TICE BCG- bacillus calmette-guerin powder, for suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN (UNII: 2XQ558L16Z) (BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN - UNII:2XQ558L16Z)

Available from:

Merck Sharp & Dohme LLC

INN (International Name):

BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN

Composition:

BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN 50 mg in 50 mL

Administration route:

INTRAVESICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

TICE® BCG is indicated for: - the treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder - the prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR) Limitations of Use: - TICE BCG is not recommended for stage TaG1 papillary tumors, unless they are judged to be at high risk of tumor recurrence. - TICE BCG is not indicated for papillary tumors of stages higher than T1. TICE® BCG should not be used in immunosuppressed patients with congenital or acquired immune deficiencies, whether due to concurrent disease (e.g., AIDS, leukemia, lymphoma) cancer therapy (e.g., cytotoxic drugs, radiation), or immunosuppressive therapy (e.g., corticosteroids). Treatment should be postponed until resolution of a concurrent febrile illness, urinary tract infection, or gross hematuria. Seven to 14 days should elapse before BCG is administered following biopsy, TUR, or traumatic catheterization. TICE BCG should not be administered to persons with active tuberculosis. Active tuberculosis should be ruled out in individuals who are PPD positive before starting treatment with TICE BCG.

Product summary:

TICE® BCG is supplied in a box of 1 single-dose vial of TICE BCG. Each vial contains 1 to 8 × 108 CFU, which is equivalent to approximately 50 mg (wet weight), as lyophilized (freeze-dried) powder, NDC 0052-0602-02. The intact vials of TICE® BCG should be stored refrigerated, at 2–8°C (36–46°F). This agent contains live bacteria and should be protected from direct sunlight. The product should not be used after the expiration date printed on the label.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

TICE BCG- BACILLUS CALMETTE-GUERIN POWDER, FOR SUSPENSION
MERCK SHARP & DOHME LLC
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TICE BCG
BCG LIVE
FOR INTRAVESICAL USE
WARNING
TICE BCG CONTAINS LIVE, ATTENUATED MYCOBACTERIA. BECAUSE OF THE
POTENTIAL RISK FOR TRANSMISSION, PREPARE, HANDLE, AND DISPOSE OF TICE
BCG AS A BIOHAZARD MATERIAL (SEE PRECAUTIONS AND DOSAGE AND
ADMINISTRATION SECTIONS).
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 SECTIONS).
DESCRIPTION
TICE BCG for intravesical use, is an attenuated, live culture
preparation of the Bacillus
of Calmette and Guerin (BCG) strain of _Mycobacterium bovis._
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 × 10
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 PH