ﺑﺎﺯﮔﺸﺖ ﺑﻪ ﺻﻔﺤﻪ ﻗﺒﻠﯽ
خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
نسخه الکترونیک
medimedia.ir

Diphtheria, tetanus toxoids, acellular pertussis, inactivated poliovirus combination vaccine (DTaP-IPV): Drug information

Diphtheria, tetanus toxoids, acellular pertussis, inactivated poliovirus combination vaccine (DTaP-IPV): Drug information
(For additional information see "Diphtheria, tetanus toxoids, acellular pertussis, inactivated poliovirus combination vaccine (DTaP-IPV): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Kinrix;
  • Quadracel
Brand Names: Canada
  • Adacel-Polio;
  • Boostrix-Polio;
  • Infanrix-IPV
Pharmacologic Category
  • Vaccine;
  • Vaccine, Inactivated (Bacterial);
  • Vaccine, Inactivated (Viral)
Dosing: Adult

Note: Consult CDC/Advisory Committee on Immunization Practices (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 (Ref).

Booster immunization

Booster immunization: Adacel-Polio, Boostrix-Polio [Canadian products]: IM: 0.5 mL as a single dose.

Dosing: Kidney Impairment: Adult

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

Dosing: Hepatic Impairment: Adult

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

Dosing: Pediatric

(For additional information see "Diphtheria, tetanus toxoids, acellular pertussis, inactivated poliovirus combination vaccine (DTaP-IPV): Pediatric drug information")

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 (Ref).

Immunization

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 (Ref). See manufacturer labeling for specific interchangeability details.

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 or fifth 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.

Dosing: Kidney Impairment: Pediatric

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

Dosing: Hepatic Impairment: Pediatric

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

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/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).

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. 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

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

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 2023]). 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.

• Shoulder injury related to vaccine administration: Vaccine administration that is too high on the upper arm may cause shoulder injury (eg, shoulder bursitis or tendinopathy) resulting in shoulder pain and reduced range of motion following injection. Use proper injection technique for vaccines administered in the deltoid muscle (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).

• 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]).

• 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 2023]).

• 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 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]).

Special populations:

• Adults: Safety and efficacy of Kinrix, Quadracel, and Infanrix IPV [Canadian product] have not been established for use in adults.

• 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. In general, household and close contacts of persons with altered immunocompetence may receive all age-appropriate vaccines. Nonlive vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible; nonlive vaccines administered during chemotherapy should be readministered after immune competence is regained (ACIP [Kroger 2023]; 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.

• 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 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 2023]).

Dosage Forms: US

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 29 D-antigen units, type 2 poliovirus 7 D-antigen units, and type 3 poliovirus 26 D-antigen units per 0.5 mL (0.5 mL) [contains aluminum, formaldehyde, neomycin sulfate, polymyxin B, polysorbate 80]

Injection, prefilled syringe [preservative free]:

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 29 D-antigen units, type 2 poliovirus 7 D-antigen units, and type 3 poliovirus 26 D-antigen units per 0.5 mL (0.5 mL) [contains aluminum, formaldehyde, neomycin sulfate, polymyxin B, polysorbate 80]

Generic Equivalent Available: US

No

Pricing: US

Suspension Prefilled Syringe (Kinrix Intramuscular)

0.5 mL (per 0.5 mL): $72.70

Suspension Prefilled Syringe (Quadracel Intramuscular)

0.5 mL (per 0.5 mL): $74.05

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Injection, suspension [preservative free]:

Adacel-Polio: Diphtheria toxoid 2 Lf, tetanus toxoid 5 Lf, acellular pertussis antigens [inactivated pertussis toxoid 2.5 mcg, filamentous hemagglutinin 5 mcg, pertactin 3 mcg, types 2 and 3 fimbriae 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, neomycin sulfate, polymyxin B, polysorbate 80, streptomycin]

Boostrix-Polio: Diphtheria toxoid 2.5 Lf, tetanus toxoid 5 Lf, acellular pertussis antigens [inactivated pertussis toxoid 8 mcg, filamentous hemagglutinin 8 mcg, pertactin 2.5 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, neomycin sulfate, polymyxin B]

Infanrix-IPV: Diphtheria toxoid 25 Lf, tetanus toxoid 10 Lf, acellular pertussis antigens [inactivated pertussis toxoid 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]

Administration: Adult

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 (Ref). Use proper injection technique in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Ref). To prevent syncope-related injuries, adolescents should be vaccinated while seated or lying down (Ref). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.

