IMMUCYST
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Package:
VIALS: 1 x 81 mg + diluent of 1 x 3 ml.
Dosage:
See prescribing information for full details.
Prescribing Restrictions:
Indications:
Carcinoma in situ of urinary bladder.
Contra-Indications:
Patients who have had a transurethral resection or traumatic bladder catheterization (associated with hematuria) in the previous week. Patients receiving immunosuppressive therapy (drugs or radiation) or with compromised immune systems. Asymptomatic carriers with a positive HIV serology and in patients receiving steroids at immunosuppressive doses. Patients with active tuberculosis. Should not be administered as an immunizing agent for the prevention of tuberculosis. Is not a vaccine for the prevention of cancer. Previous evidence of systemic BCG reaction. Fever, unless the cause of the fever has been determined and evaluated. Bacterial urinary tract infection. See prescribing information for full details.
Special Precautions:
Should not be handled by persons with an immunologic deficiency. Care must be taken not to introduce contaminants into the urinary tract nor to traumatize unduly the urinary mucosa. If the bladder catheterization has been traumatic, ImmuCyst should not be administered and there must be a treatment delay of at least one week. The possibility of allergic reactions should be assessed. Patients with small bladder capacity. If UTI occurs during the course of treatment, instillation should be withheld until complete resolution. Patients undergoing antimicrobial therapy for other infections should be evaluated to assess whether the therapy might diminish the efficacy.
Pregnancy and lactation: Should be given to a pregnant woman only if clearly needed. Women should be advised not to become pregnant while on therapy. Caution should be exercised when administered to a nursing woman.
Use in children: Safety and effectiveness in children has not been established. See prescribing information for full details.
Side Effects:
Transient fever, hematuria, urinary frequency and dysuria. Such reactions may to some degree be taken as evidence that BCG is evoking the desired response, but patients should be carefully monitored for serious adverse events. Serious side effects have occurred in <1% of recipients. Common local reactions are transient dysuria and urinary frequency. During the induction course, these reactions occurred on at least one occasion in 26% and 14% of patients, respectively. This rose to 46% and 34% during maintenance therapy. Gross hematuria has occurred among 11-19%, while more serious genitourinary adverse events have occurred in <0.5% of recipients. Infrequent associations include bacterial UTI, bladder contracture, symptomatic granulomatous prostatitis, epididymo-orchitis, ureteral obstruction, and renal abscess. Transient fever of <38.5 Celsius of <48 hours among 17% of recipients during induction and among 31% during maintenance. Skin rash, arthralgia and migratory arthritis are rare. See prescribing information for full details.
Drug Interactions:
Drug combinations containing bone marrow depressants and/or immunosuppressants and/or radiation may impair the response to therapy or increase the risk od disseminated BCG reaction.
