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BLEOMYCIN FOR is a brand name for Bleomycin, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USES Bleomycin for Injection USP should be used as first-line therapy and/or adjuvant to surgery and radiation therapy. It has been shown to be useful in the following neoplasms: Squamous Cell Carcinoma: Skin, larynx and paralarynx, penis, cervix and vulva. Bleomycin in combination with radiotherapy shows…
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Skin 50% of the patients develop either hyperpigmentation of the skin, hyperkeratosis of hands and nails, and edema and erythema of the hands and feet. The skin toxicity occurred more frequently at higher doses: 200 to 300 unit range and can be dose-limiting.
Rash forms on the pressure areas of the body and abdominal skin creases. 25 to 35 mg/m2. Pulmonary Pulmonary toxicity is potentially the most serious side effect, occurring in approximately 10% of treated patients. The most frequent manifestation is pneumonitis occasionally progressing to pulmonary fibrosis which may result in death.
Approximately 1% of patients treated succumb to pulmonary toxicity. Pulmonary toxicity is usually both dose- and age- related, being more common in patients over 70 years of age receiving over 400 units total dose. However, this toxicity is unpredictable and has been seen occasionally in young patients receiving low doses.
The identification of patients with pulmonary toxicity due to bleomycin has been extremely difficult due to the lack of specificity of the clinical syndrome, the X-ray changes and even the tissue changes seen on examination of biopsy and autopsy specimens.
Bleomycin-induced pneumonitis apparently produces dyspnea and fine rales that are in no way different from those produced by infectious pneumonias or the signs and symptoms produced by primary or metastatic lung disease in some patients.
The microscopic tissue changes due to bleomycin toxicity are frequently present as bronchiolar squamous metaplasia, reactive macrophages, atypical alveolar epithelial cells, fibrinous edema Product Monograph - PrBleomycin for Injection USP Page 8 of 30 and interstitial fibrosis and are in line with interstitial pneumonitis.
These microscopic findings are non-specific. Serial pulmonary function tests in approximately 20% of patients receiving bleomycin therapy reveal some demonstrable alteration. The most common changes are decrease in total lung volume and decrease in vital capacity.
However, there are no predictive correlations between these changes and the development of pulmonary fibrosis. Frequent roentgenograms are not a preferable method of follow-up or detection of pulmonary toxicity from bleomycin. Current practice consists of frequent physical examination (cough, basal rales and pleuritic chest pain are frequently first signs of toxicity) and baseline evaluation of carbon monoxide diffusion capacity, which also allows for the exclusion of patients with low pulmonary reserve, as well as for follow-up of progression of the pneumonitis after cessation of bleomycin therapy.
Bleomycin for Injection USP is contraindicated in patients who have demonstrated a hypersensitive or an idiosyncratic reaction to the drug. When used as indicated, the physician must carefully weigh the therapeutic benefit versus risk of toxicity which may occur.
WARNINGS Idiosyncratic reactions similar to anaphylaxis have been reported in 1% of lymphoma patients treated with bleomycin. Since these usually occur after the first or second dose, careful monitoring is essential after these doses.
It is recommended that bleomycin be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Since facilities for necessary laboratory studies must be available, hospitalization of patients is recommended.
Patients receiving bleomycin must be observed carefully and frequently during and after therapy. It should be used with extreme caution in patients with significant impairment of renal function or compromised pulmonary function. Patients who are undergoing bleomycin treatment are predisposed to respiratory failure following exposure to high concentrations of O2 (general anesthesia).
Since this effect may be observed for up to one year after treatment with bleomycin, the oxygen administration to these patients should be kept at the lowest possible concentrations in order to minimize the risk of severe pneumonitis.
Pulmonary toxicities occur in approximately 10% of treated patients. In approximately 1%, the non-specific pneumonitis induced by bleomycin progresses to pulmonary fibrosis and death. Although this is age- and dose- related, the toxicity is unpredictable.
Product Monograph - PrBleomycin for Injection USP Page 6 of 30 A method suggested to lower the incidence of pulmonary toxicity is the continuous intravenous administration of bleomycin. Renal or hepatic toxicity, beginning as a deterioration in renal or liver function tests, have been reported infrequently.
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If pulmonary changes are noted, treatment should be discontinued until it can be determined if they are drug-related. Sequential measurement of the pulmonary diffusion capacity for carbon monoxide (DLCO) during treatment with bleomycin may be an indicator of subclinical pulmonary toxicity.
It is recommended that the DLCO be monitored monthly if it is to be employed to detect pulmonary toxicities, and thus the drug should be discontinued when the DLCO falls below 30 to 35% of the pretreatment value. Concurrent or prior lung irradiation will also predispose patients to increased pulmonary toxicity.
The reaction, which may be immediate or after several hours delay, occurs only after the first or second dose. It consists of hypotension, fever, chills, mental confusion and wheezing. In order to minimize the incidence of pneumonitis due to bleomycin therapy, it is recommended not to exceed total dose 200 units/m2, not to exceed 100 units/m2 if concurrent lung irradiation is also given, not to exceed 100 units/m2 in patients over the age of 70, and to use continuous infusion to avoid peak serum levels.
