Dosing & Uses
Dosage Forms & Strengths
suspension reconstituted
- 50mg (Tice BCG)
- 81mg (TheraCys)
Tuberculosis Immunization
Used as TB immunization, primarily in developing countries
ACIP recommended use: TB exposed health care workers in high risk settings
0.2-0.3 mL percutaneous
Conduct tuberculin test 2-3 months after percutaneous administration; if test negative repeat vaccination
Immunotherapy for Bladder Cancer
Initiate treatment 7-14 days after biopsy
TheraCys: Instill one dose into bladder; retain for 2 hr; repeat dose once weekly for 6 weeks followed by 1 treatment at 3, 6, 12, 18, and 24 months after initial treatment
TICE BCG: Instill one dose into blatter; retain for 2 hr; repeat dose once weekly for 6 weeks (may repeat cycle once) followed by once monthly for 6-12 months
Administration
Okay to give Hib, DTP, OPV, IPV, MMR, influenza, and hepatitis B at same time
Dosage Forms & Strengths
suspension reconstituted
- 50mg (Tice BCG)
- 81mg (TheraCys)
Tuberculosis Immunization
Used as TB immunization, primarily in developing countries
ACIP recommended use: TB exposed TB skin test-negative infants and children
<1 month
- Half-strength (reconstitute with 2 mL instead of 1 mL sterile water)
- 0.2-0.3 mL percutaneous
- Conduct tuberculin test 2-3 months after percutaneous administration; if test negative repeat vaccination after 1 year
>1 month
- 0.2-0.3 mL percutaneous
- Conduct tuberculin test 2-3 months after percutaneous administration; if test negative repeat vaccination
Additional Information
Okay to give Hib, DTP, OPV, IPV, MMR, influenza, and hepatitis B at same time
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
>10%
Malaise (7-40%)
Fever (17-38%)
Pain (17%)
Chills (9-34%)
Nausea/vomiting (3-16%)
Dysuria (52-60%)
Hematutia (26-39%)
Urinary urgency (6-18%)
Infection (2-18%)
Anemia (21%)
Flu-lik syndrome (24-33%)
1-10%
Rash (2-3%)
Diarrhea (6%)
Abdominal pain (2-3%)
Headache (2%)
Leukopenia (6%)
Genital inflammation /abscess (2%)
Renal toxicity (10%)
Hemorrhagic cystitis (9%)
Nocturia (5%)
Urinary incontinence (2-6%)
Arthralgia/myalgia (3-7%)
Pulmonary infection (3%)
<1%
Urea nitrogen in blood increased
Creatinine increased
Disseminated sepsis
Hepatitis
Coagulopathy
Myoglobinuria
Nephritis
Uveitis
Warnings
Black Box Warning
Intravesical administration may cause disseminated infections
Contains live attenuated mycobacteria (handle with care and dispose properly)
Contraindications
Hypersensitivity, immunosuppression (corticosteroids)
Acquired immune deficiencies
Active tuberculosis
HIV infected patients
Bladder
- Febrile illness
- Urinary tract infection
- Gross hematuria
- Biopsy
- Transurethral resection
- Traumatic catherization
Cautions
Bacillus Calmette-Guérin strain of Mycobacterium bovis
Patient should have Mantoux skin test prior to vaccine administration
Following vaccination, Mantoux skin test usually positive; this is not a sensitive indicator of degree of protection
Immunity not permanent; duration unpredictable
Treat anaphylactoid reactions immediately
Intravesical administration may cause symptoms of bladder irritability 4-6 hr after instillation and increase in severity following each instillation; may last 24-72 hr
Use caution in patients with small bladder capacity
Postpone intravesical instillation during antibiotic therapy
Vaccination not recommended for patients with positive PPD reaction
Not for the treatment of active tuberculosis or prevention of cancer
May not result in effective immunity in all patients
Packaging may contain latex
Suspected adverse events after administration of any vaccine may be reported to Vaccine Adverse Events Reporting System (VAERS), 1-800-822-7967
Up-to-date vaccination schedules available at www.cdc.gov/nip/publications
Pregnancy & Lactation
Pregnancy Category: C
Lactation: Not known if excreted in breast milk, 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
Mechanism of Action
M. bovis strain in the vaccine, immunologically similar to M. tuberculosis, produces cell-mediated immunity and simulates M. tuberculosis infection
May convey active immunity via stimulation of production of endogenously produced antibodies
The onset of protection from disease is relatively slow, but duration is long lasting (years)
In bladder cancer a local inflammatory reaction may lead to destruction of superficial tumor cells of the endothellium; stimulates the host's immune system to reject the tumor
Images
Patient Handout
Formulary
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