Version May 2024
(For additional information see "Diphtheria, tetanus toxoids, acellular pertussis, inactivated poliovirus, and haemophilus influenzae type b conjugate vaccine (DTaP-IPV/Hib): Pediatric drug information")
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 (Ref).
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 (Ref). See manufacturer labeling for specific interchangeability details.
Infants and Children 6 weeks to <5 years: IM: 0.5 mL per dose for a total of 4 doses administered at 2, 4, 6, and 15 to 18 months of age. The first dose may be administered as early as 6 weeks of age.
Canadian labeling: Pediacel, Infanrix IPV/Hib: Note: Approved ages may vary by product; refer to manufacturer labeling. Infants ≥6 weeks and Children <7 years: IM: 0.5 mL per dose for a total of 4 doses administered at 2, 4, 6, and 18 months of age.
Catch-up immunization: Infants and Children 6 weeks to <5 years: IM: 0.5 mL per dose for 1 to 4 doses; refer to current immunization guidelines for specific schedule and timing of doses based on patient age and previous number of doses for each component; do not restart the series.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Central nervous system: Irritability (≤77%), uncontrolled crying (36% to 59%), hypoactivity (≤46%), lethargy (≤46%)
Endocrine & metabolic: Increased arm circumference (34%)
Local: Tenderness at injection site (39% to 56%), erythema at injection site (7% to 17%)
Miscellaneous: Fussiness in an infant or toddler (≤77%), fever (6% to 16%)
1% to 10%: Local: Swelling at injection site (5% to 10%)
<1%: Encephalopathy, seizure
Frequency not defined:
Endocrine & metabolic: Dehydration
Gastrointestinal: Gastroenteritis
Respiratory: Asthma, bronchiolitis, pneumonia
Postmarketing: Abscess at injection site, anaphylaxis, apnea, cough, cyanosis, decreased appetite, diarrhea, drowsiness, erythema of skin, hypersensitivity reaction, hypotonia, hypotonic/hyporesponsive episode, impaired consciousness, injection site reaction, meningitis, pallor, rhinitis, screaming, skin discoloration, swelling of injected limb, viral infection, vomiting
Severe allergic reaction to any vaccine containing diphtheria toxoid, tetanus toxoid, pertussis, poliovirus, or Haemophilus type b, or any component of this vaccine; encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) occurring within 7 days of a previous pertussis-containing vaccine (not attributable to another identifiable cause); progressive neurologic disorders (including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy)
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 [Kroger 2023]).
• Arthus-type hypersensitivity: Patients with a history of severe local reaction (Arthus-type) following a previous diphtheria toxoid or tetanus toxoid-containing vaccine dose should not be given further routine or emergency doses of Td unless ≥10 years since most recent dose, even if using for wound management with wounds that are not clean or minor; these patients generally have high serum antitoxin levels (CDC/ACIP [Liang 2018]).
• Reactions from previous pertussis vaccine: Carefully consider use in patients with history of any of the following effects from previous administration of a pertussis-containing vaccine: Fever ≥105°F (40.5°C) 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 (CDC/ACIP [Liang 2018]).
• Shoulder injury related to vaccine administration: Vaccine administration that is too high on the upper arm may cause shoulder injury (eg, shoulder bursitis or tendinopathy) resulting in shoulder pain and reduced range of motion following injection. Use proper injection technique for vaccines administered in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Cross 2016; Foster 2013).
• 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 [Kroger 2023]).
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. Postpone 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 [Kroger 2023]).
• Bleeding disorders: Use with caution in patients with 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 [Kroger 2023]).
• 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: According to the manufacturer, use is contraindicated in patients with history of progressive neurologic disease including infantile spasms, uncontrolled seizure, or a progressive encephalopathy. ACIP guidelines recommend deferring immunization until health status can be assessed and condition stabilized (CDC/ACIP [Liang 2018]).
Special populations:
• Altered immunocompetence: Postpone vaccination during periods of severe immunosuppression (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]) if appropriate; may have a reduced response to vaccination. In general, household and close contacts of persons with altered immunocompetence may receive all age-appropriate vaccines. Nonlive vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible; nonlive vaccines administered during chemotherapy should be readministered after immune competence is regained (ACIP [Kroger 2023]; IDSA [Rubin 2014]).
• Pediatric: If inadvertently administered to children ≥5 years as a booster dose, it may be counted as a valid dose (CDC 2008). 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 [Kroger 2023]).
