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

Medically reviewed by Drugs.com. Last updated on Sep 24, 2020.

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 in ak ti VAY ted, & hem OF fi lus in floo EN za bee KON joo gate ad SORBED vak SEEN)

Index Terms

  • Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B (Recombinant), Inactivated Poliovirus Vaccine, and Haemophilus influenzae Type B Combined
  • DTaP-HepB-IPV-Hib
  • Vaxelis

Pharmacologic Category

  • Vaccine
  • Vaccine, Inactivated (Bacterial)
  • Vaccine, Inactivated (Viral)

Pharmacology

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

Onset of Action

Immune response observed to all components 1 month following the 3-dose series.

Use: Labeled Indications

Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzaetype b disease prevention:

Active immunization against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzae type b in infants and children 6 weeks through 4 years of age.

The Advisory Committee on Immunization Practices (ACIP) recommends Vaxelis for primary vaccination against DTaP, HepB, IPV, and Hib at ages 2, 4, and 6 months; use is not recommended for the subsequent doses, but doses do not need to be repeated if Vaxelis is inadvertently administered for these doses (CDC/ACIP [Oliver 2020]). Vaxelis may also be used in patients <5 years of age as part of an appropriate catch-up schedule.

Contraindications

Severe allergic reaction to any component of vaccine or formulation; encephalopathy of unknown etiology within 1 week following prior vaccination with a pertussis-containing vaccine; progressive neurologic disorders, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy, until a treatment regimen is established and the condition is stabilized.

Infanrix hexa [Canadian product]: Additional contraindications: Use in persons ≥7 years of age; moderate or severe acute febrile illness or acute infection.

Dosing: Pediatric

Note: Immunization during coronavirus disease 2019 (COVID-19) pandemic: Routine vaccination should NOT be delayed because of the COVID-19 pandemic (CDC 2020; WHO 2020). In general, simultaneous administration of all vaccines for which a patient is eligible (according to current immunization schedules/guidelines) is recommended (ACIP [Ezeanolue 2020]). However, outpatient visits solely for vaccination should be delayed in persons in quarantine due to close contact with COVID-19 or persons who have suspected or confirmed COVID-19 infection (regardless of symptoms); refer to the CDC's "Interim Guidance for Immunization Services During the COVID-19 Pandemic" for current recommendations (https://www.cdc.gov/vaccines/pandemic-guidance/index.html). Additional information is available from the American Academy of Pediatrics and the Immunization Action Coalition.

Note: Consult CDC/ACIP annual immunization schedules for additional information including specific detailed recommendations for catch-up scenarios and/or care of patients with high-risk conditions. According to ACIP, doses administered ≤4 days before minimum interval or age are considered valid; however, local or state mandates may supersede this timeframe (ACIP [Ezeanolue 2020]).

Primary immunization: Note: Whenever feasible, the same manufacturer should be used for all doses of the vaccination series; however, vaccination should not be deferred if a specific brand is not known or is not available (ACIP [Ezeanolue 2020]; NACI/CATMAT 2016).

Infants ≥6 weeks and Children <5 years: IM: 0.5 mL per dose for a total of 3 doses administered at 2, 4, and 6 months of age; the first dose may be administered as early as 6 weeks of age; minimum interval between doses is 4 weeks for the first 2 doses; the third dose should not be administered before 6 months of age. Preterm infants should be vaccinated according to their chronological age from birth (ACIP [Oliver 2020]; manufacturer's labeling).

Catch-up immunization: Infants and Children <5 years: IM: 0.5 mL per dose; refer to current immunization recommendations for specific schedule and timing of doses based on patient age and vaccine history.

Canadian labeling:

Primary immunization: Infants ≥6 weeks and Children <2 years: IM: 0.5 mL per dose for 2 or 3 doses administered ≥1 month apart; infants ≥6 weeks of age born prior to 24 weeks gestation should receive 3 doses; refer to current provincial and territorial immunization recommendations (NACI/CATMAT 2020; manufacturer's labeling).

