(For additional information see "Diphtheria, tetanus toxoids, acellular pertussis, inactivated poliovirus, Haemophilus influenzae type B, hepatitis B conjugate vaccine (DTaP-IPV-Hib-HepB): 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 (ACIP [Kroger 2023]).
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 [Kroger 2023]; NACI/CATMAT 2016). See manufacturer labeling for specific interchangeability details.
Vaxelis:
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).
Infanrix hexa [Canadian product]:
Primary Immunization: Canadian labeling: 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: Canadian labeling: 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).
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.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
All serious adverse reactions must be reported to the US Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS) 1-800-822-7967 or online at https://vaers.hhs.gov/esub/index .
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported within 5 days of vaccination at 2, 4, and 6 months of age in infants given Vaxeis concomitantly with Prevnar 13 vaccine and RotaTeq vaccine.
>10%:
Gastrointestinal: Decreased appetite (23% to 29%), vomiting (10% to 13%)
Local: Erythema at injection site (26% to 32%), pain at injection site (45% to 53%), swelling at injection site (19% to 23%)
Nervous system: Drowsiness (41% to 56%), irritability (55% to 62%)
Miscellaneous: Crying (45% to 52%), fever (≥38°C: 19% to 29%; ≥39.5°C: ≤2%)
Postmarketing:
Cardiovascular: Edema, facial edema, swelling of injected limb
Dermatologic: Erythema multiforme, skin rash, urticaria
Hypersensitivity: Anaphylactic shock, anaphylaxis, angioedema
Nervous system: Seizure
Respiratory: Dyspnea
Miscellaneous: Febrile seizure, hypotonic/hyporesponsive episode
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.
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]).
• 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 [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 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 [Kroger 2023]).
• 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 [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 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]). 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: 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. 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. Non-live vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible; non-live vaccines administered during chemotherapy should be readministered after immune competence is regained (ACIP [Kroger 2023]; 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 [Kroger 2023]).
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 [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 2021]).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, Intramuscular [preservative free]:
Vaxelis: 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], inactivated polioviruses [type 1 (Mahoney) 29 D-antigen units (DU), type 2 (MEF-1) 7 DU, type 3 (Saukett) 26 DU], polyribosylribitol phosphate of H. influenzae type b 3 mcg [bound to Neisseria meningitidis OMPC 50 mcg], HBsAg 10 mcg per 0.5 ml (0.5 mL) [latex free; contains albumin bovine, formaldehyde solution, neomycin, polysorbate 80]
Suspension Prefilled Syringe, Intramuscular [preservative free]:
Vaxelis: 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], inactivated polioviruses [type 1 (Mahoney) 29 D-antigen units (DU), type 2 (MEF-1) 7 DU, type 3 (Saukett) 26 DU], polyribosylribitol phosphate of H. influenzae type b 3 mcg [bound to Neisseria meningitidis OMPC 50 mcg], HBsAg 10 mcg per 0.5 ml (0.5 mL) [latex free; contains albumin bovine, formaldehyde solution, neomycin, polysorbate 80]
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, Intramuscular:
Infanrix Hexa: Diphtheria toxoid 25 Lf, filamentous hemagglutinin 25 mcg, HBsAg 10 mcg, pertactin 8 mcg, pertussis toxoid 25 mcg, tetanus toxoid 10 Lf, type 1 poliovirus 40 D antigen units, type 2 poliovirus 8 D antigen units and type 3 poliovirus 32 D antigen units, Haemophilus b capsular polysaccharide 10 mcg [bound to tetanus toxoid ~25 mcg] per 0.5 mL (0.5 mL) [contains aluminum, neomycin sulfate (trace amounts), polymyxin B (trace amounts), polysorbate 20, and polysorbate 80; Pediarix vaccine used to reconstitute Hib forms Infanrix Hexa]
Parenteral: IM: Administer by IM injection only; in infants, preferably in the anterolateral aspects of the thigh; administer in deltoid muscle of the upper arm in older children (Infanrix hexa Canadian product monograph); do not inject in the gluteal area. 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 (Cross 2016; Foster 2013). Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection (ACIP [Kroger 2023]; NACI/CATMAT 2020).
Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzae type 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.
Infanrix Hexa may be confused with Infanrix or Infanrix-Polio
Infanrix Hexa is supplied in two vials, one containing DTaP-HepB-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.
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
This combination vaccine is not indicated for use in patients of reproductive age.
This combination vaccine is not indicated for use in patients who are breastfeeding. Breastfeeding infants should be vaccinated according to the recommended schedules (ACIP [Kroger 2023]).
Observe for hypersensitivity for 15 minutes following administration (ACIP [Kroger 20212023]).
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: Immune response observed to all components 1 month following the 3-dose series.
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