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WHAT YOU NEED TO KNOW

Frequently asked questions about TRUMENBA
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MenB is an uncommon but potentially deadly bacterial infection that attacks the linings of the brain and spinal cord, called the meninges, and can also cause an infection of the blood.1-3 Neisseria meningitidis is the bacterium that causes this disease, and MenB is one type of meningococcal disease (also known as meningtis).1 MenB represents approximately 60% of all meningitis cases among adolescents and young adults in the US.4 All other common types of the disease (A, C, W, Y) comprise only about 40% of disease incidence in the US.

Early symptoms may seem like the flu, but MenB can lead to death within 24 hours.1,2 MenB can also cause long-term effects in survivors, such as loss of limbs, seizures, or deafness.5,6

TRUMENBA is an FDA-approved vaccine for the prevention of MenB in individuals 10 through 25 years of age. Patients who participated in the TRUMENBA clinical trials were adolescents and young adults.7

If your teen previously received a vaccine for meningitis (such as the MCV4 vaccine), they may not be protected against MenB.8 Talk to your doctor or pharmacist about whether your teen has received both types of meningitis vaccines. Teens and young adults between ages 16 and 23 may be at higher risk for MenB. The CDC immunization schedule supports MenB vaccination for 16 year olds.9

TRUMENBA follows a 2- or 3-dose schedule.7 Discuss with your teen’s health care provider or pharmacist which schedule is appropriate for your teen.

  • ACIP* recommends 2 doses for healthy adolescents and young adults10

  • ACIP recommends 3 doses (0, 1-2, 6 months) for people 10 years of age or older who are at increased risk10†

Your teen must complete all recommended doses of TRUMENBA to help protect them against MenB. When you're in the office to receive the first dose, make an appointment to receive the next dose so you stay on schedule.

Teens and young adults between ages 16 and 23 may be at higher risk for MenB.11 Ask your teen's health care provider about administering TRUMENBA at 16, when they are receiving a booster dose of a vaccine for other types of meningitis (the MCV4 vaccine, which covers meningitis A, C, W and Y).7,9

*The CDC Advisory Committee on Immunization Practices.

These persons include: persons with persistent complement component deficiencies; persons with anatomic or functional asplenia; microbiologists routinely exposed to isolates of Neisseria meningitidis; persons identified as at increased risk of a MenB disease outbreak.

TRUMENBA is a vaccine indicated for individuals 10 through 25 years of age for active immunization to prevent invasive disease caused by Neisseria meningitidis group B.7

  • In adolescents and young adults, the incidence of MenB peaks at age 19, so if your child is between 16 and 23, they may be at higher risk.11 You can help protect your teen by vaccinating with TRUMENBA7

  • The CDC immunization schedule supports MenB vaccination for 16 year olds9

TRUMENBA should not be given to anyone with a history of severe allergic reaction after a previous dose of TRUMENBA. Individuals with weakened immune systems may have a reduced immune response. TRUMENBA should only be given to pregnant women if it is clearly needed.7

TRUMENBA, like any vaccine, could possibly cause serious problems, such as severe allergic reactions. The most common adverse reactions in adolescents and young adults were pain at injection site, fatigue, headache, and muscle pain.7

Look for any unusual conditions, such as signs of a severe allergic reaction, a high fever, or changes in behavior. Signs of a severe allergic reaction may include hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, and weakness.

  • Call 911 or a doctor, or get the person to a doctor right away

  • Tell the doctor what happened, the date and time it happened, and when the vaccination was given

  • Ask your health care provider to report the reaction by filing a Vaccine Adverse Event Reporting System (VAERS) form. Or you can file this report through the VAERS website at www.vaers.hhs.gov, or by calling 1-800-822-7967. VAERS does not provide medical advice

Talk with a doctor or pharmacist about vaccinating with TRUMENBA. Ask for the full Prescribing Information for TRUMENBA and suggestions for other sources of information. You can also

