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Diphtheria and Tetanus Toxoids, Acellular Pertussis, Poliovirus and Haemophilus b Conjugate Vaccine

Pronunciation

(dif THEER ee a & TET a nus TOKS oyds ay CEL yoo lar per TUS sis POE lee oh VYE rus & hem OF fi lus bee KON joo gate vak SEEN)

Index Terms

  • Haemophilus influenzae
  • Acellular pertussis
  • Diphtheria
  • DTaP - IPV / Hib
  • Hib
  • IPV
  • Pertussis
  • Poliovirus
  • Tetanus

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]

Brand Names: U.S.

  • Pentacel

Pharmacologic Category

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

Use: Labeled Indications

Diphtheria, pertussis, teatunus, poliomyelitis, and haemophilus B disease prevention: Active immunization against diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease caused by H. influenzae type b in children 6 weeks to <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 b, or any component of this vaccine; encephalopathy occurring within 7 days of a previous pertussis vaccine not (not attributable to another identifiable cause); progressive neurologic disorders (including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy)

Dosing: Pediatric

Primary immunization: Infants and Children 6 weeks to < 5 years: IM: 0.5 mL per dose administered at 2, 4, 6 and 15-18 months of age (total of 4 doses). 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 or IPV should be used.

Use in infants and children previously vaccinated with one or more component, and who are also scheduled to receive all vaccine components:

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.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Reconstitution

Pentacel is supplied in two vials, one containing DTaP-IPV liquid and one containing Hib powder, which must be mixed together before administering. Gently shake vial containing DTaP-IPV component. Withdraw liquid contents and inject into vial containing Hib powder; gently swirl until a cloudy, uniform suspension results.

Administration

For IM administration only. Do not administer IV or SubQ. Administer in the anterolateral aspect of thigh in children <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. US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, and the administering person's name, title, and address be entered into the patient's permanent medical record. 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 intramuscular injection, the vaccine should be administered intramuscularly 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, intramuscular vaccination can be scheduled shortly after such therapy is administered. A fine needle (23-gauge or smaller) can be used for the vaccination and firm pressure applied to 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 (NCIRD/ACIP 2011).

Compatibility

Do not mix with other vaccines or injections. Separate needles and syringes should be used for each injection.

Storage

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.

Drug Interactions

Belimumab: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Patients should receive inactivated vaccines prior to initiation of belimumab therapy whenever possible, due to the risk for an impaired response to the vaccine during belimumab therapy. Consider therapy modification

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

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

Adverse Reactions

All serious adverse reactions must be reported to the U.S. 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. In Canada, adverse reactions may be reported to local provincial/territorial health agencies or to the Vaccine Safety Section at Public Health Agency of Canada (1-866-844-0018).

>10%:

Central nervous system: Irritability (≤54% to 77%; >3 hours: ≤4% to 5%), uncontrolled crying (36% to 60%; >3 hours: ≤2%), lethargy (≤24% to 46%; severe: ≤3%), hypoactivity (≤24% to 46%; severe: ≤3%)

Endocrine & metabolic: Increased arm circumference (>5 mm: 34%; >40 mm: <1%)

Local: Tenderness at injection site (39% to 56%; severe: 1% to 5%), erythema at injection site (>5 mm: 7% to 17%)

Miscellaneous: Fussiness (≤54% to 77%; >3 hours: ≤4% to 5%), fever (≥38°C: 6% to 16%)

1% to 10%: Local: Swelling at injection site (>5 mm: 5% to 10%)

<1% (Limited to important or life-threatening): Anaphylaxis, apnea, asthma, brain disease, bronchiolitis, cough, cyanosis, decreased appetite, dehydration, diarrhea, drowsiness, erythema, gastroenteritis, hypersensitivity reaction, hypotonia, hypotonic/hyporesponsive episode, impaired consciousness, injection site reaction (includes abscess at injection site, extensive swelling of injected limb, inflammation at injection site, residual mass at injection site), meningitis, pallor, pneumonia, screaming, seizure, skin discoloration, 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 (NCIRD/ACIP 2011).

• Arthus-type hypersensitivity: Patients with a history of severe local reaction (Arthus-type) following a previous tetanus toxoid dose should not be given further routine or emergency doses of Td more frequently than every 10 years, even if using for wound management with wounds that are not clean or minor; these patients generally have high serum antitoxin levels (NCIRD/ACIP 2011).

• 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.

• 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 (NCIRD/ACIP 2011).

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. Consider deferring 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) (NCIRD/ACIP 2011).

• Bleeding disorders: Use with caution in patients with bleeding disorders (including thrombocytopenia) and patients on anticoagulant therapy; 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 (NCIRD/ACIP 2011).

• Guillain-Barré syndrome: Use with caution if Guillain-Barré syndrome occurred within 6 weeks of prior tetanus toxoid-containing vaccine (NCIRD/ACIP 2011).

• Neurologic disorders: Use with caution in patients with history of seizure disorder, progressive neurologic disease, or conditions predisposing to seizures; ACIP guidelines recommend deferring immunization until health status can be assessed and condition stabilized (NCIRD/ACIP 2011).

Special populations:

• Adults: Safety and efficacy have not been established in adults.

• Altered immunocompetence: Use with caution in severely immunocompromised patients (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 (IDSA [Rubin 2014]; NCIRD/ACIP 2011); inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible (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 (NCIRD/ACIP 2011).

Concurrent drug therapy issues:

• 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 (NCIRD/ACIP 2011).

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: Antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (NCIRD/ACIP 2011). 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 (NCIRD/ACIP 2011).

Monitoring Parameters

Monitor for syncope for 15 minutes following administration (NCIRD/ACIP 2011). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

Pregnancy Risk Factor

C

Pregnancy Considerations

Animal reproduction studies have not been conducted for this combination product. This product is not indicated for use in women of childbearing age.

Patient Education

• Discuss specific use of vaccine and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• 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.

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