Booster immunization: Infants ≥11 months and Children <5 years: IM: 0.5 mL per dose for a single dose; refer to current provincial and territorial immunization recommendations to determine need and timing for booster dose (NACI/CATMAT 2020; manufacturer's labeling).

Storage

Store at 2°C to 8°C (36°F to 46°F); do not freeze (discard if frozen). Protect from light. Immediate use after reconstitution is recommended.

Infanrix hexa [Canadian product]: If inadvertent excursion from recommended storage temperature occurs, vaccine components are stable at temperatures up to 25°C (77°F) for 72 hours. If vaccine cannot be administered immediately following reconstitution, vaccine may be stored for 8 hours at 21°C (69.8°F).

Drug Interactions

Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting fingolimod. If vaccinated during fingolimod therapy, revaccinate 2 to 3 months after fingolimod discontinuation. Consider therapy modification

Immunosuppressants: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated less than 2 weeks before starting or during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification

Meningococcal (Groups A / C / Y and W-135) Conjugate Vaccine: Tetanus Toxoids Vaccines may diminish the therapeutic effect of Meningococcal (Groups A / C / Y and W-135) Conjugate Vaccine. Management: When possible, administer the meningococcal polysaccharide (groups A / C / Y and W-135) conjugate vaccine (Nimenrix brand) either together with, or at least one month before, a tetanus toxoids-containing vaccine. Consider therapy modification

Siponimod: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Avoid administration of vaccines (inactivated) during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. Consider therapy modification

Venetoclax: May diminish the therapeutic effect of Vaccines (Inactivated). Monitor therapy

Test Interactions

May interfere with interpretation of urine antigen detection tests for H. influenzae; antigenuria may occur up to 2 weeks following immunization.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Central nervous system: Irritability (83%), hypersomnia (63%), sleep disorder (sleeping decreased: 51%), emotional lability (crying: 43%), fatigue, restlessness

Gastrointestinal: Anorexia (49%), diarrhea (36%), vomiting (25%)

Local: Erythema at injection site (49%), pain at injection site (43%), swelling at injection site (36%)

Miscellaneous: Fever (≥38°C [100.4°F]: 56%; >39.5°C [103.1°F]*)

1% to 10%:

Central nervous system: Nervousness

Local: Induration at injection site

<1%, postmarketing, and/or case reports: Angioedema, apnea, bronchitis, bronchospasm, cellulitis (inflammatory cellulitis without bacterial infection), collapse, cough, dermatitis, drowsiness, edema (diffuse edema of injected limb), hypersensitivity reaction (including anaphylactoid reaction and anaphylaxis), hypotonic/hyporesponsive episode, injection-site vesicle, lymphadenopathy, seizure (including febrile seizure), skin rash, thrombocytopenia, upper respiratory tract infection, urticaria

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (ACIP [Ezeanolue 2020]).

• Reactions from previous pertussis vaccination: Carefully consider use and weigh risks/benefits in patients with history of any of the following effects from previous administration of a pertussis-containing vaccine: Fever ≥40.5°C (105°F) within 48 hours of unknown cause; seizures with or without fever occurring within 3 days; persistent, inconsolable crying episodes lasting ≥3 hours and occurring within 48 hours; collapse or shock-like state (hypotonic-hyporesponsive episode) occurring within 48 hours. Vaccine should not be administered in patients with a history of severe allergic reaction after a previous dose or encephalopathy not attributable to another cause within 7 days following a previous dose of pertussis-containing vaccine (CDC/ACIP [Liang 2018]).

• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (ACIP [Ezeanolue 2020]).

Disease-related concerns:

• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Defer administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (ACIP [Ezeanolue 2020]).

