Onco-BCG (Bcg Vials) 40mg/ml

Onco-BCG is an immunotherapy used in the treatment of bladder cancer. It is specifically indicated for:

• Flat Urothelial Cell Carcinoma in Situ of the urinary bladder: Helps in the treatment of this specific type of bladder cancer.
• Adjunctive therapy following Transurethral resection: Used after the surgical removal of primary or relapsing superficial noninvasive papillary tumors limited to the bladder mucosa (stage Ta or T1).
• Reduction of tumor recurrence: Intravesical BCG Immunotherapy has been shown to reduce tumor recurrence and prevent progression.

• Onco-BCG works by stimulating the body’s immune system to recognize and attack cancer cells in the bladder. When instilled directly into the bladder, it activates immune cells that target and destroy abnormal cancer cells, thereby reducing the risk of tumor recurrence and disease progression.

Onco-BCG may cause side effects, which can be categorized as follows:

Common Side Effects

• Frequency, urgency of micturition, and dysuria: These symptoms usually occur from the second or third instillation onwards.
• Malaise and low to medium-grade fever: These symptoms usually occur within 4 hours after instillation and disappear within 24-48 hours.
• Cystitis and typical granulomatous inflammatory reactions: These occur in the mucosa of the urinary bladder and usually disappear within 2 days.

Serious or Rare Side Effects

• Fever more than 39°C: The fever resolves within 24-48 hours with antipyretics and fluids.
• Systemic BCG infections: These may be manifested by pneumonitis, hepatitis, or cytopenia, especially due to traumatic catheterization or perforation of the bladder.
• Granulomatous Prostatitis: This is a rare but serious side effect that may occur.

Onco-BCG should be used with caution and under the supervision of a healthcare professional. Important precautions include:

• Impaired immune response: The product is not intended for use in patients with impaired immune responses, whether congenital or caused by disease, drugs, or other therapy.
• Traumatic catheterization: Delay treatment in patients who experience traumatic catheterization until mucosal damage has healed.
• Urinary tract infections: Treatment should be withheld until urine culture is negative and antibiotic therapy is stopped.
• Pregnancy and lactation: The safety of the mode of therapy in pregnant women, nursing mothers, and children has not been evaluated.
• Storage: Store at 2-8°C: Keep refrigerated, protect from light, do not freeze or shake.

Onco-BCG may interact with other medications, which can be categorized as follows:

Major Interactions (Avoid)

• Antitubercular drugs: SII-ONCO-BCG is sensitive to most antibiotics, especially anti-tubercular drugs like Streptomycin, Isoniazid, Ethambutol, Rifampicin, and PAS (Para-amino Salicylic Acid).
• On-going treatment with antitubercular agents: If a patient is receiving antibiotics treatment, intravesical instillation should be postponed until completion of antibiotics treatment.

Moderate Interactions (Monitor Closely)

• Antibiotics: It is not known whether interactions occur during intravesical instillation of SII-ONCO-BCG or whether the interactions result in clinically relevant reduction of multiplication activity of SII-ONCO-BCG.
• Other drugs: Studies on interaction with other drugs are not performed.