From the Guidelines
Bleomycin used in the pericardial space can cause several side effects, including chest pain, fever, nausea, vomiting, and general malaise, with more serious complications such as arrhythmias, pericardial constriction, and pulmonary toxicity. The most common immediate reaction is chest pain, occurring in up to 40% of patients, followed by fever, which typically develops within 4-12 hours after administration 1. Patients may also experience nausea, vomiting, and general malaise. More serious complications include arrhythmias, which can range from mild to severe, and pericardial constriction, a rare but significant long-term complication that may develop months after treatment. Hypotension can occur during or shortly after the procedure. Some patients develop an inflammatory response with pericarditis symptoms. Pulmonary toxicity, while more commonly associated with intravenous bleomycin, is less frequent with intrapericardial administration but remains a concern, especially in patients with pre-existing lung disease, as noted in studies on bleomycin toxicity 1. Allergic reactions ranging from mild rash to anaphylaxis are possible. The side effects of bleomycin in the pericardial space are due to its mechanism of action as a sclerosing agent, which creates an inflammatory reaction in the pericardial space to prevent fluid reaccumulation, but this same mechanism can lead to these adverse effects. Key considerations for minimizing these side effects include careful patient selection, monitoring for signs of toxicity, and adjusting the treatment regimen as needed, based on guidelines for the management of pericardial diseases 1.
From the FDA Drug Label
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. Sudden onset of an acute chest pain syndrome suggestive of pleuropericarditis has been reported during bleomycin infusions. Pulmonary adverse events which may be related to the intrapleural administration of bleomycin have been reported. Intrapleural administration of bleomycin has been associated with local pain. Hypotension possibly requiring symptomatic treatment has been reported. Death has been reported in association with bleomycin pleurodesis in seriously ill patients.
The side effects of using bleomycin in the pericardial space include:
- Pulmonary toxicity
- Pleuropericarditis
- Local pain
- Hypotension
- Death (in seriously ill patients) These side effects are reported in the context of intrapleural administration of bleomycin, which is similar to pericardial space administration 2.
From the Research
Side Effects of Bleomycin in the Pericardial Space
- The use of bleomycin in the pericardial space has been associated with several side effects, including:
- The incidence of acute toxicity was reported to be low, occurring in 32% of patients in one study 3
- Non-fatal complications, such as relapse, can also occur, although the rate of these complications is relatively low 6
Comparison with Other Sclerosing Agents
- Bleomycin has been compared to other sclerosing agents, such as doxycycline, in terms of efficacy and toxicity 4
- Bleomycin was found to be associated with significantly less morbidity than doxycycline, including less retrosternal pain and shorter hospitalization times 4
Overall Safety and Efficacy
- The use of intrapericardial bleomycin instillation has been found to be a safe and effective method for managing malignant pericardial effusions 3, 6, 5
- The procedure has a high success rate, with complete response rates ranging from 54% to 95% in different studies 3, 5
- However, overall survival rates remain relatively low, with median survival times ranging from 2.6 months to 17.9 weeks in different studies 6, 5, 7