WARNINGS
Administration of PEDIARIX is associated with higher rates of fever relative to separately administered vaccines. In one study that evaluated medically attended fever after the first dose of PEDIARIX or separately administered vaccines, infants who received PEDIARIX had a higher rate of medical encounters for fever within the first 4 days following vaccination. In some infants, these encounters included the performance of diagnostic studies to evaluate other causes of fever (see ADVERSE REACTIONS).
The vial stopper is latex-free. The tip cap and the rubber plunger of the needleless prefilled syringes contain dry natural latex rubber that may cause allergic reactions in latex sensitive individuals.
If any of the following events occur in temporal relation to receipt of whole-cell DTP or a vaccine containing an acellular pertussis component, the decision to give subsequent doses of PEDIARIX or any vaccine containing a pertussis component should be based on careful consideration of the potential benefits and possible risks: 38,39
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Temperature of >/=40.5°C (105°F) within 48 hours not due to another identifiable cause;
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Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours;
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Persistent, inconsolable crying lasting >/=3 hours, occurring within 48 hours;
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Seizures with or without fever occurring within 3 days.
When a decision is made to withhold pertussis vaccine, immunization with DT vaccine, hepatitis B vaccine, and IPV should be continued.
If Guillain-Barré syndrome occurs within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give subsequent doses of PEDIARIX or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks. 10
A committee of the Institute of Medicine (IOM) has concluded that evidence is consistent with a causal relationship between whole-cell DTP vaccine and acute neurologic illness, and under special circumstances, between whole-cell DTP vaccine and chronic neurologic disease in the context of the National Childhood Encephalopathy Study (NCES) report. 40,41 However, the IOM committee concluded that the evidence was insufficient to indicate whether or not whole-cell DTP vaccine increased the overall risk of chronic neurologic disease.41 Acute encephalopathy and permanent neurologic damage have not been reported causally linked or in temporal association with administration of PEDIARIX, but the experience with PEDIARIX is insufficient to rule this out. Encephalopathy has been reported following INFANRIX (see ADVERSE REACTIONS, Postmarketing Reports), but data are not sufficient to evaluate a causal relationship.
The decision to administer a pertussis-containing vaccine to children with stable CNS disorders must be made by the physician on an individual basis, with consideration of all relevant factors, and assessment of potential risks and benefits for that individual. The Advisory Committee on Immunization Practices (ACIP) and the Committee on Infectious Diseases of the American Academy of Pediatrics (AAP) have issued guidelines for such children. 38,42 The parent or guardian should be advised of the potential increased risk involved (see PRECAUTIONS, Information for Vaccine Recipients and Parents or Guardians).
A family history of seizures or other CNS disorders is not a contraindication to pertussis vaccine.38
For children at higher risk for seizures than the general population, an appropriate antipyretic may be administered at the time of vaccination with a vaccine containing an acellular pertussis component (including PEDIARIX) and for the ensuing 24 hours according to the respective prescribing information recommended dosage to reduce the possibility of post-vaccination fever.10,38
Vaccination should be deferred during the course of a moderate or severe illness with or without fever. Such children should be vaccinated as soon as they have recovered from the acute phase of the illness.10
As with other intramuscular injections, PEDIARIX should not be given to children on anticoagulant therapy unless the potential benefit clearly outweighs the risk of administration (see PRECAUTIONS).
PRECAUTIONS
PEDIARIX should be given with caution in children with bleeding disorders such as hemophilia or thrombocytopenia, with steps taken to avoid the risk of hematoma following the injection.
Before the injection of any biological, the physician should take all reasonable precautions to prevent allergic or other adverse reactions, including understanding the use of the biological concerned, and the nature of the side effects and adverse reactions that may follow its use.
Prior to immunization, the patient's current health status and medical history should be reviewed. The physician should review the patient's immunization history for possible vaccine sensitivity, previous vaccination-related adverse reactions and occurrence of any adverse-event-related symptoms and/or signs, in order to determine the existence of any contraindication to immunization with PEDIARIX and to allow an assessment of benefits and risks. Epinephrine injection (1:1000) and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur.
A separate sterile syringe and sterile disposable needle or a sterile disposable unit should be used for each individual patient to prevent transmission of hepatitis or other infectious agents from one person to another. Needles should be disposed of properly and should not be recapped.
Special care should be taken to prevent injection into a blood vessel.
As with any vaccine, if administered to immunosuppressed persons, including individuals receiving immunosuppressive therapy, the expected immune response may not be obtained. 37 Information for Vaccine Recipients and Parents or Guardians: Parents or guardians should be informed by the healthcare provider of the potential benefits and risks of the vaccine, and of the importance of completing the immunization series. When a child returns for the next dose in a series, it is important that the parent or guardian be questioned concerning occurrence of any symptoms and/or signs of an adverse reaction after a previous dose of the same vaccine. The physician should inform the parents or guardians about the potential for adverse events that have been temporally associated with administration of PEDIARIX or other vaccines containing similar components. The parent or guardian accompanying the recipient should be told to report severe or unusual adverse events to the physician or clinic where the vaccine was administered.
The parent or guardian should be given the Vaccine Information Statements, which are required by the National Childhood Vaccine Injury Act of 1986 to be given prior to immunization. These materials are available free of charge at the CDC website (www.cdc.gov/nip).
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. 10 The VAERS toll-free number is 1-800-822-7967. Drug Interactions: For information regarding concomitant administration with other vaccines, refer to DOSAGE AND ADMINISTRATION.
PEDIARIX should not be mixed with any other vaccine in the same syringe or vial.
Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to vaccines. Although no specific data from studies with PEDIARIX under these conditions are available, if immunosuppressive therapy will be discontinued shortly, it would be reasonable to defer immunization until the patient has been off therapy for 3 months; otherwise, the patient should be vaccinated while still on therapy.37 If PEDIARIX is administered to a person receiving immunosuppressive therapy, or who received a recent injection of immune globulin, or who has an immunodeficiency disorder, an adequate immunologic response may not be obtained.
Tetanus Immune Globulin or Diphtheria Antitoxin, if needed, should be given at a separate site, with a separate needle and syringe.
Carcinogenesis, Mutagenesis, Impairment of Fertility: PEDIARIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.
Pregnancy: Pregnancy Category C: PEDIARIX is not indicated for women of child-bearing age. Animal reproduction studies have not been conducted with PEDIARIX. It is not known whether PEDIARIX can cause fetal harm when administered to a pregnant woman or if PEDIARIX can affect reproductive capacity.
Geriatric Use: PEDIARIX is not indicated for use in adult populations. Pediatric Use: Safety and effectiveness of PEDIARIX in infants younger than 6 weeks of age have not been evaluated (see DOSAGE AND ADMINISTRATION). PEDIARIX is not recommended for persons 7 years of age or older. Tetanus and Diphtheria Toxoids Adsorbed (Td) For Adult Use, IPV, and Hepatitis B Vaccine (Recombinant) should be used in individuals 7 years of age or older.
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