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, the active ingredient in Oncotice, is a live bacterial immunotherapy presented as a lyophilized powder for intravesical use. It is employed to treat non‑muscle invasive bladder cancer in adult patients, helping to reduce tumour recurrence after transurethral resection.

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

Manufacturer / TM Owner

Merck Sharp & Dohme Pharmaceutical Trading Single Member S.A.

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Indications & Clinical Uses

Oncotice is a live bacterial immunotherapy used in the management of bladder cancer and related urothelial conditions.

  • Non‑muscle invasive bladder cancer (NMIBC): reduces recurrence and progression after transurethral resection.
  • Carcinoma in situ of the bladder: induces a local immune response to eradicate tumour cells.
  • High‑risk recurrent NMIBC: provides adjunctive therapy to improve disease‑free survival.

How It Works

  • Bacillus Calmette‑Guérin adheres to the urothelial lining and is internalised by antigen‑presenting cells, triggering a Th1‑type cytokine cascade. The resulting immune activation recruits macrophages, NK cells and cytotoxic T‑lymphocytes that target and destroy malignant urothelial cells, while also promoting local inflammation that hinders tumour regrowth.

Side Effects

Oncotice may cause a range of adverse reactions, most of which are local to the bladder, while rare systemic events can be serious.

Common Side Effects

  • Cystitis‑like symptoms: urgency, frequency, dysuria.
  • Hematuria: visible blood in urine.
  • Low‑grade fever and chills.
  • Fatigue or malaise.
  • Mild abdominal discomfort.
  • Transient urinary incontinence.

Serious or Rare Side Effects

  • Systemic BCG infection or sepsis.
  • Disseminated mycobacterial disease.
  • Severe allergic or anaphylactic reaction.
  • Granulomatous prostatitis.
  • Bladder contracture or fibrosis.
  • Persistent high‑grade fever with organ involvement.

Precautions & Warnings

Prior to initiating Oncotice therapy, clinicians should evaluate patient suitability and monitor for complications.

  • Active urinary infection: treat and resolve before BCG instillation.
  • Immunosuppression: avoid in patients receiving systemic steroids, chemotherapy or biologics.
  • Bladder integrity: contraindicated in cases of traumatic catheterisation or recent bladder surgery.
  • Pregnancy and breastfeeding: not recommended due to unknown fetal risk.
  • Monitoring: observe for systemic symptoms such as fever, weight loss or respiratory signs.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

BCG interacts with several drug classes that modulate immune function or affect bladder healing.

Major Interactions (Avoid)

  • Systemic corticosteroids or high‑dose steroids.
  • Immunosuppressive biologics (e.g., anti‑TNF agents).
  • Cytotoxic chemotherapy administered concurrently.
  • Live vaccines given within 4 weeks of BCG.
  • Severe renal impairment requiring dialysis.

Moderate Interactions (Monitor Closely)

  • Intravesical chemotherapy agents given sequentially.
  • Anticoagulants: increased risk of hematuria.
  • NSAIDs used for fever control: may mask infection signs.
  • Antifungal agents that alter immune response.
  • Proton‑pump inhibitors: potential effect on bladder mucosa.

Frequently Asked Questions

Oncotice is a formulation of Bacillus Calmette‑Guérin (BCG) used as an intravesical immunotherapy for non‑muscle invasive bladder cancer, including carcinoma in situ and high‑risk recurrent disease, to reduce tumour recurrence after surgical resection.

BCG attaches to the bladder lining and is taken up by immune cells, initiating a Th1‑type cytokine response. This activates macrophages, natural killer cells and cytotoxic T‑lymphocytes that attack and eliminate malignant urothelial cells while creating an inflammatory environment that hinders tumour regrowth.

The specific dose and schedule of Oncotice are determined by the prescribing oncologist or urologist based on the patient’s disease stage, prior treatments and clinical guidelines. Dosage information is not standardized in public sources and must be individualized.

Oncotice is not recommended for use in pregnant or breastfeeding women because the safety of intravesical BCG in these populations has not been established. Clinicians should consider alternative therapies and discuss potential risks with the patient.

To place an order, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain if needed) and any required import documentation.

Oncotice (BCG) is the only approved live‑attenuated bacterial therapy for NMIBC and is considered the standard of care for high‑risk disease. Compared with intravesical chemotherapy agents, BCG provides a stronger immune‑mediated response, leading to lower recurrence rates, but it may have a higher incidence of local inflammatory side effects.

Oncotice must be stored at 2‑8 °C in a refrigerator, protected from light, and should never be frozen or shaken. The product should be kept in its original packaging until reconstitution and used according to the manufacturer’s instructions.

Oncotice is reconstituted with sterile diluent and instilled directly into the bladder via a catheter. The solution is retained for a prescribed dwell time, typically 2 hours, after which it is drained. Administration is performed by a trained healthcare professional in a clinical setting.

The most serious risks include systemic BCG infection or sepsis, disseminated mycobacterial disease, severe allergic reactions, granulomatous prostatitis, and bladder contracture. Patients should be monitored closely for fever, weight loss, respiratory symptoms or any signs of systemic infection.

Oncotice is contraindicated in patients with active urinary tract infection, recent bladder surgery or traumatic catheterisation, severe immunosuppression (e.g., high‑dose steroids, chemotherapy, HIV with low CD4), and those who are pregnant or breastfeeding.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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