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

Pronunciation: (dif-THEER-ee-a/TET-a-nus/aye-SELL-yoo-ler per-TUS-is/hep-a-TYE-tis/POE-lee-oh-VYE-rus)Class: Toxoid

Trade Names:Pediarix- Injection diphtheria toxoid (DT) 25 Lf, tetanus toxoid 10 Lf, inactivated pertussis toxin (PT) 25 mcg, filamentous hemagglutinin (FHA) 25 mcg, pertactin 8 mcg, hepatitis B surface antigen (HBsAg) 10 mcg, type 1 poliovirus 40 D-antigen units (DU), type 2 poliovirus 8 DU, and type 3 poliovirus 32 DU per 0.5 mL

Pharmacology

Diphtheria and tetanus toxoids induce antibodies against toxins made by Corynebacterium diphtheriae and Clostridium tetani ; pertussis vaccine protects against Bordetella pertussis ; hepatitis B vaccine induces specific antibodies against hepatitis B virus (HBV); poliovirus vaccine induces protective antipoliovirus antibodies, reducing pharyngeal excretion of poliovirus types 1, 2, and 3.

Indications and Usage

Active immunization against diphtheria, tetanus, pertussis, all known types of HBV, and poliomyelitis (caused by types 1, 2, and 3).

Contraindications

Use of this vaccine after a serious allergic reaction temporally associated with a previous dose of the vaccine or with any components of this vaccine; encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous dose of a pertussis-containing vaccine not attributable to another identifiable cause; progressive neurologic disorder (including infantile spasms, progressive encephalopathy, or uncontrolled epilepsy) until a treatment regimen has been established and the condition has stabilized; hypersensitivity to any component of the vaccine (including neomycin, polymyxin B, and yeast).

Dosage and Administration

Primary ImmunizationChildren 6 wk through 6 yr of age

IM 3 doses of 0.5 mL at 6- to 8-wk intervals (preferably 8 wk); customary age for the first dose is 2 mo.

Children Previously Vaccinated With Hepatitis B VaccineChildren born of HBsAg-negative mothers who have received a dose of hepatitis B at or shortly after birth

IM 3 doses of 0.5 mL according to the recommended schedule.

Children Previously Vaccinated With Inactivated Poliovirus Vaccine (IPV)Children

IM Pediarix may be used to complete the first 3 doses of the IPV series in infants who have received 1 or 2 doses of IPV and who are also scheduled to receive the other vaccine components of Pediarix .

Children Previously Vaccinated With InfanrixChildren

IM Pediarix may be used to complete the first 3 doses of the DTaP series in infants who have received 1 or 2 doses of Infanrix and also are scheduled to receive the other vaccine components of Pediarix .

Interchangeability of Licensed DTaP, IPV, or Recombinant Hepatitis B Vaccines and Pediarix

It is recommended that Pediarix be given for all 3 doses because data are limited regarding the safety and efficacy of using acellular pertussis vaccines from different manufacturers for successive doses of the pertussis vaccination series. Because of a lack of data, Pediarix is not recommended for completion of a DTaP vaccination series initiated with a DTaP vaccine from a different manufacturer. However, Pediarix may be used to complete hepatitis B vaccination series initiated with a licensed hepatitis B (recombinant) vaccine from a different manufacturer and may be used complete the first 3 doses of the IPV vaccination series initiated with IPV from a different manufacturer.

General Advice

  • If any recommended dose of pertussis vaccine cannot be given, DT (for pediatric use), hepatitis B (recombinant), and IPV should be given as needed to complete the series. Children who have received a 3-dose primary series of Pediarix should be given a fourth dose of IPV at 4 to 6 yr of age and a fourth dose of DTaP vaccine at 15 to 18 mo of age.
  • For IM injection only.
  • Interruption of recommended schedule with a delay between doses does not interfere with development of final immunity. There is no need to start the series over again.
  • Administer IM in anterolateral thigh in infants or the deltoid muscle of the upper arm in toddlers and young children. Avoid injection into gluteal area or areas where there may be a major nerve trunk or blood vessel. Gluteal injections may result in a suboptimal hepatitis B immune response.
  • Use separate syringes and different sites for coadministration of other vaccines.
  • Always record manufacturer's name and vaccine lot number in patient's permanent medical record file along with date of administration, and name and title of person administering vaccine.
  • Not recommended for persons 7 yr of age and older.

