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TICE BCG
Overview
What is TICE BCG?
TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of
The TICE strain was developed at the University of Illinois from a strain originated at the Pasteur Institute.
The medium in which the BCG organism is grown for preparation of the freeze-dried cake is composed of the following ingredients: glycerin, asparagine, citric acid, potassium phosphate, magnesium sulfate, and iron ammonium citrate. The final preparation prior to freeze drying also contains lactose. The freeze-dried BCG preparation is delivered in glass vials, each containing 1 to 8 × 10 colony forming units (CFU) of TICE BCG which is equivalent to approximately 50 mg wet weight. Determination of potency is achieved through colony counts derived from a serial dilution assay. A single dose consists of 1 reconstituted vial (see ).
For intravesical use the entire vial is reconstituted with sterile saline. TICE BCG is viable upon reconstitution.
No preservatives have been added.
What does TICE BCG look like?
What are the available doses of TICE BCG?
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What should I talk to my health care provider before I take TICE BCG?
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How should I use TICE BCG?
TICE BCG is indicated for the treatment and prophylaxis of carcinoma (CIS) of the urinary bladder, and for the prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR). TICE BCG is not recommended for stage TaG1 papillary tumors, unless they are judged to be at high risk of tumor recurrence.
TICE BCG is not indicated for papillary tumors of stages higher than T1.
The dose for the intravesical treatment of carcinoma and for the prophylaxis of recurrent papillary tumors consists of of TICE BCG suspended in 50 mL preservative-free saline.
Do not inject subcutaneously or intravenously.
What interacts with TICE BCG?
TICE BCG should not be used in immunosuppressed patients or persons with congenital or acquired immune deficiencies, whether due to concurrent disease (e.g., AIDS, leukemia, lymphoma) cancer therapy (e.g., cytotoxic drugs, radiation), or immunosuppressive therapy (e.g., corticosteroids).
Treatment should be postponed until resolution of a concurrent febrile illness, urinary tract infection, or gross hematuria. Seven to 14 days should elapse before BCG is administered following biopsy, TUR, or traumatic catheterization.
TICE BCG should not be administered to persons with active tuberculosis. Active tuberculosis should be ruled out in individuals who are PPD positive before starting treatment with TICE BCG.
What are the warnings of TICE BCG?
In general, diuretics should not be given concomitantly with lithium because they reduce its renal clearance and add a high risk of lithium toxicity. Read prescribing information for lithium preparations before use of such concomitant therapy.
BCG LIVE (TICE BCG) is not a vaccine for the prevention of cancer.
TICE BCG is an infectious agent. Physicians using this product should be familiar with the literature on the prevention and treatment of BCG-related complications, and should be prepared in such emergencies to contact an infectious disease specialist with experience in treating the infectious complications of intravesical BCG. The treatment of the infectious complications of BCG requires long-term, multiple-drug antibiotic therapy. Special culture media are required for mycobacteria, and physicians administering intravesical BCG or those caring for these patients should have these media readily available.
Instillation of TICE BCG with an actively bleeding mucosa may promote systemic BCG infection. Treatment should be postponed for at least 1 week following transurethral resection, biopsy, traumatic catheterization, or gross hematuria.
Deaths have been reported as a result of systemic BCG infection and sepsis. Patients should be monitored for the presence of symptoms and signs of toxicity after each intravesical treatment. Febrile episodes with flu-like symptoms lasting more than 72 hours, fever ≥103°F, systemic manifestations increasing in intensity with repeated instillations, or persistent abnormalities of liver function tests suggest systemic BCG infection and may require antituberculous therapy. Local symptoms (prostatitis, epididymitis, orchitis) lasting more than 2 to 3 days may also suggest active infection (see section).
The use of TICE BCG may cause tuberculin sensitivity. Since this is a valuable aid in the diagnosis of tuberculosis, it is advisable to determine the tuberculin reactivity by PPD skin testing before treatment.
Intravesical instillations of BCG should be postponed during treatment with antibiotics, since antimicrobial therapy may interfere with the effectiveness of TICE BCG (see ). TICE BCG should not be used in individuals with concurrent infections.
Small bladder capacity has been associated with increased risk of severe local reactions and should be considered in deciding to use TICE BCG therapy.