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IMPORTANT SAFETY INFORMATION
  • Trumenba should not be given to anyone with a history of a severe allergic reaction after a previous dose of Trumenba
  • Some individuals with weakened immune systems may have a reduced immune response
  • Persons with certain complement deficiencies and persons receiving treatments such as Soliris® (eculizumab), are at increased risk for invasive disease caused by Neisseria meningitidis group B even with receipt of vaccination with Trumenba
  • As with any vaccine, vaccination with Trumenba may not protect all vaccine recipients against N meningitidis group B infections
  • Fainting can occur in association with administration of injectable vaccines, including Trumenba
  • The most common adverse reactions in adolescents and young adults were pain at injection site, fatigue, headache, and muscle pain. Nausea was reported in adolescents in early phase studies
  • Data are not available on the safety and effectiveness of using Trumenba and other meningococcal group B vaccines interchangeably to complete the vaccination series
  • Tell your health care provider if you are pregnant, or plan to become pregnant
  • Ask your health care provider about the risks and benefits of Trumenba. Only a health care provider can decide if Trumenba is right for you or your child
INDICATION
  • Trumenba is a vaccine indicated for individuals 10 through 25 years of age for active immunization to prevent invasive disease caused by Neisseria meningitidis group B
  • The effectiveness of the two-dose schedule of Trumenba against diverse N meningitidis group B strains has not been confirmed

Patients should always ask their doctors for medical advice about adverse events.

You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit www.vaers.hhs.gov or call 1-800-822-7967.

This site is intended only for U.S. residents. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only and is not intended to replace discussions with a healthcare provider.

REFERENCES
  1. Centers for Disease Control and Prevention. Meningococcal disease. Centers for Disease Control and Prevention website. http://www.cdc.gov/meningococcal/index.html. Updated January 21, 2020. Accessed March 10, 2020.
  2. Thompson MJ, Ninis N, Perera R, et al. Clinical recognition of meningococcal disease in children and adolescents. Lancet. 2006;367(9508):397-403.
  3. Soeters HM, McNamara LA, Whaley M, et al. Serogroup B meningococcal disease outbreak and carriage evaluation at a college—Rhode Island, 2015. MMWR Morb Mortal Wkly Rep. 2015;64(22):606-607.
  4. Centers for Disease Control and Prevention. Enhanced Meningococcal Disease Surveillance Report, 2016. https://www.cdc.gov/meningococcal/downloads/NCIRD-EMS-Report.pdf. September 2017. Accessed March 10, 2020.
  5. Bettinger JA, Scheifele DW, Le Saux N, et al. The disease burden of invasive meningococcal serogroup B disease in Canada. Pediatr Infect Dis J. 2013;31(1):e20-e25.
  6. Borg J, Christie D, Coen PG, et al. Outcomes of meningococcal disease in adolescence: prospective, matched-cohort study. Pediatrics. 2009;123(3):e502-e509.
  7. TRUMENBA [package insert]. Philadelphia, PA: Pfizer Inc.; 2019.
  8. MacNeil JR, Rubin L, Folaranmi T. Use of serogroup B meningococcal vaccines in adolescents and young adults: recommendations of the Advisory Committee on Immunization Practices, 2015. MMWR Morb Mortal Wkly Rep. 2015;64(41):1171-1176.
  9. Centers for Disease Control and Prevention. Recommended child and adolescent immunization schedule for ages 18 years or younger: United States, 2020. Centers for Disease Control and Prevention website. https://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf. Updated January 29, 2020. Accessed March 10, 2020.
  10. Patton ME, Stephens D, Moore K, et al. Updated recommendations for use of MenB-FHbp serogroup B meningococcal vaccine–Advisory Committee on Immunization Practices, 2016. MMWR Morb Mortal Wkly Rep. 2017;66(19):509-513.
  11. National Foundation for Infectious Diseases. Addressing the challenges of serogroup B meningococcal disease outbreaks on campuses: a report by the National Foundation for Infectious Diseases. https://www.nfid.org/wp-content/uploads/2019/08/meningococcal-b-report.pdf. Published May 2014. Accessed March 10, 2020.
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