TICE BCG
Generic Name/API: Mycobacterium bovis
Manufacturer: Organon Teknika Corporation LLC
Dosage Forms & Strength & Pack Size:
TICE® BCG is supplied in a box of one vial of TICE® BCG. Each vial contains 1 to 8 x 108
CFU, which is equivalent to approximately 50 mg (wet weight), as lyophilized (freeze-dried) powder.
NDC 0052-0602-02.
Storage:
The intact vials of TICE® BCG should be stored refrigerated, at 2–8°C (36–46°F)
INDICATIONS AND USAGE
TICE® BCG is indicated for the treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder, and for the prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR). 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.
WARNINGS
BCG LIVE (TICE® BCG) is not a vaccine for the prevention of cancer. BCG Vaccine, U.S.P., not
BCG LIVE (TICE® BCG), should be used for the prevention of tuberculosis. For vaccination use, refer to BCG Vaccine, U.S.P. prescribing information.
TICE® BCG is an infectious agent. Physicians using this product should be familiar with the literature on the prevention and treatment of BCG-related complications, and should be prepared in such emergencies to contact an infectious disease specialist with experience in treating the infectious
complications of intravesical BCG. The treatment of the infectious complications of BCG requires longterm, multiple-drug antibiotic therapy. Special culture media are required for mycobacteria, and physicians administering intravesical BCG or those caring for these patients should have these media
readily available.
Instillation of TICE® BCG with an actively bleeding mucosa may promote systemic BCG infection.
Treatment should be postponed for at least one week following transurethral resection, biopsy, traumatic catheterization, or gross hematuria.
Deaths have been reported as a result of systemic BCG infection and sepsis.2,3 Patients should be monitored for the presence of symptoms and signs of toxicity after each intravesical treatment. Febrile episodes with flu-like symptoms lasting more than 72 hours, fever ≥103°F, systemic manifestations
increasing in intensity with repeated instillations, or persistent abnormalities of liver function tests suggest systemic BCG infection and may require antituberculous therapy. Local symptoms (prostatitis, epididymitis, orchitis) lasting more than 2–3 days may also suggest active infection (see Management of Serious BCG Complications subsection of WARNINGS).
The use of TICE® BCG may cause tuberculin sensitivity. Since this is a valuable aid in the diagnosis of tuberculosis, it is advisable to determine the tuberculin reactivity by PPD skin testing before treatment.
Intravesical instillations of BCG should be postponed during treatment with antibiotics, since antimicrobial therapy may interfere with the effectiveness of TICE® BCG (see PRECAUTIONS). TICE®
BCG should not be used in individuals with concurrent infections.
Small bladder capacity has been associated with increased risk of severe local reactions and should be considered in deciding to use TICE® BCG therapy.
*The contents of this site are for reference only. We do not offer drug procurement service. All information must not be used for any commercial purpose.