Management of Serious BCG Complications
Acute, localized irritative toxicities of TICE BCG may be accompanied by systemic manifestations, consistent with a "flu-like" syndrome. Systemic adverse effects of 1 to 2 days' duration such as malaise, fever, and chills often reflect hypersensitivity reactions. However, ≥
In patients who develop persistent fever or experience an acute febrile illness consistent with BCG infection, 2 or more antimycobacterial agents should be administered while diagnostic evaluation, including cultures, is conducted. Negative cultures do not necessarily rule out infection. Physicians using this product should be familiar with the literature on prevention, diagnosis, and treatment of BCG-related complications and, when appropriate, should consult an infectious disease specialist or other physician with experience in the diagnosis and treatment of mycobacterial infections.
TICE BCG is sensitive to the most commonly used antituberculous agents (isoniazid, rifampin, and ethambutol).
What are the precautions of TICE BCG?
General
TICE BCG contains live mycobacteria and should be prepared and handled using aseptic technique (see section). BCG infections have been reported in health care workers preparing BCG for administration. Needle stick injuries should be avoided during the handling and mixing of TICE BCG. Nosocomial infections have been reported in patients receiving parenteral drugs which were prepared in areas in which BCG was prepared.
BCG is capable of dissemination when administered by intravesical route, and serious reactions, including fatal infections, have been reported in patients receiving intravesical BCG. Care should be taken not to traumatize the urinary tract or to introduce contaminants into the urinary system. Seven to 14 days should elapse before TICE BCG is administered following TUR, biopsy, or traumatic catheterization.
TICE BCG should be administered with caution to persons in groups at high risk for HIV infection.
Laboratory Tests
The use of TICE BCG may cause tuberculin sensitivity. It is advisable to determine the tuberculin reactivity of patients receiving TICE BCG by PPD skin testing before treatment is initiated.
Information for Patients
TICE BCG is retained in the bladder for 2 hours and then voided. Patients should void while seated in order to avoid splashing of urine. For the 6 hours after treatment, urine voided should be disinfected for 15 minutes with an equal volume of household bleach before flushing. Patients should be instructed to increase fluid intake in order to "flush" the bladder in the hours following BCG treatment. Patients may experience burning with the first void after treatment.
Patients should be attentive to side effects, such as fever, chills, malaise, flu-like symptoms, or increased fatigue. If the patient experiences severe urinary side effects, such as burning or pain on urination, urgency, frequency of urination, blood in urine, or other symptoms such as joint pain, cough, or skin rash, the physician should be notified.
Drug Interaction
Drug combinations containing immunosuppressants and/or bone marrow depressants and/or radiation interfere with the development of the immune response and should not be used in combination with TICE BCG. Antimicrobial therapy for other infections may interfere with the effectiveness of TICE BCG. There are no data to suggest that the acute, local urinary tract toxicity common with BCG is due to mycobacterial infection, and
Carcinogenesis, Mutagenesis, Impairment of Fertility
TICE BCG has not been evaluated for its carcinogenic, mutagenic potentials, or impairment of fertility.
Pregnancy
Animal reproduction studies have not been conducted with TICE BCG. It is also not known whether TICE BCG can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. TICE BCG should not be given to a pregnant woman except when clearly needed. Women should be advised not to become pregnant while on therapy.
Nursing Mothers
It is not known whether TICE BCG is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions from TICE BCG in nursing infants, it is advisable to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
Safety and effectiveness of TICE BCG for the treatment of superficial bladder cancer in pediatric patients have not been established.
Geriatric Use
Of the total number of subjects in clinical studies of TICE BCG, the average age was 66 years old. No overall difference in safety or effectiveness was observed between older and younger subjects. Other reported clinical experience has not identified differences in response between elderly and younger patients, but greater sensitivity of some older individuals to BCG cannot be ruled out.
What are the side effects of TICE BCG?
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 to 6 hours after instillation and last 24 to 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. 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.
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. The most serious infectious complication of BCG is disseminated sepsis with associated mortality. In addition, infections have been reported in lung, liver, bone, bone marrow, kidney, regional lymph nodes, and prostate in patients who have received intravesical BCG. Systemic infections may be manifested by pneumonitis, hepatitis, cytopenia, infective aneurysm and/or sepsis after a period of fever and malaise during which symptoms progressively increase. 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 ).
