Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS Pulmonary The most serious side effects are pulmonary adverse reactions, 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 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 bleomycin has been extremely difficult.
The earliest symptom associated with bleomycin pulmonary toxicity is dyspnea.
The earliest sign is fine rales.
WARNINGS 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.
Pulmonary toxicities occur in 10% of treated patients.
In approximately 1%, the nonspecific pneumonitis induced by bleomycin progresses to pulmonary fibrosis and death.
Although this is age and dose related, the toxicity is unpredictable.
Like all medications, Bleomycin can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: