Version May 2024
Prevention of invasive disease caused by Haemophilus influenzae type b (Hib):
Note: May use any of the Hib conjugate vaccines (Ref).
Adults who have not received the childhood Hib series and are at increased risk for invasive Hib disease due to sickle cell disease, anatomic/functional asplenia, or splenectomy: IM: One dose (0.5 mL) (Ref). For patients undergoing elective splenectomy, consider administering the dose at least 14 days prior to the procedure (Ref).
Adults who are recipients of a successful hematopoietic stem cell transplant: IM: Revaccinate with a 3-dose regimen (0.5 mL/dose) beginning 6 to 12 months after the transplant, regardless of vaccination history. Doses should be administered ≥4 weeks apart (Ref).
There are no dosage adjustments provided in manufacturer’s labeling.
There are no dosage adjustments provided in manufacturer’s labeling.
Refer to adult dosing.
(For additional information see "Haemophilus influenzae type b conjugate vaccine (Hib): Pediatric drug information")
Note: Consult CDC/ACIP annual immunization schedules for additional information including specific detailed recommendations for catch-up scenarios and/or care of patients with high-risk conditions. According to ACIP, doses administered ≤4 days before minimum interval or age are considered valid; however, local or state mandates may supersede this timeframe (Ref).
Primary immunization : Note: Preterm infants should be vaccinated according to their chronological age, beginning at 2 months of age; number of doses for completion of Hib series dependent upon products including some combination formulations (3 doses: ActHIB, Hiberix; 2 doses: PedvaxHIB) (Ref) (see combination product monographs for specific dosing information)
Infants 6 weeks to 6 months: Minimum age for first dose is 6 weeks.
ActHIB, Hiberix (PRP-T): IM: 0.5 mL per dose for a total of 3 doses administered as follows: 2, 4, and 6 months of age
PedvaxHIB (PRP-OMP): IM: 0.5 mL per dose for a total of 2 doses administered as follows: 2 and 4 months of age
Booster immunization: ACIP recommendation: ActHIB, Hiberix, PedvaxHIB: Children 12 to 15 months: IM: 0.5 mL as a single dose (Ref).
Catch-up immunization: Note: Do not restart the series. If doses have been given, refer to current immunization guidelines for specific schedule and timing of dose based on patient age and previous number of doses.
Infants and Children 4 to 59 months: IM: 0.5 mL per dose for a total of 1 to 4 doses:
Children ≥5 years and Adolescents; unimmunized and are at increased risk for invasive Hib disease due to anatomic/functional asplenia or splenectomy, HIV infection, immunoglobulin deficiency, early component complement deficiency, or chemotherapy or radiation therapy: IM: 0.5 mL as a single dose; may use any of the Hib conjugate vaccines (Ref). Unimmunized defined as persons who have not received a primary series and booster dose or at least 1 dose of a Hib vaccine after 14 months of age.
Repeat immunization for high-risk conditions (Ref):
Invasive Hib disease: Infants and Children <24 months: Revaccinate with a second primary series beginning 4 weeks after onset of disease
Undergoing chemotherapy or radiation therapy: Infants and Children <60 months: If dose administered within 14 days of starting or given during therapy: Repeat the doses at least 3 months after therapy completion
Hematopoietic stem cell transplant recipient: Children and Adolescents: Revaccinate with a 3-dose regimen beginning 6 to 12 months after successful transplant, regardless of vaccination history. Doses should be administered ≥4 weeks apart.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for infants and children, unless otherwise specified.
