Vaccine, BCG


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : Intradermal Active immunisation against tuberculosis 0.1 mL via slow injection into the deltoid muscle. Intravesical Treatment and prophylaxis of carcinoma in situ of the urinary bladder; Prophylaxis of primary or recurrent Ta and/or T1 papillary tumours following transurethral resection Induction: Instill 50 mL solution into the bladder, once weekly for 6 consecutive weeks, beginning min 14 days after biopsy or TUR. Retain solution for up to 2 hours for Max effect. Patient may be repositioned every 15 minutes for Max area contact. Maintenance: Instill 50 mL once weekly for 3 consecutive weeks at 3, 6, 12 months after initiation of treatment.
Dosage Details
Intradermal
Active immunisation against tuberculosis
Adult: 0.1 mL via slow injection into the deltoid muscle.
Child: <12 months 0.05 mL via slow injection into the deltoid muscle.

Intravesical
Prophylaxis 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 bladder
Adult: As freeze-dried BCG containing 1 to 16 x 108 colony forming units of live attenuated strain of Mycobacterium bovis: Induction: Instill 50 mL solution into the bladder, once weekly for 6 consecutive weeks, beginning min 14 days after biopsy or transurethral resection (TUR). Retain solution for up to 2 hours for Max effect. Patient may be repositioned every 15 minutes for Max area contact. Maintenance: Instill 50 mL once weekly for 3 consecutive weeks at 3, 6, 12 months after initiation of treatment.
Reconstitution
Intradermal: Reconstitute with appropriate volume of solvent provided. Intravesical: Dilute freeze-dried powder with NaCl 0.9% solution to a final concentration of 50 mL.
Contraindications
Hypersensitivity. Impaired immune response, congenital or acquired immune deficiencies (e.g. HIV-infection, leukaemia, lymphoma, cancer therapy, Hodgkin’s disease), active tuberculosis, acute severe febrile illness, generalised infected skin conditions, current or previous evidence of BCG infection, urinary tract infection, gross haematuria, <14 days of biopsy, TUR, or traumatic catheterisation. Concomitant therapy with immunosuppressive agents, bone marrow depressants, antibiotics, radiation therapy.
Special Precautions
Patient with small bladder capacity (intravesical). Pregnancy and lactation.
Adverse Reactions
Significant: Risk of bladder contracture (intravesical), malaise, fever and chills, flu-like symptoms.
Blood and lymphatic system disorders: Anaemia.
Gastrointestinal disorders: Abdominal pain, nausea, diarrhoea.
General disorders and administration site conditions: Rigors.
Musculoskeletal and connective tissue disorders: Arthralgia, arthritis, myalgia.
Renal and urinary disorders: Cystitis, dysuria, pollakuria, haematuria, UTI, urinary incontinence.
Respiratory, thoracic and mediastinal disorders: Pneumonitis.
Potentially Fatal: Rarely, systemic granulomatous illness.
MonitoringParameters
Perform PPD test prior to vaccination. Monitor for anaphylaxis and syncope, 15 mins post vaccination; fever, flu-like symptoms and other adverse effects up to 3 days after treatment.
Drug Interactions
Diminished therapeutic effect with immune globulins.
Potentially Fatal: Diminished therapeutic effect with immunosuppressants, bone marrow depressants, antibiotics, radiation therapy.
Lab Interference
May diminish diagnostic effect of tuberculin skin test.
Action
Description: BCG vaccine is an attenuated strain of bacillus Calmette-Guérin Mycobacterium bovis used as biologic response modifier. It is also used as an active immunotherapy for the treatment of bladder carcinoma in situ by causing a local, chronic inflammatory response involving macrophage and leukocyte infiltration of the bladder, resulting in the destruction of superficial tumour cells of the urothelium.
Storage
Store at 2-8°C.
ATC Classification
L03AX03 - BCG vaccine ; Belongs to the class of other immunostimulants.
References
Anon. BCG (Intravesical). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/07/2018.

Anon. BCG Vaccine (Immunization). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/07/2018.

Anon. BCG Vaccine. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 03/07/2018.

BCG Vaccine Substrate Tice Live Antigen Injection, Powder, Lyophilized, for Solution (Organon USA Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 03/07/2018.

Buckingham R (ed). BCG Vaccines. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/07/2018.

Joint Formulary Committee. Bacillus Calmette-Guérin Vaccine. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/07/2018.

Sequiriz (NZ) Ltd. BCG Vaccine SSI Powder and Solvent for Suspension for Injection data sheet 14 March 2018. Medsafe. http://www.medsafe.govt.nz/. Accessed 03/07/2018.

Tice BCG Powder, for Suspension (Organon USA Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 03/07/2018.

Disclaimer: This information is independently developed by MIMS based on Vaccine, BCG from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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