Home' Australian Pharmacist : Australian Pharmacist August 2014 Contents Novartis Vaccines & Diagnostics Pty Ltd.
54 Waterloo Road, North Ryde, NSW 2113,
ABN 60 089 509 544 April 2014 NVP0419/AP
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.
References: 1. BEXSERO® Approved Product Information, 14 August 2013. 2. Granoff DM. Clin Infect Dis 2010; 50(suppl 2): S54--S65.
3. Therapeutic Goods Administration, Australian Register of Therapeutic Goods. Available from https://www.ebs.tga.gov.au. Accessed on 25 November 2013.
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.
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
Department of Health's clinical advice
regarding the use of Bexsero® is available at
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