Monograph Details
|
|
Neoplasms
> Miscellaneous oncology agents
|
|
TICE BCG |
| Manufacturer |
|
Schering Corporation |
| Legal Classification |
|
Rx
|
| Pharmacological Class |
|
BCG Live. |
| Generic Name |
|
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. |
| Indications |
|
Treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder. Prophylaxis of stage Ta and/or T1 papillary tumor of the urinary bladder. |
| Children |
|
Not recommended. |
| Adults |
|
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 4 hrs before treatment and void immediately before administration. Retain in bladder for 2 hours. |
| Contraindications |
|
Immunosuppressed. Active TB. Febrile illness. UTI. Gross hematuria. Do not give within 7 days after bladder biopsy, transurethral resection (TUR), or traumatic catheterization. |
| Precautions |
|
Not a vaccine for prevention of cancer or TB. Not for IV or SC 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). 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 (Cat.C). Nursing mothers: not recommended. |
| Interactions |
|
Immunosuppressants, myelosuppressants, radiation, antimicrobial therapy may reduce efficacy. |
| Adverse Reactions |
|
Urine discoloration, bladder irritation, inflammation (begins after 4 hrs and last up to 72 hrs), malaise, fever, chills, flu-like syndrome, systemic BCG infection, dysuria, urinary frequency, hematuria, cystitis, urgency, nocturia, cramps, pain, incontinence, rigors, arthralgia. |
| How Supplied |
|
Vial—1 |
| Additional Resources |
|
• Related Prescribing Note |
|
|
|
|
