BCG LIVE (for intravesical use) -

TICE BCG
Proper Name: BCG Live
Tradename: TICE BCG
Manufacturer: Organon Teknika Corp, License #0956
Indication:

To expand the indication for intravesical instillation, to include adjunct treatment of stage Ta or T1 papillary tumors of the bladder.

BCG LIVE
(FOR INTRAVESICAL USE)
TICE® BCG
WARNING
TICE® BCG contains live, attenuated mycobacteria. Because of the potential risk for transmission, it should be prepared, handled, and disposed of as a biohazard material (see PRECAUTIONS and DOSAGE AND ADMINISTRATION).
BCG infections have been reported in health care workers, primarily from exposures resulting from accidental needle sticks or skin lacerations during the preparation of BCG for administration. Nosocomial infections have been reported in patients receiving parenteral drugs that were prepared in areas in which BCG was reconstituted. BCG is capable of dissemination when administered by the intravesical route, and serious infections, including fatal infections, have been reported in patients receiving intravesical BCG (see WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS).
DESCRIPTION
TICE® BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis.1 The TICE® strain was developed at the University of Illinois from a strain originated at the Pasteur Institute.
The medium in which the BCG organism is grown for preparation of the freeze-dried cake is composed of the following ingredients: glycerin, asparagine, citric acid, potassium phosphate, magnesium sulfate, and iron ammonium citrate. The final preparation prior to freeze drying also contains lactose. The freeze-dried BCG preparation is delivered in glass vials, each containing 1 to 8 x 108 colony forming units (CFU) of TICE® BCG which is equivalent to approximately 50 mg wet weight. Determination of in-vitro potency is achieved through colony counts derived from a serial dilution assay. A single dose consists of 1 reconstituted vial (see DOSAGE AND ADMINISTRATION).
For intravesical use the entire vial is reconstituted with sterile saline. TICE® BCG is viable upon reconstitution.
No preservatives have been added.
CLINICAL PHARMACOLOGY
TICE® BCG induces a granulomatous reaction at the local site of administration. Intravesical TICE® BCG has been used as a therapy for, and prophylaxis against, recurrent tumors in patients with carcinoma in situ (CIS) of the urinary bladder, and to prevent recurrence of Stage TaT1 papillary tumors of the bladder at high risk of recurrence. The precise mechanism of action is unknown.
CLINICAL STUDIES
To evaluate the efficacy of intravesical administration of TICE® BCG in the treatment of carcinoma in situ, patients were identified who had been treated with TICE® BCG under six different Investigational New Drug (IND) applications in which the most important shared aspect was the use of an induction
plus maintenance schedule. Patients received TICE® BCG (50 mg; 1 to 8 x 108 CFU) intravesically, once weekly for at least 6 weeks and once monthly thereafter for up to 12 months. A longer maintenance was given in some cases. The study population consisted of 153 patients, 132 males, 19 females, and 2 unidentified as to gender. Thirty patients lacking baseline documentation of CIS and four patients lost to follow-up were not evaluable for treatment response. Therefore, 119 patients were available for efficacy evaluation. The mean age was 69 years (range: 38–97 years). There were two categories of clinical response: (1) Complete Histological Response (CR), defined as complete resolution of carcinoma in situ documented by cystoscopy and cytology, with or without biopsy; and (2) Complete Clinical Response Without Cytology (CRNC), defined as an apparent complete disappearance of tumor upon cystoscopy. The results of a 1987 analysis of the evaluable patients are shown in Table I.


abrir aquí para acceder al archivo PDF, aprobado por la FDA:
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM163039.pdf

o bien, abrir aquí:
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm134033.htm