impaired renal function patients with pre-existing lung disease, patients with a history of or receiving concomitant thoracic radiotherapy, and patients requiring oxygen administration.
These patients should be carefully monitored and the bleomycin dosage reduced or the dose interval prolonged based on clinical observation of the patient. Bleomycin should be used with extreme caution in patients with lung cancer as these patients show an increased incidence of pulmonary toxicity As 2/3 of the administered dose of bleomycin is excreted unchanged in the urine, renal function has a major effect on the rate of excretion.
Plasma concentrations are significantly elevated when usual doses are administered to patients with renal function disorders. Other clinical conditions requiring caution include patients with severe heart disease or hepatic dysfunction as toxicity may be increased and patients with varicella as fatal systematic dysfunctions may occur.
Idiosyncratic reactions/ hypersensitivity Idiosyncratic reactions, clinically similar to anaphylaxis, have been reported in approximately 1% of lymphoma patients treated with bleomycin. The reaction may be immediate or after a few hours delay, and usually occurs after the first or second dose.
It consists of hypotension, confusion, fever, chills, wheezing and stridor. Treatment is symptomatic and comprises volume expansion, vasopressors, antihistamines and corticosteroids. Because of the possibility of an anaphylactoid reaction (in 1% of lymphoma patients, according to the literature), patients should initially receive a test dose of 1-2 units.
If there is no acute reaction, the full dose can be administered. Miscellaneous There have been reports of vascular toxicity following use of bleomycin, in particular in combination with other antineoplastic agents. g. haemolytic uraemic syndrome and cerebral arteritis.
In adults or adolescents capable of reproduction, effects on the sexual glands should be considered. Like other cytotoxic active substances, bleomycin can trigger tumour lysis syndrome in patients with rapidly growing tumours. Appropriate supportive treatment and pharmacological measures might prevent or alleviate such complications.
Patients with creatinine clearance values of less than 50 mL/min should be treated with caution and their renal function should be carefully monitored during the administration of bleomycin. Lower doses of bleomycin may be required in these patients than those with normal renal function (see […]