Presentation and Status in Health Basket
1, 5 and 10 X 0.5 ml
Primary series: 2 doses (0.5 ml each) administered at a 6 month interval.
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.
Booster dose: A booster dose should be considered following either dosing regimen for individuals at continued risk of invasive meningococcal disease.
Other paediatric population: Trumenba is not indicated for children under 10 years old.
Safety and efficacy of Trumenba in children below 10 years of age have not been established. No data are available.
Method of administration: For intramuscular injection only. The preferred site for injection is the deltoid muscle of the upper arm.
Trumenba is indicated for active immunisation of individuals 10 years and older to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B.
Hypersensitivity to the active substance or to any of the excipients.
In order to improve the traceability of biological medicinal products, it is advised that the tradename and batch number of the administered product be clearly recorded (or stated) in the patient file.
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 no data on the use of Trumenba in subjects above 65 years of age.
The most common adverse reactions observed were injection site pain, redness and swelling at the vaccination site, headache, fatigue, chills, diarrhoea, muscle pain, joint pain, and nausea.
See prescribing information for full details.
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, Y, W 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.
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.
Lactation: 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.
Experience of overdose is limited. In the event of overdose, monitoring of vital functions and possible symptomatic treatment is recommended.
Incompatibilities: Do not mix Trumenba with other vaccines or medicinal products in the same syringe. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Storage: Store in a refrigerator (2 °C-8 °C). Syringes should be stored in the refrigerator horizontally to minimize the re-dispersion time. Do not freeze.