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TICE BCG
Bladder, kidney, and other urologic cancers
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Drug Name:

TICE BCG Rx

Generic Name and Formulations:
Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis live, attenuated culture preparation; 50mg per vial; pwd for intravesical administration after reconstitution and dilution; preservative-free.

Company:
Merck & Co., Inc.

Therapeutic Use:

Indications for TICE BCG:

Treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder. Prophylaxis of stage Ta and/or T1 papillary tumor of the urinary bladder.

Adult:

1 vial in 50mL preservative-free saline intravesically once per week for 6 weeks (may repeat this regimen once if remission not achieved); then monthly for 6–12 months if needed. Avoid fluid at least 4 hrs before treatment and void immediately before administration. Retain in bladder for 2 hours.

Children:

Not recommended.

Contraindications:

Immunosuppressed. Active TB. Febrile illness. UTI. Gross hematuria. Do not give within 7 days after bladder biopsy, transurethral resection (TUR), or traumatic catheterization.

Warnings/Precautions:

Not a vaccine for prevention of cancer or TB. Not for IV or SC use. Determine PPD status prior to therapy; rule out active TB if (+). Monitor for signs of systemic BCG infection: flu-like symptoms >72 hrs, fever ≥103°F, persistent LFT abnormalities; prostatitis, epididymitis, orchitis >2 days; treat with at least 2 antimycobacterial drugs (except pyrazinamide). Local irritative toxicities: do not treat with antimycobacterials. Bleeding bladder mucosa, small bladder. Disinfect fluid voided after therapy with bleach. PPD seroconversion may occur with treatment. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:

Immunosuppressants, myelosuppressants, radiation, antimicrobial therapy may reduce efficacy.

Pharmacological Class:

BCG Live.

Adverse Reactions:

Urine discoloration, bladder irritation, inflammation (begins after 4 hrs and last up to 72 hrs), malaise, fever, chills, flu-like syndrome, systemic BCG infection, dysuria, urinary frequency, hematuria, cystitis, urgency, nocturia, cramps, pain, incontinence, rigors, arthralgia.

How Supplied:

Vial—1

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