Bexsero Meningococcal group B vaccine Suspension

BEXSERO is a meningococcal group B vaccine. BEXSERO contains four different components from the surface of the bacteria Neisseria meningitidis group B. BEXSERO is given to individuals from 2 months of age and older to help protect against disease caused by the Neisseria meningitidis group B bacteria. These bacteria can cause serious, and sometimes life-threatening, infections such as meningitis (inflammation of the covering of the brain and spinal cord) and sepsis (blood poisoning). As with all vaccines, BEXSERO may not fully protect all people who are vaccinated. BEXSERO helps your body make its own protection (antibodies). This will protect you against this disease. The vaccine cannot cause the disease that it protects you from.

BEXSERO should not be administered to you:

• if you are allergic (hypersensitive) to BEXSERO or any of the ingredients contained in BEXSERO (listed in section 6). Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. Check with your doctor if you think any of these apply to you.

Warnings and precautions:

Take special care with BEXSERO: Tell your doctor or healthcare provider before being given the injection:

• if you have a severe infection with a high temperature. In these cases, the vaccination may be postponed until recovery. A minor infection such as a cold should not be a problem, but talk to your doctor first
• if you receive treatment that blocks the part of the immune system known as complement activation, such as eculizumab. Even if you have been vaccinated with BEXSERO you remain at increased risk of disease caused by the Neisseria meningitidis group B bacteria
• if your child was born prematurely (before or at 28 weeks of pregnancy), 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 three days following vaccination in these babies and they may need special monitoring
• if you have an allergy to the antibiotic kanamycin, talk to your doctor or nurse first. Fainting can occur following, or even before, any needle injection. Therefore, tell the doctor or nurse if you fainted with a previous injection.
• Tell your doctor or nurse if you know that you are allergic to latex. Although no natural rubber latex is detected in the syringe tip cap, the safe use of BEXSERO in latex-sensitive individuals has not been established.
• The safety and efficacy of BEXSERO in individuals above 50 years of age have not been established. There are limited data on the use of BEXSERO in patients with chronic medical conditions or with weakened immunity. Persons with a weakened immune system, for example due to human immunodeficiency virus (HIV) or due to medicines that suppress the immune system, may not get the full benefit from BEXSERO.

Other medicines and BEXSERO:

Always tell your healthcare provider if you are taking any other medicine. This includes all complementary or traditional medicines. BEXSERO can be given at the same time as any of the following vaccine components: diphtheria, tetanus, whooping cough (pertussis), Haemophilus influenzae type b, polio, hepatitis B, pneumococcus, measles, mumps, rubella, chickenpox and meningococcus A, C, W, Y. A different injection site will be used for each type of vaccine. Your doctor or nurse may ask you to give your child medicines that lower fever at the time and after BEXSERO has been given. This will help to reduce some of the side effects of BEXSERO.

BEXSERO (0,5 mL) will be given to you by a doctor or nurse. It will be injected into a muscle, usually the thigh for infants or the upper arm for children, adolescents and adults. It is important to follow the instructions from the doctor or nurse so that you complete the course of injections.

Infants 2 months to 5 months of age at the time of first dose: Your child should receive an initial course of two or three injections of the vaccine followed by an additional injection (booster).

• The interval between injections should be at least 2 months if two initial doses are given or at least 1 month if three initial doses are given.
• A booster will be given in the second year of life after an interval of at least 6 months from the last injection of the initial course.

Infants 6 months to 11 months of age at the time of first dose: Infants 6 months to 11 months of age should receive two injections of the vaccine followed by an additional injection (booster).

• The interval between each injection should be at least 2 months.
• A booster will be given in the second year of life after an interval of at least 2 months from the second injection.

Children 12 months to 23 months of age at the time of first dose: Children 12 months to 23 months of age should receive two injections of the vaccine followed by an additional injection (booster).

