TRUMENBA 60 MICROGRAMS / DOSE SUSPENSION FOR INJECTION - summary of medicine characteristics

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

1 NAME OF THE MEDICINAL PRODUCT

Trumenba suspension for injection in pre-filled syringe

Meningococcal group B vaccine (recombinant, adsorbed)

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 dose (0.5 ml) contains:

Neisseria meningitidis serogroup B fHbp subfamily A1,2,3 60 micrograms

Neisseria meningitidis serogroup B fHbp subfamily B1,2,3

60 micrograms

1 Recombinant lipidated fHbp (factor H binding protein)

2

2 Produced in Escherichia coli cells by recombinant DNA technology

3 Adsorbed on aluminium phosphate (0.25 milligram aluminium per dose)

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Suspension for injection.

White liquid suspension.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Trumenba is indicated for active immunisation of individuals 10 years and older to prevent invasive meningococcal disease caused by

Neisseria meningitidis serogroup B.

See section 5.1 for information on the immune response against specific serogroup B strains.

The use of this vaccine should be in accordance with official recommendations.

4.2 Posology and method of administration

Posology

Primary series

2 doses: (0.5 ml each) administered at a 6 month interval (see section 5.1).

3 doses: 2 doses (0.5 ml each) administered at least 1 month apart, followed by a third dose at least 4 months after the second dose (see section 5.1).

Booster dose

A booster dose should be considered following either dosing regimen for individuals at continued risk of invasive meningococcal disease (see section 5.1).

Other paediatric populations

Safety and efficacy of Trumenba in children younger than 10 years of age have not been established. Currently available data for children 1 to 9 years of age are described in sections 4.8 and 5.1; however, no recommendation on a posology can be made as data are limited.

Method of administration

For intramuscular injection only. The preferred site for injection is the deltoid muscle of the upper arm.

For instructions on the handling of the vaccine before administration, see section 6.6.

There are no data available on the interchangeability of Trumenba with other meningococcal group B vaccines to complete the vaccination series.

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

In order to improve the traceability of biological medicinal products, the tradename and batch number of the administered product should be clearly recorded.

Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.

As with other injectable vaccines, syncope (fainting) can occur in association with administration of Trumenba. Procedures should be in place to avoid injury from fainting.

Vaccination should be postponed in individuals 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 intravenously, intradermally, or subcutaneously.

Trumenba should not be given to individuals with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection, unless the potential benefit clearly outweighs the risk of administration.

Persons with familial complement deficiencies (for example, C5 or C3 deficiencies) and persons receiving treatments that inhibit terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis serogroup B, even if they develop antibodies following vaccination with Trumenba.

As with any vaccine, vaccination with Trumenba may not protect all vaccine recipients.

Limitations of clinical trials

There are no data on the use of Trumenba in immunocompromised individuals. Immunocompromised individuals, including individuals receiving immunosuppressant therapy, may have a diminished immune response to Trumenba.

There are limited data on the use of Trumenba in individuals 40 to 65 years of age and there are no data on the use of Trumenba in individuals older than 65 years of age.

This medicinal product contains less than 1 mmol sodium (23 mg) per dose. Individuals on low sodium diets can be informed that this medicinal product is essentially sodium-free.

4.5 Interaction with other medicinal products and other forms of interaction

Trumenba can be given concomitantly with any of the following vaccines: Tetanus Toxoid, Reduced Diphtheria Toxoid, Acellular Pertussis, and Inactivated Poliovirus Vaccine (TdaP-IPV), Quadrivalent Human Papillomavirus vaccine (HPV4), Meningococcal Serogroups A, C, W, Y conjugate vaccine (MenACWY) and Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap).

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

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

4.6 Fertility, Pregnancy and lactation

Pregnancy

There are no data from the use of Trumenba in pregnant women. The potential risk for pregnant women is unknown. Nevertheless, vaccination should not be withheld when there is a clear risk of exposure to meningococcal infection.

Reproduction studies performed in female rabbits have revealed no evidence of impaired female fertility or harm to the foetus due to Trumenba.

Breast-feeding

It is unknown whether Trumenba is excreted in human milk. Trumenba should only be used during breast-feeding when the possible advantages outweigh the potential risks.