>10%:
Gastrointestinal: Anorexia (6% to 29%)
Local: Erythema at injection site (≤30%), pain at injection site (41% to 49%), swelling at injection site (2% to 19%), tenderness at injection site (children: ≤20%)
Nervous system: Drowsiness (infants: 49% to 60%; children: 13% to 39%), irritability (infants: 67% to 70%; children: 13% to 58%)
Miscellaneous: Fever (≤19%)
1% to 10%:
Dermatologic: Skin rash (infants: >1%)
Local: Induration at injection site (children: ≤6%)
<1%:
Gastrointestinal: Vomiting (children)
Hematologic & oncologic: Thrombocytopenia
Respiratory: Pneumonia
Frequency not defined: Nervous system: Fussiness in an infant or toddler, restlessness
Postmarketing:
Cardiovascular: Peripheral edema, syncope
Dermatologic: Pruritus, urticaria
Hematologic & oncologic: Lymphadenopathy
Hypersensitivity: Hypersensitivity reaction (including anaphylaxis, angioedema, nonimmune anaphylaxis)
Local: Abscess at injection site (sterile), swelling of injected limb (extensive)
Nervous system: Febrile seizure, seizure
Respiratory: Apnea
Miscellaneous: Hypotonic/hyporesponsive episode
Hypersensitivity to Haemophilus b polysaccharide, tetanus toxoid-containing vaccine (Hiberix and ActHIB only), or any component of the formulation
Concerns related to adverse effects:
• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (ACIP [Kroger 2023]).
• Shoulder injury related to vaccine administration: Vaccine administration that is too high on the upper arm may cause shoulder injury (eg, shoulder bursitis or tendinopathy) resulting in shoulder pain and reduced range of motion following injection. Use proper injection technique for vaccines administered in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Cross 2016; Foster 2013).
• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (ACIP [Kroger 2023]).
Disease-related concerns:
• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Postpone administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (ACIP [Kroger 2023]).
• Bleeding disorders: Use with caution in patients with a history of bleeding disorders (including thrombocytopenia); bleeding/hematoma may occur from IM administration; if the patient receives antihemophilia or other similar therapy, IM injection can be scheduled shortly after such therapy is administered (ACIP [Kroger 2023]).
• Guillain-Barré syndrome (GBS): ActHIB, Hiberix: Use with caution in patients with history of GBS; carefully consider risks and benefits to vaccination in patients known to have experienced GBS within 6 weeks following previous tetanus-containing vaccination.
• Tetanus immunization: Immunization with ActHIB or Hiberix does not substitute for routine tetanus immunization.
Concurrent drug therapy issues:
• Anticoagulant therapy: Use with caution in patients receiving anticoagulant therapy; bleeding/hematoma may occur from IM administration (ACIP [Kroger 2023]).
• Vaccines: In order to maximize vaccination rates, the ACIP recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or nonlive) for which a person is eligible at a single medical visit, unless contraindications exist. The use of combination vaccines is generally preferred over separate injections, taking into consideration provider assessment, patient preference, and adverse events. According to the ACIP, monovalent Hib vaccines are interchangeable; however, if different brands are used in the primary series and the number of doses required for series completion varies, then the higher number of doses is recommended for series completion (ACIP [Kroger 2023]).
Special populations:
• Altered immunocompetence: Postpone vaccination during periods of severe immunosuppression (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]) if appropriate; may have a reduced response to vaccination (ACIP [Kroger 2023]). In general, household and close contacts of persons with altered immunocompetence may receive all age-appropriate vaccines). Nonlive vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible; nonlive vaccines administered during chemotherapy should be readministered after immune competence is regained (ACIP [Kroger 2023]; IDSA [Rubin 2014]).
• Pediatric: Apnea has occurred following intramuscular vaccine administration in premature infants; consider clinical status implications. In general, preterm infants should be vaccinated at the same chronological age as full-term infants (AAP [Saari 2003]; ACIP [Kroger 2023]).
Dosage form specific issues:
• Lactose: Some products may contain lactose.
• Latex: Packaging may contain natural latex rubber.
Other warnings/precautions:
• Antipyretics: Antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (ACIP [Kroger 2023]). One study reported that routine prophylactic administration of acetaminophen to prevent fever prior to vaccination decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula 2009).
