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TRUMENBA®(Meningococcal Group B Vaccine)

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TRUMENBA® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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1 INDICATIONS AND USAGE

Trumenba is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup...

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2 DOSAGE AND ADMINISTRATION

For intramuscular use only.

2.1 Dose and Schedule

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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 (e.g. anaphylaxis) to any component of Trumenba [see Description (11)].

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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%).

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7 DRUG INTERACTIONS

In clinical trials, Trumenba was administered concomitantly with HPV4 in adolescents 11 through 17 years of age and with MenACWY and Tdap in adolescents 10 through 12 years of age [...

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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 described in this section is based on results from four clinical studies:

  • Following the two-dose schedule (0 and 6 months) in subjects 10 through 25...
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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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