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Theracys Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
TheraCys [BCG Live (Intravesical)] is made using the organisms of a bacteria (Bacillus Calmette and Guérin) used to treat bladder cancer that is localized (has not spread to other parts of the body). Common side effects of TheraCys include bladder irritation (e.g., difficult/painful/frequent/bloody urination), urine leakage or incontinence, bladder or groin pain, tissue particles in your urine (not blood), fever, or chills. High/persistent fever may be a sign of an infection. Tell your doctor if side effects occur, persist, or worsen. Other side effects of TheraCys include nausea, vomiting, stomach pain, loss of appetite, diarrhea, constipation, headache, skin rash, dizziness, or tired feeling.
One dose of TheraCys consists of 81 mg (dry weight) BCG, administered through a urethral catheter. TheraCys may interact with antibiotics, or drugs that weaken your immune system, such as: cancer medicine or radiation, cyclosporine, sirolimus, tacrolimus, basiliximab, efalizumab, muromonab-CD3, mycophenolate mofetil, azathioprine, leflunomide, etanercept, or steroids. Tell your doctor all medications you use. During pregnancy, TheraCys should be used only when prescribed. Women receiving this medication should avoid pregnancy. Consult your doctor to discuss using 2 forms of birth control (e.g., condoms, birth control pills) while receiving this medication. If you become pregnant or think you may be pregnant, tell your doctor. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended.
Our TheraCys [BCG Live (Intravesical)] Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Theracys in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Report any side effects to your doctor. Some side effects may be serious, including:
- fever, chills, cough, body aches, joint pain, weakness, vomiting, or other flu symptoms;
- nausea, vomiting, stomach pain, jaundice (yellowing of your skin or eyes);
- pain or burning when you urinate;
- difficult urination;
- more frequent or urgent urinating;
- blood in your urine, lower back pain;
- pain or swelling in your testicles;
- easy bruising or bleeding;
- eye pain, redness, watering, severe burning or itching; or
- vision changes, increased sensitivity to light.
Less serious side effects may include:
- mild nausea, stomach pain, or loss of appetite;
- mild bladder or groin pain;
- urine leakage or incontinence;
- diarrhea, constipation;
- mild skin rash;
- dizziness, tired feeling; or
- tissue particles in your urine (not blood).
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Theracys (BCG Live (Intravesical))
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Theracys Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: muscle/joint pain, pain/swelling of the testes, unusual tiredness, fast/pounding heartbeat, shortness of breath, cough, vision changes, redness/swelling/pain in the eye, eye sensitivity to light, severe stomach/abdominal pain, yellowing skin/eyes.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Theracys (BCG Live (Intravesical))
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Theracys FDA Prescribing Information: Side Effects
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|
|Urinary tract infection||17.9||0||17.6||0|
|Blood and Lymphatic System Disorders|
|Metabolism and Nutrition Disorders|
|Nervous System Disorders|
|Skin and Subcutaneous Tissue Disorders|
|Musculoskeletal, Connective Tissue, and Bone Disorders|
|Renal and Urinary Disorders|
|Renal toxicity (NOS)||9.8||1.8||9.2||0.8|
|Tissue in urine||0.9||0||1.7||0|
|Reproductive System and Breast Disorders|
|General Disorders and Administration Site Conditions|
|Fever ( > 38°C)||38.4||2.7||9.2||0|
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.
Respiratory, Thoracic and Mediastinal Disorders
Pneumonia, interstitial lung disease
Skin and Subcutaneous Tissue Disorders
Renal and Urinary Disorders
Urinary retention (including bladder tamponade and feeling of residual urine)
General Disorders and Administration Site Conditions
Investigations (Laboratory Tests)
Abnormal/increased blood creatinine or blood urea nitrogen (BUN)
Read the entire FDA prescribing information for Theracys (BCG Live (Intravesical))
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