• Bleeding disorders: Use with caution in patients with a history of bleeding disorders (including thrombocytopenia); bleeding/hematoma may occur from IM administration; if the patient receives antihemophilia or other similar therapy, IM injection can be scheduled shortly after such therapy is administered (ACIP [Ezeanolue 2020]).

• Brachial neuritis: Has occurred following tetanus toxoid-containing vaccines; use with caution (CDC/ACIP [Liang 2018]).

• Guillain-Barré syndrome: Use with caution if Guillain-Barré syndrome occurred within 6 weeks of prior tetanus toxoid-containing vaccine (CDC/ACIP [Liang 2018]).

• Neurologic disorders: Use pertussis-containing vaccines with caution in patients with progressive neurologic disease including infantile spasms, uncontrolled seizure, or a progressive encephalopathy, or conditions predisposing to seizures; the Advisory Committee on Immunization Practices (ACIP) guidelines recommend deferring immunization until health status can be assessed and condition stabilized (CDC/ACIP [Liang 2018]). Per the manufacturer, it is contraindicated to administer vaccine until a treatment regimen is established and the condition is stabilized.

• Poliomyelitis: Infanrix hexa [Canadian product]: Defer elective immunization of individuals ≥6 months of age during outbreaks of poliomyelitis.

Concurrent drug therapy issues:

• Anticoagulant therapy: Use with caution in patients receiving anticoagulant therapy; bleeding/hematoma may occur from IM administration (ACIP [Ezeanolue 2020]).

• Vaccines: In order to maximize vaccination rates, the ACIP recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist. The use of combination vaccines is generally preferred over separate injections, taking into consideration provider assessment, patient preference, and adverse events. When using combination vaccines, the minimum age for administration is the oldest minimum age for any individual component; the minimum interval between dosing is the greatest minimum interval between any individual components. The ACIP prefers each dose of a specific vaccine in a series come from the same manufacturer when possible; however, vaccination should not be deferred because a specific brand name is unavailable (ACIP [Ezeanolue 2020]). An increased incidence of febrile reactions, convulsions (with or without fever) and hypotonic hyporesponsive episode have been observed with concomitant use of Infanrix hexa [Canadian product] and pneumococcal conjugate vaccine.

Special populations:

• Altered immunocompetence: Consider deferring immunization during periods of severe immunosuppression (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy (including high-dose corticosteroids); may have a reduced response to vaccination. May be used in patients with HIV infection. In general, household and close contacts of persons with altered immunocompetence may receive all age appropriate vaccines. Inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible; inactivated vaccines administered during chemotherapy should be readministered after immune competence is regained (ACIP [Ezeanolue 2020]; IDSA [Rubin 2014]).

• Pediatric: Apnea has been reported following IM vaccine administration in premature infants; consider clinical status implications. In general, preterm infants should be vaccinated at the same chronological age as full-term infants (AAP [Saari 2003]; ACIP [Ezeanolue 2020]).

Dosage form specific issues:

• Aluminum: Formulation may contain aluminum.

• Neomycin: Formulation contains trace amounts of neomycin; use caution in patients with prior hypersensitivity to neomycin.

• Polymyxin B: Formulation contains trace amounts of polymyxin B; use caution in patients with prior hypersensitivity to polymyxin B.

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.

Other warnings/precautions:

• Antipyretics: Antipyretics have not been shown to prevent febrile seizures. Antipyretics may be used to treat fever or discomfort following vaccination (ACIP [Ezeanolue 2020]). One study reported that routine prophylactic administration of acetaminophen to prevent fever prior to vaccination decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula 2009).

• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval. Vaccines may not be effective if administered during periods of altered immune competence (ACIP [Ezeanolue 2020]).

Monitoring Parameters

Observe for hypersensitivity following administration (ACIP [Ezeanolue 2020]).

Pregnancy Considerations

This combination vaccine is not indicated for use in patients of reproductive age.

More about diphtheria toxoid / haemophilus b conjugate (prp-omp) vaccine / hepatitis b pediatric vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid

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