Fertility

Animal studies do not indicate direct or indirect harmful effects with respect to fertility in females (see section 5.3).

Trumenba has not been evaluated for impairment of fertility in males.

4.7 Effects on ability to drive and use machines

Trumenba has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under section 4.8 may temporarily affect the ability to drive or use machines.

4.8 Undesirable effects

Summary of the safety profile

The safety profile presented is based on analysis of approximately 17,000 subjects (1 year of age and older) who have been vaccinated with at least 1 dose of Trumenba in completed clinical studies.

In over 16,000 subjects > 10 years of age studied, the most common adverse reactions were headache, diarrhoea, nausea, muscle pain, joint pain, fatigue, chills, and injection site pain, swelling and redness.

Adverse reactions following booster vaccination in 301 subjects 15 to 23 years of age were similar to adverse reactions during the primary Trumenba vaccination series approximately 4 years earlier.

List of adverse reactions

Adverse reactions reported in clinical studies of subjects 10 years of age and older are listed in decreasing order of frequency and seriousness.

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)

Not known (cannot be estimated from available data)

Immune system disorder

Not known:     Allergic reactions*

Nervous system disorders

Very Common: Headache

Gastrointestinal disorders

Very Common: Diarrhoea; nausea

Common:      Vomiting

Musculoskeletal and connective tissue disorders

Very Common: Muscle pain (myalgia); joint pain (arthralgia)

General disorders and administration site conditions

Very Common: Chills; fatigue; redness (erythema), swelling (induration) and pain at injection site

Common:      Fever > 38 °C (pyrexia)

* Reported in the postmarketing experience. Because this reaction was derived from spontaneous reports, the frequency could not be determined and is thus considered as not known.

In a study of 220 toddlers 1 to < 2 years of age, the following adverse reactions occurred at a frequency of very common (> 1/10): drowsiness, irritability (fussiness), loss of or decreased appetite, fever, and injection site pain, swelling and redness.

In a study of 294 children 2 to 9 years of age, the following adverse reactions occurred at a frequency of very common (> 1/10): headache, diarrhoea, vomiting, muscle pain, joint pain, fever, fatigue, and injection site pain, swelling and redness.

In clinical studies, fever (> 38°C) occurred more frequently as subject age decreased. Of subjects 1 to < 2 years of age, 37.3% reported fever; of subjects 2 to 9 years of age, 24.5% reported fever; of subjects 10 to 18 years of age, 9.8% reported fever; and of subjects 18 to 25 years of age, 4.4% reported fever. Fever followed a predictable pattern after vaccination: onset occurred within 2 to 4 days, lasted 1 day, and was mild to moderate in severity. Fever rate and severity tended to decrease with subsequent Trumenba vaccinations.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

5   PHARMACOLOGICAL PROPERTIES

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

Non-clinical data revealed no special hazard for humans based on conventional studies of repeated dose toxicity and reproduction and developmental toxicity.

6.1

6.3    Shelf life

6.4 Special precautions for storage

Store in a refrigerator (2 °C-8 °C).

Syringes should be stored in the refrigerator horizontally to minimize the redispersion time.

Do not freeze.

6.5 Nature and contents of container

0.5 ml suspension in a pre-filled syringe (Type I glass) with plastic Luer Lok adapter, chlorobutyl rubber plunger stopper, and a synthetic isoprene bromobutyl rubber tip cap with a plastic rigid tip cap cover with or without needle. The tip cap and rubber plunger of the pre-filled syringe are not made with natural rubber latex.

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

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

During storage, a white deposit and clear supernatant may be observed in the pre-filled syringe containing the suspension.

Before use, the pre-filled syringe should be shaken vigorously to ensure that a homogeneous white suspension is obtained.

Do not use the vaccine if it cannot be re-suspended.

The vaccine should be visually inspected for particulate matter and discoloration prior to administration. In the event of any foreign particulate matter and/or variation of physical aspect being observed, do not administer the vaccine.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Pfizer Limited

Ramsgate Road

Sandwich, Kent

CT13 9NJ

United Kingdom