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Overdosage occurs if more than one vial of TheraCys (bcg live (intravesical)) is administered per instillation. If overdosage occurs, the patient should be closely monitored for signs of active local or systemic infection. For acute local or systemic reactions suggesting active infection, an infectious disease specialist experienced in BCG complications should be consulted.
Because of the risk of disseminated BCG infection, TheraCys (bcg live (intravesical)) should not be used in immunosuppressed patients or persons with congenital or acquired immune deficiencies, whether due to concurrent disease (eg, AIDS, leukemia, lymphoma), cancer therapy (eg, cytotoxic drugs, radiation), or immunosuppressive therapy (eg, corticosteroids). (See PRECAUTIONS: DRUG INTERACTIONS.)
TheraCys (bcg live (intravesical)) is contraindicated for patients with current symptoms or a previous history of systemic BCG reaction. (See WARNINGS.) Treatment should be postponed until resolution ofa concurrent febrile illness, urinary tract infection, or gross hematuria. Seven to 14 days should elapse before TheraCys (bcg live (intravesical)) is administered following biopsy, TUR, or traumatic catheterization.
TheraCys (bcg live (intravesical)) should not be administered to persons with active tuberculosis. Active tuberculosis should be ruled out before starting treatment with TheraCys (bcg live (intravesical)) . A test for detecting Mycobacterium tuberculosis infection should be performed if PPD (purified protein derivative of tuberculin) status is unknown. A positive Mantoux test, by itself, is not a contraindication to using TheraCys (bcg live (intravesical)) but an assessment must be made regarding whether the patient has signs, symptoms and/or a chest x-ray consistent with active or latent tuberculosis that requires treatment with antimycobacterial drugs. (5)
5. CDC. Guidelines for preventing the transmission of Mycobacterium tuberculosis in health-care settings. MMWR 2005;54(RR-17):1-89.
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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