Hibtiter (Haemophilus b Conjugate Vaccine (Diphtheria CRM 197 Protein Conjugate)) - Warnings and Precautions

WARNINGS

HibTITER WILL NOT PROTECT AGAINST H. INFLUENZA OTHER THAN TYPE b STRAINS, NOR WILL HibTITER PROTECT AGAINST OTHER MICROORGANISMS THAT CAUSE MENINGITIS OR SEPTIC DISEASE.

AS WITH ANY INTRAMUSCULAR INJECTION, HibTITER SHOULD BE GIVEN WITH CAUTION TO INFANTS OR CHILDREN WITH THROMBOCYTOPENIA OR ANY COAGULATION DISORDER, OR TO THOSE RECEIVING ANTICOAGULANT THERAPY (SEE DRUG INTERACTIONS).

ANTIGENURIA HAS BEEN DETECTED FOLLOWING RECEIPT OF HAEMOPHILUS b CONJUGATE VACCINE³⁶ AND THEREFORE ANTIGEN DETECTION IN URINE MAY NOT HAVE DIAGNOSTIC VALUE IN SUSPECTED HAEMOPHILUS b DISEASE WITHIN 2 WEEKS OF IMMUNIZATION.

The vial stopper contains dry natural rubber that may cause hypersensitivity reactions when handled by or when the product is injected in persons with known or possible latex sensitivity.

PRECAUTIONS

GENERAL

1. CARE IS TO BE TAKEN BY THE HEALTH CARE PROVIDER FOR SAFE AND EFFECTIVE USE OF THIS PRODUCT.
2. PRIOR TO ADMINISTRATION OF ANY DOSE OF HibTITER, THE PARENT OR GUARDIAN SHOULD BE ASKED ABOUT THE PERSONAL HISTORY, FAMILY HISTORY, AND RECENT HEALTH STATUS OF THE VACCINE RECIPIENT. THE HEALTH CARE PROVIDER SHOULD ASCERTAIN PREVIOUS IMMUNIZATION HISTORY, CURRENT HEALTH STATUS, AND OCCURRENCE OF ANY SYMPTOMS AND/OR SIGNS OF AN ADVERSE EVENT AFTER PREVIOUS IMMUNIZATION IN THE CHILD TO BE IMMUNIZED, IN ORDER TO DETERMINE THE EXISTENCE OF ANY CONTRAINDICATION TO IMMUNIZATION WITH HibTITER AND TO ALLOW AN ASSESSMENT OF BENEFITS AND RISKS.
3. BEFORE THE INJECTION OF ANY BIOLOGICAL, THE HEALTH CARE PROVIDER SHOULD TAKE ALL PRECAUTIONS KNOWN FOR THE PREVENTION OF ALLERGIC OR ANY OTHER SIDE REACTIONS. This should include: a review of the patient's history regarding possible sensitivity; the ready availability of epinephrine 1:1,000 and other appropriate agents used for control of immediate allergic reactions; and a knowledge of the recent literature pertaining to use of the biological concerned, including the nature of side effects and adverse reactions that may follow its use.
4. Children with impaired immune responsiveness, whether due to the use of immunosuppressive therapy (including irradiation, corticosteroids, antimetabolites, alkylating agents, and cytotoxic agents), a genetic defect, human immunodeficiency virus (HIV) infection, or other causes, may have reduced antibody response to active immunization procedures. ^37,38 Deferral of administration of vaccine may be considered in individuals receiving immunosuppressive therapy.³⁷ Other groups should receive this vaccine according to the usual recommended schedule.^37-39(See DRUG INTERACTIONS.)
5. This product is not contraindicated based on the presence of human immunodeficiency virus infection.⁴⁰
6. As reported with Haemophilus b polysaccharide vaccine, cases of Haemophilus b disease may occur prior to the onset of the protective effects of the vaccine.^3,41
7. The vaccine should not be injected intradermally, subcutaneously, or intravenously since the safety and immunogenicity of these routes have not been evaluated. The vaccine should be given intramuscularly.
8. A separate sterile syringe and needle or a sterile disposable unit should be used for each individual patient to prevent transmission of infectious agents from one person to another. Needles should be disposed of properly and should not be recapped.
9. Special care should be taken to prevent injection into a blood vessel.
10. The vaccine is to be administered immediately after being drawn up into a syringe. Single dose 0.5 mL vial contains no preservative. Use one dose per vial; do not re-enter vial. Discard unused portions.

ALTHOUGH SOME ANTIBODY RESPONSE TO DIPHTHERIA TOXIN OCCURS, IMMUNIZATION WITH HibTITER DOES NOT SUBSTITUTE FOR ROUTINE DIPHTHERIA IMMUNIZATION.

