Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 14 April 2017


TheraCys is indicated for intravesical treatment and prophylaxis of urinary bladder carcinoma in situ (CIS) and for the prophylaxis of primary or recurrent stage Ta
and/or T1 papillary tumors following transurethral resection (TUR). (1)

Limitation of Use: TheraCys is not recommended for
• Stage Ta low-grade papillary tumors, unless they are judged to be at high risk of recurrence. (1)
• Immunization against tuberculosis. (1)

Full Prescribing information

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Advisory information

• Known systemic hypersensitivity reaction to any component of TheraCys or after a previous administration of TheraCys. (4.1)
• Immunosuppression due to congenital or acquired immune deficiencies, concurrent disease, cancer therapy, or immunosuppressive therapy. (4.2)
• Symptoms or a previous history of systemic BCG reaction. (4.3)
• Concurrent febrile illness, urinary tract infection, or macroscopic hematuria. (4.4)
• Active tuberculosis. (4.5)
Special warnings and precautions

• TheraCys®, BCG Live (Intravesical) contains live, attenuated mycobacteria. Because of the potential risk for transmission, prepare, handle, and dispose of TheraCys as a biohazard material. (2, 5)
• BCG is capable of dissemination when administered by the intravesical route. Serious infections, including fatal infections, have been reported in patients receiving Intravesical BCG. (5, 6)

• If TheraCys is administered within two weeks of either biopsy, TUR or traumatic bladder catheterization (associated with hematuria), a systemic BCG reaction is much more likely to occur. (5.1)
• If a bacterial urinary tract infection (UTI) occurs during the course of TheraCys treatment, withhold TheraCys instillation until complete resolution of the bacterial UTI. (5.3)
• If a patient develops persistent fever or experiences an acute febrile illness consistent with BCG infection, permanently discontinue BCG instillations. Initiate treatment with 2 or more antimycobacterial agents promptly while conducting diagnostic evaluation, including cultures. (5.2)
• Prepare and handle TheraCys using aseptic technique. Avoid needle stick injuries during the handling and mixing of TheraCys. (5.5)

Adverse reactions

The most common adverse reactions observed with TheraCys treatment at a rate > 10% were transient dysuria, urinary frequency and urgency, malaise, hematuria, fever, chills, cystitis, and mild nausea.

Symptoms of bladder irritability were reported in approximately 50% of patients receiving TheraCys, typically beginning 4-6 hours after instillation and lasting 24-72 hours. (6.1)

Usage information

Dosing and administration

For intravesical instillation only.
• Induction therapy: Administer one dose (81mg) TheraCys each week for 6 consecutive weeks. (2.1)
• Maintenance therapy: one dose given 3, 6, 12, 18 and 24 months following the initial dose. (2.1)

Use in special populations

Bladder capacity: There is an increased risk of bladder contracture when instilling TheraCys in patients with small bladder capacity. (8.6)


• Immunosuppressants interfere with the development of the immune response to TheraCys and increase the risk of disseminated BCG infection. (7.1)
• Antimicrobial therapy for other infections may interfere with the effectiveness of TheraCys. (7.2)
• Intravesical treatment with TheraCys may induce a positive response to a tuberculin skin test. (7.3)

More information

Category Value
Authorisation number BLA103943
Orphan designation No
Product NDC 49281-880
Date First Approved 22-07-2011
Marketing authorisation holder Sanofi Pasteur Inc.