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Theracys

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Theracys

Theracys

Theracys Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

TheraCys [BCG Live (Intravesical)] is used to treat bladder cancer that is localized (has not spread to other parts of the body). BCG (Bacillus Calmette and Guérin) is made using the organisms of a bacteria. Common side effects include bladder irritation (e.g., difficult/painful/frequent/bloody urination), fever, or chills. High/persistent fever may be a sign of an infection. Tell your doctor if effects occur, persist, or worsen. Nausea, vomiting, loss of appetite, or diarrhea may also occur.

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.

  • 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;
  • headache;
  • 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

SIDE EFFECTS: Bladder irritation (e.g., difficult/painful/frequent/bloody urination), fever, or chills may occur. High/persistent fever may be a sign of an infection. Tell your doctor or pharmacist promptly if any of these effects occur, persist, or worsen. Your doctor may prescribe additional medications to help control these symptoms. Nausea, vomiting, loss of appetite, or diarrhea may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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
(Adverse Reactions)

SIDE EFFECTS

Data from Clinical Studies

Administration of TheraCys (bcg live (intravesical)) causes an inflammatory response in the bladder and has been frequently associated with transient fever, hematuria, urinary frequency and dysuria; careful patient monitoring is required. Symptoms of bladder irritability are reported in approximately 50% of patients receiving TheraCys (bcg live (intravesical)) and typically begin 4-6 hours after instillation and last 24-72 hours. The irritative side effects are usually seen following the third instillation and tend to increase in severity after each administration. The mechanism of action of the irritative side effects has not been studied, but is most consistent with an immunological mechanism. There is no evidence that dose reduction or antituberculous drug therapy can prevent or lessen the irritative symptoms ofTheraCys (bcg live (intravesical)) .

The adverse reactions which occurred among 127 recipients of TheraCys (bcg live (intravesical)) during a US clinical trial are listed in Table 2. (4) The adverse reactions are combined totals caused by both the original bladder cancer and the TheraCys (bcg live (intravesical)) treatment.

Table 2: Adverse Reactions: Toxicity Data Derived From a US Clinical Trial (4)

Adverse Event Percent of Patients
(N = 127)
Overall (Grade ≥ 3)
Adverse Event Percent of Patients
(N = 127)
Overall (Grade ≥ 3)
Dysuria 52% (4%) Nausea/Vomiting 16% (0%)
Urinary Frequency 40% (2%) Anorexia 11% (0%)
Malaise 40% (2%) Renal Toxicity (NOS) 10% (2%)
Hematuria 39% (7%) Genital Pain 10% (0%)
Fever (>38°C) 38% (3%) Arthralgia/Myalgia 7% (1%)
Chills 34% (3%) Urinary Incontinence 6% (0%)
Cystitis 29% (0%) Cramps/Pain 6% (0%)
Anemia 21% (0%) Diarrhea 6% (0%)
Urinary Tract Infection 18% (1%) Contracted Bladder 5% (0%)
Urgency 18% (0%) Leukopenia 5% (0%)

The following adverse reactions were reported in < 5% of patients: coagulopathy, abdominal pain, liver involvement, systemic infection, pulmonary infection, cardiac (unclassified), headache, skin rash, tissue in urine, local infection, constipation, dizziness, fatigue, thrombocytopenia, ureteral obstruction and flank pain.

In a US Clinical Trial, 112 patients received TheraCys (bcg live (intravesical)) . The incidence of adverse reactions associated with intravesical TheraCys (bcg live (intravesical)) is given below.

The following adverse events were reported in =1% of patients: tissue in urine, local infection, constipation, dizziness, fatigue, thrombocytopenia and flank pain.

In this study, local irritative symptoms were more common with TheraCys (bcg live (intravesical)) than with doxorubicin; however, grade ≥ 3 irritative toxicity was similar, occurring in approximately 2-7% of patients. Systemic symptoms (fever, chills, malaise, etc.) were also more common with TheraCys (bcg live (intravesical)) . Overall, grade ≥ 3 toxicities were seen in 26 patients (23%) treated with TheraCys (bcg live (intravesical)) and 25 patients (21%) treated with doxorubicin. "Systemic infection" was reported to occur in three patients treated with TheraCys (bcg live (intravesical)) (one grade 2 and two grade 3) and one patient treated with doxorubicin (grade 2). In four patients, treatment was discontinued because of toxicity (two with irritative symptoms, one with severe hematuria and one with possible BCG infection). In addition, six patients refused further treatment because of severe local toxicity and/or chills. Six of these ten patients received TheraCys (bcg live (intravesical)) . Table 3 compares the common adverse events reported in this study.

