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Theracys

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Theracys

WARNINGS

Systemic BCG Reaction

A systemic BCG reaction is a systemic granulomatous illness, which may occur subsequent to exposure to BCG. Because it is usually difficult to isolate BCG organisms from affected organs, it is often unclear to what extent such a reaction is caused by an infectious process versus an inflammatory hypersensitivity reaction, hence the term "systemic BCG reaction". Based on past clinical experience with intravesical BCG, "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 for ≥ 12 hours; fever ≥ 38.5°C 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. (6) If TheraCys (bcg live (intravesical)) is administered within one week 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 (bcg live (intravesical)) in association with systemic BCG reaction in post-marketing experience.

Patients should be monitored 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, BCG instillations should be permanently discontinued, the patient immediately evaluated and treated for BCG infection and an infectious diseases consultation sought. (See PRECAUTIONS.)

Additional Warnings

TheraCys (bcg live (intravesical)) is not a vaccine for the prevention ofcancer.

TheraCys (bcg live (intravesical)) is an infectious agent. Physicians using this product should be familiar with the literature on the prevention and treatment of BCG-related complications and should be prepared in such emergencies to contact an infectious disease specialist with experience in treating the infectious complications of intravesical BCG. The treatment of the infectious complications of BCG requires long-term, multiple-drug antimycobacterial therapy. Special culture media are required for mycobacteria and physicians administering intravesical BCG should have these media readily available.

The use of TheraCys (bcg live (intravesical)) may cause tuberculin sensitivity. Since this is a valuable aid in the diagnosis of tuberculosis, it may be advisable to determine the tuberculin reactivity by testing before treatment.

Intravesical instillations of BCG should be postponed during treatment with antibiotics, since antimicrobial therapy may interfere with the effectiveness of TheraCys. (See DRUG INTERACTIONS) TheraCys (bcg live (intravesical)) should not be used in individuals with concurrent infections.

In patients with small bladder capacity, increased risk of bladder contracture should be considered in decisions to treat with TheraCys (bcg live (intravesical)) .

BCG infection of aneurysms and prosthetic devices (including arterial grafts, cardiac devices and artificial joints) have been reported following intravesical administration of BCG. (7) (8) The risk of these ectopic BCG infections has not been determined. The benefits of BCG therapy must be carefully weighed against the possibility of an ectopic BCG infection in patients with pre-existing arterial aneurysms or prosthetic devices ofany kind.

If a bacterial urinary tract infection (UTI) occurs during the course of TheraCys (bcg live (intravesical)) treatment, TheraCys (bcg live (intravesical)) instillation should be withheld until complete resolution of the bacterial UTI for two reasons: • the combination of a UTI and BCG-induced cystitis may lead to more severe adverse effects on the genitourinary tract and • BCG bacilli are sensitive to a wide variety of antibiotics; (9) antimicrobial administration may therefore diminish the efficacy of TheraCys (bcg live (intravesical)) . Similarly, patients undergoing antimicrobial therapy for other infections should be evaluated to assess whether the therapy might diminish the efficacy of TheraCys (bcg live (intravesical)) .

Caution: the stopper ofthe vial for this product contains natural rubber latex which may cause allergic reactions.

Management of Serious BCG Complications

Acute, localized irritative toxicities of TheraCys (bcg live (intravesical)) may be accompanied by systemic manifestations, consistent with a "flu-like" syndrome. Systemic adverse effects of 1-2 days' duration such as malaise, fever and chills often reflect hypersensitivity reactions. However, symptoms such as fever of ≥ 101.3°F (38.5°C), or acute localized inflammation such as epididymitis, prostatitis, or orchitis persisting longer than 2-3 days suggest active infection and evaluation for serious infectious complications should be considered.

In patients who develop persistent fever or experience an acute febrile illness consistent with BCG infection, two or more antimycobacterial agents should be administered while diagnostic evaluation, including cultures, is conducted. BCG treatment should be discontinued. Negative cultures do not necessarily rule out infection. Physicians using this product should be familiar with the literature on prevention, diagnosis and treatment of BCG-related complications and, when appropriate, should consult an infectious disease specialist or other physician with experience in the diagnosis and treatment of mycobacterial infections.

