TICE BCG Rx
Generic Name and Formulations:
Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis live, attenuated culture preparation; 50mg per vial; pwd for intravesical administration after reconstitution and dilution; preservative-free.
Merck & Co., Inc.
Indications for TICE BCG:
Treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder. Prophylaxis of stage Ta and/or T1 papillary tumors following transurethral resection (TUR).
1 vial in 50mL preservative-free saline intravesically once per week for 6 weeks (may repeat this regimen once if remission not achieved); then monthly for 6–12 months if needed. Avoid fluid at least 4hrs before treatment and void immediately before administration. Retain in bladder for 2hrs.
Immunosuppressed. Active TB. Febrile illness. UTI. Gross hematuria. Do not give within 7 days after bladder biopsy, TUR, or traumatic catheterization.
Prepare, handle, and dispose of as a biohazard material. BCG infections. Nosocomial infections.
Not a vaccine for prevention of cancer or TB. Not for IV or SC inj use. Determine PPD status prior to therapy; rule out active TB if (+). Monitor for signs of systemic BCG infection: flu-like symptoms >72 hrs, fever ≥103°F, persistent LFT abnormalities; prostatitis, epididymitis, orchitis >2 days; treat with at least 2 antimycobacterial drugs (except pyrazinamide). High risk for HIV infection. Local irritative toxicities: do not treat with antimycobacterials. Bleeding bladder mucosa, small bladder. Disinfect fluid voided after therapy with bleach. PPD seroconversion may occur with treatment. Pregnancy, nursing mothers: not recommended.
Immunosuppressants, myelosuppressants, radiation, antimicrobial therapy may reduce efficacy.
Dysuria, urinary frequency, urgency, flu-like syndrome, hematuria, fever, malaise/fatigue, cystitis, bladder irritation, inflammation (begins after 4 hrs and last up to 72 hrs), chills, systemic BCG infection, nocturia, cramps, pain, incontinence, rigors, arthralgia.