July 24, 2016
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Overdosage occurs if more than one vial of TheraCys is administered per instillation. If overdosage occurs, closely monitor the patient for signs of active local or systemic infection [See WARNINGS AND PRECAUTIONS].



Known systemic hypersensitivity reaction to any component [See Latex and DESCRIPTION] of TheraCys or after a previous administration of TheraCys or after a previous administration of TheraCys or a medicinal product containing the same substances is a contraindication to the administration of TheraCys.

Immunosuppressed Persons

Because of the risk of disseminated BCG infection, immunosuppressed persons with congenital or acquired immune deficiencies, whether due to concurrent disease (e.g., AIDS, leukemia, lymphoma), cancer therapy (e.g., cytotoxic drugs, radiation), or immunosuppressive therapy (e.g., corticosteroids) should not receive TheraCys. [See DRUG INTERACTIONS]

Systemic BCG Reaction

Do not use TheraCys in patients with current symptoms or a previous history of systemic BCG reaction. [See WARNINGS AND PRECAUTIONS]

A minimum of 14 days must elapse before TheraCys is administered following biopsy, TUR, or traumatic catheterization.

Patients With Increased Risk Of BCG Infection

Postpone TheraCys treatment until resolution of a concurrent febrile illness, urinary tract infection, or macroscopic hematuria.

Active Tuberculosis

Do not administer TheraCys to persons with active tuberculosis. Rule out active tuberculosis before starting treatment with TheraCys.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 2/4/2016


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