GNH USA

Europe — EMA

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

GNH USA supplies Oncotice (Bacillus Calmette‑Guérin), a live attenuated bacterial vaccine for non‑muscle‑invasive bladder cancer.

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What is Bacillus Calmette-Guérin (Bcg), Tice?

Bacillus Calmette-Guérin, the active ingredient in Oncotice, is a live attenuated bacterial vaccine presented as a sterile suspension for intravesical use. It is employed in the treatment of non‑muscle‑invasive bladder cancer, primarily in patients who have undergone transurethral resection of the tumour. GNH USA supplies Oncotice as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.

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

What is Bacillus Calmette-Guérin (Bcg), Tice used for?

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.

What are the side effects of Bacillus Calmette-Guérin (Bcg), Tice?

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.

What precautions apply to Bacillus Calmette-Guérin (Bcg), Tice?

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.

What does Bacillus Calmette-Guérin (Bcg), Tice interact with?

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.

Frequently asked questions

What is Oncotice used for?+
Oncotice is an intravesical immunotherapy containing Bacillus Calmette‑Guérin that is used to treat non‑muscle‑invasive bladder cancer, including carcinoma in situ and high‑risk superficial tumours, by reducing recurrence and progression after tumour resection.
How does Bacillus Calmette‑Guérin work in bladder cancer?+
BCG stimulates a local immune response when instilled into the bladder. Live mycobacterial cells are taken up by urothelial and antigen‑presenting cells, leading to cytokine release and recruitment of immune cells that create a Th1‑dominant environment, which attacks and eliminates malignant cells.
What is the usual dose of Oncotice?+
The dose of Oncotice is determined by the prescribing clinician based on the patient’s condition, treatment protocol and regulatory guidelines. Healthcare professionals set the volume and concentration for each intravesical instillation.
Is Oncotice safe during pregnancy or breastfeeding?+
Oncotice is contraindicated in pregnancy and breastfeeding because the safety profile for the fetus or infant is not established. Women of child‑bearing potential should use effective contraception during treatment and for a period thereafter as advised by their physician.
How do I order Oncotice from GNH USA?+
To order Oncotice, submit an enquiry on the product page at gnh-usa.com with the required quantity. GNH USA supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain if needed) and import documentation.
How does Oncotice compare with other bladder cancer therapies?+
Oncotice (BCG) is the standard intravesical immunotherapy for high‑risk non‑muscle‑invasive bladder cancer, offering superior long‑term recurrence‑free survival compared with chemotherapy alone. Alternatives such as intravesical mitomycin C lack the same durable immune‑mediated protection, though they may be used when BCG is contraindicated.
What are the storage and handling requirements for Oncotice?+
Oncotice must be stored at 2‑8 °C, protected from light, and should never be frozen or shaken. The product should be kept in its original packaging until ready for use to maintain stability and potency.
How is Oncotice administered?+
Oncotice is administered by a healthcare professional who instills the sterile suspension directly into the bladder through a catheter, typically once weekly for an induction course followed by maintenance cycles as per the treating physician’s protocol.
What are the most serious risks associated with Oncotice?+
The most serious risks include systemic BCG infection (disseminated BCGitis), severe allergic reactions such as anaphylaxis, and organ‑specific complications like granulomatous prostatitis or hepatitis. Prompt recognition and medical management are essential if these events occur.
Who should not use Oncotice?+
Oncotice should not be used in patients with severe immunosuppression, active urinary tract infection, recent bladder instrumentation, gross haematuria, or in pregnant or lactating women. Contra‑indications are determined by the treating clinician based on individual risk factors.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Bacillus Calmette-Guérin (Bcg), Tice
Route
Intravesical Use
Manufacturer
Msd Belgium
Origin
EU

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