TRUMENBA INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE

Introduction

Package Leaflet: Information for the Patient

Trumenba injectable suspension in a pre-filled syringe

vaccine against meningococcal group B

(recombinant, adsorbed)

Read all of this leaflet carefully before you or your child receive this vaccine, because it contains important information for you or your child.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This vaccine has been prescribed for you or your child only.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Trumenba and what is it used for
2. What you need to know before you or your child receive Trumenba
3. How Trumenba is administered
4. Possible side effects
5. Storage of Trumenba
6. Contents of the pack and further information

1. What is Trumenba and what is it used for

Trumenba is a vaccine to prevent invasive meningococcal disease, caused by Neisseria meningitidisserogroup B, for use in individuals 10 years of age and older. This type of bacteria can cause serious and sometimes life-threatening infections, such as meningitis (inflammation of the lining of the brain and spinal cord) and sepsis (blood infection).

The vaccine contains 2 important components of the surface of the bacteria.

The vaccine works by helping the body to produce antibodies (the body's natural defenses) that protect you or your child against this disease.

2. What you need to know before you or your child receive Trumenba

Trumenba must not be administered

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before vaccination with Trumenba. Inform your doctor, pharmacist, or nurse if you or your child:

• Have a severe infection with high fever. In this case, vaccination will be postponed. The presence of a minor infection, such as a cold, is not a reason to postpone vaccination, but talk to your doctor first.
• Have bleeding problems or bruise easily.
• Have a weakened immune system that may prevent you or your child from getting the full benefit of Trumenba.
• Have had any problems after a dose of Trumenba, such as an allergic reaction or difficulty breathing.

Fainting, feeling weak, or other reactions related to stress, such as a response to any injection with a needle, may occur. Inform your doctor, pharmacist, or nurse if you have had this type of reaction before.

Other medicines and Trumenba

Tell your doctor, pharmacist, or nurse if you or your child are using, have recently used, or might use any other medicine, or if you have recently been given another vaccine.

Trumenba can be administered at the same time as any of the following vaccine components: tetanus, diphtheria, and pertussis, poliovirus, and human papillomavirus, and meningococcal serogroups A, C, W, and Y.

The administration of Trumenba with vaccines other than those listed above has not been studied.

If you receive more than one vaccine at the same time, it is important to use different injection sites.

If you are taking medicines that affect your immune system (such as radiation therapy, corticosteroids, or some types of chemotherapy for cancer), you may not get the full benefit of Trumenba.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before you receive Trumenba. Your doctor may still recommend that you receive Trumenba if you are at risk of exposure to meningococcal infection.

Driving and using machines

Trumenba has no or negligible influence on the ability to drive and use machines.

However, some of the side effects mentioned in section 4 "Possible side effects" may temporarily affect you. If this happens, wait until the effects have disappeared before driving or using machines.

Trumenba contains polysorbate 80

This vaccine contains 0.018 mg of polysorbate 80 per dose. Polysorbates may cause allergic reactions. Inform your doctor if you or your child have any known allergy.

Trumenba contains sodium

This vaccine contains less than 1 mmol of sodium (23 mg) per dose; i.e., it is essentially "sodium-free".

3. How Trumenba is administered

Trumenba will be administered to you or your child by a doctor, pharmacist, or nurse. It will be injected into a muscle in the upper arm.

It is important that you follow the doctor's, pharmacist's, or nurse's instructions so that you or your child complete the series of injections.

Individuals 10 years of age and older

• You or your child will receive 2 injections of the vaccine, with the second injection given 6 months after the first;

or

• You or your child will receive 2 injections of the vaccine with an interval of at least 1 month, and a third injection at least 4 months after the second.
• You or your child may receive a booster dose.

4. Possible side effects

Like all vaccines, this vaccine can cause side effects, although not everybody gets them.

When Trumenba is administered to you or your child, the following side effects may occur:

Very common(may affect more than 1 in 10 people)

• Redness, swelling, and pain at the injection site
• Headache
• Diarrhea
• Nausea
• Muscle pain
• Joint pain
• Chills
• Fatigue

Common(may affect up to 1 in 10 people)

• Vomiting
• Fever ≥ 38°C

Frequency not known(cannot be estimated from the available data)

• Allergic reactions

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Trumenba

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date is the last day of the month shown.

Store in a refrigerator (between 2°C and 8°C).

The syringes should be stored in the refrigerator horizontally to minimize the time of re-dispersion.

Do not freeze.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Trumenba

One dose (0.5 ml) contains:

Active substances:

fHbp from the A subfamily of Neisseria meningitidisserogroup B 60 micrograms

fHbp from the B subfamily of Neisseria meningitidisserogroup B 60 micrograms

1 recombinant lipidated fHbp (factor H binding protein)

2 produced in Escherichia colicells using recombinant DNA technology

3 adsorbed on aluminum phosphate (0.25 milligrams of aluminum per dose)

Other components:

Sodium chloride (see section 2 "Trumenba contains sodium"), histidine, water for injections, aluminum phosphate, and polysorbate 80 (E433, see section 2 "Trumenba contains polysorbate 80").

Appearance and pack of Trumenba

Trumenba is a white injectable suspension in a pre-filled syringe.

Pack sizes of 1, 5, and 10 pre-filled syringes, with or without needles.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

You can request more information about this medicine from the local representative of the marketing authorization holder:

Date of last revision of this leaflet: 04/2025.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.

The leaflet can be found on the European Medicines Agency website in all languages of the European Union/European Economic Area.

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This information is intended for healthcare professionals only:

During storage, a white deposit and a clear supernatant may be observed.

Inspect the vaccine visually for particulate matter and discoloration prior to administration. If any foreign particles and/or change in physical appearance are observed, do not administer the vaccine.

Shake well before use to obtain a homogeneous white suspension.

Trumenba is for intramuscular use only. Do not administer intravascularly or subcutaneously.

Trumenba must not be mixed with other vaccines in the same syringe.

When administered at the same time as other vaccines, Trumenba should be administered in a separate injection site.

Disposal of unused medicine and all materials that have come into contact with it should be done in accordance with local regulations.