Haemophilus b Conjugate Vaccine

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may interact with haemophilus B conjugate vaccine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell the doctor about all medications and treatments your child has recently received. Not all possible interactions are listed in this medication guide.

This vaccine is injected into a muscle. Your child will receive this injection in a doctor's office or clinic setting.

This vaccine is given in a series of shots. The first shot is usually given when the child is 2 months old. The booster shots are then given at 4 months and 6 months of age, and again at 12 to 15 months of age.

For children who do not start this series of shots before 15 months of age, the vaccine is usually given as a one-time injection. Unless your doctor's tells you otherwise, you will not need a booster vaccine.

Your child's individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.

Your doctor may recommend treating fever and pain with an aspirin free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to give your child.

It is especially important to prevent fever from occurring in a child who has a seizure disorder such as epilepsy.

An overdose of this vaccine is not likely to occur.

Contact your doctor if you will miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.

Be sure your child receives all recommended doses of this vaccine. If your child does not receive the full series of vaccines, he or she may not be fully protected against the disease.

More than 7,000 infants and young children ( ≤ 2 years of age) have received at least one dose of ActHIB vaccine during US clinical trials. Of these, 1,064 subjects 12 to 24 months of age who received ActHIB vaccine alone reported no serious or life threatening adverse reactions.

Adverse reactions commonly associated with a first ActHIB vaccine immunization of children 12 to 15 months of age who were previously unimmunized with any Haemophilus b conjugate vaccine, include local pain, redness, and swelling at the injection site. Systemic reactions include fever, irritability, and lethargy.4,10

Adverse reactions associated with ActHIB vaccine generally subsided after 24 hours and usually do not persist beyond 48 hours after immunization.

In a US trial, safety of TriHIBit vaccine, ActHIB vaccine combined with Tripedia vaccine by reconstitution, in 110 children aged 15 to 20 months was compared to ActHIB vaccine given with Tripedia vaccine at separate sites to 110 children. All children received three doses of Haemophilus b conjugate vaccine (ActHIB vaccine or HibTITER) and three doses of whole-cell DTP at approximately 2, 4, and 6 months of age.

Table 5: Local and Systemic Reactions at 6, 24, and 48 Hours Following Immunization with ActHIB and Tripedia Vaccines Given Concomitantly at Separate Sites Compared to TriHIBita Vaccine in Children 15- to 20-months-old10

TriHIBit vaccine, ActHIB vaccine combined with Tripedia vaccine by reconstitution, was administered to approximately 850 children, aged 15 to 20 months. All children received three doses of a Haemophilus b conjugate vaccine (ActHIB vaccine or HibTITER) and three doses of whole-cell DTP at approximately 2, 4, and 6 months of age. Local reactions were typically mild and usually resolved within the 24 to 48 hour period after immunization. The most common local reactions were pain and tenderness at the injection site. Systemic reactions occurring were usually mild and resolved within 72 hours of immunization. The reaction rates were similar to those observed in TABLE 5 when TriHIBit vaccine, ActHIB vaccine reconstituted with Tripedia vaccine, was administered and when Tripedia vaccine was administered alone as a booster.10

The number of subjects studied with TriHIBit vaccine, ActHIB vaccine combined with Tripedia vaccine by reconstitution, was inadequate to detect rare serious adverse events.

Reporting of Adverse Events

Reporting by the parent or guardian of all adverse events occurring after vaccine administration should be encouraged. Adverse events following immunization with vaccine should be reported by the health-care provider to the US Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS). Reporting forms and information about reporting requirements or completion of the form can be obtained from VAERS through a tollfree number 1-800-822-7967.15,16,18

Health-care providers also should report these events to Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 or call 1-800-822-2463.

Post-Marketing Experience

The following events have been spontaneously reported during the post-approval use of ActHIB. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.

• Immune System Disorders: Anaphylaxis, other allergic/hypersensitivity reactions (including urticaria, angioedema)
• Nervous System Disorders: Convulsions
• General Disorders and Administration Site Conditions: Extensive limb swelling, peripheral edema, pruritus, and rash

Read the entire FDA prescribing information for Acthib (Haemophilus b Conjugate Vaccine)

• Haemophilus Influenza
• Hib
• PRP-OMP (PedvaxHIB)
• PRP-T (ActHIB)
• PRP-T (Hiberix)

Active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b (Hib):

ActHIB: Immunization of infants and children 2 months to 5 years of age.

