meningococcal group B vaccine

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 ?
TRUMENBA (Meningococcal Group B Vaccine) is indicated for active immunization of individuals 10 years and older to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B.
M2 PHARMA-May 23, 2016-Pfizer's MAA for TRUMENBA (Meningococcal Group B Vaccine) accepted for EMA's review
(NYSE:PFE) today announced the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for TRUMENBA (Meningococcal Group B Vaccine) for review.
M2 EQUITYBITES-May 23, 2016-Pfizer's MAA for TRUMENBA (Meningococcal Group B Vaccine) accepted for EMA's review
GSK today presented new data for its meningococcal group B vaccine, Bexsero,1 Meningococcal group B Vaccine (rDNA, component, adsorbed) comparing safety and immunogenicity with different dosing schedules in infants and young children, at the annual meeting of the European Society for Paediatric Infectious Diseases (ESPID).
Healthcare company Pfizer Inc (NYSE:PFE) stated on Friday that the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has recommended TRUMENBA's (Meningococcal Group B Vaccine) marketing authorisation in the EU for active immunisation against the invasive meningococcal disease.
M2 EQUITYBITES-May 31, 2017-Pfizer granted EU approval for its meningococcal group B vaccine
- The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending that US-based pharmaceutical company Pfizer Inc.'s (NYSE: PFE) Trumenba (Meningococcal Group B Vaccine) be granted marketing authorisation in the European Union for active immunisation of individuals ten years and older to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B, the company said.
M2 PHARMA-May 31, 2017-Pfizer granted EU approval for its meningococcal group B vaccine
TRUMENBA (Meningococcal Group B Vaccine) is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.
Bexsero (Meningococcal group B vaccine, rDNA, 4-component, adsorbed) is the brand name for Novartis' four-component meningococcal vaccine that is indicated to protect children, adolescents, and adults two months of age and older against invasive infection caused by N.
Last year, Pfizer's Trumenba (Meningococcal Group B Vaccine) was approved in the U.S.