meningococcal C and Y/haemophilus influenza type B vaccine (MenHibrix)

Dosing and uses of MenHibrix (meningococcal C and Y/haemophilus influenza type B vaccine)

• Adult
• Pediatric

 

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