Onko Bcg 100 (Live Bcg Bacilli (Bacillus Calmette-Guerin), Brasilian Moreau Substrain)

Onko Bcg 100 is a live‑attenuated mycobacterial vaccine used in the management of uro‑urological malignancies. It is applied as part of intravesical therapy for bladder cancer.

• Non‑muscle‑invasive bladder cancer: reduces recurrence and progression after transurethral resection.
• Carcinoma in situ of the bladder: induces tumour regression through immune activation.
• High‑risk bladder tumours: provides additional disease‑free survival when combined with standard resection.
• BCG‑refractory disease (selected cases): may be used in clinical trials or compassionate use protocols.
• Maintenance therapy: prolongs the benefit of induction therapy in eligible patients.
• Adjunct to intravesical chemotherapy: enhances overall response rates in combination regimens.

• Onko Bcg 100 contains live attenuated Mycobacterium bovis (BCG) of the Brazil‑I (Moreau) substrain. When instilled into the bladder, the bacilli are internalised by urothelial and antigen‑presenting cells, triggering a Th1‑dominant immune response. Cytokine release (e.g., IFN‑γ, TNF‑α) recruits macrophages, NK cells and cytotoxic T‑lymphocytes that recognise and destroy residual tumour cells, providing local immunotherapy without systemic absorption.

Adverse reactions are primarily local and systemic immune‑mediated events.

Common Side Effects

• Cystitis‑like symptoms: dysuria, urgency, frequency.
• Low‑grade fever or chills.
• Hematuria or mild bladder irritation.
• Fatigue or malaise.
• Transient flu‑like syndrome.

Serious or Rare Side Effects

• BCG‑induced sepsis or disseminated infection.
• Severe allergic reaction (anaphylaxis).
• Persistent high‑grade fever.
• Organ‑specific granulomatous inflammation (e.g., hepatitis, pneumonitis).
• Life‑threatening bladder contracture.
• Autoimmune phenomena (e.g., vasculitis).

Before initiating therapy, evaluate patient suitability and monitor for complications.

• Contraindication: active tuberculosis or immunosuppression: avoid use due to infection risk.
• Prior BCG exposure: assess for hypersensitivity reactions.
• Recent urinary surgery: postpone treatment until healing is complete.
• Hematuria of unknown origin: investigate before instillation.
• Pregnancy or lactation: defer treatment; discuss risks with obstetric specialist.
• Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

BCG therapy can be influenced by concurrent medications and clinical conditions.

Major Interactions (Avoid)

• Systemic immunosuppressants (e.g., high‑dose steroids, azathioprine): may diminish vaccine efficacy and increase infection risk.
• Live‑virus vaccines administered within 4 weeks: risk of compounded infection.

Moderate Interactions (Monitor Closely)

• Intravesical chemotherapy agents (e.g., mitomycin C): schedule to avoid overlapping toxicity.
• Anticoagulants: monitor for haematuria.
• Antifungal azoles (e.g., fluconazole): may alter immune response.
• Cytokine‑modulating drugs (e.g., interferon‑α): assess additive immune activation.