Diphtheria, Tetanus Toxoids, Acellular Pertussis, Hepatitis B (Recombinant), and Poliovirus (Inactivated) Vaccine

Pronunciation

(dif THEER ee a, TET a nus TOKS oyds, ay CEL yoo lar per TUS sis, hep a TYE tis bee ree KOM be nant, & POE lee oh VYE rus vak SEEN, in ak ti VAY ted vak SEEN)

U.S. Brand Names

Pediarix™

Synonyms

Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined

Generic Available

No

Use

Combination vaccine for the active immunization against diphtheria, tetanus, pertussis, hepatitis B virus (all known subtypes), and poliomyelitis (caused by poliovirus types 1, 2, and 3)

Pregnancy Risk Factor

C

Pregnancy Implications

Reproduction studies have not been conducted; not indicated for women of childbearing age.

Contraindications

Hypersensitivity to diphtheria and tetanus toxoids, pertussis, hepatitis B, poliovirus vaccine, yeast, neomycin, polymyxin B, or any component of the vaccine; encephalopathy occurring within 7 days of a previous pertussis vaccine not (not attributable to another identifiable cause); progressive neurologic disorders (including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy)

Warnings/Precautions

Immediate treatment for anaphylactic/anaphylactoid reaction should be available during vaccine use. Infants born of HBsAg-positive mothers should receive monovalent hepatitis B vaccine and hepatitis B immune globulin; infants born of HBsAg-unknown mothers should receive monovalent hepatitis B vaccine; use of combination product in these patients to complete the hepatitis B vaccination series has not been studied. Use caution if one or more has occurred following the use of whole-cell DTP or a vaccine containing acellular pertussis: Temperature 40.5°C (105°F) within 48 hours not due to an identifiable cause; collapse or shock-like state within 48 hours; persistent, inconsolable crying that occurs within 48 hours and lasts 3 hours; seizures with or without fever that occur within 3 days. Use caution if Guillain-Barré syndrome occurs within 6 weeks of prior vaccination with tetanus toxoid. Defer administration during moderate or severe illness with or without fever. Antipyretics should be administered at the time of and for 24 hours following vaccination to patients at high risk for seizures. Use caution with bleeding disorders. Not for use as a booster dose following the 3-dose primary series. Safety and efficacy have not been established for use in children <6 weeks or adults and children 7 years of age.

Adverse Reactions

All serious adverse reactions must be reported to the U.S. Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS) 1-800-822-7967.

As reported in a U.S. lot Consistency Study:

>10%:

Central nervous system:

Sleeping increased (28% to 47%, grade 3: <1% to 2%)

Restlessness (28% to 30%, grade 3: 1%)

Fever 100.4°F (26% to 31%); >103.1°F (<1%); incidence of fever is higher than reported with separately administered vaccines

Gastrointestinal: Appetite decreased (19% to 22%, grade 3: <1%)

Local: Injection site:

Redness (25% to 36%, >20 mm: 1%)

Pain (23% to 30%, grade 3: 1%)

Swelling (15% to 22%; >20 mm: 1%)

Miscellaneous: Fussiness (57% to 64%; grade 3: 2% to 3%)

Refer to individual product monographs for additional adverse reactions, including postmarketing and case reports.

Drug Interactions

Diphtheria antitoxin: May be administered concomitantly at separate sites.

Haemophilus influenzae type b vaccine (Hib): May be administered concomitantly at separate sites.

Immunosuppressant medications or therapies (antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids, irradiation): The effect of the vaccine may be decreased; consider deferring vaccination for 3 months after immunosuppressant therapy is discontinued.

Pneumococcal conjugate vaccine: May be administered concomitantly at separate sites.

Tetanus immune globulin: May be administered concomitantly at separate sites.

Stability

Store under refrigeration at 2°C to 8°C (36°F to 46°F). Do not freeze; discard if frozen.

Compatibility

Do not mix with other vaccines or injections.

Mechanism of Action

Promotes active immunity to diphtheria, tetanus, pertussis, hepatitis B and poliovirus (types 1, 2 and 3) by inducing production of specific antibodies and antitoxins.

Pharmacodynamics/Kinetics

Onset of action: Immune response observed to all components 1 month following the 3-dose series

Dosage

I.M.: Children:

Immunization: 0.5 mL; repeat in 6-8 week intervals (preferably 8-week intervals) for a total of 3 doses. Vaccination usually begins at 2 months, but may be started as early as 6 weeks of age.

