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

Oncotice is a live‑attenuated bacterial therapy that acts on the urothelial immune environment to reduce tumour recurrence in bladder cancer.

• Non‑muscle‑invasive bladder cancer (NMIBC): helps prevent recurrence and progression after transurethral resection.
• High‑risk NMIBC: provides additional disease‑free survival benefit when used as maintenance therapy.
• Carcinoma in situ of the bladder: used as an intravesical agent to achieve local disease control.

• Oncotice contains live Mycobacterium bovis (BCG) that, when instilled into the bladder, is taken up by urothelial and antigen‑presenting cells. This triggers a Th1‑dominant immune response, releasing cytokines such as IFN‑γ, TNF‑α and interleukins that recruit macrophages and cytotoxic lymphocytes to destroy residual cancer cells.

Adverse reactions to intravesical BCG are primarily local bladder effects and systemic immune‑mediated events.

Common Side Effects

• Cystitis‑like symptoms: dysuria, frequency, urgency.
• Low‑grade fever and chills.
• Hematuria or mild bladder irritation.
• Fatigue.
• Nausea.

Serious or Rare Side Effects

• BCG‑induced sepsis or disseminated infection.
• Severe allergic reactions including anaphylaxis.
• Persistent high‑grade fever.
• Hepatitis or hepatic dysfunction.
• Renal impairment secondary to obstructive uropathy.
• Autoimmune phenomena such as granulomatous prostatitis.

When using Oncotice, clinicians should observe several safety measures to minimise risk.

• Contraindications: active urinary tract infection or gross hematuria.
• Prior BCG exposure: assess for hypersensitivity before repeat courses.
• Immunocompromise: avoid in patients with significant immunosuppression.
• Bladder integrity: ensure no traumatic catheterisation or recent bladder surgery.
• Monitoring: watch for systemic symptoms such as fever, chills or malaise.
• Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Oncotice may interact with other agents that modify immune function or cause overlapping toxicity.

Major Interactions (Avoid)

• Systemic immunosuppressants (e.g., high‑dose corticosteroids, azathioprine) – may reduce BCG efficacy.
• Live viral vaccines administered within 4 weeks – risk of compounded infection.

Moderate Interactions (Monitor Closely)

• Chemotherapy agents given concurrently – may increase bladder irritation.
• Antifungal azoles (e.g., fluconazole) – potential for altered BCG metabolism.
• Intravenous antibiotics that cause neutropenia – may predispose to disseminated BCG infection.