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Haemophilus b Conjugate Vaccine

Pronunciation: he-MAF-i-lus
Class: Vaccine, bacterial

Trade Names

ActHIB
- Injection, lyophilized powder for solution or suspension 10 mcg of purified capsular polysaccharide, 24 mcg of inactivated tetanus toxoid per 0.5 mL

Hiberix
- Injection, lyophilized powder for solution 10 mcg of purified Haemophilus b capsular polysaccharide, 25 mcg of tetanus toxoid per 0.5 mL

Liquid PedvaxHIB
- Injection, suspension 7.5 mcg of Haemophilus b polyribosylribitol phosphate, 125 mcg of Neisseria meningitidis outer membrane protein complex per 0.5 mL

Pharmacology

Induces specific protective antibodies against Haemophilus influenzae type b (Hib).

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Indications and Usage

Induction of active immunity against Hib infection. Routine immunization of all infants beginning at 2 mo of age is recommended.

Contraindications

Hypersensitivity to any product component (some products contain thimerosal).

Dosage and Administration

ActHIB
Children 2 to 18 mo of age

IM Beginning at 2 mo of age, give 3 doses (0.5 mL each) 2 mo apart, plus a booster dose at 15 to 18 mo of age.

Hiberix
Children 15 mo to 4 y of age (prior to fifth birthday)

IM Booster dose (0.5 mL) generally recommended at 15 to 18 mo of age.

Liquid PedvaxHIB
Children 2 to 71 mo of age

IM Beginning at 2 mo of age, give 2 doses (0.5 mL each) 2 mo apart, plus a booster dose at 12 to 15 mo of age. Children 15 mo to 5 years of age who are unvaccinated require only 1 dose (0.5 mL).

General Advice

  • Administer IM in the midlateral muscles of the thigh or deltoid. Do not inject in gluteal area or near major nerve trunk.
  • Do not inject IV, intradermally, or subcutaneously.
  • Refer to the manufacturer's prescribing information for directions on reconstituting ActHIB and Hiberix .
  • Liquid PedvaxHIB should be used as supplied; no reconstitution is necessary. Shake well before withdrawal and use. Thorough agitation is necessary to maintain suspension of the vaccine.
  • After insertion of the needle, aspirate to help avoid inadvertent injection into a blood vessel.
  • During the course of primary immunizations, injections should not be made more than once at the same site.
  • If there is an interruption or delay between doses in the primary series, there is no need to repeat the series, but dosing should be continued at the next clinic visit. Interruption of the recommended schedule with a delay between doses should not interfere with the final immunity.
  • May be given simultaneously with diphtheria, tetanus toxoid, and pertussis vaccine; measles, mumps, rubella vaccine; oral polio vaccine; varicella virus vaccine live; hepatitis B vaccine (recombinant); or inactivated poliovirus vaccine.
  • Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration, whenever solution and container permit.
  • As part of the child's immunization record, the date, lot number, and manufacturer of the vaccine administered should be recorded.

Storage/Stability

Store vials in refrigerator (36° to 46°F). Do not freeze.

Drug Interactions

Anticoagulants (eg, warfarin)

As with other IM injections, use with caution in patients on anticoagulant therapy.

Immunosuppressive therapies (eg, alkylating agents, antimetabolites, corticosteroids [used in greater than physiologic doses], cytotoxic drugs, irradiation)

The immune response to vaccines may be reduced.

Laboratory Test Interactions

Diagnostic value of antigen detection (eg, with latex agglutination kits) may be diminished in suspected Hib disease within 1 to 2 wk (for PedvaxHIB , at least 30 days) after immunization.

Adverse Reactions

CNS

Irritability; lethargy; sleepiness; unusual high-pitched crying/prolonged crying; convulsions with or without fever, febrile seizures, hypotonic-hyporesponsive episode, somnolence, syncope or vasovagal responses to injection (postmarketing).

Dermatologic

Rash; urticaria (postmarketing).

GI

Diarrhea; vomiting.

Hypersensitivity

Allergic reactions including anaphylactic and anaphylactoid reactions; angioedema (postmarketing).

Local

Erythema, induration, pain, redness, soreness, and swelling at the injection site; extensive swelling of the vaccinated limb, injection-site abscess (postmarketing).

Miscellaneous

Fever; Guillain-Barré syndrome; otitis media; upper respiratory tract infection; apnea, lymphadenopathy (postmarketing).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

ActHIB

Not recommended in children younger than 2 mo of age or older than 19 mo of age.

Hiberix

Not recommended in children younger than 15 mo of age or older than 5 y of age.

PedvaxHIB

Not recommended in children younger than 2 mo of age or 6 y of age and older.

Elderly

These vaccines are not indicated for use in adult populations.

Antibodies

May not induce protective antibody levels immediately following vaccination.

Immunosuppression

Children with impaired immune responsiveness, whether due to the use of immunosuppressive therapy (including radiation, corticosteroids, antimetabolites, alkylating agents, and cytotoxic agents), HIV infection, severe combined immunodeficiency, hypogammaglobulinemia, agammaglobulinemia, or altered immune states caused by disease such as leukemia, lymphoma, or generalized malignancy, may have reduced antibody response to active immunization procedures. Deferral of administration of vaccine may be considered in individuals receiving immunosuppressive therapy.

Infection

The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and etiology of the disease. All vaccines can be administered to persons with minor illnesses (eg, diarrhea, mild upper respiratory tract infection with or without low-grade fever, other low-grade febrile illness). Vaccinate persons with moderate or severe illness as soon as they have recovered from the acute phase of the illness.

Interchangeability

In general, complete the vaccination series begun with one brand of Hib vaccine with that brand unless specific information about interchangeability is available.

Latex allergy

Stopper for diluent vial for ActHIB contains dry natural latex rubber; tip caps of the Hiberix prefilled diluent syringes may contain natural rubber latex.

Overdosage

None well documented.

Patient Information

  • Inform the parent or guardian of the importance of completing the immunization series.
  • Advise that acetaminophen (appropriate for age) may be given every 4 h for low-grade fever. Emphasize that aspirin should not be given to children.
  • Instruct parent or guardian to report any adverse reactions after vaccine administration.
  • Remind parent to keep child's immunization record up to date.
  • Provide the parent or guardian with the vaccine information materials, which are required to be given with each immunization.

Copyright © 2009 Wolters Kluwer Health.

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