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 (Ref).

Administration: Pediatric

Shake well; do not use unless a homogeneous, turbid, white suspension forms; administer IM the deltoid muscle of the upper arm; not for IV or SUBQ administration. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection (Ref). Use proper injection technique in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Ref). To prevent syncope-related injuries, adolescents should be vaccinated while seated or lying down (Ref). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.

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) should be used for the vaccination and firm pressure on 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 (Ref).

Medication Guide and/or Vaccine Information Statement (VIS)

In the United States, the appropriate CDC-approved Vaccine Information Statement (VIS) must be provided to the patient/caregiver before administering each dose of this vaccine; the VIS edition date and date it was provided to the patient/caregiver should be recorded as required by US law; VIS is available at http://www.cdc.gov/vaccines/hcp/vis/vis-statements/dtap.html and http://www.cdc.gov/vaccines/hcp/vis/vis-statements/ipv.html .

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 of age 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; vaccination during pregnancy for passive immunization against pertussis disease in young infants (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; vaccination during pregnancy for passive immunization against pertussis disease in young infants (refer to current NACI guidelines); may be used for wound management when a tetanus toxoid-containing vaccine is needed for wound management (refer to current NACI guidelines).

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

Medication Safety Issues
Sound-alike/look-alike issues:

Adacel (trade name for Diphtheria and Tetanus Toxoids, and Acellular Pertussis Vaccine) should not be confused with Adacel-Polio (trade name for Diphtheria and Tetanus Toxoids, Acellular Pertussis, and Poliovirus Vaccine in Canada)

Boostrix (trade name for Diphtheria and Tetanus Toxoids, and Acellular Pertussis Vaccine) should not be confused with Boostrix-Polio (trade name for Diphtheria and Tetanus Toxoids, Acellular Pertussis, and Poliovirus Vaccine in Canada)

Infanrix (trade name for Diphtheria and Tetanus Toxoids, and Acellular Pertussis Vaccine) should not be confused with Infanrix-IPV (trade name for Diphtheria and Tetanus Toxoids, Acellular Pertussis, and Poliovirus Vaccine in Canada)

DTaP-IPV (diphtheria and tetanus toxoids, acellular pertussis and poliovirus [inactivated] vaccine) may be confused with DTaP-IPV/Hib (diphtheria and tetanus toxoids, acellular pertussis, poliovirus [inactivated], and Haemophilus influenzae type b conjugate vaccine) and DTaP-HepB-IPV (diphtheria and tetanus toxoids, acellular pertussis, hepatitis B, and poliovirus [inactivated] vaccine)

International issues:

Repevax [Multiple International Markets] may be confused with Revaxis brand name for diphtheria, tetanus, and poliomyelitis vaccine [Multiple International Markets]

Metabolism/Transport Effects

None known.

Drug Interactions

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

Pregnancy Considerations

Kinrix and Quadracel are not approved for use in patients >7 years of age.

Adacel-Polio and Boostrix Polio [Canadian products] are approved for use during pregnancy to provide passive immunization against pertussis in infants. Based on available data, adverse maternal or fetal outcomes have not been observed following maternal vaccination (most exposures occurred during the third trimester). Vaccination should be done during third trimester or as recommended by the National Advisory Committee on Immunization guidelines.

Breastfeeding Considerations

According to the manufacturer, consider the benefits of immunization and risk of infection prior to administration of Adacel-Polio or Boostrix Polio [Canadian products] to breastfeeding patients. Nonlive vaccines have not been shown to affect the safety of the breastfed infant or mother (ACIP [Kroger 2023]). Refer to the National Advisory Committee on Immunization guidelines for additional information.

Breastfeeding infants should be vaccinated according to the recommended schedules (ACIP [Kroger 2023]).

Monitoring Parameters

Observe for hypersensitivity and syncope for 15 minutes following administration (ACIP [Kroger 2023]). 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.

