BCG Live

Trade Names:
TICE BCG
- Powder for suspension, lyophilized 1 to 8 × 10 ⁸ colony-forming units

Trade Names:
TheraCys
- Powder for suspension, lyophilized 10.5 ± 8.7 × 10 ⁸ colony-forming units

Pharmacology

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

Indications and Usage

Intravesical use for the treatment of primary and relapsed carcinoma in-situ of the urinary bladder. Prevention of tuberculosis (TB) in the following: people not previously infected with Mycobacterium tuberculosis , infants and children with negative tuberculin skin test who are at high risk of intimate and prolonged exposure to persistently untreated or ineffectively treated patients with infectious pulmonary TB, health care workers in settings where a high percentage of TB patients are infected with M. tuberculosis strains resistant to both isoniazid and rifampin (BCG vaccine [TICE strain, lyophilized injection]).

Unlabeled Uses

Local control of accessible tumor.

Contraindications

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

Dosage and Administration

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

Intravesical Do not inject subcutaneously or IV. Each dose is administered intravesically via catheter once a wk 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 at least 6 to 12 mo.

Percutaneous 0.2 to 0.3 mL of vaccine on cleansed surface of the skin and spread over 1- by 2-inch area administered utilizing a sterile multiple-puncture devise. An additional 1 to 2 gtt of BCG vaccine may be added to ensure a very wet vaccination site. Repeat vaccination for individuals who remain negative to 5 tuberculin units of tuberculin after 2 to 3 mo.

Percutaneous Reduce the dose of vaccine 50% by using 2 mL of sterile water when reconstituting.

General Advice

• 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 h.
• After usage, immediately place all equipment and materials used for instillation of the product into the bladder (eg, syringes, catheters, and containers that may have come into contact with BCG) into plastic bags labeled “Infectious Waste” and dispose of accordingly as biohazardous waste.

Storage/Stability

Keep BCG and any accompanying diluent refrigerated between 2° and 8°C (35° and 46°F). Use immediately after reconstitution and discard after 2 h. 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.

Drug Interactions

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

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

Laboratory Test Interactions

May result in tuberculin skin reactivity.

Adverse Reactions

CNS

Malaise; fatigue.

GI

Nausea; vomiting; anorexia.

Genitourinary

Blood in urine; urinary frequency and urgency; painful urination; UTI; urinary incontinence.

Hematologic

Anemia.

Hypersensitivity

Tuberculin sensitivity; fever; chills; myalgia.

Respiratory

Cough.

Miscellaneous

Joint pain.

Precautions

Pregnancy

Category C .

Lactation

Because of the potential for serious adverse reactions in breast-feeding infants, discontinue breast-feeding or the drug, taking into account the importance of the drug to the mother.

Children

Safety and efficacy not established.

Hypersensitivity

Systemic adverse reactions (eg, malaise, fever, chills) of 1 to 2 days' duration may represent hypersensitivity reactions and can be treated with antihistamines.

BCG infection

Fever of 103°F or more, or acute localized inflammation persisting longer than 2 or 3 days suggest active infections and evaluation for serious infectious complications should be considered.

Immune deficiency syndromes

Administer with caution to individuals at high risk for HIV infection. Do not vaccinate children with a family history of immune deficiency disease.

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.

Management of BCG complications

The acute, localized irritative toxicities of BCG may be accompanied by systemic manifestations consistent with flu-like syndrome.

Rubber latex

The vial stopper for Thera-Cys contains natural rubber latex that may cause allergic reactions.

TUR

Do not give intravesical BCG any sooner than 1 to 2 wk following TUR, biopsy, traumatic catherization, or gross hematuria.

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.

Overdosage

Symptoms

Overdosage occurs if more than 1 amp/vial is given per instillation.

Patient Information

• 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 immediately if a cough develops.
• Void in a seated position to avoid splashing of urine.
• Disinfect urine voided for 6 h 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 h following BCG treatment. Patients may experience burning with the first void after treatment.

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Tuberculosis -- Prophylaxis, Urinary Tract Tumors

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