Table 3: Comparative Toxicity from a US Clinical Trial (4)

  Study Arm
TheraCys (N=112) Doxorubicin (N=119)
All Grades Grade =3 All Grades Grade =3
Dysuria 58 (52%) 4 (4%) 48 (40%) 7 (6%)
Frequency 45 (40%) 2 (2%) 34 (29%) 5 (4%)
Malaise 45 (40%) 2 (2%) 17 (14%) 0
Hematuria 44 (39%) 8 (7%) 33 (28%) 8 (7%)
Fever (>38°C) 43 (38%) 3 (3%) 11 (9%) 0
Chills 38 (34%) 3 (3%) 7 (6%) 0
Cystitis 33 (29%) 0 23 (19%) 1 (<1%)
Urgency 20 (18%) 1 (<1%) 14 (12%) 3 (2%)
Nausea/Vomiting 18 (16%) 0 10 (8%) 1 (<1%)
Bladder Cramps/Pain 7 (6%) 0 6 (5%) 2 (1%)

Acute, localized irritative side effects of TheraCys (bcg live (intravesical)) 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 ≥ 38.5°C, or acute localized inflammation such as epididymitis, prostatitis, or orchitis, persisting longer than 48 hours suggest active infection and evaluation for serious infectious complication should be considered.

Data from Postmarketing Experience

These events were reported voluntarily from a population of uncertain size, it is not possible to reliably calculate their frequencies.

Symptomatic granulomatous prostatitis, epididymo-orchitis, and renal abscess associated with administration of intravesical BCG have been reported.

Ocular symptoms (including uveitis, conjunctivitis, iritis, keratitis, granulomatous choreoretinitis) alone, or in combination with joint symptoms (arthritis or arthralgia), urinary symptoms and/or skin rash, have been reported following administration of intravesical BCG. The risk appears to be elevated among patients who are positive for HLA-B27. (13)

Skin rash, arthralgia and migratory arthritis may be allergic reactions.

Serious infectious complications of intravesical BCG have been reported. The most serious infectious complication of BCG is disseminated sepsis associated with death. In addition, BCG infections have been reported in eye, lung, liver, bone, bone marrow, kidney, regional lymph nodes, peritoneum and prostate in patients who have received intravesical BCG. Some male genitourinary tract infections (orchitis/epididymitis) have been refractory to multiple drug antimycobacterial therapy and required orchiectomy.

Treatment ofAdverse Reactions

If a patient develops persistent fever or experiences an acute febrile illness consistent with BCG infection, BCG instillations should be permanently discontinued, the patient immediately evaluated and treated for BCG infection and an infectious disease consultation sought. (See WARNINGS and PRECAUTIONS.) Treatment with two or more antimycobacterial agents should be initiated promptly while diagnostic evaluation, including cultures, is conducted. Negative cultures do not necessarily rule out infection. TheraCys (bcg live (intravesical)) is sensitive to the most commonly used antimycobacterial agents (isoniazid, rifampin and ethambutol). TheraCys (bcg live (intravesical)) is not sensitive to pyrazinamide. (14)

Reporting ofAdverse Reactions

Patients should be encouraged to report all adverse events after treatment with TheraCys (bcg live (intravesical)) . Adverse events should be reported by health care providers to MEDWATCH (call 1-800-FDA-1088 or report on line to www.fda.gov/medwatch). Physicians, physician assistants, nurses and pharmacists should report adverse occurrences temporally related to the administration of the product to the Pharmacovigilance Department, Sanofi Pasteur Inc., Discovery Drive, Swiftwater PA 18370 or call 1-800-822-2463.

Read the entire FDA prescribing information for Theracys (BCG Live (Intravesical)) »

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Report Problems to the Food and Drug Administration

 

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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