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 (Adult Data Unless Noted)

Onset of action: Immune response observed to all components ~1 month following vaccination

Duration: 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.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Di te per pol;
  • (AT) Austria: Repevax | Tetravac;
  • (AU) Australia: Boostrix ipv | Infanrix ipv;
  • (BE) Belgium: Boostrix polio | Infanrix ipv | Repevax | Tetravac | Triaxis polio;
  • (BG) Bulgaria: Tetraxim;
  • (BR) Brazil: Adacel polio | Refortrix ipv | Tetraxim | Vacina ads difteria, tetano, pertussis e poli;
  • (CH) Switzerland: Tetravac;
  • (CI) Côte d'Ivoire: Adacel polio;
  • (CO) Colombia: Tetraxim;
  • (CZ) Czech Republic: Adacel polio | Boostrix polio;
  • (DE) Germany: Boostrix polio | Repevax | Tetravac;
  • (EC) Ecuador: Tetracoq | Tetraxim;
  • (EE) Estonia: Tetraxim;
  • (ES) Spain: Boostrix polio | Tetraxim;
  • (FI) Finland: Boostrix polio | Tetravac;
  • (FR) France: Boostrixtetra | Infanrix polio | Repevax | Tetravac acellulaire | Tetravac acellular | Tetraxim;
  • (GB) United Kingdom: Boostrix ipv | Infanrix ipv | Repevax;
  • (GR) Greece: Boostrix polio | Tetracoq | Tetravac;
  • (HK) Hong Kong: Adacel polio | Boostrix polio | Quadracel | Tetracoq;
  • (HU) Hungary: Adacel polio | Boostrix polio | Tetraxim;
  • (IE) Ireland: Ipv boostrix | Ipv infanrix | Repevax;
  • (IN) India: Tetraxim;
  • (IT) Italy: Tetravac | Triaxis polio;
  • (JO) Jordan: Tetraxim;
  • (KE) Kenya: Adacel polio | Tetraxim;
  • (KR) Korea, Republic of: Infanrix ipv | Tetraxim;
  • (LB) Lebanon: Tetraxim;
  • (LT) Lithuania: Boostrix polio | Tetraxim;
  • (LU) Luxembourg: Infanrix ipv | Tetravac | Triaxis polio;
  • (LV) Latvia: Tetraxim;
  • (MA) Morocco: Adacel polio | Infanrix polio | Tetraxim | Vaccin dtcp;
  • (MX) Mexico: Infanrix ipv | Quadracel;
  • (MY) Malaysia: Adacel polio | Tetracoq | Tetraxim;
  • (NL) Netherlands: Boostrix polio | Dktp vaccin | Infanrix ipv;
  • (NO) Norway: Boostrix polio | Repevax | Tetravac | Tetraxim;
  • (NZ) New Zealand: Adacel polio;
  • (PE) Peru: Tetraxim;
  • (PH) Philippines: Tetracoq | Tetraxim;
  • (PL) Poland: Boostrix polio | Dtap ipv szczepionka | Infanrix ipv | Tetraxim;
  • (PR) Puerto Rico: Quadracel;
  • (PY) Paraguay: Tetraxim;
  • (RO) Romania: Tetracoq | Tetraxim;
  • (RU) Russian Federation: Tetraxim;
  • (SE) Sweden: Repevax;
  • (SG) Singapore: Adacel polio;
  • (SK) Slovakia: Boostrix polio | Tetraxim;
  • (TH) Thailand: Adacel polio | Boostrix polio | Tetracoq | Tetracoq 05 | Tetraxim;
  • (TN) Tunisia: Tetraxim;
  • (TR) Turkey: Adacel polio;
  • (TW) Taiwan: Tetraxim;
  • (UA) Ukraine: Boostrix polio | Infanrix ipv;
  • (UG) Uganda: Tetraxim;
  • (VE) Venezuela, Bolivarian Republic of: Tetraxim;
  • (ZA) South Africa: Adacel quadra | Boostrixtetra | Tetraxim
  1. Adacel (diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) [prescribing information]. Swiftwater, PA: Sanofi Pasteur Inc; September 2017.
  2. Adacel-Polio (diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) [product monograph]. Toronto, Ontario, Canada: Sanofi Pasteur Limited; August 2023.
  3. Alade SL, Brown RE, Paquet A Jr. Polysorbate 80 and E-Ferol toxicity. Pediatrics. 1986;77(4):593-597. [PubMed 3960626]
  4. Boostrix-Polio (diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) [product monograph]. Mississauga, Ontario, Canada: GlaxoSmithKline Inc; November 2023.
  5. “Canadian Immunization Guide, Seventh Edition, 2006,” Ottawa, ONT: Minister of Public Works and Government Services Canada, Public Health Agency of Canada, National Advisory Committee on Immunization, 2006. https://publications.gc.ca/collections/Collection/HP40-3-2006E.pdf.
  6. Centers for Disease Control and Prevention (CDC). Licensure of a Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine and Guidance for Use as a Booster Dose. MMWR Morb Mortal Wkly Rep. 2008;57(39):1078-1079. [PubMed 18830212]
