Haemophilus Influenzae Type B Vaccine

Haemophilus influenzae type B vaccine is used for H. influenzae type B immunization.

• Haemophilus influenzae type B vaccine is available under the following different brand names: ActHIB, Hiberix, and Liquid PedvaxHIB.

Adult and Pediatric Dosage Forms and Strengths

Injection

• 10 mcg Haemophilus b, 25mcg tetanus toxoid/0.5mL (ActHIB, Hiberix)
• 7.5 mcg Haemophilus b PRP, 125mcg Neisseria meningitides OMPC/0.5 mL (PedVaxHib)

H. influenzae Type B Immunization, Adult

• FFP: 10-20 mL/kg of body weight will increase factor levels by 20-30%
• Not indicated for routine immunization in otherwise healthy adults
• For more information, see the CDC vaccine guidelines at: http://www.cdc.gov/vaccines/schedules/hcp/index.html

Asplenia

• Indicated for adults with functional or anatomic asplenia (including sickle cell disease) or are undergoing elective splenectomy
• One dose of HIB vaccine should be administered if the HIB vaccine has not previously been received
• HIB vaccination should be given 14 days or more before splenectomy

Complement deficiency

• Indicated for adults with persistent complement component deficiencies
• One dose of HIB vaccine should be administered if HIB vaccine has not previously been received

Post-HSCT Recipients

• Recipients of a hematopoietic stem cell transplant (HSCT) should be vaccinated with a 3-dose regimen 6 to 12 months after a successful transplant, regardless of vaccination history
• At least 4 weeks should separate doses

Dosing Considerations, Adult

• Not recommended for adults with HIV infection since their risk for HIB infection is low, unless another risk factor is present (i.e., asplenia, complement deficiency, HSCT recipient)

H. influenzae Type B Immunization, Pediatric

• Intramuscular (IM) injection indicated for routine immunization in children aged 2 months to 15 months and up to 5 years for a catch up vaccination
• Primary series (6 weeks to 12 months): 2 or 3 doses
• Booster: 3rd or 4th dose between 12-15 months

PRP-OMP

• Monovalent vaccine; polyribosylribotol phosphate (PRP) conjugated to outer membrane protein (OMP) complex from Neisseria meningitidis
• PEDvaxHIB: 2 and 4 months (primary series); 12-15 months (booster)

PRP-T

• Monovalent vaccines; polyribosylribotol phosphate (PRP) conjugated to tetanus toxoid (T)
• ActHIB, Hiberix: 0.5 mL IM as 4-dose series at 2, 4, and 6 months (primary series) and between 12-15 months (booster)

Combination vaccines

• PRP-OMP-HepB (Comvax): 2 and 4 months (primary series); 12-15 months (booster)
• DTap-IPV/PRP-T (Pentacel): 2, 4, and 6 months (primary series); 12-15 months (booster)
• MenCY-PRP-T (MenHibRix): 2, 4, and 6 months (primary series); 12-15 months (booster)

Considered fully immunized if

• At least 1 dose after age 14 months, or
• 2 doses between 12-14 months old, or
• More than 2 doses during the first year of life followed by a booster when older than 1 year

Immunosuppressed individuals

• Consider administering in patients 5 years or older if not already vaccinated and are immunosuppressed (e.g., sickle cell disease, leukemia, HIV, or anatomic/functional asplenia)

Dosing Considerations, Pediatric

• PRP-T: Polyribosylribotol phosphate conjugated to tetanus toxoid
• OMP: Outer membrane protein complex from Neisseria meningitidis
• The minimum age for vaccination is 6 weeks old for PRP-T (ActHIB), DTaP-IPV/Hib (Pentacel), and Hib-MenCY (MenHibrix), or PRP-OMP (PedvaxHIB, Comvax)
• The minimum age for vaccination is 12 months old for PRP-T (Hiberix)
• ActHIB: Reconstituted with 0.4% NaCl diluent is indicated for active immunization of children aged 2 months through 5 years for the prevention of invasive disease caused by Haemophilus influenzae type b
• TriHIBit: ActHIB reconstituted with Tripedia (DTP) vaccine creates TriHIBit vaccine; it is indicated for the active immunization of children aged 15 through 18 months for the prevention of invasive disease caused by Haemophilus influenzae type b and diphtheria, tetanus, and pertussis

Side effects of Haemophilus influenzae Type B Vaccine may include:

• Irritability
• Drowsiness
• Fever
• Loss of appetite
• Injection site reactions (swelling, tenderness, hard lump, pain, soreness, warmth)
• Diarrhea
• Vomiting
• Crying (unusual, high pitched, prolonged)
• Sleepiness
• Rash
• Ear infection
• Upper respiratory tract infection

Postmarketing side effects of Haemophilus influenzae type B vaccine reported include:

• Anaphylactoid reactions
• Angioedema
• Erythema multiforme
• Facial swelling
• Febrile seizure
• Feeling unwell (malaise)
• Guillain-Barre syndrome
• Headache
• Hives
• Hypersensitivity
• Hyporesponsive episodes
• Injection site abscess
• Lethargy
• Lymphadenopathy
• Mass
• Reduced muscle tone
• Seizure
• Shock
• Skin discoloration

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Haemophilus influenzae Type B Vaccine has no listed severe interactions with other drugs.
• Serious interactions of Haemophilus influenzae Type B Vaccine include:
  • siponimod
• Haemophilus influenzae Type B Vaccine has no listed moderate interactions with other drugs.
• Haemophilus influenzae Type B Vaccine has no listed mild interactions with other drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

This medication contains Haemophilus influenzae type B vaccine. Do not take ActHIB, Hiberix, or Liquid PedvaxHIB if you are allergic to Haemophilus influenzae type B vaccine or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any H. influenzae type B- or tetanus toxoid-containing vaccine or any component of the vaccine

Effects of Drug Abuse

• No information is available.

Short-Term Effects

• See "What Are Side Effects Associated with Using Haemophilus influenzae Type B Vaccine?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Haemophilus influenzae Type B Vaccine?"

Cautions

• If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the decision to give any tetanus toxoid-containing vaccine should be based on careful consideration of the potential benefits and possible risks
• Syncope can occur in association with administration of injectables and may be accompanied by transient neurological signs (e.g., visual disturbance, paresthesia, tonic-clonic limb movements): procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope
• Apnea reported following IM vaccination in some infants born prematurely; decisions about when to administer an IM vaccine to infants born prematurely should be based on consideration of the individual infant’s medical status, and the potential benefits and possible risks of vaccination
• Prior to administration, the healthcare provider should review the patient's immunization history for possible vaccine hypersensitivity; epinephrine and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur
• Safety and effectiveness in immunosuppressed children have not been evaluated; if administered to immunosuppressed children, the expected immune response may not be obtained
• Urine antigen detection may not have a diagnostic value in suspected disease due to H. influenzae type B within 1 to 2 weeks after receipt of an H. influenzae type B-containing vaccine

Pregnancy and Lactation

• Use Haemophilus influenzae type B vaccine with caution during pregnancy if benefits outweigh risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done.
• It is unknown if the Haemophilus influenzae type B vaccine passes into breast milk. Consult your doctor before breastfeeding.