Product Monograph - PrBleomycin for Injection USP Page 9 of 30 Fever Pretreatment with antipyretics or antihistamines is frequently given as fever occurs in 50% of patients with intravenous administration and 25% with intramuscular administration.
GI toxicity Mucositis and stomatitis occur in 30% of patients. Other Fever, chills and vomiting are frequently reported side effects. Anorexia and weight loss are common and may persist long after termination of this medication. Pain at tumor site, phlebitis and other local reactions are reported infrequently.
There are also isolated reports of Raynaud's phenomenon occurring in patients with testicular carcinomas treated with a combination of bleomycin and vinblastine. It is currently unknown if the cause for the Raynaud's phenomenon in these cases is the disease, either drug, or a combination of any or all of these.
Toxicity to the renal, hepatic and central nervous system is rare, but as with any potent drug, these symptoms should be monitored. It is noteworthy that there has been little evidence of bone marrow or immunological depression to date.
This is contrary to the currently available antineoplastic drugs. 0 units of sterile Bleomycin Sulphate USP. Because of the possibility of anaphylaxis, all lymphoma patients should be started with 2 units or less for the first 2 doses.
If no acute reaction occurs, then the regular dose schedule may be followed. Product Monograph - PrBleomycin for Injection USP Page 10 of 30 Bleomycin may be given by the intramuscular, intravenous, intra-arterial, intracavitary or subcutaneous routes.
50 units/kg (10 to 20 units/m2) given intravenously or intramuscularly, weekly or twice weekly. 50 units/kg (10 to 20 units/m2) intravenously or intramuscularly, weekly or twice weekly. After a 50% response, a maintenance dose of 1 unit daily subcutaneously or 5 […]
However, these toxicities may occur at any time after initiation of therapy.
Usage in Pregnancy:
Safe use of bleomycin in pregnant women has not been established. PRECAUTIONS General Bleomycin for Injection USP should be administered preferably to patients who are hospitalized and who can be observed carefully and frequently during and after therapy.
It should be used with extreme caution in patients with significant impairment of renal function or compromised pulmonary function due to disease other than malignancy and in patients over 70 years of age because of the apparent increased danger of pulmonary toxicity.
Frequent roentgenograms are not a preferable method of follow-up or detection of pulmonary toxicity from bleomycin. Current practice consists of frequent physical examination (cough, basal rales and pleuritic chest pain are frequently first signs of toxicity) and baseline evaluation of carbon monoxide diffusion capacity which also allows for the exclusion of patients with low pulmonary reserve, as well as for follow-up of progression of the pneumonitis after cessation of bleomycin therapy.
If pulmonary changes are noted, treatment should be discontinued until it can be determined whether the cause is drug-related. Pneumonitis due to bleomycin should be treated with corticosteroids in an effort to prevent progression to pulmonary fibrosis.
Infectious pneumonitis should receive appropriate antibiotic therapy. Product Monograph - PrBleomycin for Injection USP Page 7 of 30 ADVERSE REACTIONS Skin 50% of the patients develop either hyperpigmentation of the skin, hyperkeratosis of hands and nails, and edema and erythema of the hands and feet.
The skin toxicity occurred more frequently at higher doses: 200 to 300 unit range and can be dose-limiting. Rash forms on the pressure areas of the body and abdominal skin creases. 25 to 35 mg/m2. Pulmonary Pulmonary toxicity is potentially the most serious side effect, occurring in approximately 10% of treated patients.
The most frequent manifestation is pneumonitis occasionally progressing to pulmonary fibrosis which may result in death. Approximately 1% of patients treated succumb to pulmonary toxicity. Pulmonary toxicity is usually both dose- and age- related, being more common in patients over 70 years of age receiving over 400 units total dose.
However, this toxicity is unpredictable and has been seen occasionally in young patients receiving low doses. The identification of patients with pulmonary toxicity due to bleomycin has been extremely difficult due to the lack of specificity of the clinical syndrome, the X-ray changes and even the tissue changes seen on examination of biopsy and autopsy specimens.
Bleomycin-induced pneumonitis apparently produces dyspnea and fine rales that are in no way different from those produced by infectious pneumonias or the signs and symptoms produced by primary or metastatic lung disease in some patients.
The microscopic tissue changes due to bleomycin toxicity are frequently present as bronchiolar squamous metaplasia, reactive macrophages, atypical alveolar epithelial cells, fibrinous edema Product Monograph - PrBleomycin for Injection USP Page 8 of 30 and interstitial fibrosis and are in line with interstitial pneumonitis.
These microscopic findings are non-specific. Serial pulmonary function tests in approximately 20% of patients receiving bleomycin therapy reveal some demonstrable alteration. The most common changes are decrease in total lung volume and decrease in vital capacity.
However, there are no predictive correlations between these changes and the development of pulmonary fibrosis. Frequent roentgenograms are not a preferable method of follow-up or detection of pulmonary toxicity from bleomycin. Current practice consists of frequent physical examination (cough, basal rales and pleuritic chest pain are […]