Immunobladder Adverse Reactions

The incidence rate of subjective and/or objective symptoms was 78.3% (155 cases) out of evaluated 198 patients in the clinical trials conducted for approval.
The incidence rate of subjective and/or objective symptoms was 64.4% (2,210 cases) out of evaluated 3,431 patients in the post-marketing surveillance.
The summary of adverse reactions seen in the clinical trials and post-marketing surveillance are as follows (incidence unknown for some adverse reactions).
Serious adverse reactions: BCG Infections: Because Immunobladder contains live mycobacteria, intravesical instillation of Immunobladder may cause disseminated, local, and/or ectopic BCG infections. Cases of sepsis, hepatitis, cerebrospinal meningitis, cystitis, pyelonephritis, nephritis, prostatitis, epididymitis, and aneurysms due to BCG infections have been reported. If a patient develops such symptoms, intravesical instillation of Immunobladder should be discontinued. The patients who developed any of these symptoms should be treated by anti-tuberculosis chemotherapy with the combination of isoniazid, rifampicin with or without ethambutol. In addition to the appropriate symptomatic treatment, pyrazinamide should not be used, because BCG is resistant to pyrazinamide.
Disseminated BCG infections: Fatal cases due to disseminated BCG infection have been reported. Such dissemination might be induced by traumatic catheterization. Flu-like febrile symptoms lasting more than 48 hours, fever ≥39°C, systemic manifestations increasing in intensity with repeated instillations, or persistent abnormalities in liver function tests suggest disseminated BCG infection.
Local BCG infections: BCG infections of uro-genital organs, such as kidney, renal pelvis, ureter, bladder, urethra, prostate and epididymis have been reported.
Ectopic BCG infection: BCG infection of aneurysms has also been reported.
Interstitial pneumonia: Treatment with Immunobladder may develop severe interstitial pneumonia. The patient who developed interstitial pneumonia complains subjective symptoms such as high fever, cough, and dyspnea and shows characteristic abnormalities in chest X-ray examination and hypoxemia in arterial blood examination. If not treated properly, death may occur. If interstitial pneumonia is suspected, further instillation of Immunobladder should be discontinued and potent steroid-therapy should be promptly started in addition to appropriate supportive therapy.
If the differential diagnosis between disseminated BCG infection is difficult it is advisable to use steroids in combination with antituberculosis drugs.
Systemic delayed-type hypersensitivity (DTH): Deaths presumably due to DTH with anaphylaxis-like symptoms, such as cough, skin-rash, have been reported in the clinical trials of Immunobladder. (The patients who showed any symptom suggestive systemic DTH should be discontinued from further instillation of Immunobladder and immediately treated with steroids in combination with antituberculosis chemotherapy.)
Contracted bladder: Contracted bladders have been reported during treatment with Immunobladder.
Renal failure: The patient should be closely monitored for signs of serious renal disorder such as renal failure. Appropriate measure such as discontinuation of the treatment should be taken when any abnormalities are noticed.
Reiter's syndrome (conjunctivitis, polyarthritis, etc): Reiter's syndromes have been reported during treatment with Immunobladder.
Other adverse reactions: See Table 2.

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