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Systemic BCG Reaction
A systemic BCG reaction is a systemic granulomatous illness, which may occur subsequent to exposure to TheraCys. Because it is usually difficult to isolate BCG organisms from affected organs, the extent such a reaction is caused by an infectious process versus an inflammatory hypersensitivity reaction often is unclear. “Systemic BCG reaction” may be defined as the presence of any of the following signs, if no other etiologies for such signs are detectable: fever ≥ 39.5°C(&ge103.1°F)for ≥ 12 hours; fever ≥ 38.5°C ( ≥ 101.3°F) for ≥ 48 hours; pneumonitis; hepatitis; other organ dysfunction outside of the genitourinary tract with granulomatous inflammation on biopsy; or the classical signs of sepsis, including circulatory collapse, acute respiratory distress, and disseminated intravascular coagulation. If TheraCys is administered within two weeks of either biopsy, TUR or traumatic bladder catheterization (associated with hematuria), a systemic BCG reaction is much more likely to occur. Death has been reported with the use of TheraCys in association with systemic BCG reaction in post-marketing experience.
To help prevent serious infections, avoid trauma and/or introduction of contaminants to the urinary tract. Wait a minimum of 14 days after traumatic catheterization before administering TheraCys. Resume TheraCys treatment according to the original schedule. BCG infections of aneurysms and prosthetic devices (including arterial grafts, cardiac devices, and artificial joints) have been reported following intravesical administration of BCG. The risk of these ectopic BCG infections has not been determined. The benefits of TheraCys therapy must be carefully weighed against the possibility of an ectopic BCG infection in patients with pre-existing arterial aneurysms or prosthetic devices of any kind.
Monitor patients for the presence of symptoms and signs of toxicity after each intravesical treatment. If a patient develops persistent fever or experiences an acute febrile illness consistent with BCG infection, permanently discontinue BCG instillations, evaluate and treat the patient immediately for BCG infection, and seek an infectious diseases consultation. As standard therapy for BCG infection, promptly initiate treatment with 2 or more antimycobacterial agents while conducting diagnostic evaluation, including cultures. Do not use single antibiotic therapy. Negative cultures do not rule out infection.
TheraCys is not sensitive to pyrazinamide.
Bacterial Urinary Tract Infection (UTI)
Do not use antimycobacterial drugs (e.g., isoniazid) prophylactically to prevent the local, irritative side effects of TheraCys. They may affect the effectiveness of TheraCys and there are no data to suggest that the acute, local urinary tract symptoms common with intravesical BCG are due to mycobacterial infection.
Because TheraCys contains live mycobacteria, prepare, handle and dispose of TheraCys, and all equipment, supplies and receptacles in contact with TheraCys, as biohazardous waste (or material). Use aseptic techniques, wear gloves and eye protection, and take precautions to avoid contact of TheraCys with broken skin. Avoid needle stick injuries during the handling and mixing of TheraCys.
BCG infections have been reported in health care workers preparing BCG for administration. Nosocomial infections have been reported in immunosuppressed patients receiving parenteral drugs that were prepared in areas in which BCG was prepared.
The stopper of the vial for this product contains natural rubber latex, which may cause allergic reactions.
Use In Specific Populations
Pregnancy Category C
Animal reproduction studies have not been conducted with TheraCys. It is also not known whether TheraCys can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. TheraCys should not be given to a pregnant woman unless clearly needed. Women should be advised not to become pregnant while on therapy.
It is not known whether TheraCys can be excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions from TheraCys in nursing infants, it is advisable to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness of TheraCys for the treatment of superficial bladder cancer in pediatric patients have not been established.
In clinical studies with TheraCys, analyses evaluating the differences in safety and efficacy between study subjects 65 years of age and older versus younger subjects were not performed. No other data are available about the potential impact of age on the safety and efficacy of TheraCys.
Small Bladder Capacity
In patients with small bladder capacity, consider increased risk of bladder contracture when making the decision to treat with TheraCys.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 2/4/2016
Additional Theracys Information
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