August 24, 2016
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Side Effects


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.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a medicinal product cannot be directly compared to rates in the clinical trials of another medicinal product and may not reflect the rates observed in practice.

Administration of TheraCys causes an inflammatory response in the bladder, thus requiring careful patient monitoring. Symptoms of bladder irritability are reported in approximately 50% of patients receiving TheraCys and typically begin 4-6 hours after instillation and last 24-72 hours. The irritative reactions usually are seen following the third instillation and tend to increase in severity after each administration. There is no evidence that dose reduction or antituberculous drug therapy can prevent or lessen the irritative symptoms of TheraCys.

In a clinical trial conducted in the United States, patients with stage Ta or T1 papillary tumor with 2 or more recurrences within the last 12 months, with carcinoma in situ (CIS), or with both of these conditions, were randomized to receive treatment with intravesical TheraCys or doxorubicin. Prior therapy with either BCG or doxorubicin was not allowed. Patients with muscle-invasive cancers or incomplete resection of papillary tumors were not eligible. Onehundred and twelve patients received TheraCys in 6 weekly instillations, followed by single instillations at 3, 6, 12, 18, and 24 months after enrollment, and were included in safety analyses. In the control group, 119 patients received doxorubicin in 5 weekly treatments, followed by 11 monthly treatments. Safety information was collected prior to each treatment dose.

Table 1 shows the frequency of adverse reactions observed in this trial. Local irritative symptoms were more common with TheraCys than with doxorubicin; however, grade ≥ 3 irritative toxicity was similar, occurring in approximately 2-7% of patients. Systemic symptoms (fever, chills, malaise, anorexia) were also more common with TheraCys. Overall, grade ≥ 3 toxicities were seen in 26 patients (23%) treated with TheraCys and 25 patients (21%) treated with doxorubicin. TheraCys treatment was discontinued in twelve patients due to toxicity.

Table 1: Adverse Reactions Reported in Patients Treated with TheraCys in a Trial Conducted in the United States

System/Organ Class Adverse reaction Study Arm
All Grades % Grade ≥ 3 % All Grades % Grade ≥ 3 %
Infections and Infestations
  Cystitis 29.5 0 19.3 0.8
  Urinary tract infection 17.9 0 17.6 0
  Pulmonary infection 2.7 0 4.2 0.8
  Systemic infection 2.7 1.8 0.8 0
  Infection 0.9 0.9 0.8 0
Blood and Lymphatic System Disorders
  Anemia 20.5 0 24.4 0
  Leukopenia 5.4 0 5.9 0
  Coagulopathy/ Thrombocytopenia 0.9 0 0.8 0
Metabolism and Nutrition Disorders
  Anorexia 10.7 0 5.0 0
Nervous System Disorders
  Headache 1.8 0 3.4 0
  Dizziness 0.9 0 0.8 0
Cardiac Disorders
  Cardiac (unclassified) 2.7 0 3.4 0.8
Gastrointestinal Disorders
  Nausea/Vomiting 16.1 0 8.4 0.8
  Diarrhea 6.3 0 1.7 0
  Abdominal pain 2.7 0 2.5 0
  Constipation 0.9 0 0.8 0
Hepatobiliary Disorders
  Liver involvement 2.7 0 0.8 0
Skin and Subcutaneous Tissue Disorders
  Skin rash 1.8 0 2.5 0
Musculoskeletal, Connective Tissue, and Bone Disorders
  Arthralgia/Myalgia/ Arthritis 7.1 0.9 4.2 0
  Flank pain 0.9 0 0.8 0
Renal and Urinary Disorders
  Dysuria 51.8 3.6 40.3 5.9
  Urinary frequency 40.2 1.8 28.6 4.2
  Hematuria 39.3 7.1 27.7 6.7
  Urinary urgency 17.9 0.9 11.8 2.5
  Renal toxicity (NOS) 9.8 1.8 9.2 0.8
  Urinary incontinence 6.3 0 0.8 0.8
  Bladder cramps/pain 6.3 0 5.0 1.7
  Contracted bladder 5.4 0.9 5.0 0.8
  Tissue in urine 0.9 0 1.7 0
  Ureteral obstruction 0.9 0.9 0 0
Reproductive System and Breast Disorders
  Genital pain 9.8 0 13.4 1.7
General Disorders and Administration Site Conditions
  Malaise 40.2 1.8 14.3 0
  Fever ( > 38°C) 38.4 2.7 9.2 0
  Chills 33.9 2.7 5.9 0
  Fatigue 0.9 0 0 0

Postmarketing Experience

The following additional adverse reactions have been identified during post-approval use of TheraCys. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Infections and Infestations

BCG Infection: BCG is capable of dissemination when administered by the intravesical route. Serious infections, including sepsis with associated mortality, have been reported. BCG infections have also been reported in eye, lung, liver, bone, bone marrow, kidney, regional lymph nodes, peritoneum, genitourinary tract (orchitis/epididymitis), and prostate (e.g., Granulomatous prostatitis). BCG infection of aneurysms and prosthetic devices (including arterial grafts, cardiac devices and artificial joints) has also been reported.

Joint symptoms (arthritis, arthralgia), ocular symptoms (including conjunctivitis, uveitis, iritis, keratitis, granulomatous choreoretinitis), urinary symptoms (including urethritis), skin rash, alone or in combination (Reiter's syndrome), have been reported following administration of TheraCys. For the reports of Reiter's syndrome, the risk seems to be more elevated among patients who are positive for HLA-B27.

Renal abscess

Respiratory, Thoracic and Mediastinal Disorders

Pneumonia, interstitial lung disease

Skin and Subcutaneous Tissue Disorders

Erythema nodosum

Renal and Urinary Disorders

Renal failure, pyelonephritis, nephritis (including tubulointerstitial nephritis, interstitial nephritis and glomerulonephritis)

Urinary retention (including bladder tamponade and feeling of residual urine)

General Disorders and Administration Site Conditions

Flu-like symptoms

Investigations (Laboratory Tests)

Abnormal/increased blood creatinine or blood urea nitrogen (BUN)

Read the Theracys (bcg live (intravesical)) Side Effects Center for a complete guide to possible side effects


Immunosuppressive Treatments

Treatments using immunosuppressants, myelosuppressants, or radiation interfere with the development of the immune response to TheraCys and increase the risk of disseminated BCG infection.

Carefully consider TheraCys treatment decisions in patients with a condition that may require future mandatory immunosuppression (e.g., awaiting an organ transplant, myasthenia gravis).

Antimicrobial Therapy

Antimicrobial therapy for other infections may interfere with the effectiveness of TheraCys.

Clinical Test Interactions

Intravesical treatment with TheraCys may induce a positive response to a tuberculin skin test [tuberculin purified protein derivative (PPD)], which may complicate future interpretations of skin test reactions to PPD when used to diagnose suspected mycobacterial infections. If a patient's reactivity to PPD needs to be determined, the Tuberculin Skin Test should be conducted before administration of TheraCys.

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

Last reviewed on RxList: 2/4/2016

Side Effects

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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