The local and systemic adverse reactions reported in a review of 674 patients with superficial bladder cancer, including 153 patients with carcinoma , are summarized in .
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 (=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 2 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. summarizes the most common adverse reactions reported in this trial.
| Percent of patients | Percent of patients | ||||
|---|---|---|---|---|---|
| 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/ | ||
| Nocturia | 30 | 5% (1%) | 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%) |
| Study arm | |||||
| TICE BCG (N=222) | MMC (N=220) | ||||
| Adverse event | 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%) |
What should I look out for while using TICE BCG?
TICE BCG should not be used in immunosuppressed patients or persons with congenital or acquired immune deficiencies, whether due to concurrent disease (e.g., AIDS, leukemia, lymphoma) cancer therapy (e.g., cytotoxic drugs, radiation), or immunosuppressive therapy (e.g., corticosteroids).
Treatment should be postponed until resolution of a concurrent febrile illness, urinary tract infection, or gross hematuria. Seven to 14 days should elapse before BCG is administered following biopsy, TUR, or traumatic catheterization.
TICE BCG should not be administered to persons with active tuberculosis. Active tuberculosis should be ruled out in individuals who are PPD positive before starting treatment with TICE BCG.
BCG LIVE (TICE BCG) is not a vaccine for the prevention of cancer.
TICE BCG is an infectious agent. Physicians using this product should be familiar with the literature on the prevention and treatment of BCG-related complications, and should be prepared in such emergencies to contact an infectious disease specialist with experience in treating the infectious complications of intravesical BCG. The treatment of the infectious complications of BCG requires long-term, multiple-drug antibiotic therapy. Special culture media are required for mycobacteria, and physicians administering intravesical BCG or those caring for these patients should have these media readily available.
Instillation of TICE BCG with an actively bleeding mucosa may promote systemic BCG infection. Treatment should be postponed for at least 1 week following transurethral resection, biopsy, traumatic catheterization, or gross hematuria.
Deaths have been reported as a result of systemic BCG infection and sepsis. Patients should be monitored for the presence of symptoms and signs of toxicity after each intravesical treatment. Febrile episodes with flu-like symptoms lasting more than 72 hours, fever ≥103°F, systemic manifestations increasing in intensity with repeated instillations, or persistent abnormalities of liver function tests suggest systemic BCG infection and may require antituberculous therapy. Local symptoms (prostatitis, epididymitis, orchitis) lasting more than 2 to 3 days may also suggest active infection (see section).
The use of TICE BCG may cause tuberculin sensitivity. Since this is a valuable aid in the diagnosis of tuberculosis, it is advisable to determine the tuberculin reactivity by PPD skin testing before treatment.
Intravesical instillations of BCG should be postponed during treatment with antibiotics, since antimicrobial therapy may interfere with the effectiveness of TICE BCG (see ). TICE BCG should not be used in individuals with concurrent infections.
Small bladder capacity has been associated with increased risk of severe local reactions and should be considered in deciding to use TICE BCG therapy.
What might happen if I take too much TICE BCG?
Overdosage occurs if more than 1 vial of TICE BCG is administered per instillation. If overdosage occurs, the patient should be closely monitored for signs of active local or systemic BCG infection. For acute local or systemic reactions suggesting active infection, an infectious disease specialist experienced in BCG complications should be consulted.
How should I store and handle TICE BCG?
Store atTICE BCG is supplied in a box of 1 vial of TICE BCG. Each vial contains 1 to 8 × 10 CFU, which is equivalent to approximately 50 mg (wet weight), as lyophilized (freeze-dried) powder, NDC 0052-0602-02.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
TICE BCG induces a granulomatous reaction at the local site of administration. Intravesical TICE BCG has been used as a therapy for, and prophylaxis against, recurrent tumors in patients with carcinoma (CIS) of the urinary bladder, and to prevent recurrence of Stage TaT1 papillary tumors of the bladder at high risk of recurrence. The precise mechanism of action is unknown.
