SUMMARY CMI

BEXSERO

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor, nurse or pharmacist.

1. Why am I receiving BEXSERO?

BEXSERO is a vaccine used for the immunisation of children from the age of 2 months and older, adolescents and adults to prevent disease caused by Neisseria meningitidis Group B. Neisseria meningitidis can cause meningitis, a very serious infection.

For more information, see Section 1. Why am I receiving BEXSERO? in the full CMI.

2. What should I know before I receive BEXSERO?

Do not receive if you have ever had an allergic reaction to BEXSERO or any of the ingredients listed at the end of the CMI.

Tell your doctor or nurse if you or your child have an allergy to kanamycin (an antibiotic), or allergy to any other vaccine or you have a very high fever or any other infection.

Talk to your doctor or nurse if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I receive BEXSERO? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with BEXSERO and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I receive BEXSERO?

• Your doctor or nurse will give you BEXSERO as an injection into your upper arm or for children into the upper thigh muscle.

More instructions can be found in Section 4. How do I receive BEXSERO? in the full CMI.

5. What should I know after receiving BEXSERO?

For more information, see Section 5. What should I know after receiving BEXSERO? in the full CMI.

6. Are there any side effects?

Side effects which have been reported following administration of BEXSERO include pain at the injection site, redness at the injection site, swelling of the skin at the injection site, hardness of skin at the injection site, fever, a general feeling of being unwell, feeling irritable, unusual crying, loss of appetite, painful muscles and joints, headache, nausea, vomiting, diarrhoea, skin rashes and sleepiness.

Allergic reactions have also occurred following administration of BEXSERO. Allergy is rare and severe reactions will usually occur within the first few hours of vaccination. If this occurs go to the Emergency Department of the nearest hospital immediately.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

BEXSERO

Active ingredient(s): multicomponent meningococcal group B vaccine (recombinant, adsorbed)

Consumer Medicine Information (CMI)

This leaflet provides important information about using BEXSERO. You should also speak to your doctor, nurse or pharmacist if you would like further information or if you have any concerns or questions about using BEXSERO.

Where to find information in this leaflet:

1. Why am I receiving BEXSERO?
2. What should I know before I receive BEXSERO?
3. What if I am taking other medicines?
4. How do I receive BEXSERO?
5. What should I know after receiving BEXSERO?
6. Are there any side effects?
7. Product details

1. Why am I receiving BEXSERO?

BEXSERO is a vaccine used for the active immunisation of individuals from 2 months of age and older to help prevent disease caused by Neisseria meningitidis serogroup B.

Neisseria meningitidis (meningococcal disease) can cause meningitis (inflammation of the spinal fluid and the tissues that surround the brain) or sepsis (blood poisoning). Meningococcal disease is an infectious disease that is spread from person to person through regular close contact through respiratory droplets. It is a very serious disease and is sometimes fatal. It may cause permanent physical and neurological damage.

BEXSERO can help to protect you or your child from meningococcal disease caused by Neisseria meningitidis group B. It is not expected to provide protection against all circulating meningococcal group B types or from meningococcal disease caused by different kinds of microbes.

BEXSERO works by causing your body to produce its own protection (antibodies) against meningococcal bacteria. Your body usually takes a few weeks after receiving the vaccination to develop protection against Neisseria meningitidis group B.

If a vaccinated person comes into contact with Neisseria meningitidis group B, the body is usually able to destroy it. However, as with all vaccines, 100% protection cannot be guaranteed.

Sometimes individuals may react unfavourably to the vaccine. The chance of a severe reaction from BEXSERO is very small but the risks from not being vaccinated against meningococcal disease may be very serious.

2. What should I know before I receive BEXSERO?

Warnings

Do not receive BEXSERO if you or your child:

• are allergic to BEXSERO, or any of the ingredients listed at the end of this leaflet.
• Always check the ingredients to make sure you can use this medicine.

Check with your doctor or nurse if you or your child:

• are allergic to kanamycin, an antibiotic. If present, the level of kanamycin in the vaccine is low.
• have had an allergic reaction or become unwell after receiving any other vaccine.
• have a severe infection with a high temperature.
  In this case vaccination with BEXSERO may have to be delayed. A minor infection such as a cold should not be problem however talk to your doctor or nurse about this before being vaccinated.
• have any other medical conditions including any that involve your immune system
  Little is known about the effectiveness of BEXSERO when administered to individuals with weakened immunity due to the use of immunosuppressive medications or genetic disorders of the body's natural defence system. It is possible the effectiveness of BEXSERO could be reduced in such individuals.
• take any medicines for any other condition
• are receiving treatment that blocks part of the immune system known as complement activation such as eculizumab. Individuals could remain at risk of Neisseria meningitidis group B infection even after vaccination with BEXSERO.

