BEXSERO

BEXSERO (Multicomponent Meningococcal group B vaccine [recombinant, absorbed])

Bexsero is indicated for active immunisation against invasive meningococcal disease caused by Neisseria meningitidis group B in individuals from 2 months of age and older.¹

The Australian Immunisation Handbook recommends Meningococcal B vaccination for the following groups:²

• Infants and Young Children (aged <2 years)
• All Aboriginal and Torres Strait Islander People (aged 2 months – 19 years)
• Healthy Adolescents (aged 15-19 years)
• Adolescents and Young Adults aged 15-24 years living in close quarters or who are current smokers
• Other, including laboratory personnel that frequently handle N. Meningitidis or any person with certain medical conditions* that increase their risk of Invasive Meningococcal Disease.

  For further information, please refer to the Australian Immunisation Handbook.²

 *For list of medical conditions refer to the Australian Immunisation Handbook.²

 

About BEXSERO 

 

PLEASE REVIEW BEXSERO PRODUCT INFORMATION BEFORE PRESCRIBING.

FULL PRODUCT INFORMATION IS AVAILABLE AT WWW.GSK.COM.AU/BEXSERO

PBS Information: BEXSERO is listed on the National Immunisation Program (NIP) for Aboriginal and Torres Strait Islander children aged <2 years and for people of all ages with some medical risk conditions. Refer to NIP schedule or your State or Territory Health department.

 

BEXSERO Dosage Schedule

Note: Each dose is 0.5 ml in a pre-filled syringe. Administered by deep intramuscular injection.

Bexsero must not be injected intravenously, subcutaneously or intradermally.¹ ~Alternate schedule available – refer to Product Information.¹ *The safety and efficacy of the vaccine in infants less than 8 weeks have not been established. No data available.¹ ^The safety and efficacy of the vaccine in individuals above 50 years of age have not been established.¹ +A booster dose should be considered in individuals at continued risk of exposure to meningococcal disease¹, based on official recommendations.²

 

Prophylactic Paracetamol Recommendations

Due to the increased risk of fever¹, prophylactic paracetamol is recommended with every dose of Bexsero in children <2 years of age²

Note: The Australian Immunisation Handbook recommends the prophylactic use of paracetamol with every dose of Bexsero administered to children <2 years of age, regardless of presence of fever. ² †Or as soon as practicable afterward.² *ATAGI recommends doses of paracetamol to be given 6 hours apart.²

 

Bexsero can be given concomitantly with the following vaccine antigens (monovalent or as combination vaccines)¹

• Diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis, Haemophilus influenzae type B
• Meningococcal group A, C, W, Y conjugate
• Heptavalent pneumococcal conjugate
• Measles, mumps, rubella, varicella

 

Bexsero is generally well tolerated. The most common adverse reactions observed in clinical trials were:¹

• In Infants, Toddlers & Children (up to 10 years of age): injection site reactions, fever (≥38°C), irritability, eating disorders, diarrhea, headache, vomiting, rash, unusual crying, sleepiness and arthralgia. ¹
• In Adolescents (from 11 years of age) & Adults: injection site reactions, headache, nausea, malaise, myalgia and arthralgia. ¹

The safety profiles of the co-administered vaccines were unaffected by concomitant administration of Bexsero with the exception of more frequent occurrence of fever, tenderness at the injection site, change in eating habits and irritability. Separate injection sites must be used if more than one vaccine is administered at the same time. Administer in accordance with local guidelines. ¹