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Acthib

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ActHIB

WARNINGS

The stopper of the diluent vial contains natural rubber latex which may cause allergic reactions. The lyophilized vaccine vial is not made with natural rubber latex.

If ActHIB vaccine or ActHIB vaccine reconstituted with Tripedia vaccine (TriHIBit vaccine) is administered to immunosuppressed persons or persons receiving immunosuppressive therapy, the expected antibody responses may not be obtained. This includes patients with asymptomatic or symptomatic HIV infection12, severe combined immunodeficiency, hypogammaglobulinemia, or agammaglobulinemia; altered immune states due to diseases such as leukemia, lymphoma, or generalized malignancy; or an immune system compromised by treatment with corticosteroids, alkylating drugs, antimetabolites, or radiation.13 (Refer to product insert for Tripedia vaccine.)

PRECAUTIONS

General

Care is to be taken by the health-care provider for the safe and effective use of this vaccine.

Epinephrine injection (1:1000) must be immediately available should an anaphylactic or other allergic reactions occur due to any component of the vaccine.

Prior to an injection of any vaccine, all known precautions should be taken to prevent adverse reactions. This includes a review of the patient's history with respect to possible sensitivity and any previous adverse reactions to the vaccine or similar vaccines, and to possible sensitivity to natural rubber latex, previous immunization history, current health status (see CONTRAINDICATIONS and WARNINGS sections), and a current knowledge of the literature concerning the use of the vaccine under consideration. (Refer to product insert for Tripedia vaccine.)

The health-care provider should ask the parent or guardian about the recent health status of the infant or child to be immunized including the infant's or child's previous immunization history prior to administration of ActHIB vaccine or Tripedia vaccine.

If Guillain-Barre syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the decision to give any tetanus toxoid-containing vaccine, including ActHIB or TriHIBit, should be based on careful consideration of the potential benefits and possible risks.

Minor illnesses such as upper respiratory infection with or without low-grade fever are not contraindications for use of ActHIB vaccine.14

Immunization with ActHIB vaccine does not substitute for routine tetanus immunization.

Information For Parents And Guardians Of Vaccine Recipients

The health-care provider should inform the parent or guardian of the benefits and risks of the vaccine.

Prior to administration of ActHIB vaccine reconstituted with saline diluent (0.4% Sodium Chloride) or Tripedia vaccine (TriHIBit vaccine), the parent or guardian should be asked about the recent health status of the infant or child to be immunized.

The health-care provider should inform the parent or guardian of the importance of completing the immunization series.

The physician should inform the parent or guardian about the significant adverse reactions that have been temporally associated with the administration of ActHIB vaccine reconstituted with saline diluent (0.4% Sodium Chloride) or ActHIB vaccine reconstituted with Tripedia vaccine (TriHIBit vaccine). The parent or guardian should be instructed to report any serious adverse reactions to their health-care provider.

As part of the child's immunization record, the date, lot number, and manufacturer of the vaccine administered should be recorded.15,16,17

The US Department of Health and Human Services has established a Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine, including but not limited to the reporting of events required by the National Childhood Vaccine Injury Act of 1986.15 The toll-free number for VAERS forms and information is 1-800-822-7967.

The National Vaccine Injury Compensation Program, established by the National Childhood Vaccine Injury Act of 1986, requires physicians and other health-care providers who administer vaccines to maintain permanent vaccination records and to report occurrences of certain adverse events to the US Department of Health and Human Services. Reportable events include those listed in the Act for each vaccine and events specified in the package insert as contraindications to further doses of the vaccine.16,17

The health-care provider should provide the Vaccine Information Statements (VISs), which are required to be given with each immunization.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

ActHIB vaccine reconstituted with saline diluent (0.4% Sodium Chloride) or Tripedia vaccine (TriHIBit vaccine) has not been evaluated for its carcinogenic, mutagenic potential or impairment of fertility.

Pregnancy Category C

Animal reproduction studies have not been conducted with ActHIB vaccine reconstituted with saline diluent (0.4% Sodium Chloride) or Tripedia vaccine (TriHIBit vaccine). It is also not known whether ActHIB vaccine reconstituted with saline diluent (0.4% Sodium Chloride) or Tripedia vaccine (TriHIBit vaccine) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ActHIB vaccine reconstituted with saline diluent (0.4% Sodium Chloride) or Tripedia vaccine (TriHIBit vaccine) is not approved for use in pregnant women.

Pediatric Use

Safety and effectiveness of ActHIB vaccine reconstituted with saline diluent (0.4% Sodium Chloride) in infants below the age of 6 weeks have not been established. (See DOSAGE AND ADMINISTRATION section.)

Safety and effectiveness of TriHIBit vaccine, ActHIB vaccine reconstituted with Tripedia vaccine, in infants below the age of 15 months have not been established. (See DOSAGE AND ADMINISTRATION section.)

REFERENCES

10 Data on file, Sanofi Pasteur Inc.

12 Steinhoff MC, et al. Antibody responses to Haemophilus influenzae type b vaccines in men with human immunodeficiency virus infection. N Engl J Med 325(26):1837-1842, 1991.

13 ACIP. General recommendations on immunization. MMWR 38:205-227, 1989.

14 ACIP. Diphtheria, Tetanus, and Pertussis: Recommendations for Vaccine Use and Other Preventive Measures. MMWR 40:No. RR-10, 1991.

15 Vaccine Adverse Event Reporting System United States. MMWR 39:730-733, 1990.

16 CDC. National Childhood Vaccine Injury Act: Requirements for permanent vaccination records and for reporting of selected events after vaccination. MMWR 37:197-200, 1988.

17 National Childhood Vaccine Injury Act of 1986 (Amended 1987).

Last reviewed on RxList: 8/21/2014
This monograph has been modified to include the generic and brand name in many instances.

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