Blenoxane Side Effects
Generic name: bleomycin
Note: This document contains side effect information about bleomycin. Some of the dosage forms listed on this page may not apply to the brand name Blenoxane.
Some side effects of Blenoxane may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to bleomycin: injectable powder for injection
Get emergency medical help if you have any of these signs of an allergic reaction while taking bleomycin (the active ingredient contained in Blenoxane) hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
fever or chills;
sudden chest pain or discomfort, wheezing, dry cough or hack;
shortness of breath;
confusion, feeling weak or tired, loss of appetite, rapid weight loss;
a light-headed feeling, feeling like you might pass out;
white patches or sores inside your mouth or on your lips;
severe redness, itching, rash, blistering, or tenderness of your skin; or
unusual hardening or thickening of your skin.
Common side effects may include:
dark streaks or discoloring on your skin;
fingernail or toenail changes;
temporary hair loss;
pain near your tumor; or
redness, warmth, itching, or swelling around the IV needle.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to bleomycin: injectable powder for injection
Pulmonary toxicity occurs most frequently in patients over 70 years of age and in those receiving over 400 units of total dosage. Patients often present with dry cough, dyspnea, rales, and infiltrate. One case of fatal pulmonary fibrosis has been reported in a patient (with normal renal function) who received a total cumulative dose of only 20 units.
Sudden onset of an acute chest pain syndrome suggestive of pleuropericarditis has rarely been reported during bleomycin (the active ingredient contained in Blenoxane) infusions. Although each patient must be individually evaluated, further courses of bleomycin do not appear to be contraindicated.
The earliest sign and symptom of pulmonary toxicity are fine rales and dyspnea. A specific clinical syndrome has not been defined. Radiographically, the pneumonitis produces nonspecific patchy opacities, usually of the lower lung field. The most common changes in pulmonary function tests are decreases in total lung volume and vital capacity. However, these changes are not predictive of the development of pulmonary fibrosis.
Microscopic tissue changes include bronchiolar squamous metaplasia, reactive macrophages, atypical alveolar epithelial cells, fibrinous edema, and interstitial fibrosis. The acute stage may involve capillary changes and subsequent fibrinous exudation into alveoli producing a change similar to hyaline membrane formation and progressing to a diffuse interstitial fibrosis resembling Hamman-Rich syndrome. These microscopic findings are nonspecific. (Similar changes are seen in radiation pneumonitis and pneumocystic pneumonitis.)
Respiratory side effects (10%) are potentially the most serious. The most frequent respiratory presentation has been pneumonitis, which has sometimes progressed to pulmonary fibrosis. Approximately 1% of treated patients have died of pulmonary fibrosis. Two cases of fatal pneumothorax and one case reported of fatal diffuse alveolar injury have also been reported.
Skin toxicity is a relatively late manifestation, usually developing in the 2nd and 3rd week of treatment, after a cumulative dose of 150 to 200 units.
Dermatologic side effects including erythema, rash, striae, vesiculation, hyperpigmentation, and skin tenderness are the most frequent (50%) type of side effect. Hyperkeratosis, nail changes, alopecia, and pruritus have also been reported. One case of fatal fulminant angioedema involving the skin and lungs has been reported. A case of bleomycin-induced flagellate dermatitis has also been reported.
Relative to other chemotherapeutic agents, bleomycin (the active ingredient contained in Blenoxane) is felt to have low emetogenic potential.
Gastrointestinal side effects have frequently included vomiting, which can generally be controlled with oral phenothiazines. Anorexia and weight loss have also been frequently reported and may persist long after discontinuation of treatment. Mucosal lesions including stomatitis and ulceration of the lips and tongue have been reported rarely.
Hypersensitivity side effects have included an idiosyncratic reaction (hypotension, mental confusion, fever, chills, and wheezing) in approximately 1% of lymphoma patients.
The reaction may be immediate or delayed for several hours. It usually occurs after the first or second dose. Treatment is symptomatic and can include volume expansion, epinephrine, antihistamines and corticosteroids.
Two known cases have been reported of fatal hyperpyrexia in patients with lymphoma who had previously received bleomycin (without prior hyperpyrexia). One of the patients had previously received multiple doses. There has also been a case report of fatal hyperpyrexia in a patient premedicated with high-dose dexamethasone, to an initial 7.5 mg dose for a poorly differentiated metastatic carcinoma.
Cardiovascular side effects (myocardial infarction, cerebrovascular accident, thrombotic microangiopathy (HUS)) have been reported rarely (in combination antineoplastic therapy).
Other side effects include fever (up to 50%), and chills which have frequently been reported. Cerebral arteritis and Raynaud's phenomenon have also been reported. Three known cases of scleroderma have been reported.
Local side effects including pain at the tumor site and phlebitis have been reported infrequently.
Oncologic side effects have been reported. Bleomycin (the active ingredient contained in Blenoxane) has tested positive in the great majority of genetic toxicity assays. These genotoxic effects are similar to those induced by ionizing radiation.
The most frequent mutations produced in mammalian cells are large multilocus deletions, which probably arise by misrepair of (DNA) double strand breaks.
More Blenoxane resources
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