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TRUMENBA®(Meningococcal Group B Vaccine)

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TRUMENBA® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

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1 INDICATIONS AND USAGE

Trumenba is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. Trumenba is approved for use in individuals 10...

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2 DOSAGE AND ADMINISTRATION

For intramuscular use only.

2.1 Dose and Schedule

Three-dose schedule: Administer a dose (0....

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3 DOSAGE FORMS AND STRENGTHS

Trumenba is a suspension for intramuscular injection in 0.5 mL single-dose prefilled syringe.

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4 CONTRAINDICATIONS

Severe allergic reaction after a previous dose of Trumenba.

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5 WARNINGS AND PRECAUTIONS

5.1 Management of Allergic Reactions

Epinephrine and other appropriate agents used to manage immediate allergic reactions must be...

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6 ADVERSE REACTIONS

In clinical studies, the most common solicited adverse reactions in adolescents and young adults were pain at the injection site (≥85%), fatigue (≥60%), headache (≥55%), and muscle pain (≥35%). Nausea was...

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7 DRUG INTERACTIONS

In clinical trials, Trumenba was administered concomitantly with HPV4 in adolescents 11 to <18 years of age and with MCV4 and Tdap in adolescents 10 to <13 years of age [see...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

All pregnancies have a risk...

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11 DESCRIPTION

Trumenba is a sterile suspension composed of two recombinant lipidated factor H binding protein (fHBP) variants from N. meningitidis serogroup B, one from fHBP subfamily A and one...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Protection against invasive meningococcal disease is conferred mainly by complement-mediated antibody-dependent...

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13 NONCLINICAL TOXICOLOGY

Trumenba has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility in males. Vaccination of female rabbits with Trumenba had no effect on fertility...

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14 CLINICAL STUDIES

The immunogenicity of Trumenba following the three-dose schedule (0, 2, and 6 months) was evaluated in individuals 10 to 25 years of age in the U.S., Canada, and Europe (Studies 1 and 2) and following the...

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15 REFERENCES

  1. Wang X, et al. Prevalence and genetic diversity of candidate vaccine antigens among invasive Neisseria meningitidis isolates in the U.S. Vaccine 2011; 29:4739–4744.
  2. ...
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16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Trumenba is supplied in the following strengths and package configurations:

Prefilled Syringe, 1 Dose (10...

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17 PATIENT COUNSELING INFORMATION

Prior to administration of this vaccine, the healthcare professional should inform the individual, parent, guardian, or other responsible adult of the following:

  • The importance of...
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