Use in children previously vaccinated with one or more component, and who are also scheduled to receive all vaccine components:

Hepatitis B vaccine: Infants born of HBsAg-negative mothers who received 1 dose of hepatitis B vaccine at birth may be given Pediarix™ (safety data limited); use in infants who received more than 1 dose of hepatitis B vaccine has not been studied. Infants who received 1 or more doses of hepatitis B vaccine (recombinant) may be given Pediarix™ to complete the hepatitis B series (safety and efficacy not established).

Diphtheria and tetanus toxoids, and acellular pertussis vaccine (DTaP): Infants previously vaccinated with 1 or 2 doses of Infanrix® may use Pediarix™ to complete the first 3 doses of the series (safety and efficacy not established); use of Pediarix™ to complete DTaP vaccination started with products other than Infanrix® is not recommended.

Inactivated polio vaccine (IPV): Infants previously vaccinated with 1 or 2 doses of IPV may use Pediarix™ to complete the first 3 doses of the series (safety and efficacy not established).

Administration

For I.M. use only; do not administer I.V. or SubQ. Shake well prior to use; do not use unless a homogeneous, turbid, white suspension forms. Administer in the anterolateral aspects of the thigh or the deltoid muscle of the upper arm. Do not inject in the gluteal area (suboptimal hepatitis B immune response) or where there may be a major nerve trunk. Do not administer additional vaccines or immunoglobulins at the same site, or using the same syringe.

For patients at risk of hemorrhage following intramuscular injection, the ACIP recommends "it should be administered intramuscularly if, in the opinion of the physician familiar with the patients bleeding risk, the vaccine can be administered with reasonable safety by this route. If the patient receives antihemophilia or other similar therapy, intramuscular vaccination can be scheduled shortly after such therapy is administered. A fine needle (23 gauge or smaller) can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection."

Federal law requires that the date of administration, name of the vaccine manufacturer, lot number of vaccine, and the administering person's name, title, and address be entered into the patient's permanent medical record.

Patient Education

Children who are moderately to severely ill (with or without fever) should not get this vaccination until they have recovered. Inform prescriber of all previous allergic reactions and any other medications being used. Three doses will be required for effective immunity; consult prescriber for appropriate schedule of vaccinations. May cause increased sleeping, restlessness, fussiness, decreased appetite, or fever (use antipyretic if directed by prescriber, or consult prescriber for appropriate antipyretic). May cause some redness, pain, or swelling at injection site; consult prescriber if excessive or persistent. Notify prescriber immediately of any excessive or persistent reactions (eg, fever >105°F within 48 hours, inconsolable crying that occurs within 48 hours and lasts 3 hours, seizures that occur within 3 days).

Additional Information

Contains the following three pertussis antigens: inactivated pertussis toxin (PT), filamentous hemagglutinin (FHA) and pertactin. Contains the same diphtheria and tetanus toxoids and pertussis antigens found in Infanrix®. Contains the same hepatitis B surface antigen (HBsAg) found in Engerix-B® (recombinant vaccine). Thimerosal is used during manufacturing, but removed to less than detectable levels in the final suspension.

Dental Health: Effects on Dental Treatment

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

No information available to require special precautions

Mental Health: Effects on Mental Status

Sedation and restlessness are common

Mental Health: Effects on Psychiatric Treatment

Contraindicated in patients with progressive neurologic disorders

Dosage Forms

Injection, suspension [single-dose]: Diphtheria toxoid 25 Lf, tetanus toxoid 10 Lf, inactivated PT 25 mcg, FHA 25 mcg, pertactin 8 mcg, HBsAg 10 mcg, poliovirus type 1 40 DU, poliovirus type 2 8 DU, and poliovirus type 3 32 DU per 0.5 mL [contains neomycin sulfate 0.05 ng/0.5 mL, polymyxin B 0.01 ng/0.5 mL, and yeast protein 5%; packaged in vials or prefilled syringes; the needleless prefilled syringes contain dry natural latex rubber in the tip cap and plunger]

References

Centers for Disease Control, "Recommendations of the Advisory Committee on Immunization Practices (ACIP): General Recommendations on Immunization,"MMWR Recomm Rep, 1994, 43(RR-1):23.