Concurrent drug therapy issues:
• Anticoagulant therapy: Use with caution in patients receiving anticoagulant therapy; bleeding/hematoma may occur from IM administration (ACIP [Kroger 2023]).
• 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 nonlive) for which a person is eligible at a single visit, unless contraindications exist. The use of combination vaccines is generally preferred over separate injections, taking into consideration provider assessment, patient preference, and potential 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 [Kroger 2023]).
Dosage form specific issues:
• Aluminum: Product may contain aluminum.
• Neomycin: Product may contain neomycin.
• Polymyxin B: Product may contain 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: Per the manufacturer, antipyretic prophylaxis may be considered for patients at high risk for seizures. However, antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (ACIP [Kroger 2023]). 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 (ACIP [Kroger 2023]).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, suspension:
Pentacel: Diphtheria toxoid 15 Lf, tetanus toxoid 5 Lf, acellular pertussis antigens [pertussis toxin detoxified 20 mcg, filamentous hemagglutinin 20 mcg, pertactin 3 mcg, fimbriae (types 2 and 3) 5 mcg], type 1 poliovirus 40 D-antigen units; type 2 poliovirus 8 D-antigen units; type 3 poliovirus 32 D-antigen units, and Haemophilus b capsular polysaccharide 10 mcg [bound to tetanus toxoid 24 mcg] per 0.5 mL (0.5 mL) [contains albumin, aluminum, neomycin, polymyxin B sulfate, and polysorbate 80; supplied in two vials, one containing DTaP-IPV liquid and one containing Hib powder]
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, suspension:
Infanrix-IPV/Hib: Diphtheria toxoid 25 Lf, tetanus toxoid 10 Lf, acellular pertussis antigens [pertussis toxoid 25 mcg, filamentous hemagglutinin 25 mcg, pertactin 8 mcg], type 1 poliovirus 40 D-antigen units; type 2 poliovirus 8 D-antigen units; type 3 poliovirus 32 D-antigen units, and Haemophilus b capsular polysaccharide 10 mcg [bound to tetanus toxoid 30 mcg] per 0.5 mL (0.5 mL) [contains aluminum, neomycin, polymyxin B sulfate, and polysorbate 80; supplied in pre-filled syringe or vial containing DTaP-IPV liquid and vial containing Hib powder].
Pediacel: Diphtheria toxoid 15 Lf, tetanus toxoid 5 Lf, acellular pertussis antigens [pertussis toxoid 20 mcg, filamentous hemagglutinin 20 mcg, pertactin 3 mcg, fimbriae (types 2 and 3) 5 mcg], type 1 poliovirus 40 D-antigen units; type 2 poliovirus 8 D-antigen units; type 3 poliovirus 32 D-antigen units, and Haemophilus b capsular polysaccharide 10 mcg [bound to tetanus protein 18 to 30 mcg] per 0.5 mL (0.5 mL) [contains albumin, aluminum, neomycin, polymyxin B sulfate, streptomycin, and polysorbate 80; supplied in vials].
IM: Administer IM in the anterolateral aspect of thigh in infants <1 year of age or deltoid muscle of upper arm in older children. Do not administer to gluteal area or areas near a major nerve trunk; not for IV or SUBQ administration. If injecting in the deltoid muscle, use proper injection technique (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Ref). Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection (Ref). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and the date it was provided, and the administering person's name, title, and address be recorded. Lot numbers are different for each component of the DTaP-IPV/Hib vaccine; numbers should be recorded separately for the DTaP-IPV and Hib components. The vaccine components should not be administered separately.
For patients at risk of hemorrhage following IM injection, the vaccine should be administered IM if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, IM vaccination can be scheduled shortly after such therapy is administered. A fine needle (23-gauge or smaller) should be used for the vaccination and firm pressure on the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (Ref).
Active immunization against diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease caused by H. influenzae type b (FDA approved in ages 6 weeks to <5 years).
Pentacel is not indicated for the polio booster dose given at 4 to 6 years of age. Children should also receive an additional dose of DTaP vaccine at 4 to 6 years of age; Daptacel or Quadracel is recommended for consistency of pertussis antigen between products.
