Trumenba injectable suspension in pre-filled syringe

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Trumenba injectable suspension in a pre-filled syringe

Meningococcal group B vaccine

(recombinant, adsorbed)

Read the entire leaflet carefully before you or your child receives this vaccine, as it contains important information for you or your child.

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

Leaflet Contents

1. What Trumenba is and what it is 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. How to store Trumenba
6. Contents of the pack and other information

1. What Trumenba is and what it is used for

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

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

The vaccine works by helping the body 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

Do not administer Trumenba

• if you or your child are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

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 serious infection with a high fever. In this case, vaccination will be postponed. A minor infection, such as a cold, is not a reason to delay vaccination, but speak to your doctor first.
• Have bleeding problems or bruise easily.
• Have a weakened immune system, which may prevent you or your child from obtaining full protection from Trumenba.
• Have had any problems after a dose of Trumenba, such as an allergic reaction or breathing difficulties.

Fainting, weakness, or other stress-related reactions may occur as a response to any needle injection. Inform your doctor, pharmacist, or nurse if you have previously experienced such reactions.

Other medicines and Trumenba

Inform your doctor, pharmacist, or nurse if you or your child are taking, have recently taken, or might need to take any other medicines, or if another vaccine has recently been administered.

Trumenba may be given at the same time as any of the following vaccine components: tetanus, diphtheria, and pertussis, poliovirus, 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 more than one vaccine is given simultaneously, it is important to use different injection sites.

If you are taking medicines that affect your immune system (such as radiotherapy, corticosteroids, or certain types of chemotherapy for cancer), you may not obtain full benefit from Trumenba.

Pregnancy and breastfeeding

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

Driving and using machines

The influence of Trumenba on the ability to drive and operate machinery is none or negligible.

However, some of the adverse effects mentioned in section 4, “Possible side effects,” may temporarily affect you. If this occurs, wait until the effects have subsided before driving or operating machinery.

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 allergies.

Trumenba contains sodium

This vaccine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially “sodium-free”.

3. How Trumenba is given

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 instructions of the doctor, pharmacist, or nurse so that you or your child complete the series of injections.

Individuals aged 10 years 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 at least 1 month apart, and a third injection at least 4 months after the second.
• You or your child may receive a booster dose.

4. Possible adverse reactions

Like all vaccines, this vaccine may cause adverse reactions, although not everyone experiences them.

When Trumenba is administered to you or your child, the following adverse reactions 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 available data)

• Allergic reactions

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse reactions, 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 on the carton after EXP. The expiry date refers to the last day of the month indicated.

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

Syringes should be stored horizontally in the refrigerator to minimize re-dispersion time.

Do not freeze.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Trumenba

One dose (0.5 ml) contains:

Active substances:

fHbp from subfamily A of Neisseria meningitidis serogroup B1,2,3 60 micrograms
fHbp from subfamily B of Neisseria meningitidis serogroup B1,2,3 60 micrograms

1 Recombinant lipidated fHbp (factor H binding protein)
2 Produced in Escherichia coli cells using recombinant DNA technology
3 Adsorbed to aluminium phosphate (0.25 milligrams of aluminium per dose)

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

Appearance of Trumenba and contents of the pack

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.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

You can request further information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of the most recent review of this leaflet: 04/2025.

Other sources of information

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

This 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.

Visually inspect the vaccine for particles and discoloration before administration. Do not administer the vaccine if any foreign particles and/or physical changes are observed.

Shake well before use to obtain a homogeneous white suspension.

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

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

When administered simultaneously with other vaccines, Trumenba must be given at a separate injection site.

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