Bacillus Calmette Guerin Live BCG

Bacillus Calmette Guerin Live BCG Brand Names- Theracys | TICE BCG

What is Bacillus Calmette Guerin Live BCG

Bacillus Calmette Guerin Live BCG is a live, attenuated strain of Mycobacterium bovis used in the treatment of superficial bladder cancer.

All BCG strains were derived from the original Calmette-Guerin strain of the Pasteur Institute.

Strains currently available for clinical use in the U.S. include the Connaught (TheraCys®) and Tice (TICE® BCG) strains.

In 1998, the FDA required Organon to label the indications for TICE® BCG strain separately as two products, BCG Vaccine, USP (see Bacillus Calmette-Guerin Vaccine, BCG monograph), and BCG Live (intravesical).

Bacillus Calmette-Guerin Live is not a vaccine against cancer and should not be used as an immunizing agent for tuberculosis prevention.

Outcome data from clinical trials and expert opinion support the use of BCG Live or mitomycin C as adjuvant therapy after transurethral resection of carcinoma in situ, T1 bladder cancers, or high grade Ta tumors.

Tumor recurrence probability was lower after use of intravesical treatment as compared with resection alone, but there is no evidence that intravesical therapy affects long-term progression to muscle invasive disease.

The FDA approved TheraCys® in May 1990 for the treatment of carcinoma in situ of the bladder and in November 1999 for the prophylaxis of primary or recurrent carcinoma in situ of the bladder.

TICE® BCG was approved in August 1990 for the treatment of carcinoma in situ of the bladder and for the prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection.

Both products are not recommended for stage TaG1 papillary tumors unless the patient is judged to be at high risk of tumor recurrence.

  • bladder cancer

For the treatment and prophylaxis of bladder cancer in situ (CIS) or the prophylaxis of primary or recurrent stage Ta or T1 papillary tumors following transurethral resection

NOTE: The optimal dose and treatment regimen has not been determined. Therefore, dosing may vary from protocol to protocol. If questions arise, clinicians should consult the appropriate references to verify the dose.

NOTE: There are no data to support the interchangeability of the BCG live products.

NOTE: Neither TICE BCG nor TheraCys are recommended for stage TaG1 papillary tumors unless the patient is judged to be at high risk of tumor recurrence.

Side Effects

  1. abdominal pain
  2. anemia
  3. anorexia
  4. arthralgia
  5. bladder discomfort
  6. chills
  7. coagulopathy
  8. conjunctivitis
  9. constipation
  10. cystitis
  11. diaphoresis
  12. diarrhea
  13. dizziness
  14. dysuria
  15. epididymitis
  16. fatigue
  17. fever
  18. flank pain
  19. headache
  20. hematuria
  21. hemorrhagic cystitis
  22. hepatitis
  23. increased urinary frequency
  24. infection
  25. iritis
  26. keratitis
  27. leukopenia
  28. malaise
  29. myalgia
  30. nausea
  31. nocturia
  32. pneumonitis
  33. prostatitis
  34. pyuria
  35. rash
  36. thrombocytopenia
  37. urinary incontinence
  38. urinary urgency
  39. uveitis
  40. vomiting
  41. weight loss

Monitoring Parameters

  • LFTs

Contraindications

  • accidental exposure
  • acquired immunodeficiency syndrome (AIDS)
  • aneurysm
  • bone marrow suppression
  • breast-feeding
  • chemotherapy
  • children
  • corticosteroid therapy
  • diabetes mellitus
  • fever
  • hematuria
  • human immunodeficiency virus (HIV) infection
  • immunosuppression
  • infection
  • intravenous administration
  • irritable bladder
  • latex hypersensitivity
  • leukemia
  • lymphoma
  • myasthenia gravis
  • mycobacterial infection
  • pregnancy
  • prosthetic heart valves
  • radiation therapy
  • renal failure
  • severe combined immunodeficiency (SCID)
  • subcutaneous administration
  • trauma
  • tuberculosis
  • urinary tract infection (UTI)

Interactions

There are no drug interactions associated with Bacillus Calmette-Guerin Live, BCG products.

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