Home' Australian Pharmacist : Australian Pharmacist October 2014 Contents BEXSERO® -- Multicomponent Meningococcal B vaccine (recombinant, adsorbed). Indication: Active immunisation against invasive disease caused by N. meningitidis group B strains. See full PI for information on protection against specific group B strains.
BEXSERO is indicated for vaccination of individuals from 2 months of age and older. Contraindications: Hypersensitivity to the active substances or to any of the excipients. Precautions: Administration should be postponed in subjects suffering from an acute severe febrile
illness. Do not inject intravascularly. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine. Protection against all circulating meningococcal group B strains should not be
expected. Healthcare professionals should be aware that fever occurs very commonly following vaccination of infants and toddlers. Patients and/or their care givers should be made aware of the risks and management of fever and its sequelae. Prophylactic administration of
antipyretics at the time of and closely after vaccination can reduce the incidence and intensity of post-vaccination febrile reactions. Antipyretic medication should be initiated according to local guidelines in infants and toddlers. There are no data in subjects above 50 years of
age or in patients with chronic medical conditions or in subjects with impaired immune responsiveness. In immunocompromised individuals, vaccination may not result in a protective antibody response. May contain natural rubber latex. May contain kanamycin. Some of the
effects may temporarily affect the ability to drive or use machines. Use in Pregnancy: Category B1. Use in Lactation: The benefit-risk ratio must be examined before making the decision to immunise during lactation. Interactions: Can be given concomitantly with any
of the following vaccine antigens, either as monovalent or as combination vaccines: diphtheria, tetanus, acellular pertussis, Haemophilus influenzae type b, inactivated poliomyelitis, hepatitis B, heptavalent (7-valent) pneumococcal conjugate, measles, mumps, rubella and
varicella. More frequent occurrence of fever, tenderness at the injection site, change in eating habits and irritability. Prophylactic use of paracetamol reduces the incidence and severity of fever without affecting the immunogenicity of the vaccines. Concomitant administration
with vaccines other than those mentioned above has not been studied. Should be administered at separate injection sites, when given concomitantly with other vaccines. Dosage and administration: Complex dose and administration -- see full PI before prescribing. Side
effects: Infants and Toddlers: Very common: eating disorders, sleepiness, unusual crying, diarrhoea, vomiting, rash, fever (≥38°C), injection site tenderness (including severe injection site tenderness defined as crying when injected limb is moved), injection site erythema,
injection site swelling, injection site induration, irritability. Common: fever (≥39.5°C). Adolescents and Adults: Very common: headache, nausea, injection-site pain (including severe injection site pain defined as unable to perform normal daily activity), injection site
swelling, injection site induration, injection site erythema, malaise, myalgia, arthralgia. PI approved 14 August 2013 (bex010813m.doc). ® Registered Trademark.
Reference: 1. Australian Technical Advisory Group on Immunisation (ATAGI) Statement. Advice for immunisation providers regarding the use of Bexsero® -- a recombinant multicomponent meningococcal B vaccine (4CMenB) March 2014. Accessed September 2014
See TGA approved Product Information before prescribing.
For the most up to date Product Information go to http://www.novartis.com.au/products_healthcare.html
PBS Information: This product is not listed on the National Immunisation Program (NIP) or the PBS.
The Department of Health (Australian Technical Advisory
Group on Immunisation) recommends meningococcal B (MenB)
vaccination for adolescents as well as infants under
24 months for the prevention of meningococcal B disease.1
ADOLESCENTS AGED 15--19
YEARS ARE AT GREATEST
RISK OF MenB.1
BEXSERO can be ordered through the following wholesalers
Team Medical Supplies (ACT, NSW, NT, QLD and WA)
Warner & Webster (SA, TAS and VIC)
1300 224 450
1300 363 306
Novartis Vaccines & Diagnostics Pty Ltd. 54 Waterloo Road, North Ryde, NSW 2113, Australia. BEX-AUG-2014-054
ABN 60 089 509 544 September 2014 NVP0441/AP
Multicomponent Meningococcal group B Vaccine
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