Dosing and uses of TheraCys, Tice BCG (BCG intravesical live)
Adult dosage forms and strengths
intravesical solution
- 1-8 x 10^8CFU/vial
- 10^8-10^9CFU/vial
Carcinoma in Situ (CIS) of the Urinary Bladder
Tice BCG: 1 vial of Tice BCG suspended in preservative-free saline 50 mL instilled into bladder by gravity flow via catheter; agent should be retained in bladder 2 hours and then voided
TheraCys: One dose consists of intravesical instillation of BCG 81 mg; insert catheter into bladder under aseptic conditions and drain bladder; instill 53 mL suspension of TheraCys slowly by gravity, begin 7-14 days after biopsy or transurethral resection
- Induction: administer 1 dose each week for 6 consecutive weeks
- Maintenance, administer 1 dose 3, 6, 12, 18, and 24 months following initial dose
Papillary Tumors
Indicated for prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR)
Limitations: BCG live is not recommended for stage TaG1 papillary tumors, unless they are judged to be at high risk of tumor recurrence
Tice BCG: 1 vial of Tice BCG suspended in preservative-free saline 50 mL instilled into bladder by gravity flow via catheter; agent should be retained in bladder 2 hours and then voided
TheraCys: One dose consists of intravesical instillation of BCG 81 mg; insert catheter into bladder under aseptic conditions and drain bladder; instill 53 mL suspension of TheraCys slowly by gravity, begin 7-14 days after biopsy or transurethral resection
- Induction: administer 1 dose each week for 6 consecutive weeks
- Maintenance, administer 1 dose 3, 6, 12, 18, and 24 months following initial dose
Tice BCG Administration
Patients should not drink fluids for 4 hours before treatment and should empty their bladder prior to Tice BCG administration
Draw 1 mL of sterile diluent (preservative-free NS) at 4C-25C (39F-77F), into a small syringe and add to one ampule to resuspend
Leave them in contact for about 1 minute
Then mix the suspension by withdrawing it into the syringe and expelling it gently back into the ampule 2 or 3 times
Avoid the production of foam; do not shake
Dilute the reconstituted product in an additional 49 mL of saline diluent, bringing the total volume to 50 mL
Instill into bladder slowly by gravity flow, via the catheter
Administration
See also BCG vaccine
Monitor q3Months for recurrence/progression of CIs
Pediatric dosage forms and strengths
Not recommended
TheraCys, Tice BCG (BCG intravesical live) adverse (side) effects
>10%
Dysuria (60%)
Urinary frequency (50%)
Hematuria (39%)
Fever (38%)
Chills (34%)
Flu like syndrome (33%)
Cystitis (29%)
Anemia (21%)
Urinary urgency (18%)
UTI (18%)
Pain (17%)
Nausea (16%)
Vomiting (16%)
Anorexia (11%)
Nocturia (11%)
Leukopenia (5%)
1-10%
Genital pain (10%)
Renal toxicity (10%)
Arthralgia (7%)
Myalgia (7%)
Urinary incontinence (7%)
Urinary retention (6%)
Abdominal pain (5%)
Coagulopathy (<5%)
Constipation (<5%)
Contracted bladder (5%)
Pulmonary infection (<5%)
Skin rash (<5%)
Thrombocytopenia (<5%)
Diarrhea (3%)
Rigors (3%)
Respiratory unclassified (2%)
Weight loss (2%)
Hepatic granuloma (1%)
Hepatitis (1%)
Pneumonitis (1%)
Urethritis (1%)
Urinary obstruction (1%)
Warnings
Black box warnings
Contains live, attenuated mycobacteria; potential risk for transmission
Prepare, handle, and dispose of as a biohazardous materiaL
BCG infections have been reported in health care providers, primarily from exposures resulting from accidental needle sticks or skin lacerations during preparation for administration
Nosocomial infections have been reported in patients receiving parenteral drugs that were prepared in areas in which BCG live was reconstituted
Capable of infection dissemination when administered by intravesical route; serious infections, including fatal infections, have been reported
Contraindications
Immunosuppression (any cause), febrile illness, active tuberculosis
Perforated bladder mucosa
Cautions
May cause tuberculin sensitivity
Pregnancy and lactation
Pregnancy category: C
Lactation: excretion in milk unknown/not recommended
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of TheraCys, Tice BCG (BCG intravesical live)
Half-Life: no studies conducted
Metabolism: no studies conducted
Excretion: no studies conducted
Mechanism of action
Live, attenuated Mycobacterium bovis; stimulates immune response
