TheraCysÒ is not a vaccine for the prevention of cancer.

TheraCysÒ 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 antibiotic therapy. Special culture media are required for mycobacteria and physicians administering intravesical BCG should have these media readily available.

Intravesical instillation of TheraCysÒ into a patient with an actively bleeding urinary mucosa may promote systemic BCG infection. Treatment should be postponed for at least 1 week following transurethral resection, biopsy, traumatic catheterization, or gross hematuria.

Deaths have been reported as a result of systemic BCG infection and sepsis. Patients should be monitored for the presence of symptoms and signs of toxicity after each intravesical treatment. Febrile episodes with flu-like symptoms lasting more than 72 hours, fever ≥103° F (39.4° C), systemic manifestations increasing in intensity with repeated instillations, or persistent abnormalities of liver function tests suggest systemic BCG infection and may require antituberculous therapy. Local symptoms (prostatitis, epididymitis, orchitis) lasting more than 2-3 days may also suggest active infection (See Management of Serious BCG Complications subsection of Warnings).

The use of TheraCysÒ 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 PPD skin testing before treatment.

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

Small bladder capacity has been associated with increased risk of severe local reactions and should be considered in deciding to use TheraCysÒ therapy.

BCG infection 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, but is considered to be very small. 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 of any kind.

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

Management of Serious BCG Complications. Acute, localized irritative toxicities of TheraCysÒ 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.

TheraCysÒ is sensitive to the most commonly used antituberculous agents (isoniazid, rifampin and ethambutol). TheraCysÒ is not sensitive to pyrazinamide.

General

TheraCysÒ contains live mycobacteria and should be prepared and handled using aseptic technique (See Preparation of Agent subsection of Dosage and Administration). 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 TheraCysÒ . Nosocomial infections have been reported in immunosuppressed patients receiving parenteral drugs which were prepared in areas in which BCG was prepared.³ BCG is capable of dissemination when administered by intravesical route and serious infections, including fatal infections, have been reported in patients receiving intravesical BCG.⁴ 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 TheraCysÒ is administered following TUR, biopsy, or traumatic catheterization. TheraCysÒ should be administered with caution to persons in groups at high risk for HIV infection.

The use of TheraCysÒ may cause tuberculin sensitivity. It may therefore be advisable to determine the tuberculin reactivity by PPD skin testing before treatment.

Information For Patients

See Patient Information Section.

Pregnancy Category C: Animal reproduction studies have not been conducted with TheraCysÒ . It is also not known whether TheraCysÒ can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. TheraCysÒ 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 TheraCysÒ is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions from TheraCysÒ 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.

Pediatric Use: Safety and effectiveness of TheraCysÒ for the treatment of superficial bladder cancer in pediatric patients have not been established.

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