Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, suspension [preservative free]:
Kinrix: Diphtheria toxoid 25 Lf, tetanus toxoid 10 Lf, acellular pertussis antigens [inactivated pertussis toxin 25 mcg, filamentous hemagglutinin 25 mcg, pertactin 8 mcg], type 1 poliovirus 40 D-antigen units, type 2 poliovirus 8 D-antigen units, and type 3 poliovirus 32 D-antigen units per 0.5 mL (0.5 mL) [contains aluminum, neomycin sulfate, polymyxin B, polysorbate 80; may contain natural rubber/natural latex in prefilled syringe]
Quadracel: Diphtheria toxoid 15 Lf, tetanus toxoid 5 Lf, acellular pertussis antigens [detoxified pertussis toxin 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, and type 3 poliovirus 32 D-antigen units per 0.5 mL (0.5 mL) [contains aluminum, formaldehyde, neomycin sulfate, polymyxin B, polysorbate 80]
Pharmacology
Mechanism of Action
Promotes active immunity to diphtheria, tetanus, pertussis, and poliovirus (types 1, 2 and 3) by inducing production of specific antibodies and antitoxins.
Pharmacokinetics/Pharmacodynamics
Onset of Action
Immune response observed to all components ~1 month following vaccination
Duration of Action
Immunity against diphtheria, tetanus, and polio persists for 10 or more years after a complete primary immunizing series was given. Periodic tetanus and diphtheria booster doses help maintain specific antitoxin levels above 0.01 antitoxin units/mL for each antigen. More recently, a level of 0.1 to 0.2 units/mL or more has been considered protective. Protection against pertussis from DTaP in children persists approximately 4 to 6 years.
Use: Labeled Indications
Diphtheria, tetanus, pertussis, and poliovirus disease prevention:
Kinrix: Active 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 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
Contraindications
Severe allergic reaction (eg, anaphylaxis) after a previous dose of any diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, or inactivated poliovirus vaccine, or to any component of the vaccine, including neomycin and polymyxin B; encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous dose of a pertussis-containing vaccine that is not attributable to another identifiable cause; progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy.
Boostrix Polio [Canadian product]: Additional contraindications: History of transient thrombocytopenia following an earlier immunization against diphtheria and/or tetanus
Dosage and Administration
Dosing: Adult
Booster immunization: Adacel-Polio, Boostrix-Polio [Canadian products]: IM: 0.5 mL as a single dose
Dosing: Pediatric
Note: Consult CDC/ACIP annual immunization schedules or National Advisory Committee on Immunization (NACI) guidelines (Canada) 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]).
Immunization: Children 4 to 6 years: Kinrix, Quadracel: IM: 0.5 mL as a single dose; Note: For use as the fifth dose in the DTaP series and the fourth dose in the IPV series
Canadian labeling:
Adacel-Polio: Children ≥4 years and Adolescents: IM: 0.5 mL as a single dose
Boostrix-Polio: Children ≥4 years and Adolescents: IM: 0.5 mL as a single dose
Infanrix-IPV: Children 15 months to 6 years: IM: 0.5 mL as initial booster dose at 15 to 18 months of age and 0.5 mL as second booster dose between 4 to 6 years of age (may be administered with monovalent H. influenzae type b vaccine). If primary immunization is delayed, same booster interval can be used prior to seventh birthday.
Quadracel: Infants ≥2 months and Children to 6 years: IM: 0.5 mL administered as a 4-dose primary series, usually administered at 2, 4, 6, and 18 months of age; followed by a booster dose at 4 to 6 years of age
Administration
IM: For IM use only, preferably in the deltoid; Adacel-Polio [Canadian product] label recommends avoiding administration into the buttocks. Do not administer intradermally, IV, or SubQ. Shake well prior to use; do not use unless a homogeneous, turbid, white suspension forms. Discard if the suspension is discolored or if there are cracks in the vial or syringe. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection (ACIP [Kroger 2017]). 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.
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 (ACIP [Kroger 2017]).
Storage
Kinrix, Quadracel: Store under refrigeration of 2°C to 8°C (36°F to 46°F); do not freeze. Discard if frozen. Quadracel Canadian labeling indicates that the vaccine is stable at >8°C to 25°C (>36°F to 77°F) for 72 hours
Adacel-Polio [Canadian product]: Store under refrigeration of 2°C to 8°C (36°F to 46°F); stable for 72 hours at temperatures up to 25°C (77°F); do not freeze. Discard if frozen.
Boostrix-Polio, Infanrix-IPV [Canadian products]: Store under refrigeration of 2°C to 8°C (36°F to 46°F); do not freeze. Discard if frozen.
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
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/. 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).
Adverse events reported within 4 to 7 days of vaccination:
>10%:
Cardiovascular: Swelling of injected limb (arm circumference increase: 36% to 68%), swelling of injected limb (extensive, 2%)
Central nervous system: Malaise (35%), drowsiness (19%), headache (16%)
Gastrointestinal: Decreased appetite (16%)
Local: Injection site: Pain at injection site (57% to 77%), erythema at injection site (37% to 59%), swelling (26% to 40%)
Neuromuscular & skeletal: Myalgia (54%)
Miscellaneous: Fever (6% to 16%)
<1%, postmarketing, and/or case reports: Abscess at injection site, anaphylaxis, cerebrovascular accident, convulsions, cyanosis, dehydration, febrile seizures, gastroenteritis, hypernatremia, hypersensitivity reaction, hypotonia, hypotonic/hyporesponsive episode, inflammation at injection site, injection site cellulitis, lethargy, pallor, pruritus, residual mass at injection site, screaming, skin vesicle (injection site), sterile abscess at injection site, syncope
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]). 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 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 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 (CDC/ACIP [Liang 2018]). 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 (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 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 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: Use with caution in patients with progressive neurologic disease including infantile spasms, uncontrolled seizure, or a progressive encephalopathy, or conditions predisposing to seizures. ACIP guidelines recommend deferring immunization until health status can be assessed and condition stabilized (CDC/ACIP [Liang 2018]).
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 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; however, vaccination should not be deferred because a specific brand name is unavailable (ACIP [Kroger 2017]).
Special populations:
- Adults: Safety and efficacy of Kinrix, Quadracel, and Infanrix IPV [Canadian product] have not been established for use in adults.
- 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 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 (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. Boostrix-Polio and Infanrix-IPV [Canadian products] labeling recommend monitoring for hypersensitivity reactions for 30 minutes after administration.
Pregnancy
Pregnancy Considerations
Kinrix and Quadracel are not approved for use in patients >7 years of age.
Patient Education
What is this drug used for?
- It is used to prevent diphtheria, tetanus, pertussis, and polio.
Frequently reported side effects of this drug
- Injection site pain or irritation
- Fatigue
- Headache
- Muscle pain
- Loss of strength and energy
- Lack of appetite
Other side effects of this drug: Talk with your caregiver right away if you have any of these signs of:
- Confusion
- Passing out
- High fever
- Seizures
- Burning or numbness feeling
- Muscle weakness
- Persistent crying
- Abnormal movements
- Signs of a significant reaction like 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. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