  7. Centers for Disease Control (CDC). Unusual syndrome with fatalities among premature infants: association with a new intravenous vitamin E product. MMWR Morb Mortal Wkly Rep. 1984;33(14):198-199. http://www.cdc.gov/mmwr/preview/mmwrhtml/00000319.htm. [PubMed 6423951]
  8. Centers for Disease Control and Prevention (CDC). Updated Recommendations of the Advisory Committee on Immunization Practices (ACIP) Regarding Routine Poliovirus Vaccination. MMWR Morb Mortal Wkly Rep. 2009;58(30):829-830. [PubMed 19661857]
  9. Cross GB, Moghaddas J, Buttery J, Ayoub S, Korman TM. Don't aim too high: avoiding shoulder injury related to vaccine administration. Aust Fam Physician. 2016;45(5):303-306. [PubMed 27166466]
  10. Foster SL, Davis MV. Vaccine administration: preventing serious shoulder injuries. J Am Pharm Assoc (2003). 2013;53(1):102-103. doi:10.1331/JAPhA.2013.13503 [PubMed 23636163]
  11. Infanrix-IPV (diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine). [product monograph]. Mississauga, Ontario, Canada: GlaxoSmithKline Inc; September 2014.
  12. Isaksson M, Jansson L. Contact allergy to Tween 80 in an inhalation suspension. Contact Dermatitis. 2002;47(5):312-313.
  13. Kim DK, Riley LE, Harriman KH, Hunter P, Bridges CB. Advisory Committee on Immunization Practices Recommended Immunization Schedule for Adults Aged 19 Years or Older - United States, 2017. MMWR Morb Mortal Wkly Rep. 2017;66(5):136-138. [PubMed 28182599]
  14. Kinrix (diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) [prescribing information]. Durham, NC: GlaxoSmithKline; October 2023.
  15. Kroger A, Bahta L, Long S, Sanchez P. General best practice guidelines for immunization. Best Practices Guidance of the Advisory Committee on Immunization Practices (ACIP). https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/general-recs.pdf. Updated 2023. Accessed April 20, 2023.
  16. Liang JL, Tiwari T, Moro P, et al. Prevention of pertussis, tetanus, and diphtheria with vaccines in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2018;67(2):1-44. doi:10.15585/mmwr.rr6702a1 [PubMed 29702631]
  17. Lucente P, Iorizzo M, Pazzaglia M. Contact sensitivity to Tween 80 in a child. Contact Dermatitis. 2000;43(3):172. [PubMed 10985636]
  18. National Advisory Committee on Immunization (NACI). Principles of vaccine interchangeability: Canadian Immunization Guide. Updated February 2016. https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-1-key-immunization-information/page-7-principles-vaccine-interchangeability.html. Accessed July 15, 2020.
  19. Prymula R, Siegrist CA, Chlibek R, et al. Effect of Prophylactic Paracetamol Administration at Time of Vaccination on Febrile Reactions and Antibody Responses in Children: Two Open-Label, Randomised Controlled Trials. Lancet. 2009;374(9698):1339-1350. [PubMed 19837254]
  20. Quadracel (diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) prefilled syringe [prescribing information]. Swiftwater, PA: Sanofi Pasteur Inc; August 2023.
  21. Quadracel (diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) vial [prescribing information]. Swiftwater, PA: Sanofi Pasteur Inc; August 2023.
  22. Quadracel (diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) [product monograph]. Toronto, Ontario, Canada: Sanofi Pasteur Limited; August 2011.
  23. Robinson CL, Romero JR, Kempe A, et al. Advisory Committee on Immunization Practices Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger - United States, 2017. MMWR Morb Mortal Wkly Rep. 2017;66(5):134-135. [PubMed 28182607]
  24. Rubin LG, Levin MJ, Ljungman P, et al. 2013 IDSA clinical practice guideline for vaccination of the immunocompromised host. Clin Infect Dis. 2014;58(3):e44-e100. [PubMed 24311479]
  25. Shelley WB, Talanin N, Shelley ED. Polysorbate 80 hypersensitivity. Lancet. 1995;345(8980):1312-1313. [PubMed 7746084]
  26. World Health Organization (WHO). Guiding principles for immunization activities during the COVID-19 pandemic: interim guidance, 26 March 2020. Published March 26, 2020. https://apps.who.int/iris/handle/10665/331590
Topic 8974 Version 192.0

آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