Hiberix: Immunization of infants and children 6 weeks to 4 years of age (prior to fifth birthday).

PedvaxHIB: Routine vaccination of infants and children 2 to 71 months 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 through age 59 months

- Unimmunized (defined as those who have not received a primary series and booster dose or at least 1 dose of a Hib vaccine after 14 months of age) children 12 to 59 months including chemotherapy recipients, anatomic or functional asplenia (including sickle cell disease), HIV infection, immunoglobulin deficiency or early component complement deficiency

Efficacy data are not available for use in older children and adults with chronic conditions associated with an increased risk of Hib disease. However, use may be considered for:

- Unimmunized (defined as those who have not received a primary series and booster dose or at least 1 dose of a Hib vaccine after 14 months of age) children ≥5 years, adolescents and adults with functional or anatomic asplenia, (including sickle cell disease)

- Unimmunized (defined as those who have not received a primary series and booster dose or at least 1 dose of a Hib vaccine after 14 months of age) children ≥5 years and adolescents with HIV infection

- Children <5 years undergoing chemotherapy or radiation treatment

- Successful hematopoietic stem cell transplant recipients

- Children ≥15 months and adolescents undergoing elective splenectomy

Hypersensitivity to Haemophilus b polysaccharide, tetanus toxoid-containing vaccine (Hiberix and ActHIB only), or any component of the formulation

ActHIB: Store lyophilized powder and diluent under refrigeration at 2°C to 8°C (36°F to 46°F); do not freeze. If not used immediately after reconstitution, may store under refrigeration for up to 24 hours.

Hiberix: Prior to reconstitution, store powder under refrigeration at 2°C to 8°C (36°F to 46°F). Protect from light. Diluent may be stored under refrigeration or at room temperature; do not freeze, discard diluent if frozen. If not used immediately after reconstitution, may store under refrigeration for up to 24 hours.

PedvaxHIB: Store under refrigeration at 2°C to 8°C (36°F to 46°F); do not freeze.

Belimumab: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Patients should receive inactivated vaccines prior to initiation of belimumab therapy whenever possible, due to the risk for an impaired response to the vaccine during belimumab therapy. Consider therapy modification

Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated). 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. Consider therapy modification

Immunosuppressants: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Exceptions: Cytarabine (Liposomal). Consider therapy modification

Venetoclax: May diminish the therapeutic effect of Vaccines (Inactivated). Monitor therapy

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 (NCIRD/ACIP 2011).

• 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 (NCIRD/ACIP 2011).

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. Consider deferring 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) (NCIRD/ACIP 2011).

• Bleeding disorders: Use with caution in patients with a history of bleeding disorders (including thrombocytopenia) and/or patients on anticoagulant therapy; 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 (NCIRD/ACIP 2011).

• 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:

• 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 inactivated) for which a person is eligible at a single clinic 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. When using combination vaccines, the minimum age for administration is the oldest minimum age for any individual component; the minimum interval between dosing is the greatest minimum interval between any individual components. The ACIP prefers each dose of Hib containing combination vaccines in a series come from the same manufacturer when possible; monovalent Hib vaccines are interchangeable (NCIRD/ACIP 2011).

Special populations:

• Altered immunocompetence: Use with caution in severely immunocompromised patients (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]); may have a reduced response to vaccination (NCIRD/ACIP 2011). In general, household and close contacts of persons with altered immunocompetence may receive all age appropriate vaccines (IDSA [Rubin 2014]; NCIRD/ACIP 2011). inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible (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 (NCIRD/ACIP 2011).

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 (NCIRD/ACIP 2011). 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 ACIP Recommended Adult Immunization Schedule (ACIP [Kim 2016]). 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. Vaccines may not be effective if administered during periods of altered immune competence (NCIRD/ACIP 2011). Infection may occur within the week of vaccination, prior to the onset of the vaccine.