Non-Clinical Toxicology
TICE BCG should not be used in immunosuppressed patients or persons with congenital or acquired immune deficiencies, whether due to concurrent disease (e.g., AIDS, leukemia, lymphoma) cancer therapy (e.g., cytotoxic drugs, radiation), or immunosuppressive therapy (e.g., corticosteroids).Treatment should be postponed until resolution of a concurrent febrile illness, urinary tract infection, or gross hematuria. Seven to 14 days should elapse before BCG is administered following biopsy, TUR, or traumatic catheterization.
TICE BCG should not be administered to persons with active tuberculosis. Active tuberculosis should be ruled out in individuals who are PPD positive before starting treatment with TICE BCG.
BCG LIVE (TICE BCG) is not a vaccine for the prevention of cancer.
TICE BCG is an infectious agent. Physicians using this product should be familiar with the literature on the prevention and treatment of BCG-related complications, and should be prepared in such emergencies to contact an infectious disease specialist with experience in treating the infectious complications of intravesical BCG. The treatment of the infectious complications of BCG requires long-term, multiple-drug antibiotic therapy. Special culture media are required for mycobacteria, and physicians administering intravesical BCG or those caring for these patients should have these media readily available.
Instillation of TICE BCG with an actively bleeding mucosa may promote systemic BCG infection. Treatment should be postponed for at least 1 week following transurethral resection, biopsy, traumatic catheterization, or gross hematuria.
Deaths have been reported as a result of systemic BCG infection and sepsis. Patients should be monitored for the presence of symptoms and signs of toxicity after each intravesical treatment. Febrile episodes with flu-like symptoms lasting more than 72 hours, fever ≥103°F, systemic manifestations increasing in intensity with repeated instillations, or persistent abnormalities of liver function tests suggest systemic BCG infection and may require antituberculous therapy. Local symptoms (prostatitis, epididymitis, orchitis) lasting more than 2 to 3 days may also suggest active infection (see section).
The use of TICE BCG may cause tuberculin sensitivity. Since this is a valuable aid in the diagnosis of tuberculosis, it is advisable to determine the tuberculin reactivity by PPD skin testing before treatment.
Intravesical instillations of BCG should be postponed during treatment with antibiotics, since antimicrobial therapy may interfere with the effectiveness of TICE BCG (see ). TICE BCG should not be used in individuals with concurrent infections.
Small bladder capacity has been associated with increased risk of severe local reactions and should be considered in deciding to use TICE BCG therapy.
Drug combinations containing immunosuppressants and/or bone marrow depressants and/or radiation interfere with the development of the immune response and should not be used in combination with TICE BCG. Antimicrobial therapy for other infections may interfere with the effectiveness of TICE BCG. There are no data to suggest that the acute, local urinary tract toxicity common with BCG is due to mycobacterial infection, and
TICE BCG contains live mycobacteria and should be prepared and handled using aseptic technique (see section). BCG infections have been reported in health care workers preparing BCG for administration. Needle stick injuries should be avoided during the handling and mixing of TICE BCG. Nosocomial infections have been reported in patients receiving parenteral drugs which were prepared in areas in which BCG was prepared.
BCG is capable of dissemination when administered by intravesical route, and serious reactions, including fatal infections, have been reported in patients receiving intravesical BCG. Care should be taken not to traumatize the urinary tract or to introduce contaminants into the urinary system. Seven to 14 days should elapse before TICE BCG is administered following TUR, biopsy, or traumatic catheterization.
TICE BCG should be administered with caution to persons in groups at high risk for HIV infection.
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 to 6 hours after instillation and last 24 to 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. 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.
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. The most serious infectious complication of BCG is disseminated sepsis with associated mortality. In addition, infections have been reported in lung, liver, bone, bone marrow, kidney, regional lymph nodes, and prostate in patients who have received intravesical BCG. Systemic infections may be manifested by pneumonitis, hepatitis, cytopenia, infective aneurysm and/or sepsis after a period of fever and malaise during which symptoms progressively increase. 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 ).
The local and systemic adverse reactions reported in a review of 674 patients with superficial bladder cancer, including 153 patients with carcinoma , are summarized in .
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 (=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 2 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. summarizes the most common adverse reactions reported in this trial.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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