HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the... |
Did you find an answer to your question?
Yes
No
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our medical information is accurate, up to date, and scientifically balanced.
TRUMENBA®(Meningococcal Group B Vaccine)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our medical information is accurate, up to date, and scientifically balanced.
TRUMENBA® Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
Trumenba is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup...
Did you find an answer to your question?
Yes
No
Dosage and Administration
2 DOSAGE AND ADMINISTRATION
For intramuscular use only.
2.1 Dose and Schedule
...
Did you find an answer to your question?
Yes
No
Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Trumenba is a suspension for intramuscular injection in 0.5 mL single-dose prefilled syringe.
Did you find an answer to your question?
Yes
No
Contraindications
4 CONTRAINDICATIONS
Severe allergic reaction (e.g. anaphylaxis) to any component of Trumenba [see Description (11)].
Did you find an answer to your question?
Yes
No
Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Management of Allergic Reactions
Epinephrine and other appropriate agents used to manage immediate allergic reactions must be...
Did you find an answer to your question?
Yes
No
Adverse Reactions
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%).
...
Did you find an answer to your question?
Yes
No
Drug Interactions
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 [...
Did you find an answer to your question?
Yes
No
Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
All pregnancies have a risk...
Did you find an answer to your question?
Yes
No
Description
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...
Did you find an answer to your question?
Yes
No
Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Protection against invasive meningococcal disease is conferred mainly by complement-mediated antibody-dependent...
Did you find an answer to your question?
Yes
No
Nonclinical Toxicology
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...
Did you find an answer to your question?
Yes
No
Clinical Studies
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...
Did you find an answer to your question?
Yes
No
References
15 REFERENCES
- 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. ...
Did you find an answer to your question?
Yes
No
How Supplied/Storage and Handling
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...
Did you find an answer to your question?
Yes
No
Medication Guide
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...
Did you find an answer to your question?
Yes
No
Did you find an answer to your question?
Yes
No
Didn’t find what you were looking for? Contact us.
To interact with the Medical Information Digital Assistant click here.
Contact Pfizer Medical Information to speak with a professional regarding your medical question on a Pfizer prescription product: (800) 438-1985
Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.