Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Merck Sharp & Dohme (UK) Limited, 120 Moorgate, London, EC2M 6UR, UK
OncoTICE is indicated for treatment of primary or concurrent carcinoma-in-situ of the urinary bladder and for the prevention of recurrence of high grade and/or relapsing superficial papillary transitional cell carcinoma of the urinary bladder (Stage Ta (grade 2 or 3) or T1 (grade 1, 2 or 3)) after transurethral resection.
OncoTICE is only recommended for stage Ta grade 1 papillary tumours, when there is judged to be a high risk of tumour recurrence.
For preparation of the OncoTICE suspension see section 6.6.
The contents of one vial of OncoTICE, reconstituted and diluted as indicated, are instilled into the urinary bladder.
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 (see “Therapeutic indications”), 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. Treatment should also be delayed in cases of gross haematuria or major bladder irritability.
Maintenance treatment 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 tumour classification and clinical response.
No data are available.
Insert a catheter via the urethra into the bladder and drain the bladder completely. Connect the 50ml syringe containing the prepared OncoTICE suspension to the catheter and instil the suspension into the bladder. If a closed-system transfer device is not available, the 50 ml OncoTICE suspension is instilled into the bladder by gravity flow. After instillation, remove the catheter. The instilled OncoTICE suspension must remain in the bladder for a period of 2 hours. During this period care should be taken that the instilled OncoTICE suspension has sufficient contact with the whole mucosal surface of the bladder. Therefore, the patient should not be immobilised or, in case of a bed-ridden patient, should be turned over from back to abdomen and vice versa every 15 minutes. After two hours, have the patient void the instilled suspension in a sitting position.
Urine should be voided in a sitting position for 6 hours after treatment and two cups of household bleach should be added to the toilet before flushing. The bleach and urine should be left to stand in the toilet for 15 minutes before flushing.
NOTE: The patient must not ingest any fluid for a period starting 4 hours prior to instillation, until bladder evacuation is permitted (i.e. 2 hours after instillation).
Overdosage occurs when more than one vial of OncoTICE is administered per instillation. In case of overdosage, the patient should be closely monitored for signs of systemic BCG infection and if necessary treated with anti-tuberculosis drugs.
12 months.
In-use stability of the reconstituted product has been demonstrated for 2 hours at 2-8°C protected from light. From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
Store at 2-8°C, protect from light.
2 ml Type 1 glass vials in packs of 1 and 3.
OncoTICE contains live, attenuated mycobacteria. Because of the potential risk for transmission, it should be prepared, handled and disposed of as a biohazard material (see section 4.4).
Perform the following procedures under aseptic conditions using sterile physiological saline solution as the diluent and suitable techniques to ensure protection of the health care worker. The use of closed-system transfer device products may be considered when transferring OncoTICE from primary packaging to instillation equipment.
Transfer 50ml of the diluent into a sterile container and add 1ml from the sterile container to the vial. Ensure that the needle is inserted through the center of the rubber stopper. Allow to stand for a few minutes then gently swirl until a homogenous suspension is obtained. Forceful agitation should be avoided.
Transfer the reconstituted contents of the vial back into the container. Rinse the vial by transferring 1ml from the container back into the vial, then add back to the container. If a closed-system transfer device is not available, dilute the reconstituted 1ml suspension in sterile physiological saline up to a volume of 49ml. Then rinse the empty vial with 1ml of sterile physiological saline. Add the rinse fluid to the reconstituted suspension for a final volume of 50ml.
Mix the suspension carefully.
The suspension, with a total volume of 50ml is now ready for instillation; it contains a total of 2-8 × 108 CFU of Tice BCG.
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