Frequently Asked Questions

What are the indications and usage for PedvaxHIB?

PedvaxHIB is indicated for routine vaccination against invasive disease caused by Haemophilus influenzae type b in infants and children 2 to 71 months of age.

PedvaxHIB will not protect against disease caused by Haemophilus influenzae other than type b or against other microorganisms that cause invasive disease such as meningitis or sepsis.

As with any vaccine, vaccination may not result in a protective antibody response in all individuals given the vaccine.

Because of the potential for immune tolerance, PedvaxHIB IS NOT RECOMMENDED FOR USE IN INFANTS YOUNGER THAN 6 WEEKS OF AGE.

Revaccination

Infants completing the primary 2-dose regimen before 12 months of age should receive a booster dose (see Dosage and Administration.)

What is the recommended dosing and administration for PedvaxHIB?

PedvaxHIB is administered in a 2-dose primary regimen before 14 months of age.

Infants 2 to 14 months of age should receive a 0.5 mL dose of vaccine, ideally beginning at 2 months of age, followed by a 0.5 mL dose 2 months later (or as soon as possible thereafter). When the primary 2-dose regimen is completed before 12 months of age, a booster dose (0.5 mL) should be administered at 12 to 15 months, but not earlier than 2 months after the second dose.

Infants born prematurely, regardless of birth weight, should be vaccinated at the same chronological age and according to the same schedule and precautions as full-term infants and children.

Children 15 months of age and older previously unvaccinated against Hib disease should receive a single 0.5 mL dose of vaccine.

PedvaxHIB may be interchanged with other licensed Haemophilus b conjugate vaccines for the primary and booster doses. If PedvaxHIB is given in a series with one of the other products licensed for infants, the recommended number of doses to complete the primary series is determined by the other product and not by PedvaxHIB. PedvaxHIB may be interchanged with other licensed Haemophilus b conjugate vaccines for the booster dose.

Before administering PedvaxHIB, please read the accompanying Prescribing Information.

What is the Selected Safety Information for PedvaxHIB?

PedvaxHIB is contraindicated in patients with hypersensitivity to any component of the vaccine. Persons who develop symptoms suggestive of hypersensitivity after an injection should not receive further injections of the vaccine or the diluent.

As for any vaccine, adequate treatment provisions, including epinephrine, should be available for immediate use should an anaphylactoid reaction occur.

Use caution when vaccinating latex-sensitive individuals since the vial stopper contains dry natural latex rubber that may cause allergic reactions.

As with other vaccines, PedvaxHIB may not induce protective antibody levels immediately following vaccination.

There is insufficient evidence that PedvaxHIB given immediately after exposure to natural Haemophilus influenzae type b will prevent illness.

If PedvaxHIB is used in persons with malignancies or those receiving immunosuppressive therapy or who are otherwise immunocompromised, the expected immune response may not be obtained.

Special Populations

Animal reproduction studies have not been conducted with PedvaxHIB. Liquid PedvaxHIB is not recommended for use in individuals 6 years of age and older.

Geriatric use: This vaccine is NOT recommended for use in adult populations.

In clinical trials, the most frequently reported (>1%) adverse reactions, without regard to causality, were fever (≥101°F), irritability, sleepiness, injection-site pain/soreness, injection-site erythema (≤2.5 cm diameter), injection-site swelling/induration (≤2.5 cm diameter), unusual high-pitched crying, prolonged crying (>4 hours), diarrhea, vomiting, crying, pain, otitis media, rash, and upper respiratory infection.

The following additional adverse reactions have been reported with the use of the marketed vaccine: lymphadenopathy; rarely, angioedema; febrile seizures; sterile injection-site abscess.

Where is PedvaxHIB administered?

PedvaxHIB vaccine administration should be done by injecting 0.5 mL intramuscularly, preferably into the outer front of the thigh (anterolateral) or the outside of the upper arm. The buttocks should not be used for active vaccination of infants and children, because of the potential risk of injury to the sciatic nerve. Discard vial after use.

What are the storage and preparation guidelines for PedvaxHIB?

Refrigerate immediately on arrival; store vaccine at 2°C to 8°C (36°F to 46°F); DO NOT FREEZE.

Shake well before withdrawal and use. Thorough agitation is necessary to maintain suspension of the vaccine.

The vaccine should be used as supplied; no reconstitution is necessary.

Parenteral drug products should be inspected visually for extraneous particulate matter and discoloration prior to administration whenever solution and container permit. The vaccine is a slightly opaque, white suspension.

How is PedvaxHIB supplied?

