BCG Live

Actions BCG is a lyophilized preparation of an attenuated, live culture preparation of the Bacillus of Calmette and Guérin (BCG) strain of Mycobacterium bovis used in CIS of the urinary bladder and as prophylaxis of primary or recurrent stage Ta or T1 papillary tumors following TUR.

 Indications Intravesical use for the treatment of primary and relapsed carcinoma in-situ of the urinary bladder.

Local control of accessible tumor.

 Contraindications Stage TaG1 papillary tumors unless they are judged to be at high risk of tumor recurrence; immunosuppressed patients with congenital or acquired immune deficiencies; cancer therapy; immunosuppresssive therapy; vaccine for the prevention of cancer; for the treatment of papillary tumors occurring alone; as an immunizing agent for the prevention of tuberculosis; positive Mantoux test; prevention of papillary tumors after TUR or for the treatment of papillary tumors occurring alone; active tuberculosis; papillary tumors of stages higher than T1; concurrent infections.

 Route/Dosage

Carcinoma In-Situ of the Urinary Bladder (TheraCys)

Adults: Intravesical Do not inject SC or IV. Each dose is administered intravesically via catheter once a week for 6 wk followed by maintenance therapy, consisting of 1 dose given at 3, 6, 12, 18, and 24 mo after initial treatment.

Carcinoma In-Situ of the Urinary Bladder (TICE BCG)

Adults: Intravesical Do not inject SC or IV. Each dose is administered intravesically via catheter once a week for 6 wk. This schedule may be repeated once if tumor remission is not achieved and if deemed clinically necessary thereafter, administer 1 dose at approximately monthly intervals for ³ 6 to 12 mo.

Carcinoma In-Situ of the Urinary Bladder (Pacis)

Adults: Intravesical Do not inject SC or IV. A single dose of 120 mg instilled into the bladder once weekly for 6 wk. This schedule may be repeated if tumor remission has not been achieved and if deemed clinically necessary.

Interactions

Bone marrow depressants/immunosuppressants/radiation

Bone marrow depressants, immunosuppressants, or radiation may impair response to BCG.

Antimicrobial therapy

Antimicrobial therapy for other infections may interfere with the effectiveness of TICE BCG or Pacis therapy.

Lab Test Interferences None well documented.

 Adverse Reactions

CNS: Malaise; fatigue. GI: Nausea; vomiting; anorexia. GU: Blood in urine; urinary frequency and urgency; painful urination; UTI; urinary incontinence. HEMATOLOGIC: Anemia. HYPERSENSITIVITY: Tuberculin sensitivity; fever; chills; myalgia. RESPIRATORY: Cough. OTHER: Joint pain.

 Precautions

Pregnancy: Category C. Lactation: Because of the potential for serious adverse reactions in nursing infants, discontinue nursing or discontinue the drug, taking into the account the importance of the drug to the mother. Children: Safety and efficacy not established. Management of BCG complications: The acute, localized irritative toxicities of BCG may be accompanied by systemic manifestations consistent with the “flu-like” syndrome. UTI: Do not use in the presence of a UTI because administration may result in the risk of disseminated BCG infection or in an increased severity of bladder irritation. Fever: Do not use in the presence of a fever. If the fever is caused by an infection, withhold therapy until the patient is afebrile and off all therapy. Infection of aneurysms and prosthetic devices: BCG infection of aneurysms and prosthetic devices (eg, arterial grafts, cardiac devices, artificial joints) have been reported following intravesical administration of BCG. The risk is considered to be very small. Rubber latex: The vial stopper for Thera-Cys contains natural rubber latex which may cause allergic reactions. Hypersensitivity reactions: Systemic side effects (eg, malaise, fever, chills) of 1 to 2 days' duration may represent hypersensitivity reactions and can be treated with antihistamines.

 Administration/Storage

• The suspension is instilled into the bladder slowly by gravity flow, via the catheter. Do not force the flow.
• Reconstitute and dilute immediately prior to use. If there is a delay between reconstitution and administration it must not exceed 2 hr.
• Keep BCG and any accompanying diluent refrigerated between 2° and 8°C (35° and 46°F). Use immediately after reconstitution and discard after 2 hr. Do not expose the freeze-dried or reconstituted BCG to sunlight, direct or indirect. Keep exposure to artificial light to a minimum. Do not use any reconstituted product that exhibits flocculation or clumping that cannot be dispersed with gentle shaking. Do not use after expiration date printed on label.
• After usage, immediately place all equipment and materials used for instillation of the product (eg, syringes, catheters, and containers that may have come into contact with BCG) into the bladder into plastic bags labeled “Infectious Waste” and dispose of accordingly as biohazardous waste.

 Assessment/Interventions

• Do not administer as an immunizing agent to prevent TB.
• Handle as biohazardous. Use aseptic technique.

Allergic reactions

• Assess the possibility of allergic reactions. Do not attempt administration in individuals with severe immune deficiency disease.

Infection, systemic

• Closely monitor for signs and symptoms of systemic infection.

Transurethral resection

• Do not give intravesical BCG any sooner than 1 to 2 wk following transurethral resection, biopsy, traumatic catherization, ro gross hematuria.

Urinary tract status

• Careful monitoring of urinary status is required.

 Patient/Family Education

• Check with health care provider as soon as possible if there is an increase in existing symptoms, if symptoms persist even after receiving a number of treatments, or if any of the following symptoms develop: blood in urine, fever, chills, cough, skin rash, frequent urge to urinate, increased frequency of urination, increased tiredness/fatigue, joint pain, flu-like symptoms, painful urination.
• Notify health care provider immediatly if a cough develops.
• Void in a seated position to avoid splashing of urine.
• Disinfect urine voided for 6 hr after instillation with an equal volume of 5% sodium hypochlorite solution (undiluted household bleach); allow to disinfect for 15 min before flushing.
• Increase fluid intake to “flush” the bladder in the hours following BCG treatment. Patients may experience burning with the first void after treatment.