Theracys (BCG Live (Intravesical)) Drug Information: Overdosage and Contraindications

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May 27, 2012

Theracys

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The urinary bladder, or the bladder, is a hollow organ present in the pelvis. Most of it lies behind the pubic bone of the pelvis but when full it can extend up into the lower part of the abdomen. Its primary function is to store urine that drains into it from the kidney through tube-like structures called the ureters. The ureters from both the kidneys open into the urinary bladder. The bladder forms a low-pressure reservoir which gradually stretches out as urine fills into it. In males, the prostate gland is located adjacent to the base of the bladder where urethra joins the bladder. From time to time, the muscular wall of the bladder contracts to expel urine through the urinary passage (urethra) into the outside world.

What are the layers of the bladder?

The bladder consists of three layers of tissue. The innermost layer of the bladder which comes into contact with the urine stored inside the bl...

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Theracys

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OVERDOSE

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.

CONTRAINDICATIONS

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)

REFERENCES

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.