IntradermalActive immunisation against tuberculosisAdult: As live attenuated Mycobacterium bovis (M. bovis) BCG, Danish strain 1331: 0.1 mL via slow inj into the insertion of the deltoid muscle.
Child: As live attenuated M. bovis BCG, Danish strain 1331: <12 months 0.05 mL; ≥12 months 0.1 mL. All doses are given via slow inj at the insertion of the deltoid muscle.
IntravesicalProphylaxis of carcinoma in situ of urinary bladder, Prophylaxis of primary Ta and/or T1 papillary tumours following transurethral resection, Prophylaxis of recurrent Ta and/or T1 papillary tumours following transurethral resection, Treatment of carcinoma in situ of urinary bladderAdult: As freeze-dried BCG containing live attenuated strain of M. bovis: Induction: Instil into the urinary bladder (retain for 2 hours) once weekly for 6 weeks, beginning 7-15 days after biopsy or transurethral resection (TUR), or until mucosal lesions after TUR have healed. Maintenance: Instil into the bladder (retain for 2 hours) once weekly for 3 consecutive weeks at 3, 6, and 12 months after initiation of treatment. Evaluate the need for maintenance therapy beyond 1st year of treatment based on tumour classification and clinical response. Alternatively, once monthly maintenance therapy for at least 6-12 months.
PercutaneousActive immunisation against tuberculosisAdult: As live attenuated M. bovis BCG, TICE strain: In patients who are not previously infected and who are at high risk for exposure: 0.2-0.3 mL as full-strength dilution given via single-use multiple-puncture device in the deltoid region. Repeat vaccination for those who will remain negative to tuberculin test after 2-3 months. Recommendations and vaccination guidelines may vary among countries or individual products. Refer to country- or product-specific guidelines.
Child: Same as adult dose.
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Intradermal/Intravesical: Reconstitute with appropriate volume of solvent provided. Swirl the vial gently; do not shake. Percutaneous: Adults and children: Full-strength dilution: Add 1 mL of sterile water for inj into 1 single-dose vial of vaccine. Neonates: Half-strength dilution: Add 2 mL of sterile water for inj into 1 single-dose vial of vaccine. Swirl the vial gently; do not shake.
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Intravesical: Incompatible with hypo- and hypertonic solutions.
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Hypersensitivity. Acute severe febrile illness, generalised infected skin conditions, congenital or acquired immune deficiencies (e.g. HIV infection, leukaemia, lymphoma); active TB. When used for bladder cancer: UTI, gross haematuria. Immunocompromised patients. Patients receiving systemic corticosteroids, other immunosuppressive treatment including radiotherapy, or anti-TB drugs. Infants exposed to immunosuppressive treatment in utero or via breastfeeding, for as long as a postnatal influence of the immune status of the infant remains possible (e.g. maternal treatment with tumour necrosis factor [TNF]-α antagonists).
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Patient with previous history of respiratory immaturity, high risk for HIV; small bladder capacity (intravesical). BCG vaccine is not recommended to be given to tuberculin positive patients; not indicated for the active treatment of TB. BCG live intravesical is not recommended for use for active immunisation against TB; not a vaccine for the prevention of cancer. This drug is available in several different formulations for specific indications, refer to specific product guidelines prior to administration. Neonates, children. Pregnancy and lactation.
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Significant: Anaphylactoid or hypersensitivity reactions, moderate axillary or cervical lymphadenopathy, induration or pustule formation at inj site, severe ulceration, regional suppurative lymphadenitis with draining sinuses, caseous lesions, purulent drainage, osteomyelitis, syncope; UTI, bladder irritability (intravesical).
Blood and lymphatic system disorders: Anaemia (intravesical).
General disorders and administration site conditions: Fever, fatigue, malaise, rigors.
Investigations: Urine analysis abnormal (intravesical).
Musculoskeletal and connective tissue disorders: Osteitis, arthralgia, arthritis, myalgia.
Nervous system disorders: Headache.
Renal and urinary disorders: Haematuria, pollakiuria, cystitis, dysuria, urinary incontinence, micturition urgency.
Respiratory, thoracic and mediastinal disorders: Pneumonitis (intravesical).
Potentially Fatal: Systemic BCG reaction, disseminated BCG infections.
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Intravesical/Parenteral: C
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Perform purified protein derivative (PPD) test prior to vaccination. Monitor for flu-like symptoms, fever, acute local reactions lasting >2-3 days; anaphylaxis, syncope for 15 minutes after vaccination.
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Diminished therapeutic effect with antibiotics. Enhanced adverse effect and diminished therapeutic effect with corticosteroids, immunosuppressants.
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Description:
Mechanism of Action: BCG is a live, attenuated bacterial culture of the Bacillus of Calmette and Guerin strain derived from Mycobacterium bovis which induces the development of immunity against Mycobacterium tuberculosis. It also has an anti-tumour activity which is believed to cause a local, chronic inflammatory response involving macrophage and leucocyte infiltration of the bladder.
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Store between 2-8°C. Do not freeze. Protect from light. Follow applicable procedures for receiving, handling, administration, and disposal.
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L03AX03 - BCG vaccine ; Belongs to the class of other immunostimulants.
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Anon. BCG (Intravesical). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 18/08/2023. Anon. BCG Vaccine (Immunization) (Pediatric and Neonatal Lexi-Drugs). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 09/05/2023. Anon. BCG Vaccine (Immunization). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 09/05/2023. Anon. BCG Vaccine. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 09/05/2023. Bacillus Calmette-Guerin Vaccine, BCG. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 09/05/2023. BCG Vaccine (Merck Sharp & Dohme LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 09/05/2023. BCG Vaccine AJV Powder and Solvent for Suspension for Injection (AJ Vaccines A/S). MHRA. https://products.mhra.gov.uk. Accessed 09/05/2023. Buckingham R (ed). BCG Vaccines. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 18/08/2023. Joint Formulary Committee. Bacillus Calmette-Guerin Vaccine. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/05/2023. Joint Formulary Committee. Bacillus Calmette-Guerin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 18/08/2023. Merck Sharp & Dohme (New Zealand) Ltd. OncoTICE Powder for Instillation Fluid for Intravesical Use data sheet 25 February 2019. Medsafe. http://www.medsafe.govt.nz. Accessed 18/08/2023. OncoTICE Powder for Instillation Fluid for Intravesical Use (Merck Sharp & Dohme [UK] Limited). MHRA. https://products.mhra.gov.uk. Accessed 18/08/2023. Paediatric Formulary Committee. Bacillus Calmette-Guerin Vaccine. BNF for Children [online]. London. BMJ Group, Pharmaceutical Press, and RCPCH Publications. https://www.medicinescomplete.com. Accessed 09/05/2023. Seqirus (NZ) Ltd. BCG Vaccine AJV data sheet 6 May 2021. Medsafe. http://www.medsafe.govt.nz. Accessed 09/05/2023. Tice BCG Powder, for Suspension (Merck Sharp & Dohme LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 18/08/2023.
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