• The interval between each injection should be at least 2 months.
• A booster will be given after an interval of 12 to 23 months from the second injection.

Children 2 years to 10 years of age at the time of first dose: Your child should receive two injections of the vaccine with an interval of at least 1 month. Your child may receive an additional injection (booster).

Adolescents and adults from 11 years of age at the time of first dose: You should receive two injections of the vaccine with an interval of at least 1 month. You may receive an additional injection (booster).

Adults above 50 years of age: The safety and efficacy of BEXSERO in individuals above 50 years of age have not been established. Ask your doctor for advice whether it is beneficial for you to receive BEXSERO.

If you have any further questions on BEXSERO, ask your doctor or nurse.

If you miss a dose of BEXSERO: Since a healthcare provider will administer BEXSERO, it is unlikely that the dose will be missed. If you miss a scheduled injection, it is important that you make another appointment. If you stop receiving BEXSERO: Make sure you finish the complete vaccination course. If not, you may not be fully protected against the diseases.

BEXSERO can have side effects. Not all side effects reported for BEXSERO are included in this leaflet. Should your general health worsen or if you experience any untoward effects after being given BEXSERO, please consult your healthcare provider for advice.

Allergic reaction: If any of the following happens, stop receiving BEXSERO and tell your doctor immediately or go to the casualty department at your nearest hospital:

• enlarged lymph nodes
• itchy rash of your hands and feet
• swelling of your eyes and face
• difficulty in breathing or swallowing
• sudden drop in blood pressure and loss of consciousness.
• skin rash (adolescents from 11 years of age and adults).

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to BEXSERO. You may need urgent medical attention or hospitalisation. These reactions will usually occur before leaving the healthcare provider. However, if you or your child gets any of these symptoms you should contact a doctor urgently.

When BEXSERO is given to you or your child, the most common side effects that you or your child may get (reported in all age groups) are:

• pain/tenderness at the injection site, redness of your skin at the injection site, swelling of your skin at the injection site, hardness of your skin at the injection site.

Tell your doctor if you notice any of the following:

Infants and children (up to 10 years of age):

Frequent side effects:

• loss of appetite
• sleepiness
• unusual crying
• headache
• being sick (vomiting) (uncommon after booster)
• diarrhoea
• skin rash (children aged 12 to 23 months) (uncommon after booster)
• skin rash (infants and children 2 to 10 years of age)
• painful joints
• fever (≥ 38 ºC)
• tenderness at the injection site (including severe injection site tenderness resulting in crying when injected limb is moved)
• feeling irritable.

Less frequent side effects:

• seizures (including febrile seizures)
• paleness (rare after booster)
• dry skin
• high fever (≥ 40 °C).

Other side effects that can occur:

• Kawasaki disease, which may include symptoms such as fever that lasts for more than five days, associated with a skin rash on the trunk of the body and sometimes followed by a peeling of the skin on the hands and fingers, swollen glands in the neck, red eyes, lips, throat and tongue
• itchy rash, skin rash.

Adolescents (from 11 years of age) and adults:

Frequent side effects include:

• headache
• feeling sick (nausea)
• painful muscles and joints
• pain at the injection site resulting in inability to perform normal daily activity
• generally feeling unwell.

Side effects that have been reported during marketed use include:

• allergic reactions that may include severe swelling of the lips, mouth, throat (which may cause difficulty in swallowing), difficulty breathing with wheezing or coughing, rash, loss of consciousness and very low blood pressure
• collapse (sudden onset of muscle floppiness), less responsive than usual or lack of awareness, and paleness or bluish skin discoloration in young children; feeling faint or fainting
• fever (adolescents from 11 years of age and adults); 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)

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the 6.04 Adverse Drug Reaction Reporting Form, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of BEXSERO.

Store all medicines out of the reach of children.

• Store in a refrigerator (+2 °C to +8 °C).
• Do not freeze.
• Store in the original package in order to protect from light.
• Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.