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

Oncotice is a live‑attenuated BCG vaccine used in the uro‑oncology pathway to stimulate local immune responses against bladder tumours.

• Non‑muscle‑invasive bladder cancer (NMIBC): helps prevent tumour recurrence and progression after transurethral resection.
• Carcinoma in situ of the bladder: induces immune‑mediated tumour regression.
• High‑risk recurrent NMIBC: provides additional prophylactic benefit when standard intravesical therapy is insufficient.

• 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 (e.g., IL‑2, IFN‑γ, TNF‑α) and recruits macrophages, neutrophils and lymphocytes, creating a localized Th1‑dominant immune environment that targets and destroys residual cancer cells.

Adverse reactions are primarily local bladder irritation and systemic immune responses.

Common Side Effects

• Dysuria: painful urination during or after instillation.
• Urinary frequency: increased urge to void.
• Hematuria: presence of blood in urine.
• Low‑grade fever: mild temperature elevation.
• Fatigue: general tiredness.
• Mild cystitis‑like symptoms.

Serious or Rare Side Effects

• Systemic BCG infection (disseminated mycobacterial disease).
• Severe allergic reaction or anaphylaxis.
• Persistent high‑grade fever.
• Hepatitis or liver enzyme elevation.
• Sepsis or septic shock.
• Autoimmune phenomena such as Guillain‑Barré syndrome.

Before initiating therapy, clinicians should evaluate patient suitability and monitor for adverse events.

• Contraindication: active tuberculosis or immunosuppression: increased risk of disseminated infection.
• Prior BCG therapy reaction: assess tolerance before re‑challenge.
• Bladder integrity: avoid instillation if recent traumatic catheterisation or surgery.
• Concurrent immunomodulators: consider risk of enhanced systemic effects.
• Pregnancy and lactation: avoid use; insufficient safety data.
• Store at 2‑8°C: keep refrigerated, protect from light, do not freeze or shake.

BCG interacts with several therapeutic classes; awareness helps prevent amplified immune reactions.

Major Interactions (Avoid)

• Systemic chemotherapy agents (e.g., mitomycin C, doxorubicin): may increase systemic toxicity.
• High‑dose corticosteroids: suppress intended immune response.
• Live viral vaccines: concurrent administration can cause uncontrolled infection.

Moderate Interactions (Monitor Closely)

• Immunomodulatory drugs (e.g., checkpoint inhibitors, interferon‑alpha): may augment immune‑mediated adverse events.
• Antifungal azoles (e.g., fluconazole): potential pharmacokinetic interactions.
• Anticoagulants: monitor for rare bleeding complications linked to severe cystitis.