Liquid PedvaxHIB is supplied as a box of 10 single-dose vials of liquid vaccine, NDC 0006-4897-00.

What are the clinical data for PedvaxHIB?

The protective efficacy of lyophilized PedvaxHIB was determined in the Protective Efficacy Study.

As with any vaccine, vaccination with Liquid PedvaxHIB may not result in a protective antibody response in all individuals given the vaccine.

What is the CPT code for PedvaxHIB?

The PedvaxHIB product CPT code is 90647.5

CPT, Current Procedural Terminology. CPT is a registered trademark of the American Medical Association.

At what age should PedvaxHIB be given?

PedvaxHIB is indicated for infants and children 2 to 71 months of age.

ACIP recommends: 3-dose series (2-dose primary series at age 2 and 4 months, followed by a booster dose at age 12–15 months).6

ref5

Reference

  1. Centers for Disease Control and Prevention (CDC). CPT Codes Mapped to CVX Codes. Last reviewed September 2, 2022. Accessed September 14, 2022.
    https://www2a.cdc.gov/vaccines/iis/iisstandards/vaccines.asp?rpt=cpt

ref6

Reference

  1. Advisory Committee on Immunization Practices (ACIP). Recommended Child and Adolescent Immunization Schedule for ages 18 years or younger, United States, 2022, page 1-10. Accessed September 15, 2022.
    http://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf

Indications and Usage for PedvaxHIB

PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] is indicated for routine vaccination against invasive disease caused by Haemophilus influenzae type b in infants and children 2 to 71 months of age.

PedvaxHIB will not protect against disease caused by Haemophilus influenzae other than type b or against other microorganisms that cause invasive disease such as meningitis or sepsis.

As with any vaccine, vaccination may not result in a protective antibody response in all individuals given the vaccine.

Because of the potential for immune tolerance, PedvaxHIB IS NOT RECOMMENDED FOR USE IN INFANTS YOUNGER THAN 6 WEEKS OF AGE.

Revaccination

Infants completing the primary 2-dose regimen before 12 months of age should receive a booster dose. (See Dosage and Administration)

Selected Safety Information for PedvaxHIB

PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] is contraindicated in patients with hypersensitivity to any component of the vaccine. Persons who develop symptoms suggestive of hypersensitivity after an injection should not receive further injections of the vaccine or the diluent.

As for any vaccine, adequate treatment provisions, including epinephrine, should be available for immediate use should an anaphylactoid reaction occur.

Use caution when vaccinating latex-sensitive individuals since the vial stopper contains dry natural latex rubber that may cause allergic reactions.

As with other vaccines, PedvaxHIB may not induce protective antibody levels immediately following vaccination.

There is insufficient evidence that PedvaxHIB given immediately after exposure to natural Haemophilus influenzae type b will prevent illness.

If PedvaxHIB is used in persons with malignancies or those receiving immunosuppressive therapy or who are otherwise immunocompromised, the expected immune response may not be obtained.

Special Populations

Animal reproduction studies have not been conducted with PedvaxHIB. Liquid PedvaxHIB is not recommended for use in individuals 6 years of age and older.

Geriatric use: This vaccine is NOT recommended for use in adult populations.

In clinical trials, the most frequently reported (>1%) adverse reactions, without regard to causality, were fever (≥101°F), irritability, sleepiness, injection-site pain/soreness, injection-site erythema (≤2.5 cm diameter), injection-site swelling/induration (≤2.5 cm diameter), unusual high-pitched crying, prolonged crying (>4 hours), diarrhea, vomiting, crying, pain, otitis media, rash, and upper respiratory infection.

The following additional adverse reactions have been reported with the use of the marketed vaccine: lymphadenopathy; rarely, angioedema; febrile seizures; sterile injection-site abscess.

Dosage and Administration for PedvaxHIB

PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] is administered in a 2-dose primary regimen before 14 months of age. Infants 2 to 14 months of age should receive a 0.5 mL dose of vaccine, ideally beginning at 2 months of age, followed by a 0.5 mL dose 2 months later (or as soon as possible thereafter). When the primary 2-dose regimen is completed before 12 months of age, a booster dose (0.5 mL) should be administered at 12 to 15 months, but not earlier than 2 months after the second dose.

Infants born prematurely, regardless of birth weight, should be vaccinated at the same chronological age and according to the same schedule and precautions as full-term infants and children.

Children 15 months of age and older previously unvaccinated against Hib disease should receive a single 0.5 mL dose of vaccine.

