Tice BCG

Name: Tice BCG

US Brand Name

  1. Theracys
  2. Tice BCG

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Fever—Infection may be present and could cause problems
  • Immunity problems—BCG treatment is less effective and there is a risk of infection
  • Urinary tract infection—Infection and irritation of the bladder may occur

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Uses For Tice BCG

Bacillus Calmette-Guérin (BCG) is used as a solution that is run through a tube (instilled through a catheter) into the bladder to treat bladder cancer. The exact way it works against cancer is not known, but it may work by stimulating the body's immune system.

BCG is to be administered only by or under the immediate supervision of your doctor.

Precautions While Using Tice BCG

While you are being treated with BCG, and for 6 to 12 weeks after you stop treatment with it, avoid contact with people who have tuberculosis. If you think you have been exposed to someone with tuberculosis, tell your doctor.

While you are being treated with BCG and for a few weeks after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval.

What are some other side effects of Tice BCG?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Upset stomach.
  • Not hungry.
  • Many people using Tice BCG (BCG (intravesical)) have bladder irritation. It may start within a few hours after getting this medicine and may last for 1 to 3 days. You may pass urine more often or feel the need to pass urine right away. Call your doctor if you have bladder irritation that bothers you or does not go away within 3 days.
  • It is common to have burning or pain when passing urine, chills, flu-like signs, mild fever, tiredness, or weakness. If any of these signs last more than 2 days or get worse, call your doctor.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

How do I store and/or throw out Tice BCG?

  • If you need to store Tice BCG at home, talk with your doctor, nurse, or pharmacist about how to store it.

Indications and Usage for TICE BCG

TICE® BCG is indicated for the treatment and prophylaxis of carcinoma in situ (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.

Warnings

BCG LIVE (TICE® BCG) is not a vaccine for the prevention of cancer. BCG Vaccine USP, not BCG LIVE (TICE BCG), should be used for the prevention of tuberculosis. For vaccination use, refer to BCG Vaccine USP prescribing information.

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.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 to 3 days may also suggest active infection (see WARNINGS, Management of Serious BCG Complications 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 PRECAUTIONS). 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, 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 to 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, 2 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.

TICE BCG is sensitive to the most commonly used antituberculous agents (isoniazid, rifampin, and ethambutol). TICE BCG is not sensitive to pyrazinamide.

Precautions

General

TICE® BCG contains live mycobacteria and should be prepared and handled using aseptic technique (see DOSAGE AND ADMINISTRATION, Preparation of Agent 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.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 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 antituberculosis drugs (e.g., isoniazid) should not be used to prevent or treat the local, irritative toxicities of TICE BCG.

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.

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