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Tice

Last reviewed on RxList: 8/20/2020
Tice Side Effects Center

What Is Tice?

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). Tice BCG vaccine may be available in generic form.

What Are Side Effects of Tice?

Common side effects of Tice BCG vaccine include:

Dosage for Tice

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.

What Drugs, Substances, or Supplements Interact with Tice?

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 During Pregnancy and Breastfeeding

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.

Additional Information

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.

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Tice 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 Tice (Bacillus of Calmette and Guerin)

Tice Professional 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).

The local and systemic adverse reactions reported in a review of 674 patients with superficial bladder cancer, including 153 patients with carcinoma in situ, are summarized in Table V.

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%)
Nocturia 30 5% (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 8795*

Adverse Event StudyArm
TICE® BCG
(N = 222)
MMC
(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
Myalgia/Arthralgia 7 (3%) 0 0 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

Read the entire FDA prescribing information for Tice (Bacillus of Calmette and Guerin)

Related Resources for Tice

Related Drugs

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

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