A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Tice Warnings, Precautions, Pregnancy, Nursing, Abuse - Bacillus of Calmette and Guerin
Tice Warnings, Precautions, Pregnancy, Nursing, Abuse - Bacillus of Calmette and Guerin
WARNINGS
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WARNING
TICEŽ BCG contains live, attenuated mycobacteria. Because of the potential
risk for transmission, it should be prepared, handled, and disposed of
as a biohazard material (see PRECAUTIONS and DOSAGE AND ADMINISTRATION
).
BCG infections have been reported in health care workers, primarily from
exposures resulting from accidental needle sticks or skin lacerations
during the preparation of BCG for administration. Nosocomial infections
have been reported in patients receiving parenteral drugs that were prepared
in areas in which BCG was reconstituted. BCG is capable of dissemination
when administered by the intravesical route, and serious infections, including
fatal infections, have been reported in patients receiving intravesical
BCG (see WARNINGS , PRECAUTIONS , and ADVERSE REACTIONS ).
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BCG LIVE (TICEŽ BCG) is not a vaccine for the prevention of cancer. BCG
Vaccine, U.S.P., not BCG LIVE (TICEŽ BCG), should be used for the prevention
of tuberculosis. For vaccination use, refer to BCG Vaccine, U.S.P. prescribing
information.
TICEŽ 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 TICEŽ BCG with an actively bleeding mucosa may promote systemic
BCG infection. Treatment should be postponed for at least one week following
transurethral resection, biopsy, traumatic catheterization, or gross hematuria.
Deaths have been reported as a result of systemic BCG infection and sepsis.
2,3 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
2-3 days may also suggest active infection (See Management of Serious
BCG Complications subsection of WARNINGS
).
The use of TICEŽ 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 TICEŽ BCG (see PRECAUTIONS
). TICEŽ 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 TICEŽ BCG therapy.
Management of Serious BCG Complications.
Acute, localized irritative toxicities of TICEŽ BCG 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 (101.3°F), or
acute localized inflammation such as epididymitis, prostatitis, or orchitis
persisting longer than 2-3 days suggest active infection, and evaluation for
serious infectious complication should be considered.
In patients who develop persistent fever or experience an acute febrile illness
consistent with BCG infection, two or more antimycobacterial agents should be
administered while diagnostic evaluation, including cultures, is conducted.
BCG treatment should be discontinued. 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.
TICEŽ BCG is sensitive to the most commonly used antituberculous agents (isoniazid,
rifampin and ethambutol). TICEŽ BCG is not sensitive to pyrazinamide.
PRECAUTIONS
General
TICEŽ BCG contains live mycobacteria and should be prepared and handled using
aseptic technique (See Preparation of Agent subsection of DOSAGE AND
ADMINISTRATION ). 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 TICEŽ BCG. Nosocomial infections have been reported in patients
receiving parenteral drugs which were prepared in areas in which BCG was prepared.
4
BCG is capable of dissemination when administered by intravesical route and
serious reactions, including fatal infections, have been reported in patients
receiving intravesical BCG. 3 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 TICEŽ BCG is administered following TUR, biopsy,
or traumatic catheterization.
TICEŽ BCG should be administered with caution to persons in groups at high
risk for HIV infection.
Laboratory Tests
The use of TICEŽ BCG may cause tuberculin sensitivity. It is advisable to determine
the tuberculin reactivity of patients receiving TICEŽ BCG by PPD skin testing
before treatment is initiated.
Information for Patients
TICEŽ 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 TICEŽ BCG. Antimicrobial therapy for other infections
may interfere with the effectiveness of TICEŽ BCG. There are no data to suggest
that the acute, local urinary tract toxicity common with BCG is due to mycobacterial
infection and antituberculosis drugs (e.g. isoniazid) should not be used
to prevent or treat the local, irritative toxicities of TICEŽ BCG.
Carcinogenesis, Mutagenesis, Impairment of Fertility
TICEŽ BCG has not been evaluated for its carcinogenic, mutagenic potentials
or impairment of fertility.
Pregnancy
Teratogenic Effects - Pregnancy Category C
Animal reproduction studies have not been conducted with TICEŽ BCG. It is also
not known whether TICEŽ BCG can cause fetal harm when administered to a pregnant
woman or can affect reproductive capacity. TICEŽ 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 TICEŽ BCG is excreted in human milk. Because many drugs
are excreted in human milk and because of the potential for serious adverse
reactions from TICEŽ 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 TICEŽ 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 TICEŽ 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 individual to BCG cannot be ruled out.
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