If your child was born prematurely (before or at 28 weeks gestation), particularly if they had breathing difficulties, please tell your doctor. Stopping breathing or irregular breathing for a short time may be more common in the first 3 days following vaccination in these babies and they may need special monitoring.

The safety and efficacy of BEXSERO in adults over the age of 50 has not been established. There are limited data on the use in patients with chronic medical conditions.

You may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

They will discuss with you the benefits and risks of receiving BEXSERO during pregnancy or whilst breastfeeding.

Fainting

Fainting can occur following, or even before, any needle injection. Tell the person giving you your injection if you or your child have ever fainted with a previous injection.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with BEXSERO and affect how it works.

Tell your doctor or nurse if you or your child have had any vaccines recently.

BEXSERO may be given at the same time as other vaccinations.

Other vaccines must be injected into a different arm or leg from the site of the BEXSERO injection. These include any of the following vaccine components:

• diphtheria, tetanus, whooping cough (pertussis), Haemophilius influenzae type B, polio, hepatitis B, pneumococcal, measles, mumps, rubella, chickenpox and meningococcus A, C, W and Y.

Your doctor or nurse may ask you to give your child medicines that helps to lower fever (a common side effect). This will help to reduce some of the side effects of BEXSERO.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect BEXSERO.

4. How do I receive BEXSERO?

How much is given

• Your doctor or nurse will give you BEXSERO as an injection
• The dose is 0.5 mL
• You or your child may be given more than one single dose of BEXSERO. Talk to your doctor or nurse for more information.

How it is given

• BEXSERO is injected into your upper arm or in children it can be given into the thigh muscle
• It should not be injected directly into a blood vessel or into or under the skin

If you are given too much BEXSERO

If you think that you have been given too much BEXSERO, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know after receiving BEXSERO?

Things you should do

• keep a record of your/your child's vaccination history

Driving or using machines

Be careful before you drive or use any machines or tools until you know how BEXSERO affects you.

No studies on the effects on the ability to drive and use machines have been performed.

Looking after your medicine

• BEXSERO will usually be stored at the doctor's clinic or at the pharmacy.
• If you need to store BEXSERO it is important to keep it in the refrigerator between 2°C and 8°C.
• Keep BEXSERO in the carton to protect it from light.
• DO NOT FREEZE BEXSERO. FREEZING THIS MEDICINE WILL DESTROY THE VACCINE.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you or your child do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor, nurse or pharmacist if you have any further questions about side effects.

Your doctor or nurse might ask you to remain for observation following your vaccination.

Less serious side effects

Serious side effects

Side effects reported during marketed use include:

• enlarged lymph nodes
• allergic reactions
• collapse, sudden onset of muscle floppiness
• less responsive than usual or a lack of awareness
• paleness or bluish skin discolouration in young children
• skin rash, fever (adolescents from 11 years of age and adults)
• feeling faint or fainting
• injection site reactions like extensive swelling of the vaccinated limb, blisters at or around the injection site and hard lump at the injection site (which may persist for more than one month)

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a prescription.

What BEXSERO contains

Do not take this medicine if you are allergic to any of these ingredients.

What BEXSERO looks like

BEXSERO is a white, opalescent liquid suspension for injection, supplied in a pre-filled syringe providing 1 dose of 0.5 ml.

BEXSERO pre-filled syringes without needle (AUST R 190718). Available in packs of 1 or 10.

BEXSERO pre-filled syringes with needle (AUST R 190719). Available in a pack of 1 pre-filled syringe plus 2 needles.

Not all presentations and pack sizes may be marketed.

Who distributes BEXSERO

GlaxoSmithKline Australia Pty Ltd
Level 4, 436 Johnston Street
Abbotsford, VIC 3067

Trade marks are owned by or licensed to the GSK group of companies.

© 2023 GSK group of companies or its licensor.

This leaflet was prepared 9 November 2023.

Version 11.0.

Published by MIMS January 2024

1 Name of Medicine

Multicomponent meningococcal group B vaccine (recombinant, adsorbed).

