Blenoxane Side Effects

Generic Name: bleomycin

Please note - some side effects for Blenoxane may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Blenoxane - for the Consumer

Blenoxane

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Blenoxane:

Chills; confusion; dark bands in nails; hair loss; itching; loss of appetite; redness, darkening, or tenderness of the skin; sore mouth; tiredness; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur when using Blenoxane:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision; cough; fever, chills, confusion, or wheezing; lightheadedness; numbness of an arm or leg; one-sided weakness; pain, redness, or swelling at injection site; severe stomach pain; sharp or crushing chest pain; slurred speech; sudden leg pain; sudden, severe headache, vomiting, dizziness, or fainting; sudden shortness of breath.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Blenoxane Side Effects - for the Professional

Blenoxane

Pulmonary

This is potentially the most serious side effect, occurring in approximately 10% of treated patients. The most frequent presentation is pneumonitis occasionally progressing to pulmonary fibrosis. Approximately 1% of patients treated have died of pulmonary fibrosis. Pulmonary toxicity is both dose and age related, being more common in patients over 70 years of age and in those receiving over 400 units total dose. This toxicity, however, is unpredictable and has been seen occasionally in young patients receiving low doses. Some published reports have suggested that the risk of pulmonary toxicity may be increased when bleomycin is used in combination with G-CSF (filgrastim) or other cytokines. However, randomized clinical studies completed to date have not demonstrated an increased risk of pulmonary complications in patients treated with bleomycin and G-CSF.

Because of lack of specificity of the clinical syndrome, the identification of patients with pulmonary toxicity due to Blenoxane (bleomycin sulfate for injection, USP) has been extremely difficult. The earliest symptom associated with Blenoxane pulmonary toxicity is dyspnea. The earliest sign is fine rales.

Radiographically, Blenoxane-induced pneumonitis produces nonspecific patchy opacities, usually of the lower lung fields. The most common changes in pulmonary function tests are a decrease in total lung volume and a decrease in vital capacity. However, these changes are not predictive of the development of pulmonary fibrosis.

The microscopic tissue changes due to Blenoxane toxicity 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 the Hamman-Rich syndrome. These microscopic findings are nonspecific; eg, similar changes are seen in radiation pneumonitis and pneumocystic pneumonitis.

To monitor the onset of pulmonary toxicity, roentgenograms of the chest should be taken every 1 to 2 weeks. If pulmonary changes are noted, treatment should be discontinued until it can be determined if they are drug related. Recent studies have suggested that sequential measurement of the pulmonary diffusion capacity for carbon monoxide (DLCO) during treatment with Blenoxane 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.

Because of bleomycin’s sensitization of lung tissue, patients who have received bleomycin are at greater risk of developing pulmonary toxicity when oxygen is administered in surgery. While long exposure to very high oxygen concentrations is a known cause of lung damage, after bleomycin administration, lung damage can occur at lower concentrations that are usually considered safe. Suggested preventive measures are:

1. Maintain FIO2 at concentrations approximating that of room air (25%) during surgery and the postoperative period.
2. Monitor carefully fluid replacement, focusing more on colloid administration rather than crystalloid.

Sudden onset of an acute chest pain syndrome suggestive of pleuropericarditis has been rarely reported during Blenoxane infusions. Although each patient must be individually evaluated, further courses of Blenoxane do not appear to be contraindicated.

Pulmonary adverse events which may be related to the intrapleural administration of Blenoxane have been reported only rarely.

Idiosyncratic Reactions

In approximately 1% of the lymphoma patients treated with Blenoxane (bleomycin sulfate for injection, USP), an idiosyncratic reaction, similar to anaphylaxis clinically, has been reported. The reaction may be immediate or delayed for several hours, and usually occurs after the first or second dose. It consists of hypotension, mental confusion, fever, chills, and wheezing. Treatment is symptomatic including volume expansion, pressor agents, antihistamines, and corticosteroids.

Integument and Mucous Membranes

These are the most frequent side effects, being reported in approximately 50% of treated patients. These consist of erythema, rash, striae, vesiculation, hyperpigmentation, and tenderness of the skin. Hyperkeratosis, nail changes, alopecia, pruritus, and stomatitis have also been reported. It was necessary to discontinue Blenoxane therapy in 2% of treated patients because of these toxicities.

Scleroderma-like skin changes have also been reported as part of postmarketing surveillance.

Skin toxicity is a relatively late manifestation usually developing in the second and third week of treatment after 150 to 200 units of Blenoxane have been administered and appears to be related to the cumulative dose.

Intrapleural administration of Blenoxane has occasionally been associated with local pain. Hypotension possibly requiring symptomatic treatment has been reported infrequently. Death has been very rarely reported in association with Blenoxane pleurodesis in these very seriously ill patients.

Other

Vascular toxicities coincident with the use of Blenoxane in combination with other antineoplastic agents have been reported rarely. The events are clinically heterogeneous and may include myocardial infarction, cerebrovascular accident, thrombotic microangiopathy (HUS), or cerebral arteritis. Various mechanisms have been proposed for these vascular complications. There are also reports of Raynaud’s phenomenon occurring in patients treated with Blenoxane in combination with vinblastine with or without cisplatin or, in a few cases, with Blenoxane as a single agent. It is currently unknown if the cause of Raynaud’s phenomenon in these cases is the disease, underlying vascular compromise, Blenoxane, vinblastine, hypomagnesemia, or a combination of any of these factors.

Fever, chills, and vomiting were 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 were reported infrequently.

Malaise was also reported as part of postmarketing surveillance.

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Side Effects by Body System - for Healthcare Professionals

Respiratory

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 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.

Dermatologic

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.

Gastrointestinal

Relative to other chemotherapeutic agents, bleomycin 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

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

Cardiovascular side effects (myocardial infarction, cerebrovascular accident, thrombotic microangiopathy (HUS)) have been reported rarely (in combination antineoplastic therapy).

Other

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

Local side effects including pain at the tumor site and phlebitis have been reported infrequently.

Oncologic

Oncologic side effects have been reported. Bleomycin 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.

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