Risk of Infection; Biohazard handling precautions
- Risk of transmission of live attenuated mycobacteria. Handle as biohazard. BCG infections have been reported in health care workers as a result of exposure via needlestick or skin lacerations during preparation of drug for administration. Nosocomial infections have also been reported in immunosuppressed patients receiving parenteral drugs prepared in same area as BCG.
- Disseminated infections : severe and fatal infections have occurred when administered by intravesical route.
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- Monitor patients for the presence of symptoms and signs of toxicity after each intravesical treatment. Febrile episodes with flu-like symptoms > than 72 hrs, fever > 103 degrees F, systemic manifestations increasing in intensity with repeated instillations, or persistent abnormalities of LFTs are suggestive of systemic BCG infection.
- If symptoms of persistent fever or acute febrile illness consistent with BCG infection occur, BCG treatment should be discontinued and patient evaluated and treated for BCG infection.
Updated January 2018