TheraCys (bcg live (intravesical)) is sensitive to the most commonly used antimycobacterial agents (isoniazid, rifampin and ethambutol). TheraCys (bcg live (intravesical)) is not sensitive to pyrazinamide.

PRECAUTIONS

General

TheraCys (bcg live (intravesical)) contains live mycobacteria and should be prepared and handled using aseptic technique. (See DOSAGE AND ADMINISTRATION, Preparation of Agent.) BCG infections have been reported in health care workers preparing BCG for administration. Needle stick injuries should be avoided during the handling and mixing of TheraCys (bcg live (intravesical)) .

Nosocomial infections have been reported in immunosuppressed patients receiving parenteral drugs that were prepared in areas in which BCG was prepared. (10) (11)

BCG is capable of dissemination when administered by intravesical route and serious infections, including fatal infections, have been reported in patients receiving intravesical BCG. (6) Care should be taken not to traumatize the urinary tract or to introduce contaminants into the urinary system. Seven to 14 days should elapse before TheraCys (bcg live (intravesical)) is administered following TUR, biopsy, or traumatic catheterization.

TheraCys (bcg live (intravesical)) may be administered to persons in groups at high risk for HIV infection only after careful evaluation of risk/benefit and with extra caution.

The use of TheraCys (bcg live (intravesical)) may cause a falsely positive tuberculin reaction sensitivity. It may therefore be advisable to test to determine the true tuberculin reactivity before treatment. (5)

Pregnancy Category C

Animal reproduction studies have not been conducted with TheraCys (bcg live (intravesical)) . It is also not known whether TheraCys (bcg live (intravesical)) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. TheraCys (bcg live (intravesical)) should not be given to a pregnant woman unless clearly needed. Women should be advised not to become pregnant while on therapy.

Nursing Mothers

It is not known whether TheraCys (bcg live (intravesical)) 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 (bcg live (intravesical)) in nursing infants, it is advisable to discontinue nursing or to discontinue the drug, taking into account the importance ofthe drug to the mother.

Pediatric Use

Safety and effectiveness of TheraCys (bcg live (intravesical)) for the treatment of superficial bladder cancer in pediatric patients have not been established. Therefore, TheraCys (bcg live (intravesical)) should not be used in pediatric patients.

REFERENCES

5. CDC. Guidelines for preventing the transmission of Mycobacterium tuberculosis in health-care settings. MMWR 2005;54(RR-17):1-89.

6. Lamm DL, et al. Incidence and treatment of complications of Bacillus Calmette-Guérin intravesical therapy in superficial bladder cancer. J Urol 1992;147:596-600.

7. Stone D. Mycobacterium bovis infection of an implantable defibrillator following intravesical therapy with bacille Calmette-Guérin. Clin InfDis 1993;16:825-6.

8. Wolf YG, et al. Infection of a ruptured aortic aneurysm and an aortic graft with bacille Calmette-Guérin after intravesical administration for bladder cancer. J Vasc Surg 1995;22:80-4.

9. Durek C, et al. Interference of modern antibacterials with bacillus Calmette-Guérin viability. J Urol 1999;162:1959-62.

10. Stone MM, et al. Brief report: Meningitis due to iatrogenic BCG infection in two immunocompromised children. N Engl J Med 1995,333:561-3.

11. Waecker NJ, et al. Nosocomial transmission of Mycobacterium bovis bacille Calmette-Guérin to children receiving cancer therapy and to their health-care providers. Clin Infect Dis 2000;30:356-62.

12. Böhle A, Jocham D. Intravesical immunotherapy with Bacillus Calmette-Guérin, facts, figures and results. München, Germany: Urban & Fischer; 2000. p. 111-2.

Last reviewed on RxList: 10/28/2008
This monograph has been modified to include the generic and brand name in many instances.

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