Theracys

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 8/12/2021
Theracys Side Effects Center

What Is Theracys?

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).

What Are Side Effects of Theracys?

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. Other side effects of TheraCys include:

Tell your doctor if you have unlikely but serious side effects of TheraCys including:

  • muscle or joint pain,
  • pain or swelling of the testes,
  • unusual tiredness,
  • fast or pounding heartbeat,
  • shortness of breath,
  • cough,
  • vision changes,
  • redness/swelling/pain in the eye,
  • eye sensitivity to light,
  • severe stomach or abdominal pain, or
  • yellowing skin or eyes.

Dosage for Theracys

One dose of TheraCys consists of 81 mg (dry weight) BCG, administered through a urethral catheter.

What Drugs, Substances, or Supplements Interact with Theracys?

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.

Theracys During Pregnancy or Breastfeeding

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, breastfeeding while using this drug is not recommended.

Additional Information

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.

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Skin Cancer Symptoms, Types, Images See Slideshow
Theracys Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with BCG.

Call your doctor at once if you have:

  • fever, chills, aches, weakness, flu-like symptoms;
  • cough or trouble breathing;
  • pain or burning when you urinate;
  • a weak stream of urine, trouble emptying your bladder;
  • blood in your urine, dark urine;
  • vomiting, upper stomach pain;
  • jaundice (yellowing of your skin or eyes); or
  • signs of a penis infection--burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, not feeling well.

About 4 to 6 hours after treatment, you may have bladder symptoms such as sudden urges to urinate, frequent urination, stomach discomfort, bloating, and possibly loss of bladder control. Tell your doctor right away if these side effects last for longer than 2 or 3 days.

Common side effects may include:

  • increased urination;
  • painful urination;
  • fever; or
  • flu symptoms.

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.

Read the entire detailed patient monograph for Theracys (BCG Live (Intravesical))

Theracys Professional Information

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
TheraCys
(N=112)
Doxorubicin
(N=119)
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 entire FDA prescribing information for Theracys (BCG Live (Intravesical))

© Theracys Patient Information is supplied by Cerner Multum, Inc. and Theracys Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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