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Pediarix

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Pediarix

WARNINGS

Administration of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) is associated with higher rates of fever relative to separately administered vaccines. In a safety study that evaluated medically attended fever after PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) or separately administered vaccines when coadministered with 7-valent pneumococcal and Hib conjugate vaccines, infants who received PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) had a higher rate of medical encounters for fever within the first 4 days following the first vaccination. In some infants, these encounters included the performance of diagnostic studies to evaluate other causes of fever (see ADVERSE REACTIONS). 

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. The vial stopper is latex-free. 

If any of the following events occur in temporal relation to receipt of DTwP or a vaccine containing an acellular pertussis component, the decision to give any pertussis vaccine, including PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) , should be based on careful consideration of the potential benefits and possible risks:19,20 

  • Temperature of ≥ 40.5°C (105°F) within 48 hours not due to another identifiable cause;
  • Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours;
  • Persistent, inconsolable crying lasting  3 hours, occurring within 48 hours;
  • Seizures with or without fever occurring within 3 days.

When a decision is made to withhold pertussis vaccination, DT vaccine, hepatitis B vaccine, and IPV should be given, as indicated. 

If Guillain-Barré syndrome occurs within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give any tetanus toxoid-containing vaccine, including PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) , should be based on careful consideration of the potential benefits and possible risks.5 If tetanus toxoid is withheld, other available vaccines should be given, as indicated. 

The decision to administer a pertussis-containing vaccine to individuals 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) has issued guidelines for such individuals.19 The parent or guardian should be advised of the potential increased risk involved (see PRECAUTIONS, Information for Vaccine Recipients and Parents or Guardians). 

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 (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) ) and for the ensuing 24 hours according to the respective prescribing information recommended dosage to reduce the possibility of post-vaccination fever.5,19 

The ACIP has published guidelines for vaccination of persons with recent or acute illness (www.cdc.gov/vaccines).5

PRECAUTIONS

PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) should be given with caution in children with bleeding disorders such as hemophilia or thrombocytopenia and in children on anticoagulant therapy, with steps taken to avoid the risk of hematoma following the injection.5 

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 (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) and to allow an assessment of benefits and risks. Epinephrine injection (1:1,000) 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. 

The potential risk of apnea and the need for respiratory monitoring for 48 to 72 hours should be considered when administering the primary immunization series to very premature infants (born ≤ 28 weeks of gestation) who remain hospitalized at the time of vaccination and particularly for those with a previous history of respiratory immaturity. It is generally understood that the benefit of vaccination is high in very premature infants. The decision to vaccinate should be based on careful consideration of the potential benefits and possible risks.

Carcinogenesis, Mutagenesis, Impairment of Fertility

PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

Pregnancy

Pregnancy Category C

PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) is not indicated for women of child-bearing age. Animal reproduction studies have not been conducted with PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) . It is not known whether PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) can cause fetal harm when administered to a pregnant woman or if PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) can affect reproductive capacity.

Geriatric Use

PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) is not indicated for use in adult populations.

Pediatric Use

Safety and effectiveness of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) in infants younger than 6 weeks of age have not been evaluated. 

PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) is not recommended for persons 7 years of age or older.

REFERENCES

5. Centers for Disease Control and Prevention. General recommendations on immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). MMWR 2002;51(RR-2):1-35.

19. Centers for Disease Control and Prevention. Pertussis vaccination: Use of acellular pertussis vaccines among infants and young children — Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1997;46(RR-7):1-25.

20. Centers for Disease Control and Prevention. Update: Vaccine side effects, adverse reactions, contraindications, and precautions — Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1996;45(RR-12):1-35.

21. Centers for Disease Control and Prevention. Use of vaccines and immune globulins in persons with altered immunocompetence: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1993;42(RR-4):1-18.

Last reviewed on RxList: 10/29/2009
This monograph has been modified to include the generic and brand name in many instances.

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