See Supplemental Patient Information
- Serious infections, including fatal infections, have been reported in patients receiving intravesical BCG [US BlackBox Warning]
- BCG vaccine live is not a vaccine for the prevention of cancer and tuberculosis. Physicians administering this product should be familiar with the literature on the prevention and treatment of BCG-related complications and should be prepared in emergencies to contact an infectious disease specialist experienced in treating the infectious complications of intravesical BCG
- An infectious complication of BCG may require prolonged, multiple-drug antibiotic therapy. Special culture media may be required for mycobacteria; physicians administering intravesical BCG or those caring for these patients should have these media readily available
- Deaths have occurred as a result of systemic BCG infection and sepsis. Monitor patients for the signs and symptoms of toxicity after each intravesical treatment
- Antituberculous therapy is recommended if systemic BCG infection occurs, which is manifested as febrile episodes with flu-like symptoms lasting >72 hours, fever
103°F, systemic manifestations increasing in intensity with repeated instillations, or persistent abnormalities of liver function tests - Patients receiving antibiotic treatment should postpone intravesical instillations of BCG, since antimicrobial therapy may interfere with the effectiveness of the vaccine. Avoid use in individuals with concurrent infections
- Small bladder capacity may be associated with an increased risk of severe local reactions and should be considered in deciding to use this product
- Acute, localized irritative toxicities of BCG vaccine may be characterized by systemic manifestations, consistent with a flu-like syndrome. Hypersensitivity reactions often include systemic adverse effects of 1-2 days' duration such as malaise, fever, and chills. Symptoms such as fever 38.5°C (101.3°F), or acute localized inflammation such as epididymitis, prostatitis, or orchitis persisting longer than 2-3 days may suggest active infection; consider evaluation for serious infectious complication while on therapy
- If patients develop persistent fever or experience an acute febrile illness consistent with BCG infection, administer 2 or more antimycobacterial agents during diagnostic evaluation; also discontinue BCG treatment
- Product should be prepared and handled with care using aseptic technique as it contains live mycobacteria. Avoid needle stick injuries during handling and mixing of BCG. BCG infection of aneurysms and prosthetic devices have been reported following intravesical BCG administration. Carefully weigh the benefits of BCG therapy against the possibility of an ectopic BCG infection in patients with pre-existing aretrial aneurysms or prosthetic devices
- If a bacterial urinary tract infection occurs during the course of BCG treatment, withhold therapy until complete resolution of the bacterial UTI
- Exercise caution not to traumatize the urinary tract or to introduce contaminants into the urinary system
- Tuberculin sensitivity may occur with this vaccine. Advise patients to determine tuberculin reactivity by PPD skin testing prior to treatment
Cautions: Use cautiously in
- HIV infection risk
- Hypersensitivity to latex [TheraCys]
Supplemental Patient Information
- Advise patients to retain BCG vaccine live [intravesical] in the bladder for as long as 2 hours and then void
- Advise patients to void while seated in order to avoid transmission of BCG to others for 6 hours after treatment. Disinfect urine voided with an equal volume of household bleach and allow to stand for 15 minutes before flushing
- Instruct patients to increase fluid intake in order to flush the bladder for several hours following treatment, unless medically contraindicated
- Warn patients that they may experience burning with the first void after treatment
- Advise patients to notify their physicians if they experience fever, chills, malaise, flu-like symptoms, or severe urinary symptoms that last more than 48 hours or increase in severity
- Educate patients on appropriate infection control procedures to protect family and close contacts from infection
