Immunobladder should be used only by the urologists who are well experienced in the treatment of bladder cancer at an institution that is well equipped and staffed to handle an emergency.
Immunobladder contains live Mycobacterium bovis bacillus Calmette-Guérin (BCG). Intravesical instillation of Immunobladder following traumatic catheterization or soon after transurethral resection of bladder tumor (TURBT) or biopsy of bladder tumor has the potential risk to cause severe, sometimes fatal, disseminated infection with BCG. Therefore, the instillation should be postponed for 7 to 14 days following TUR, biopsy or traumatic catheterization while monitoring the recovery of the trauma.
Intravesical instillation of Immunobladder has the potential risk to induce hypersensitive reactions against mycobacterial antigens. When any suggestive symptoms, such as high fever, cough, skin rash, are noticed, further instillation should be stopped and treatment with steroid should be started immediately. Also, administration of anti-tuberculosis drugs should be considered.
Cases of nosocomial iatrogenic infections with BCG have been reported in USA due to the contamination of US-equivalent product into other therapeutics. Immunobladder should be handled carefully as an infectious agent.