• Appropriate use: Use of this vaccine for specific medical and/or other indications (eg, immunocompromising conditions, hepatic or kidney disease, diabetes) is also addressed in the annual ACIP Recommended Immunization Schedules (refer to CDC schedule for detailed information). Specific recommendations for vaccination in immunocompromised patients with asplenia, cancer, HIV infection, cerebrospinal fluid leaks, cochlear implants, hematopoietic stem cell transplant (prior to or after), sickle cell disease, solid organ transplant (prior to or after), or those receiving immunosuppressive therapy for chronic conditions are available from the IDSA (Rubin 2014).
• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval (ACIP [Kroger 2023]).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, powder for reconstitution:
Hiberix: Haemophilus b capsular polysaccharide 10 mcg [bound to tetanus toxoid 25 mcg] per 0.5 mL
Injection, powder for reconstitution [preservative free]:
ActHIB: Haemophilus b capsular polysaccharide 10 mcg [bound to tetanus toxoid 24 mcg] per 0.5 mL [contains formaldehyde; may be reconstituted with provided diluent (forms solution)]
Hiberix: Haemophilus b capsular polysaccharide 10 mcg [bound to tetanus toxoid 25 mcg] per 0.5 mL [contains lactose 12.6 mg] [DSC]
Injection, suspension:
PedvaxHIB: Haemophilus b capsular polysaccharide 7.5 mcg [bound to Neisseria meningitidis OMPC 125 mcg] per 0.5 mL (0.5 mL) [contains aluminum; natural rubber/natural latex in packaging]
No
Solution (reconstituted) (Hiberix Injection)
10 mcg (per each): $15.21
Suspension (Pedvax HIB Intramuscular)
7.5 mcg/0.5 mL (per 0.5 mL): $35.50
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, powder for reconstitution [preservative free]:
Act-HIB: Haemophilus b 10 mcg [bound to tetanus protein 18 mcg-30 mcg] per 0.5 mL
IM: For IM administration; do not inject IV, intradermally, or subcutaneously. Shake well prior to use. Administer into the anterolateral thigh or deltoid. If injecting in the deltoid muscle, use proper injection technique (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Ref). Do not administer into buttocks due to potential risk of injury to sciatic nerve. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope-related injuries, patients should be vaccinated while seated or lying down (Ref). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.
For patients at risk of hemorrhage following intramuscular injection, the vaccine should be administered intramuscularly if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, intramuscular vaccination can be scheduled shortly after such therapy is administered. A fine needle (23 gauge or smaller) can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (Ref).
IM: Shake well prior to administration; must be administered within 24 hours of reconstitution. Administer IM into midlateral aspect of the thigh in infants and small children; administer in the deltoid area to older children and adults; not for IV or SubQ administration. If injecting in the deltoid muscle, use proper injection technique (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Ref). Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope related injuries, adolescents should be vaccinated while seated or lying down (Ref). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.
For patients at risk of hemorrhage following intramuscular injection, the vaccine should be administered intramuscularly if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, intramuscular vaccination can be scheduled shortly after such therapy is administered. A fine needle (23-gauge or smaller) should be used for the vaccination and firm pressure on the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (Ref).
In the United States, the appropriate CDC-approved Vaccine Information Statement (VIS) must be provided to the patient/caregiver before administering each dose of this vaccine; the VIS edition date and date it was provided to the patient/caregiver should be recorded as required by US law; VIS is available at http://www.cdc.gov/vaccines/hcp/vis/vis-statements/hib.html.
Prevention of invasive disease caused by Haemophilus influenzae type b (Hib) in the following ages:
ActHIB: 2 months to <6 years of age.
Hiberix: 6 weeks to <5 years of age.
PedvaxHIB: 2 months to <6 years of age.
The Advisory Committee on Immunization Practices (ACIP) recommends vaccination for the following (CDC/ACIP [Briere 2014]):
- Routine immunization of all infants and children <5 years of age.
