meningococcal group B vaccine

(redirected from Trumenba)

meningococcal group B vaccine

(me-nin-go-kok-al groop B vax-seen),

Bexsero

(trade name),

Trumenba

(trade name)

Classification

Therapeutic: vaccines immunizing agents
Pharmacologic: antigens
Pregnancy Category: B

Indications

Bexsero—Provides active immunization against invasive meningococcal disease caused by 3 strains of Neisseria meningitidis serogroup B (strains prevalent in the US). Tremenba—Provides active immunization against invasive meningococcal disease caused by 4 strains of Neisseria meningitidis serogroup B (strains prevalent in the US).

Action

Induces production of antibodies to several strains of serogroup B Neisseria meningitidis.

Therapeutic effects

Prevention of invasive meningococcal disease.

Pharmacokinetics

Absorption: Well absorbed following IM administration.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: Unknown.

Time/action profile (antibody response)

ROUTEONSETPEAKDURATION
IMwithin 2 mounknownunknown

Contraindications/Precautions

Contraindicated in: Severe allergic reaction to a previous dose; Latex allergy (Bexsero tip caps contain latex).
Use Cautiously in: Geriatric: Safe and effective use in patients >65 yr has not been established; Lactation: Use cautiously if breastfeeding; Obstetric: Use during pregnancy only if clearly needed; Pediatric: Safe and effective use in children <10 yr not established (>90% risk of fever in infants <12 mo).

Adverse Reactions/Side Effects

Central nervous system

  • fatigue (most frequent)
  • headache (most frequent)

Gastrointestinal

  • nausea (most frequent)
  • diarrhea
  • vomiting

Local

  • injection site reactions (most frequent)

Musculoskeletal

  • arthralgia (most frequent)
  • mylagia (most frequent)

Miscellaneous

  • allergic reactions including anaphylaxis
  • chills (most frequent)
  • fever
  • syncope

Interactions

Drug-Drug interaction

Concurrent use of immunosuppressives may ↓ the desired immune response.

Route/Dosage

Bexsero

Intramuscular (Adults and Children 10–25 yr) Two 0.5 ml doses one mo apart.

Trumenba

Intramuscular (Adults and Children 10–25 yr) 0.5 ml followed by a second dose 2 mo later and a third dose 4 mo after the second dose.

Availability

Suspension for IM injection (Bexsero tip caps contain latex): 0.5 ml in pre-filled syringes

Nursing implications

Nursing assessment

  • Monitor for signs and symptoms of allergic reaction (dyspnea, rash, hives, swelling of face, lips, or throat). Keep epinephrine, an antihistamine, and resuscitation equipment close by in the event of an anaphylactic reaction.
  • Assess for latex allergy. Bexsero tip cap contains latex.
  • Assess for syncope. Make patient is sitting or lying down during and immediately following injections.

Potential Nursing Diagnoses

Risk for infection (Indications)

Implementation

  • Intramuscular: Shake syringe vigorously for a homogenous white suspension; do not use if solution has separated, discolored, or contains particulate matter. Administer 0.5 mL IM into deltoid muscle of upper arm. Do not mix with other vaccines in same syringe.

Patient/Family Teaching

  • Explain purpose of vaccine to patient/parent. Emphasize need for 2 doses of immunization series for Bexseroor 3 doses for Tremenba.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

  • Prevention of invasive meningococcal disease including meningitis.
References in periodicals archive ?
Pfizer Inc today announced that detailed results from two pivotal Phase 3 studies of TRUMENBA (Meningococcal Group B Vaccine) were published in the New England Journal of Medicine (NEJM).
A complete Bexsero series costs $320; a competing vaccine, Trumenba, costs $345.
In addition, Pfizer's Meningococcal Group B (MenB) vaccine, Trumenba, was approved by the FDA for a new two-dose schedule designed to help prevent MenB in healthy adolescents and young adults.
M2 PHARMA-June 1, 2017-European Commission approves Pfizer's TRUMENBA
M2 EQUITYBITES-June 1, 2017-European Commission approves Pfizer's TRUMENBA
Either Bexsero or the 3-dose series of Trumenba is preferred for outbreak response (3).
Browse Meningococcal Vaccines Market by Meningococcal Combination Vaccines (Bexsero, Trumenba, MenHibrix, Menitorix); Meningococcal Conjugate Vaccines (Menactra, MenAfriVac, Meningitec, Menjugate, Menveo, NeisVac-C, Nimenrix, NmVac4-DT); and Meningococcal Polysaccharide Vaccine (Bi Meningo, Mencevax, Menomune, NmVac4, Quadri Meningo) and Forecast 2017-2021 at https://www.
Trumenba requires a three-dose series, with the second dose at least 2 months after the first and the third dose at least 6 months after the first.
On Read's watch, Pfizer has seen approval of 10 new medicines, including the breast cancer drug Ibrance, which analysts forecast will eventually generate $5 billion a year, and Trumenba, a potentially important meningitis vaccine, both products of Pfizer labs.
The two vaccines licensed by the Food and Drug Administration are Trumenba (by Pfizer), a three-dose series, and Bexsero (GlaxoSmithKline), a two-dose series; they are indicated for preventing meningococcal disease caused by Neisseria meningitidis serogroup B in people aged 10-25 years.
Food and Drug Administration licensed the two vaccines - trade names Bexsero and Trumenba - based on data that suggested that they prevent the specific Type B bacteria from infecting the bloodstream or the brain and spinal cord's protective membranes, causing meningitis or meningoccocemia, two rare but potentially fatal diseases, said Lucy McNamara, a CDC scientist working on the study.