The vial stopper contains dry natural rubber that may cause hypersensitivity reactions when handled by or when the product is injected in persons with known or possible latex sensitivity.

INFORMATION FOR PATIENT

PRIOR TO ADMINISTRATION OF HibTITER, HEALTH CARE PERSONNEL SHOULD INFORM THE PARENT, GUARDIAN OR OTHER RESPONSIBLE ADULT, OF THE RECOMMENDED IMMUNIZATION SCHEDULE FOR PROTECTION AGAINST HAEMOPHILUS b DISEASE AND THE BENEFITS AND RISKS TO THE CHILD RECEIVING THIS VACCINE. GUIDANCE SHOULD BE PROVIDED ON MEASURES TO BE TAKEN SHOULD ADVERSE EVENTS OCCUR, SUCH AS, ANTIPYRETIC MEASURES FOR ELEVATED TEMPERATURES AND THE NEED TO REPORT ADVERSE EVENTS TO THE HEALTH CARE PROVIDER. Parents should be provided with vaccine information pamphlets at the time of each vaccination, as stated in the National Childhood Vaccine Injury Act. ⁴²

PATIENTS, PARENTS, OR GUARDIANS SHOULD BE INSTRUCTED TO REPORT ANY SERIOUS ADVERSE REACTIONS TO THEIR HEALTH CARE PROVIDER.

DRUG INTERACTIONS

Children receiving therapy with immunosuppressive agents (large amounts of corticosteroids, antimetabolites, alkylating agents, cytotoxic agents) may not respond optimally to active immunization.^37,38,39(See PRECAUTIONS, GENERAL.)

As with other intramuscular injections, HibTITER should be given with caution to children on anticoagulant therapy.

No impairment of the antibody response to the individual antigens was demonstrated when HibTITER was given at the same time but at separate sites as DTP plus OPV to children 2 to 20 months of age or MMR to children 15 ± 1 month of age. ^20,43,44

There are no clinical studies where a direct comparison of the immune responses to HibTITER was compared with the concurrent administration of diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP), hepatitis B vaccine (Hep B), inactivated poliovirus vaccine (IPV), 7-valent Conjugate Vaccine-Diphtheria CRM₁₉₇ Protein (Prevnar), or Varicella vaccine. However, in clinical trials where HibTITER and DTaP or HibTITER, DTaP, IPV, and Hep B vaccines were administered concurrently with or without Prevnar in children at 2, 4, and 6 months of age, the percentage of children achieving Hib antibody levels of >/=0.15 or >/=1.0 µg/mL were similar. ^45,46 In one study where children 12-15 months of age were administered a booster dose of HibTITER concurrently with DTaP and Prevnar, some suppression of the Hib antibody response was observed, but over 97% of children achieved titers of >/=1.0 µg/mL. ^47,48 However, in another study where a booster dose of HibTITER was administered to children at 12-15 months of age concurrently with or without Prevnar the percentage of children achieving Hib antibody levels of >/=0.15 or >/=1.0 µg/mL was found to be similar. ^49,50

HibTITER and DTaP administered concurrently with and without Prevnar at 2, 4, and 6, and 12-15 months of age did not impair immune responses to the seven Pneumococcal vaccine serotypes in Prevnar. ^47,48,51,52

There are no clinical trials where the local and systemic reactogenicity of HibTITER was directly compared with the concurrent administration of DTaP, Hep B, IPV, Prevnar, or Varicella vaccines.

The American Academy of Pediatrics (AAP), the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP) encourage routine simultaneous administration of DTaP, IPV, Haemophilus influenzae type b vaccine, pneumococcal conjugate vaccine, measles-mumps-rubella (MMR), varicella vaccine and hepatitis B vaccine for children who are the recommended age to receive these vaccines and for whom no specific contraindications exist at the time of the visit, unless, in the judgment of the provider, complete vaccination of the child will not be compromised by administering different vaccines at different visits. Simultaneous administration is particularly important if the child might not return for subsequent vaccinations. ^32,33,34,35

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

HibTITER has not been evaluated for its carcinogenic, mutagenic potential, or impairment of fertility.

PREGNANCY

REPRODUCTIVE STUDIES-- PREGNANCY CATEGORY C

Animal reproduction studies have not been conducted with HibTITER. It is also not known whether HibTITER can cause fetal harm when administered to a pregnant woman or can affect reproduction capability. HibTITER is NOT recommended for use in a pregnant woman.

GERIATRIC USE

This vaccine is NOT recommended for use in adult populations.

PEDIATRIC USE

The safety and effectiveness of HibTITER in children below the age of 6 weeks have not been established.