Diphtheria and Tetanus Toxoids, Acellular Pertussis, and Poliovirus Vaccine

• Kinrix
• Quadracel

Immune response observed to all components ~1 month following vaccination

Diphtheria, tetanus, pertussis, and poliovirus disease prevention:

Kinrix: Active booster immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and as the fourth dose in the inactivated poliovirus vaccine (IPV) series in children 4 through 6 years of age whose previous DTaP vaccine doses have been with Infanrix (DTaP) and/or Pediarix (DTaP-hepatitis B-IPV) for the first 3 doses and Infanrix (DTaP) for the fourth dose.

Quadracel:

US labeling: Active booster immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and as the fourth or fifth dose in the inactivated poliovirus vaccine (IPV) series in children 4 through 6 years of age whose previous DTaP vaccine doses have been 4 doses of Pentacel (DTaP-IPV/Haemophilus b conjugate [tetanus toxoid conjugate] vaccine) and/or Daptacel (DTaP).

Canadian labeling: Active primary immunization against diphtheria, tetanus, pertussis, and poliomyelitis for infants and children 6 months through 6 years of age.

Adacel-Polio [Canadian product]: Active booster immunization against diphtheria, tetanus, pertussis, and poliomyelitis in patients 4 years and older; alternative to fifth dose of DTaP-IPV in patients 4 to 6 years of age; may be used for wound management when a tetanus toxoid-containing vaccine is needed for wound management [refer to current National Advisory Committee on Immunization (NACI) guidelines]

Boostrix Polio [Canadian product]: Active booster immunization against diphtheria, tetanus, pertussis, and poliomyelitis in patients 4 years and older; may be used for wound management when a tetanus toxoid-containing vaccine is needed for wound management [refer to current National Advisory Committee on Immunization (NACI) guidelines]

Infanrix-IPV [Canadian product]: Active booster immunization against diphtheria, tetanus, pertussis, and poliomyelitis in children ≥15 months through 6 years of age

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

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

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). Boostrix-Polio and Infanrix-IPV [Canadian products] labeling recommend monitoring for hypersensitivity reactions for 30 minutes after administration.

• 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.

• Reactions from previous pertussis vaccination: Carefully consider use 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. Use is contraindicated in patients who have had encephalopathy within 7 days of a previous pertussis-containing vaccine.

• 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 a history of bleeding disorders (including thrombocytopenia) and/or 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). Antipyretics may be considered at the time of and for 24 hours following vaccination to patients at high risk for seizures to reduce the possibility of postvaccination fever.

Concurrent drug therapy issues:

• Vaccines: In order to maximize vaccination rates, the ACIP and the NACI recommend 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 (NCIRD/ACIP 2011).

Special populations:

• Adults: Safety and efficacy of Kinrix, Quadracel, and Infanrix IPV [Canadian product] have not been established for use 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 Kinrix is inadvertently administered to children for an earlier dose in the series, it may be counted as a valid dose, provided the minimum interval requirements were met (CDC 57[39] 2008).

Dosage form specific issues:

• Aluminum: Product may contain aluminum.

• Latex: Packaging may contain natural latex rubber.

• 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: According to the manufacturer, antipyretics may be considered at the time of and for 24 hours following vaccination to patients at high risk for seizures to reduce the possibility of postvaccination fever. However, 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).

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. Boostrix-Polio and Infanrix-IPV [Canadian products] labeling recommend monitoring for hypersensitivity reactions for 30 minutes after administration.

• Discuss specific use of vaccine and side effects with caregiver 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?)

• Patient may experience injection site pain or irritation, fatigue, headache, muscle pain, weakness, or lack of appetite. Have caregiver report immediately to prescriber confusion, severe dizziness, passing out, vision changes, seizures, burning or numbness feeling, severe fatigue, abnormal crying (children), or abnormal movements (HCAHPS).

• Educate caregiver 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. Caregiver 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 healthcare 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.