"The U.S. Food and Drug Administration approved Varubi (rolapitant) to prevent delayed phase chemotherapy-induced nausea and vomiting (emesis). Varubi is approved in adults in combination with other drugs (antiemetic agents) that prevent nausea an"...
Tice Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Tice BCG Live is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis bacteria used to treat bladder cancer that is localized (has not spread to other parts of the body). This medication may be available in generic form. Common side effects include nausea, stomach pain, loss of appetite, bladder or groin pain, urine leakage or incontinence, diarrhea, constipation, headache, skin rash, dizziness, tired feeling, or tissue particles in your urine (not blood).
The dose for the intravesical treatment of carcinoma in situ and for the prophylaxis of recurrent papillary tumors consists of one vial of Tice BCG suspended in 50 ml preservative-free saline. Tice BCG may interact with antibiotics, cancer medicine or radiation, cyclosporine, sirolimus, tacrolimus, basiliximab, efalizumab, muromonab-CD3, mycophenolate mofetil, azathioprine, leflunomide, etanercept, or steroids. Tell your doctor all medications and supplements you use. Tice BCG may be harmful to a fetus. Before you receive Tice BCG, tell your doctor if you are pregnant. Use birth control, and tell your doctor if you become pregnant during treatment. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.
Our Tice BCG Live 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?
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Tice 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 Tice (Bacillus of Calmette and Guerin)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Tice FDA Prescribing Information: Side Effects
Symptoms of bladder irritability, related to the inflammatory response induced, are reported in approximately 60% of patients receiving TICE® BCG. The symptoms 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 irritative bladder adverse effects can usually be managed symptomatically with products such as pyridium, propantheline bromide, oxybutynin chloride and acetaminophen. The mechanism of action of the irritative side effects has not been firmly established, but is most consistent with an immunological mechanism.3 There is no evidence that dose reduction or antituberculous drug therapy can prevent or lessen the irritative toxicity of TICE® BCG.
“Flu-like” symptoms (malaise, fever, and chills) which may accompany the localized, irritative toxicities often reflect hypersensitivity reactions which can be treated symptomatically. Antihistamines have also been used.5
Adverse reactions to TICE® BCG tend to be progressive in frequency and severity with subsequent instillation. Delay or postponement of subsequent treatment may or may not reduce the severity of a reaction during subsequent instillation.
Although uncommon, serious infectious complications of intravesical BCG have been reported.2,3,6 The most serious infectious complication of BCG is disseminated sepsis with associated mortality. In addition, M. bovis infections have been reported in lung, liver, bone, bone marrow, kidney, regional lymph nodes, and prostate in patients who have received intravesical BCG. Some male genitourinary tract infections (orchitis/epididymitis) have been resistant to multiple drug antituberculous therapy and required orchiectomy.
If a patient develops persistent fever or experiences an acute febrile illness consistent with BCG infection, BCG treatment should be discontinued and the patient immediately evaluated and treated for systemic infection (see WARNINGS).
TABLE V: SUMMARY OF ADVERSE EFFECTS SEEN IN 674
PATIENTS WITH SUPERFICIAL BLADDER CANCER, INCLUDING 153 WITH CARCINOMA IN SITU
|Adverse Event||N||Overall (Grade ≥ 3)||Adverse Event||N||Overall (Grade ≥ 3)|
|Dysuria||401||60% (11%)||Arthritis/Myalgia||18||3% ( < 1%)|
|Urinary Frequency||272||40% (7%)||Headache/Dizziness||16||2% (0)|
|Flu-Like Syndrome||224||33% (9%)||Urinary Incontinence||16||2% (0)|
|Hematuria||175||26% (7%)||Anorexia/Weight Loss||15||2% ( < 1%)|
|Fever||134||20% (8%)||Urinary Debris||15||2% ( < 1%)|
|Malaise/Fatigue||50||7% (0)||Allergy||14||2% ( < 1%)|
|Cystitis||40||6% (2%)||Cardiac (Unclassified)||13||2% (1%)|
|Urgency||39||6% (1%)||Genital Inflammation/Abscess||12||2% ( < 1%)|
|Cramps/Pain||27||4% (1%)||Respiratory (Unclassified)||11||2% ( < 1%)|
|Rigors||22||3% (1%)||Urinary Tract Infection||10||2% (1%)|
|Nausea/Vomiting||20||3% ( < 1%)||Abdominal Pain||10||2% (1%)|
The following adverse events were reported in ≤ 1% of patients: anemia, BCG sepsis, coagulopathy, contracted bladder, diarrhea, epididymitis/prostatitis, hepatic granuloma, hepatitis, leukopenia, neurologic (unclassified), orchitis, pneumonitis, pyuria, rash, thrombocytopenia, urethritis, and urinary obstruction.
In SWOG study 8795, toxicity evaluations were available on a total of 222 TICE® BCG-treated patients and 220 MMC-treated patients. Direct bladder toxicity (cramps, dysuria, frequency, urgency, hematuria, hemorrhagic cystitis, or incontinence) was seen more often with TICE® BCG, with 356 events compared to 234 events for MMC. Grade ≤ 2 toxicity was seen significantly more frequently following TICE® BCG treatment (p=0.003). No life-threatening toxicity was seen in either arm. Systemic toxicity with TICE® BCG was markedly increased compared to that of MMC, with 181 events for TICE® BCG compared to 80 for MMC. The frequency of toxicity was increased in all grades, particularly for grades 2 and 3. The most common complaints were malaise, fatigue and lethargy, fever, and abdominal pain. Thirty-two TICE® BCG patients were reported to have been treated with isoniazid. Five TICE® BCG patients had liver enzyme elevation, including two with grade 3 elevations. Eighteen of the 222 (8.1%) TICE® BCG patients failed to complete the prescribed protocol compared to 6.2% in the MMC group. Table VI summarizes the most common adverse reactions reported in this trial.7
TABLE VI: MOST COMMON ADVERSE REACTIONS IN SWOG STUDY
(N = 222)
(N = 220)
|All Grades||Grade ≥ 3||All Grades||Grade ≥ 3|
|Dysuria||115 (52%)||6 (3%)||77 (35%)||5 (2%)|
|Urgency/Frequency||112 (50%)||5 (2%)||63 (29%)||7 (3%)|
|Hematuria||85 (38%)||6 (3%)||56 (25%)||5 (2%)|
|Flu-Like Symptoms||54 (24%)||1 ( < 1%)||29 (13%)||0|
|Fever||37 (17%)||1 ( < 1%)||7 (3%)||0|
|Pain (Not Specified)||37 (17%)||4 (2%)||22 (10%)||1 ( < 1%)|
|Hemorrhagic Cystitis||19 (9%)||3 (1%)||10 (5%)||0|
|Chills||19 (9%)||0||2 (1%)||0|
|Bladder Cramps||18 (8%)||0||9 (4%)||0|
|Nausea||16 (7%)||0||12 (5%)||0|
|Incontinence||8 (4%)||0||3 (1%)||0|
|Diaphoresis||7 (3%)||0||1 ( < 1%)||0|
|Rash||6 (3%)||1 ( < 1%)||16 (7%)||2 (1%)|
|*The adverse reaction profile of TICE® BCG was similar in the Nijmegen study.8|
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