Oncotice (Bacillus Calmette-Guérin (Bcg), Tice)

Oncotice is a bacillus‑based immunotherapy that acts on the urothelial lining of the bladder to stimulate an immune response against malignant cells.

• Non‑muscle‑invasive bladder cancer: reduces recurrence and progression after transurethral resection.
• Carcinoma in situ of the bladder: induces local immune‑mediated tumour control.
• High‑risk superficial bladder tumours: provides adjuvant therapy to lower the chance of disease recurrence.

• Oncotice contains live attenuated Mycobacterium bovis (BCG) that, when instilled into the bladder, is internalised by urothelial and antigen‑presenting cells. This triggers a cascade of cytokine release (including IL‑2, IFN‑γ and TNF‑α) and recruits macrophages, neutrophils and T‑lymphocytes, creating a localized Th1‑dominant immune environment that targets and destroys tumour cells.

Adverse reactions to intravesical BCG are primarily local and systemic, reflecting the immune activation within the bladder and occasional dissemination.

Common Side Effects

• Dysuria and urinary frequency.
• Mild haematuria or gross blood in urine.
• Low‑grade fever and chills.
• Irritative bladder symptoms such as urgency.
• Transient fatigue.
• Localised cystitis‑like discomfort.

Serious or Rare Side Effects

• Systemic BCG infection (disseminated BCGitis).
• Severe allergic reactions including anaphylaxis.
• Persistent high‑grade fever.
• Hepatitis or hepatic dysfunction.
• Sepsis sepsis‑like syndrome.
• Granulomatous prostatitis.

When using Oncotice, clinicians should assess patient suitability and monitor for adverse events throughout therapy.

• Contraindication in immunocompromised patients: avoid use in individuals with severe cellular immunity deficits.
• Active urinary tract infection: treat and resolve infection before instillation.
• Recent bladder instrumentation: postpone BCG until mucosal healing occurs.
• Gross haematuria: defer treatment until bleeding subsides.
• Pregnancy and lactation: avoid use due to unknown fetal risk.
• Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

BCG therapy may be influenced by concomitant medications and conditions that modify immune function.

Major Interactions (Avoid)

• Systemic chemotherapy agents administered concurrently: may diminish BCG efficacy and increase toxicity.
• Live attenuated vaccines given within 4 weeks: risk of additive infection.

Moderate Interactions (Monitor Closely)

• Immunosuppressive drugs (e.g., corticosteroids, azathioprine): may reduce therapeutic response.
• Antifungal agents such as fluoroquinolids (e.g., ciprofloxacin) that affect bladder mucosa permeability.
• Intravenous immunoglobulin (IVIG) therapy: potential alteration of immune activation.