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Related information
Dosage
Dosage: Per instillation, the contents of one reconstituted and diluted vial of OncoTICE, are instilled into the bladder.
Induction treatment: Weekly instillation with OncoTICE during the first 6 weeks When used as an adjuvant therapy after TUR of a superficial urothelial cell carcinoma of the bladder, treatment with OncoTICE should be started between 10 and 15 days after performing the TUR. Treatment should not be started until mucosal lesions after TUR have healed.
Maintenance treatment: Maintenance treatment is indicated for all patients and consists of weekly instillation with OncoTICE during 3 consecutive weeks at months 3, 6 and 12 after initiation of the treatment.
The need for maintenance treatment every 6 months beyond the first year of treatment should be evaluated on the basis of classification and clinical response.
Indications
Treatment of flat urothelial cell carcinoma in situ (CIS) of the bladder and as adjuvant therapy after transurethral resection (TUR) of primary or relapsing superficial papillary urothelial cell carcinoma of bladder stage Ta (grade 2 or 3) or T1 (grade 1, 2 or 3). Only recommended for stage Ta grade 1 papillary tumors when there is judged to be a high risk of tumor recurrence. Maintenance treatment is indicated for all patients and consists of weekly instillation during 3 consecutive weeks at months 3, 6 and 12 after initiation of the treatment. The need for maintenance treatment every 6 months beyond the first year of treatment should be evaluated on the basis of classification and clinical response.
Contra-Indications
– Urinary tract infections. In these cases therapy with OncoTICE should be interrupted until the bacterial culture from urine becomes negative and the therapy with antibiotics and/or urinary antiseptics is stopped.
– Gross haematuria. In these cases OncoTICE therapy should be stopped or
postponed until the haematuria has been successfully treated or has resolved.
– Clinical evidence of existing active tuberculosis. Active tuberculosis should be ruled out in individuals who are PPD positive before starting treatment with OncoTICE.
– Treatment with anti-tuberculosis drugs like streptomycin, para-amino-salicylic acid (PAS), isoniazid (INH), rifampicin and ethambutol.
– Impaired immune response irrespective of whether this impairment is congenital or caused by disease, drugs or other therapy.
– Positive HIV serology
– Pregnancy and lactation
