ND Clinical Board Review: BCG

Today's med: BCG (bee see jee) (brand name: BCG Vaccine, TherCys, TICE BCG)

Drug Class: Live Attenuated Bacillus Calmette-Guerin Vaccine, Live Attenuated Intravesical Bacillus Calmette-Guerin Vaccine

Indications: BCG vaccine: Immunization against Mycobacterium tuberculosis in persons not previously infected and who are at high risk for exposure. BCG vaccine is not routinely administered for the prevention of M. tuberculosis in the United States. The Advisory Committee on Immunization Practices (ACIP) recommends vaccination be considered for the following:

- Children with a negative tuberculin skin test who are continually exposed to (and cannot be separated from) adults who are untreated or ineffectively treated for TB disease when the child cannot be given long-term treatment for infection or if the adult has TB caused by strains resistant to isoniazid and rifampin.

- Healthcare workers with a high percentage of patients with M. tuberculosis strains resistant to both isoniazid and rifampin, if there is ongoing transmission of the resistant strains and subsequent infection is likely, or if comprehensive infection-control precautions have not been successful. In addition, healthcare workers should be counseled on the risks and benefits of vaccination and treatment of latent TB infection

BCG intravesical: Treatment and prophylaxis of carcinoma in situ of the bladder; prophylaxis of primary or recurrent superficial or minimally invasive papillary tumors following transurethral resection

Contraindications: Immunosuppressed patients or persons with congenital or acquired immune deficiencies (eg, HIV infection, leukemia, lymphoma, cancer therapy, immunosuppressive therapy such as corticosteroids); active tuberculosis; BCG intravesical additional contraindications: Febrile illness, urinary tract infection, or gross hematuria; current symptoms or previous history of a systemic BCG reaction; recent (<7-14 days) biopsy, transurethral resection (TUR), or traumatic catheterization; BCG vaccine additional contraindications: Prior hypersensitivity to the vaccine or any component of the formulation

Adverse Effects: Adverse reactions associated with BCG vaccination: Axillary lymphadenopathy, cervical lymphadenopathy, disseminated BCG infection (BCG osteomyelitis; may occur from 4 months to 2 years after vaccination), local reactions (induration, itching, lesions, lymphadenitis, pustule, tenderness, ulceration). Local reactions may persist for up to 3 months; more severe manifestations may occur up to 5 months after vaccination and persist for several weeks. Adverse effecs with intravesicular administration:

>10%: Central nervous system: Malaise (7% to 40%), fever (17% to 38%), chills (9% to 34%), pain (17%)

Gastrointestinal: Nausea/vomiting (3% to 16%), anorexia/weight loss (2% to 11%)

Genitourinary: Dysuria (52% to 60%), bladder irritation (50%), urinary frequency (40% to 50%), hematuria

(26% to 39%), cystitis (6% to 30%), urinary urgency (6% to 18%), urinary tract infection (2% to 18%)

Hematological: Anemia (<21%) Miscellaneous: Flu-like syndrome (24% to 33%)

1% to 10%: Central nervous system: Headache (2%), Dermatologic: Rash (2% to 3%), Gastrointestinal:

Diarrhea (6%), abdominal pain (2% to 3%), Genitourinary: Genital pain (10%), hemorrhagic cystitis (9%),

bladder cramps/pain (6% to 8%), urinary incontinence (2% to 6%), contracted bladder (5%), nocturia (5%),

urinary debris (2%), genital inflammation/abscess (2%), Hematological: Leukopenia (<6%), Neuromuscular

& skeletal: Arthralgia/myalgia (3% to 7%), cramps/pain (4%), rigors (3%), Renal: Renal toxicity (10%),

Respiratory: Pulmonary infection (<3%). Miscellaneous: Infection (<1% to 5%), diaphoresis (3%), allergy

(2%)

<1% (Limited to important or life-threatening): Abscesses, BCG infection, BCG reaction, blood urea nitrogen increased, coagulopathy, conjunctivitis, creatinine increased, disseminated sepsis, epididymitis, erythema nodosum leprosum, flank pain, granulomatous chorioretinitis, hepatic granuloma, hepatitis, interstitial lung disease, iritis, keratitis, M. bovis infection (lung, liver, bone, bone marrow, kidney, lymph nodes, prostate, eye, peritoneum), myoglobinuria, nephritis, orchitis, pneumonitis, prostatitis, pyelonephritis, renal failure, Reiter's syndrome, skin ulceration, thrombocytopenia, urethritis, urinary obstruction, urinary retention, uveitis

Standard Dosing: Should only be given intravesicularly (bladder irrigation) or percutaneously; do not administer I.V., SubQ, I.M., or intradermally.

Immunization against tuberculosis: Percutaneous: Note: Initial lesion usually appears after 10-14 days consisting of small, red papule at injection site and reaches maximum diameter of 3 mm in 4-6 weeks.

Children <1 month: 0.2-0.3 mL (half-strength dilution). Administer tuberculin test (5 TU) after 2-3 months; repeat vaccination after 1 year of age for negative tuberculin test if indications persist.

Children >1 month and Adults: 0.2-0.3 mL (full strength dilution); conduct postvaccinal tuberculin test (5 TU of PPD) in 2-3 months; if test is negative, repeat vaccination.

Immunotherapy for bladder cancer: Intravesicular: Adults: Note: Treatment should begin 7-14 days after biopsy or TUR. The contents of one vial is used for each dose.

TheraCys®: One dose instilled into bladder (retain for 2 hours) once weekly for 6 weeks followed by 1 treatment at 3, 6, 12, 18, and 24 months after initial treatment

TICE® BCG: One dose instilled into the bladder (retain for 2 hours) once weekly for 6 weeks (may repeat cycle 1 time) followed by approximately once monthly for at least 6-12 months