Use may also be considered for the following populations, if not previously immunized, despite lack of efficacy data in older children and adults with chronic conditions associated with an increased risk of Hib disease:
- Children ≥5 years of age, adolescents, and adults with functional or anatomic asplenia (including those with sickle cell disease).
- Children ≥5 years of age and adolescents who are infected with HIV.
- All recipients of a successful hematopoietic stem cell transplant.
- Children ≥15 months of age, adolescents, and adults undergoing elective splenectomy.
Hib (haemophilus b conjugate vaccine) may be confused with HepB (hepatitis B vaccine).
Hib (haemophilus b conjugate vaccine) may be confused with HPV (human papillomavirus vaccine; 2vHPV, HPV2, 4vHPV, HPV4, or 9vHPV are the correct abbreviations).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Acetaminophen: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of acetaminophen before or during vaccine administration when possible. Acetaminophen is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
Anti-CD20 B-Cell Depleting Therapies: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation or 6 months after anti-CD20 B-cell depleting therapies. If vaccinated prior to B cell recovery, consider assessing immune response to vaccination. Risk D: Consider therapy modification
Cladribine: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of cladribine when possible. Patients vaccinated less than 14 days before initiating or during cladribine should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification
Corticosteroids (Systemic): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to immunosuppressive corticosteroids if possible. If patients are vaccinated less than 14 days prior to or during such therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider therapy modification
Elivaldogene Autotemcel: May enhance the adverse/toxic effect of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may diminish the therapeutic effect of Vaccines. Management: Administration of vaccines is not recommended in the 6 weeks before myeloablative conditioning, and until hematologic recovery after elivaldogene autotemcel treatment. Risk X: Avoid combination
Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting fingolimod. If vaccinated during fingolimod therapy, revaccinate 2 to 3 months after fingolimod discontinuation. Risk D: Consider therapy modification
Immunosuppressants (Cytotoxic Chemotherapy): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of chemotherapy when possible. Patients vaccinated less than 14 days before initiating or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification
Immunosuppressants (Miscellaneous Oncologic Agents): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 3 after therapy is complete. Risk D: Consider therapy modification
Immunosuppressants (Therapeutic Immunosuppressant Agents): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider therapy modification
Methotrexate: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to methotrexate initiation, if possible. If patients are vaccinated less than 14 days prior to or during methotrexate therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider therapy modification
Propacetamol: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of propacetamol before or during vaccine administration when possible. Propacetamol is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
Siponimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Avoid administration of vaccines (inactivated) during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. Risk D: Consider therapy modification
Teplizumab: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Vaccination with inactivated or non-replicating vaccines is not recommended in the 2 weeks prior to teplizumab therapy, during treatment, or for 6 weeks following completion of therapy. Risk D: Consider therapy modification
Animal reproduction studies have not been conducted. Nonlive bacterial vaccines have not been shown to cause increased risks to the fetus (ACIP [Kroger 2023]).
Nonlive bacterial vaccines have not been shown to affect the safety of the breastfed infant or mother (ACIP [Kroger 2023]). Breastfeeding infants should be vaccinated according to the recommended schedules (ACIP [Kroger 2023]).
Monitor for hypersensitivity and syncope for 15 minutes following administration (ACIP [Kroger 2023]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.
Stimulates production of anticapsular antibodies and provides active immunity to Haemophilus influenzae type b. Vaccination provides protective antibodies in >95% of infants who are vaccinated with a 2- or 3-dose series (CDC 2012). An anti-PRP concentration of ≥1.0 mcg/mL predicts long-term protection.
Onset of action: Immunity develops progressively with each dose. Immunity can be inferred ~ 2 weeks after the initial series is complete.
Duration: Antibody concentrations exceeding 0.15 mcg/mL correlate with clinical protection from disease. Antibody concentrations exceeding 1 mcg/mL correlate with prolonged protection from disease, generally implying several years of protection.
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