2 Qualitative and Quantitative Composition

Bexsero is a multicomponent meningococcal group B vaccine presented as a suspension for injection in a prefilled syringe containing purified recombinant meningococcal protein antigens expressed in E. coli and outer membrane vesicles (OMV) derived from N. meningitidis group B. Bactericidal antibodies directed against components of the bacterium protect against invasive meningococcal disease (IMD).
1 dose (0.5 mL) of Bexsero contains:
Neisseria meningitidis group B Neisseria heparin binding antigen fusion protein^1,2 (rbe) - 50 microgram;
Neisseria meningitidis group B Neisseria adhesin A protein^1,2 (rbe) - 50 microgram;
Neisseria meningitidis group B factor H binding protein fusion protein^1,2 (rbe) - 50 microgram;
Outer membrane vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254 measured as amount of total protein containing the PorA P1.4² - 25 microgram.
¹ Produced in E. coli cells by recombinant DNA technology. The NHBA (Neisseria heparin binding antigen) is derived from strain NZ98/254 and is fused with accessory protein 953, derived from strain 2996; NadA (Neisseria adhesin A) is derived from strain 2996; fHBP (factor H binding protein) is derived from strain MC58 and is fused with accessory protein 936, derived from strain 2996.
² Adsorbed on aluminium hydroxide hydrate (0.5 mg Al³⁺).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

White opalescent liquid suspension.
Bexsero is supplied in a 1.0 mL (Type I glass) pre-filled syringe. Syringes are sealed with a plunger stopper (Type I bromobutyl rubber) and with a protective tip cap (Type II rubber).

4 Clinical Particulars

4.1 Therapeutic Indications

Bexsero is indicated for active immunisation against invasive disease caused by N. meningitidis group B strains. For information on protection against specific group B strains, see Section 5.1 Pharmacodynamic Properties.
Bexsero is indicated for vaccination of individuals from 2 months of age and older.

4.2 Dose and Method of Administration

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. Bexsero can be given at the same time as other immunisations, provided that the vaccine is administered either at a different site or away from the injection site of the other vaccine, according to local guidelines.

Infants 2 months to 5 months of age at the time of the first dose.

Infants 6 months to 11 months of age at the time of the first dose.

Toddlers 12 months to 23 months of age at the time of the first dose.

Children 2 years to 10 years of age at the time of the first dose.

Adolescents and adults from 11 years of age at the time of first dose.

Method of administration.

Instructions for the pre-filled syringe.

4.3 Contraindications

Hypersensitivity to the active substances (see Section 2 Qualitative and Quantitative Composition) or to any of the excipients (see Section 6.1 List of Excipients).

4.4 Special Warnings and Precautions for Use

As with other vaccines, administration of Bexsero should be postponed in subjects suffering from an acute severe febrile illness. However, the presence of a minor infection, such as cold, should not result in the deferral of vaccination.
Do not inject intravascularly.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.
Anxiety related reactions, including vasovagal reactions (syncope), hyperventilation or stress related reactions may occur in association with vaccination as a psychogenic response to the needle injection (see Section 4.8 Adverse Effects (Undesirable Effects)). It is important that procedures are in place to avoid injury from fainting.
As with any vaccine, vaccination with Bexsero may not protect all vaccine recipients. Bexsero is not expected to provide protection against all circulating meningococcal group B strains (see Section 5.1 Pharmacodynamic Properties).
As with many vaccines, health care professionals should be aware that a temperature elevation may occur following vaccination of infants and toddlers. Accordingly, patients and/or their care givers should be made aware of the risks and management of fever and its sequelae. In infant study V72P13, fever ≥ 38.0°C was reported by 78%, 84% and 73% of participants after dose 1, 2 and 3, respectively, in the Bexsero vaccine group, compared with 44%, 59% and 50% of participants receiving the routine vaccines alone. In the same study, fever ≥ 39.5°C was reported by 5%, 7% and 4% of participants after dose 1, 2 and 3, respectively, in the Bexsero vaccine group, compared with 1%, 1% and 2% of participants receiving the routine vaccines alone. The rate of fever was decreased by the use of prophylactic antipyretics (as demonstrated in study V72P16). Prophylactic administration of antipyretics at the time of and closely after vaccination can reduce the incidence and intensity of postvaccination febrile reactions. Antipyretic medication should be initiated according to local guidelines in infants and toddlers.
Individuals with impaired immune responsiveness, whether due to the use of immunosuppressive therapy, a genetic disorder, or other causes, may have reduced antibody response to active immunisation. Immunogenicity data are available in individuals with complement deficiencies, asplenia, or splenic dysfunction (see Section 5.1, Clinical trials).
Individuals receiving treatment that inhibits terminal complement activation (for example, eculizumab) remain at increased risk of invasive disease caused by Neisseria meningitidis group B even following vaccination with Bexsero.
Kanamycin is used in early manufacturing process and is removed during the later stages of manufacture. If present, kanamycin levels in the final vaccine are less than 0.01 microgram per dose. The safe use of Bexsero in kanamycin sensitive individuals has not been established.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Bexsero 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 pneumococcal conjugate, measles, mumps, rubella, varicella and meningococcal group A, C, W, Y conjugate.
Clinical studies demonstrated that the immune responses of the coadministered routine vaccines were unaffected by concomitant administration of Bexsero. Inconsistent results were seen across studies for responses to inactivated poliovirus type 2 and pneumococcal conjugate serotype 6B, but these data do not suggest clinically significant interference.
The safety profiles of the coadministered 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. Prophylactic use of paracetamol reduces the incidence and severity of fever without affecting the immunogenicity of either Bexsero or routine vaccines. The effect of antipyretics other than paracetamol on the immune response has not been studied.
Concomitant administration of Bexsero with vaccines other than those mentioned above has not been studied.
When given concomitantly with other vaccines Bexsero must be administered at separate injection sites (see Section 4.2 Dose and Method of Administration).

