Dosage Forms
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]
Use: Labeled Indications
Diphtheria, pertussis, tetanus, poliomyelitis, and Haemophilus b disease prevention: Active immunization against diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease caused by H. influenzae type b in infants ≥6 weeks and children <5 years of age
Advisory Committee on Immunization Practices (ACIP) recommends that Pentacel (DTaP-IPV/Hib) may be used to provide the recommended DTaP, IPV, and Hib immunization in infants and children ≤4 years of age. Whenever feasible, the same manufacturer should be used to provide the pertussis component; however, vaccination should not be deferred if a specific brand is not known or is not available. The Hib component in Pentacel contains a tetanus toxoid conjugate. 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) (CDC 57[39] 2008).
Contraindications
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 vaccine (not attributable to another identifiable cause); progressive neurologic disorders (including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy)
Dosage and Administration
Dosing: Pediatric
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 2017]).
Primary immunization:
Infants and Children 6 weeks to ≤4 years: IM: 0.5 mL per dose for a total of 4 doses administered as follows: 2, 4, 6, and 15 to 18 months of age. The first dose may be administered as early as 6 weeks of age. Following completion of the 4-dose series, children should receive a dose of DTaP vaccine at 4 to 6 years of age (Daptacel recommended due to same pertussis antigen used in both products).
Note: Per the ACIP, polio vaccine is given at 2, 4, and 6 to 18 months of age. Use of the minimum age and minimum intervals during the first 6 months of life should only be done 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 58[30] 2009). Pentacel is not indicated for the polio booster dose given at 4 to 6 years of age; Kinrix, Quadracel, or IPV should be used.
Previous vaccination with one or more components and scheduled to receive all vaccine components: Infants and Children ≤4 years:
Previously vaccinated with ≥1 dose of Daptacel or IPV vaccines: Pentacel may be used to complete the first 4 doses of the DTaP or IPV series in children scheduled to receive the other components in the vaccine.
Previously vaccinated with ≥1 dose of Haemophilus b Conjugate vaccine: Pentacel may be used to complete the series in children scheduled to receive the other components in the vaccine; however, if different brands of Haemophilus b Conjugate vaccine are administered to complete the series, 3 primary immunizing doses are needed, followed by a booster dose.
Note: Completion of 3 doses of Pentacel provides primary immunization against diphtheria, tetanus, H. influenzae type B, and poliomyelitis. Completion of the 4-dose series with Pentacel provides primary immunization against pertussis. It also provides a booster vaccination against diphtheria, tetanus, H. influenzae type B, and poliomyelitis.
Storage
Pentacel: Store at 2°C to 8°C (35°F to 46°F). Do not freeze; discard if product has been frozen. Use immediately after reconstitution.
Infanrix-IPV/Hib [Canadian product]: Store at 2°C to 8°C (35°F to 46°F). Do not freeze; discard if product has been frozen. Following reconstitution, the vaccine is stable for 8 hours at +21°C (70°F); however, the manufacturer recommends using the vaccine immediately.
Pediacel [Canadian product]: Manufacturer recommends storing at 2°C to 8°C (35°F to 46°F). Do not freeze; discard if product has been frozen. Product is stable at >8°C (46°F) to 25°C (77°F) for a maximum of 72 hours.
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: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Exceptions: Cytarabine (Liposomal). Consider therapy modification
Meningococcal Polysaccharide (Groups A / C / Y and W-135) Tetanus Toxoid Conjugate Vaccine: May diminish the therapeutic effect of Tetanus Toxoids Vaccines. Management: When possible, administer the meningococcal polysaccharide (groups A / C / Y and W-135) tetanus toxoid conjugate vaccine 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
Adverse Reactions
>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
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 [Kroger 2017]).
- 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]).
- 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 2017]).
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 [Kroger 2017]).
- 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 2017]).
- 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: 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. 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 [Kroger 2017]; IDSA [Rubin 2014]).
- Pediatric: If inadvertently administered to children ≥5 years as a booster dose, it may be counted as a valid dose (CDC 57[39] 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 (ACIP [Kroger 2017]).
Concurrent drug therapy issues:
- Anticoagulant therapy: Use with caution in patients receiving anticoagulant therapy; bleeding/hematoma may occur from IM administration (ACIP [Kroger 2017]).
- 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 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 2017]).
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 2017]). 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 [Kroger 2017]).
Monitoring Parameters
Monitor for syncope for 15 minutes following administration (ACIP [Kroger 2017]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.
Pregnancy
Pregnancy Considerations
Pentacel is not approved for use in patients >5 years of age; animal reproduction studies have not been conducted.
Patient Education
What is this drug used for?
- It is used to prevent diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae infection.
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