Storage/Stability

Store vials in refrigerator (36° to 46°F). Do not freeze. Discard if vaccine has been frozen.

Drug Interactions

Immunosuppressive agents (large amounts of alkylating agents, antimetabolites, corticosteroids, cytotoxic agents)

Children may not respond optimally to active immunization.

Other vaccines

Do not mix another vaccine in the same syringe or vial.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Cyanosis, pallor, petechiae (postmarketing).

CNS

Irritability/fussiness (65%); drowsiness (57%); brachial neuritis; cranial and peripheral mononeuropathy; demyelinating diseases of the CNS; bulging fontanelle, convulsions, crying, depressed consciousness, fatigue, febrile convulsions, hypotonia, hypotonic-hyporesponsive episode, insomnia, irritability, lethargy, nervousness, pyrexia, restlessness, screaming, somnolence, unusual crying (postmarketing).

Dermatologic

Angioedema, erythema, rash, urticaria (postmarketing).

GI

Loss of appetite (31%); diarrhea, vomiting (postmarketing).

Hypersensitivity

Anaphylactic reactions (ie, difficulty breathing, hives, hypotension, shock, swelling of the mouth); arthus-type hypersensitivity reactions characterized by severe local reactions; anaphylactoid reactions (postmarketing).

Lab Tests

Abnormal LFTs (postmarketing).

Local

Redness (40%); pain (36%); swelling (29%); injection-site cellulitis, induration, itching, nodules/lumps, and warmth (postmarketing).

Metabolic-Nutritional

Anorexia (postmarketing).

Musculoskeletal

Limb pain (postmarketing).

Respiratory

Apnea, dyspnea, upper respiratory tract infection (postmarketing).

Miscellaneous

Fever (39%); Guillain-Barré syndrome, limb swelling, sudden infant death syndrome (postmarketing).

Precautions

Monitor

When child returns for next dose in series, question child's parent or guardian about serious adverse reactions with previous dose. Note any adverse reactions that would contraindicate additional pertussis vaccine. Continue immunization series with DT, hepatitis B, and IPV vaccines to complete series.

Pregnancy

Category C .

Children

Safety and efficacy not established in children younger than 6 wk of age. Pediarix is not recommended for persons 7 yr of age and older.

Elderly

Not recommended for use in the adult population.

Special Risk Patients

Use with caution and consider the benefits and risks in the following conditions: temperature of 105°F within 48 h not attributable to an identifiable cause; collapse or shock-like state within 48 h; persistent, inconsolable crying lasting at least 3 h and occurring with 48 h; seizures with or without fever occurring within 3 days.

Acute febrile illness

Consider delaying immunization during course of moderate or severe acute febrile illness.

Allergic reactions

Epinephrine hydrochloride solution (1:1,000) and other appropriate agents and equipment must be available for immediate use in case of occurrence of an anaphylactic or acute hypersensitivity reaction.

Bleeding disorders

Use with caution in children with bleeding disorders (eg, hemophilia, thrombocytopenia); take steps to avoid the risk of hematoma following the injection.

Guillain-Barré syndrome

If Guillain-Barré syndrome occurred within 6 wk of receiving a prior vaccine containing tetanus toxoid, base the decision to give Pediarix vaccine or any vaccine containing tetanus toxoid on careful consideration of potential benefits and possible risks.

Immunosuppressed persons

The expected immune response may not be obtained.

Latex sensitivity

The tip cap and rubber plunger of the needleless prefilled syringes contain dry natural latex rubber that may cause allergic reactions in latex-sensitive individuals.

Seizures

For infants and children at risk of seizures, an appropriate antipyretic may be administered at the time of vaccination and for the following 24 h to reduce possible postvaccination fever.

Patient Information

  • Provide and review vaccine information sheet prior to immunization.
  • Review immunization schedule and advise parent or guardian that entire series must be completed to provide max benefit.
  • Provide parent or guardian with immunization history record.
  • Advise parent or guardian to use OTC analgesics (eg, acetaminophen, ibuprofen) for fever, pain, or discomfort at injection site.
  • Advise parent or guardian to notify health care provider if bothersome adverse reactions last more than 24 h.

Copyright © 2009 Wolters Kluwer Health.