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.
However, some of the effects mentioned under Section 4.8 Adverse Effects (Undesirable Effects) may temporarily affect the ability to drive or use machines.

4.8 Adverse Effects (Undesirable Effects)

Adverse reactions from clinical studies with the Bexsero are described below.
The safety of Bexsero was evaluated in 13 studies including 9 randomised controlled clinical trials with 7802 participants (from 2 months of age) who received at least one dose of Bexsero and in a subsequent study in 974 young adults. Among Bexsero recipients, 5849 were infants and toddlers (less than 2 years of age), 250 were children (2 to 10 years of age) and 2677 were adolescents and adults. Of the participants who received primary infant series of Bexsero, 3285 received a booster dose in the second year of life. Data for 988 infants and children (less than 2 years of age) and 801 children (2 to 10 years of age) exposed to Bexsero in subsequent studies have additionally been evaluated.
In infants and toddlers the most common local and systemic adverse reactions observed in clinical trials were tenderness and erythema at the injection site, fever and irritability.
In clinical studies in infants, fever occurred more frequently when Bexsero was coadministered with routine vaccines (containing the following antigens: pneumococcal 7 valent conjugate, diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis and Haemophilus influenzae type b) than when it was given alone. Higher rates of antipyretic use were also reported for infants vaccinated with Bexsero and routine vaccines. When Bexsero was given alone, the frequency of fever was similar to that associated with routine infant vaccines administered during clinical trials. When fever occurred, it generally followed a predictable pattern, with the majority resolving by the day after vaccination.
In adolescents and adults the most common local and systemic adverse reactions observed were pain at the injection site, malaise and headache.
No increase in the incidence or severity of the adverse reactions was seen with subsequent doses of the vaccination series.
Adverse reactions (following primary immunisation or booster dose) considered as being at least possibly related to vaccination have been categorised by frequency.
Frequencies are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Infants, toddlers, and children (up to 10 years of age).

Metabolism and nutrition disorders.

Nervous system disorders.

Vascular disorders.

Gastrointestinal disorders.

Skin and subcutaneous tissue disorders.

General disorders and administration site conditions.

Musculoskeletal and connective tissue disorders.

Adolescents (from 11 years of age) and adults.

Nervous system disorders.

Gastrointestinal disorders.

General disorders and administration site conditions.

Musculoskeletal and connective tissue disorders.

Adverse reactions from postmarketing spontaneous reports.

Blood and lymphatic system disorders.

General disorders and administration site conditions.

Immune system disorders.

Nervous system disorders.

Skin and subcutaneous tissue disorders.

Reporting suspected adverse effects.

4.9 Overdose

Experience of overdose is limited. In the event of overdose, monitoring of vital functions and possible symptomatic treatment is recommended.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Meningococcal vaccines, ATC code: J07AH09.

Mechanism of action.

Epidemiological data.

Clinical trials.

Immunogenicity.

Three dose primary schedule followed by a booster.

Two dose primary schedule followed by a booster.

Children and adolescents with complement deficiencies, asplenia, or splenic dysfunction.

Observational assessment of impact of vaccination on disease incidence.

5.2 Pharmacokinetic Properties

Not applicable for vaccines.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Bexsero contains the excipients sodium chloride, histidine, sucrose, and water for injections.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store in a refrigerator (2°C - 8°C). Do not freeze. Protect from light.

6.5 Nature and Contents of Container

Bexsero is presented as a 0.5 mL suspension in a pre-filled syringe (Type I glass) with a plunger stopper (butyl rubber) and with a rubber tip cap.
The tip cap and rubber plunger stopper of the pre-filled syringe are not made with natural rubber latex.
Bexsero is supplied in packs of 1 syringe with or without needle or packs of 10 syringes without needles.
Not all pack sizes may be distributed in Australia.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Not applicable for vaccines.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes