meningococcal C and Y/haemophilus influenza type B vaccine (MenHibrix)
- Dosing and uses of MenHibrix (meningococcal C and Y/haemophilus influenza type B vaccine)
- MenHibrix (meningococcal C and Y/haemophilus influenza type B vaccine) adverse (side) effects
- Warnings
- Pregnancy
- Pharmacology of MenHibrix (meningococcal C and Y/haemophilus influenza type B vaccine)
- Administration
Dosing and uses of MenHibrix (meningococcal C and Y/haemophilus influenza type B vaccine)
Adult dosage forms and strengths
This product is not indicated in adult patients
Pediatric dosage forms and strengths
Injectable lyophilized vaccine supplied as single-dose vial to be reconstituted with accompanying saline
IM solution
- 0.5mL/vial (reconstituted dose)
Immunization
Indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b in children aged 6 weeks through 18 months
4-dose regimen (not for routine vaccination); use only for HIB immunization in infants at high risk for meningococcal infection)
0.5 mL IM at 2, 4, 6, and 12-15 months
The 1st dose may be initiated as early as 6 weeks old; the 4th dose may be given as late as 18 months old
Immunization for High-Risk Conditions (ACIP Guidelines)
Asplenia
- Indicated for children with anatomic or functional asplenia (including sickle cell disease)
- 4 dose infant series administered at 2, 4, 6, and 12 through 15 months of age
- Booster dose: Every 5 years with Menveo or Menactra
Complement deficiency
- Indicated for children with persistent complement component deficiency
- 4-dose infant series administered at 2, 4, 6, and 12 through 15 months of age
- Booster dose: Every 5 years with Menveo or Menactra
Community outbreak
- For children at risk during a community outbreak attributable to a vaccine serogroup, administer or complete an age- and formulation-appropriate series of MenHibrix, Menactra, or Menveo
Dosing Considerations
Travel/reside in hyperendemic/epidemic countries: Prior receipt of MenHibrix is not sufficient for children traveling to the African meningitis belt or the Hajj because it does NOT contain serogroups A or W
Administration
For IM use only
Infants <1 years: Preferred injection site is the anterolateral aspect of the thigh
Age ≥ 1 year: May receive the vaccine in the deltoid muscle
MenHibrix (meningococcal C and Y/haemophilus influenza type B vaccine) adverse (side) effects
>10%
Pain, any (41.4-46.2%)
Redness (20.6-34.6%)
Swelling at injection site >30 mm (14.7-25.4%)
Irritability (62.1-70.8%)
Drowsiness (48.7-62.8%)
Loss of appetite (30.1-33.8%)
Fever ≥100.4 degrees Fahrenheit (11-25.9%)
1-10%
Fever ≥102.2 degrees Fahrenheit (1.1 – 3.2%)
Postmarketing Reports
Administration site: Extensive swelling of vaccinated limb, injection site induration
Immune system: Allergic reaction, anaphylaxis, angioedema
Nervous System: Convulsions with or without fever, hypotonic-hyporesponsive episode, somnolence, syncope, or vasovagal response
Respiratory: Apnea
Skin: Rash, urticaria
Warnings
Contraindications
Hypersensitivity to vaccine or any of its components
Patients that experienced severe allergic reactions (eg, anaphylaxis) after administration of H. influenzae type b-, meningococcal-, or tetanus toxoid-containing vaccine
Cautions
Guillain-Barre syndrome has occurred within 6 weeks prior to vaccine containing tetanus toxoid
Syncope reported in association with injectable vaccines and is accompanied by paresthesia, tonic-clonic limb movements, and/ or visual disturbances may occur
Premature infants are at higher risk of developing apnea following IM vaccination; consider medical status and weigh potential benefits and risks to determine about when to administer the vaccine
Review immunization history for potential hypersensitivity reactions; epinephrine and other agents must be readily available should an anaphylactic reaction occur
Safety and effectiveness have not been evaluated in immunosuppressed patients; expected immune response may not be obtained
Patients must continue to receive routine tetanus immunization as MenHibrix is not a substitution
Pregnancy and lactation
Pregnancy category: C
Lactation: Unknown whether distributed in breast milk
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of MenHibrix (meningococcal C and Y/haemophilus influenza type B vaccine)
Mechanism of action
Contains antigenic capsular polysaccharides (ie, meningococcal serogroups A and C, Haemophilus influenzae type b) that convey active immunity by stimulating endogenous antibody production; antibodies have been associated with protection from invasive meningococcal disease
Administration
IM Preparation
Clean both vial stoppers (lyophilized vaccine and diluent)
Withdraw 0.6 mL of saline from diluent vial and transfer to lyophilized vaccine viaL
Shake vial welL
Reconstitute single-dose vial containing lyophilized vaccine only with accompanying vial of saline diluent
Reconstituted solution should be clear and colorless
Withdraw 0.5 mL of reconstituted vaccine in syringe for IM administration
IM Administration
Visually inspect for particulate matter and discoloration before administration, if either of these conditions exist do not administer
For IM injection only; do not administer IV, SC, or intradermally
Use a separate sterile needle and sterile syringe for each individuaL
Preferred administration site is the anterolateral aspect of the thigh for most infants aged <1 year
Older children may receive the vaccine in the deltoid muscle
Storage
Before reconstitution
- Lyophilized vaccine vials: Store refrigerated between 2-8°C (36-46°F); protect from light
- Diluent: Store refrigerated or at controlled room temperature between 2-25°C (36-77°F); do not freeze (discard diluent if it has been frozen)
After reconstitution
- Administer immediately following reconstitution
- Do not freeze
- Discard if the vaccine has been frozen