bacillus calmette-guerin: clinical use

Prescribing considerations

• Use only by professionals experienced in intravesical BCG, with atraumatic aseptic catheterisation.
• Ensure the urothelium has healed after resection, biopsy or traumatic catheterisation.
• Discuss possible effects on sperm production and sperm preservation where relevant.
• Provide product-specific patient information; BCG-medac also requires a patient alert card.

Contraindications and cautions

• Clinically significant congenital or acquired immunosuppression, including positive HIV serology.
• Active tuberculosis or concurrent antituberculosis treatment.
• Pregnancy or breastfeeding.
• Acute urinary tract infection, visible haematuria or bladder perforation.
• Unhealed mucosal injury after urinary-tract surgery, biopsy or traumatic catheterisation.
• Hypersensitivity to BCG or product excipients.
• Previous bladder radiotherapy is specifically contraindicated for BCG-medac.

Monitoring

• Exclude urinary infection, visible haematuria, fever and significant bladder irritation before instillation.
• Review tuberculosis history and perform product-appropriate baseline tuberculin assessment; consider HIV testing where clinically indicated.
• Monitor for persistent fever, progressive systemic illness, respiratory or hepatic features and symptoms outside the urinary tract.
• Assess urinary symptoms, retention, recurrent infection and reduced bladder capacity.
• Continue tumour-response surveillance through the specialist bladder-cancer pathway.

Clinical pharmacology

Live attenuated Mycobacterium bovis organisms adhere to the urothelium and produce predominantly local, non-specific immune activation. Most organisms are eliminated in urine soon after instillation, although persistence has rarely been reported.

Formulation and product differences

• OncoTICE contains the Tice BCG strain as a freeze-dried powder for reconstitution with physiological saline; excipients include lactose, asparagine, glycerol and mineral salts.
• BCG-medac contains the RIVM strain as powder supplied with sodium chloride solvent in an intravesical administration system; powder excipients include polygeline, glucose and polysorbate 80.
• Both contain live attenuated organisms, require refrigerated light-protected storage and biohazard handling, and must never be injected or used for TB vaccination.