PedvaxHIB may be interchanged with other licensed Haemophilus b conjugate vaccines for the primary and booster doses. If PedvaxHIB is given in a series with one of the other products licensed for infants, the recommended number of doses to complete the primary series is determined by the other product and not by PedvaxHIB. PedvaxHIB may be interchanged with other licensed Haemophilus b conjugate vaccines for the booster dose.

Before administering PedvaxHIB, please read the accompanying Prescribing Information.

Indications and Usage for PedvaxHIB ® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)]

PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] is indicated for routine vaccination against invasive disease caused by Haemophilus influenzae type b in infants and children 2 to 71 months of age.

PedvaxHIB will not protect against disease caused by Haemophilus influenzae other than type b or against other microorganisms that cause invasive disease such as meningitis or sepsis.

As with any vaccine, vaccination may not result in a protective antibody response in all individuals given the vaccine.

Because of the potential for immune tolerance, PedvaxHIB IS NOT RECOMMENDED FOR USE IN INFANTS YOUNGER THAN 6 WEEKS OF AGE.

Revaccination

Infants completing the primary 2-dose regimen before 12 months of age should receive a booster dose. (See Dosage and Administration)

PedvaxHIB is indicated for routine vaccination against invasive disease caused

PedvaxHIB is indicated for routine vaccination against invasive disease caused by Haemophilus influenzae type b in infants and children 2 to 71 months of age.

PedvaxHIB will not protect against disease caused by Haemophilus influenzae other than type b or against other microorganisms that cause invasive disease such as meningitis

Selected Safety Information for PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)]

PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] is contraindicated in patients with hypersensitivity to any component of the vaccine. Persons who develop symptoms suggestive of hypersensitivity after an injection should not receive further injections of the vaccine or the diluent.

As for any vaccine, adequate treatment provisions, including epinephrine, should be available for immediate use should an anaphylactoid reaction occur.

Use caution when vaccinating latex-sensitive individuals since the vial stopper contains dry natural latex rubber that may cause allergic reactions.

As with other vaccines, PedvaxHIB may not induce protective antibody levels immediately following vaccination.

There is insufficient evidence that PedvaxHIB given immediately after exposure to natural Haemophilus influenzae type b will prevent illness.

If PedvaxHIB is used in persons with malignancies or those receiving immunosuppressive therapy or who are otherwise immunocompromised, the expected immune response may not be obtained.

Special Populations

Animal reproduction studies have not been conducted with PedvaxHIB. Liquid PedvaxHIB is not recommended for use in individuals 6 years of age and older.

Geriatric use: This vaccine is NOT recommended for use in adult populations.

In clinical trials, the most frequently reported (>1%) adverse reactions, without regard to causality, were fever (≥101°F), irritability, sleepiness, injection-site pain/soreness, injection-site erythema (≤2.5 cm diameter), injection-site swelling/induration (≤2.5 cm diameter), unusual high-pitched crying, prolonged crying (>4 hours), diarrhea, vomiting, crying, pain, otitis media, rash, and upper respiratory infection.

The following additional adverse reactions have been reported with the use of the marketed vaccine: lymphadenopathy; rarely, angioedema; febrile seizures; sterile injection-site abscess.

Dosage and Administration for PedvaxHIB

PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] is administered in a 2-dose primary regimen before 14 months of age. Infants 2 to 14 months of age should receive a 0.5 mL dose of vaccine, ideally beginning at 2 months of age, followed by a 0.5 mL dose 2 months later (or as soon as possible thereafter). When the primary 2-dose regimen is completed before 12 months of age, a booster dose (0.5 mL) should be administered at 12 to 15 months, but not earlier than 2 months after the second dose.

Infants born prematurely, regardless of birth weight, should be vaccinated at the same chronological age and according to the same schedule and precautions as full-term infants and children.

Children 15 months of age and older previously unvaccinated against Hib disease should receive a single 0.5 mL dose of vaccine.

PedvaxHIB may be interchanged with other licensed Haemophilus b conjugate vaccines for the primary and booster doses. If PedvaxHIB is given in a series with one of the other products licensed for infants, the recommended number of doses to complete the primary series is determined by the other product and not by PedvaxHIB. PedvaxHIB may be interchanged with other licensed Haemophilus b conjugate vaccines for the booster dose.

Before administering PedvaxHIB, please read the accompanying Prescribing Information.

PedvaxHIB is contraindicated in patients with hypersensitivity to any

PedvaxHIB is contraindicated in patients with hypersensitivity to any component of the vaccine. Persons who develop symptoms suggestive of hypersensitivity after an injection should not receive further injections of the vaccine or the diluent.

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