Product image of Oncotice (Bacillus Calmette-Guérin (Bcg), Tice) supplied by GNH India

Oncotice

Active Ingredient:
Bacillus Calmette-Guérin (Bcg), Tice
Origin:
EU

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

Bacillus Calmette-Guérin (BCG) Tice, the active ingredient in Oncotice, is a live attenuated bacterial vaccine presented as a powder for intravesical use. It treats non‑muscle‑invasive bladder cancer in adults. GNH India supplies Oncotice as a licensed, GDP‑compliant international pharmaceutical supplier serving oncology centres worldwide.

GNH India supplies Oncotice as a licensed, GDP‑compliant international pharmaceutical supplier serving oncology centres worldwide.

Manufacturer / TM Owner

Msd Belgium

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Indications & Clinical Uses

Oncotice is a live attenuated bacterial vaccine used in the management of bladder cancer, specifically targeting the urothelial carcinoma pathway.

  • Non‑muscle‑invasive bladder cancer (NMIBC): Reduces the risk of tumour recurrence and progression.
  • Carcinoma in situ (CIS) of the bladder: Provides local immune‑mediated tumour control.
  • High‑risk NMIBC after transurethral resection: Serves as adjuvant therapy to decrease recurrence rates.

How It Works

  • Oncotice contains live attenuated Mycobacterium bovis (BCG) that, when instilled into the bladder, is internalised by urothelial and antigen‑presenting cells. This triggers a robust Th1‑type immune response, releasing cytokines such as IFN‑γ and TNF‑α that promote cytotoxic activity against malignant cells and create an immunological environment hostile to tumour growth.

Side Effects

Oncotice may cause a range of adverse reactions following intravesical administration.

Common Side Effects

  • Mild cystitis‑like symptoms: dysuria, frequency, urgency.
  • Low‑grade fever and chills.
  • Hematuria or mild bladder irritation.
  • Flu‑like symptoms such as fatigue and myalgia.
  • Localized pain at the instillation site.

Serious or Rare Side Effects

  • Systemic BCG infection (disseminated BCGitis).
  • Severe allergic reactions including anaphylaxis.
  • Persistent high‑grade fever or sepsis.
  • Significant hematuria requiring intervention.
  • Renal impairment secondary to obstructive uropathy.

Precautions & Warnings

Before using Oncotice, clinicians should evaluate patient suitability and monitor for adverse events.

  • Contraindication: Active urinary tract infection: Delay treatment until infection resolves.
  • Immunocompromised status: Increased risk of systemic infection; assess risk‑benefit.
  • Prior BCG therapy complications: Consider alternative strategies if severe reactions occurred.
  • Pregnancy: Avoid use; potential fetal risk not established.
  • Breastfeeding: Not recommended due to unknown excretion in milk.
  • Store at 2‑8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

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

Major Interactions (Avoid)

  • Systemic immunosuppressants (e.g., high‑dose corticosteroids, azathioprine): May diminish BCG efficacy and increase infection risk.
  • Live vaccines administered concurrently: Risk of additive infection.

Moderate Interactions (Monitor Closely)

  • Antifungal agents such as fluconazole: May affect BCG metabolism indirectly.
  • Intravesical chemotherapy agents given in close succession: Potential for increased bladder irritation.
  • Cytokine‑targeting therapies (e.g., anti‑TNF agents): May alter immune response to BCG.
  • NSAIDs: May mask fever, a key safety signal.
  • Anticoagulants: Heightened risk of hematuria.

Frequently Asked Questions

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Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

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