Advisory Committee on Immunization Practices (ACIP) recommendations:
Diphtheria and tetanus toxoids, acellular pertussis, poliovirus and Haemophilus b conjugate vaccine (Pentacel [DTaP-IPV/Hib]) may be used to provide the recommended DTaP, IPV, and Hib immunization series in infants and children <5 years of age. The Hib component in Pentacel contains a tetanus toxoid conjugate (PRP-T). A Hib vaccine containing the PRP-OMP conjugate (PedvaxHIB) may provide a more rapid seroconversion following the first dose and may be preferable to use in certain populations (eg, American Indian or Alaska Native children) (ACIP [Briere 2014]).
Per the ACIP, polio vaccine is recommended at 2, 4, and 6 to 18 months of age. For the 3-dose primary series, the minimum age and minimum intervals during the first 6 months of life should only be used when the vaccine recipient is at risk for imminent exposure to circulating poliovirus (shorter intervals and earlier start dates may lead to lower seroconversion) (CDC 2009). When Pentacel is administered according to labeled recommendations, this will result in a total of 5 childhood doses of IPV.
Canadian labeling: Active immunization against diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease caused by H. influenzae type b; product specific labeling: Pediacel: Patients ≥2 months through 6 years of age; Infanrix-IPV/Hib: Patients ≥6 weeks through 4 years of age.
Canadian National Advisory Committee on Immunization (NACI) recommendations: Combination DTaP-IPV-Hib may be used to provide the component immunizations in children <7 years of age (NACI 2016).
Pentacel (DTaP-IPV/Hib) may be confused with Pediarix (DTaP-HepB-IPV).
DTaP-IPV/Hib (diphtheria and tetanus toxoids, acellular pertussis, poliovirus [inactivated], and Haemophilus influenzae type b conjugate vaccine) may be confused with DTaP-IPV (diphtheria and tetanus toxoids, acellular pertussis and poliovirus [inactivated] vaccine) and DTaP-HepB-IPV (diphtheria and tetanus toxoids, acellular pertussis, hepatitis B, and poliovirus [inactivated] vaccine).
Pentacel is supplied in two vials, one containing DTaP-IPV liquid and one containing Hib powder, which must be mixed together in order to administer the recommended vaccine components. Errors have occurred when both vials have not been used or are mixed improperly, ensure proper preparation before administering.
Pentacel (US, Canada) may be confused with Pediacel (Canada).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Acetaminophen: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of acetaminophen before or during vaccine administration when possible. Acetaminophen is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
Anti-CD20 B-Cell Depleting Therapies: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation or 6 months after anti-CD20 B-cell depleting therapies. If vaccinated prior to B cell recovery, consider assessing immune response to vaccination. Risk D: Consider therapy modification
Cladribine: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of cladribine when possible. Patients vaccinated less than 14 days before initiating or during cladribine should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification
Corticosteroids (Systemic): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to immunosuppressive corticosteroids if possible. If patients are vaccinated less than 14 days prior to or during such therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider therapy modification
Elivaldogene Autotemcel: May enhance the adverse/toxic effect of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may diminish the therapeutic effect of Vaccines. Management: Administration of vaccines is not recommended in the 6 weeks before myeloablative conditioning, and until hematologic recovery after elivaldogene autotemcel treatment. Risk X: Avoid combination
Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). 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. Risk D: Consider therapy modification
Immunosuppressants (Cytotoxic Chemotherapy): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of chemotherapy when possible. Patients vaccinated less than 14 days before initiating or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification
Immunosuppressants (Miscellaneous Oncologic Agents): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 3 after therapy is complete. Risk D: Consider therapy modification
Immunosuppressants (Therapeutic Immunosuppressant Agents): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: 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. Risk D: Consider therapy modification
Methotrexate: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to methotrexate initiation, if possible. If patients are vaccinated less than 14 days prior to or during methotrexate therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider therapy modification
Propacetamol: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of propacetamol before or during vaccine administration when possible. Propacetamol is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
Siponimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Avoid administration of vaccines (inactivated) during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. Risk D: Consider therapy modification
Teplizumab: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Vaccination with inactivated or non-replicating vaccines is not recommended in the 2 weeks prior to teplizumab therapy, during treatment, or for 6 weeks following completion of therapy. Risk D: Consider therapy modification
Pentacel is not FDA approved for use in patients >5 years of age.
Breastfeeding infants should be vaccinated according to the recommended schedules (ACIP [Kroger 2023]).
Monitor for hypersensitivity and syncope for 15 minutes following administration (ACIP [Kroger 2023]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.
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