Quadracel

— THERAPEUTIC CATEGORIES —
  • Vaccines
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Quadracel Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Diphtheria and tetanus toxoids, acellular pertussis; aluminum phosphate adsorbed + inactivated poliovirus vaccine; susp for IM inj; contains 2-phenoxyethanol, and residual amounts of formaldehyde, glutaraldehyde, bovine serum albumin, neomycin, polymyxin B; preservative-free.

    Pharmacological Class

    DTaP + IPV.

    How Supplied

    Single-dose vials (0.5mL)—10

    Storage

    • Store at 2° to 8°C (35° to 46°F). Do not freeze. Product which has been exposed to freezing should not be used. Do not use after expiration date shown on the label.

    Manufacturer

    Sanofi Pasteur, Inc.

    Generic Availability

    NO

    Mechanism of Action

    Protection against diphtheria and tetanus disease is due to the development of neutralizing antibodies to diphtheria toxin and tetanus toxin. There is no well-established serological correlate of protection for pertussis; the effectiveness of Quadracel against pertussis was based on a comparison of pertussis immune responses following Quadracel to those following Daptacel. The presence of poliovirus type-specific neutralizing antibodies has been correlated with protection against poliomyelitis.

    Quadracel Indications

    Indications

    Active immunization against diphtheria, tetanus, pertussis, and poliomyelitis in children 4–6yrs of age: as 5th dose in DTaP series or as 4th or 5th dose in the IPV series following previous DTaP doses of Pentacel, Daptacel, and/or Vaxelis.

    Quadracel Dosage and Administration

    Adult

    Not recommended.

    Children

    <4yrs or >6yrs: not established. 4–6yrs: Each dose is 0.5mL IM, given once into deltoid muscle.

    Quadracel Contraindications

    Contraindications

    Anaphylaxis associated with any previous dose or component. Encephalopathy within 7 days of a previous pertussis-containing vaccine. Progressive neurologic disorders (eg, infantile spasms, uncontrolled epilepsy, or progressive encephalopathy).

    Contraindications

    Hypersensitivity

    • Severe allergic reaction (eg, anaphylaxis) associated with previous diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, or inactivated poliovirus vaccine.

    Encephalopathy

    • Encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis-containing vaccine that is not attributable to another identifiable cause.

    Progressive Neurologic Disorder

    • Progressive neurological disorders (eg, infantile spasms, uncontrolled epilepsy, progressive encephalopathy).

    • Do not administer Quadracel to individuals with these conditions until a treatment regimen has been established and the condition has stabilized.

    Quadracel Boxed Warnings

    Not Applicable

    Quadracel Warnings/Precautions

    Warnings/Precautions

    Fever (≥105°F within 48 hours), persistent inconsolable crying (≥3 hours within 48 hours), shock (within 48 hours), seizures (within 3 days), Guillain-Barre Syndrome (within 6 weeks) of previous tetanus toxoid-containing vaccine. Immunocompromised. Have epinephrine inj (1:1000) available. Pregnancy (Cat.C).

    Warnings/Precautions

    Management of Acute Allergic Reactions

    • Have epinephrine hydrochloride solution (1:1000) and other appropriate agents and equipment immediately available in case an anaphylactic or acute hypersensitivity reaction occurs.

    Adverse Reactions Following Prior Pertussis Vaccination

    • Carefully consider the potential benefits and risks of administering Quadracel if any of the following events occur after administration of a pertussis-containing vaccine:

      • Temperature of ≥40.5°C (≥105°F) within 48 hours, not attributable to another identifiable cause. 

      • Collapse or shock-like state (hypotonic-hyporesponsive episode [HHE]) within 48 hours. 

      • Persistent, inconsolable crying lasting at least 3 hours within 48 hours. 

      • Seizures with or without fever within 3 days.

    Guillain-Barré Syndrome

    • If Guillain-Barré Syndrome (GBS) occurred within 6 weeks of a previous vaccine containing tetanus toxoid, the decision to give Quadracel should be based on careful consideration of the potential benefits and possible risks. 

    Limitations of Vaccine Effectiveness

    • May not protect all individuals.

    Altered Immunocompetence

    • May not obtain expected immune response if Quadracel is given to immunocompromised persons, including those receiving immunosuppressive therapy.

    Syncope

    • Syncope may occur. Procedures should be in place to avoid injury from fainting.

    Pediatric Considerations

    • Safety and efficacy of Quadracel has not been established in children less than 4 years of age or children 7 through 16 years of age.

    Quadracel Pharmacokinetics

    See Literature

    Quadracel Interactions

    Interactions

    Concomitant vaccines: see full labeling. Immunosuppressants (eg, radiation, chemotherapy, high-dose steroids): may get suboptimal response.

    Interactions

    Concomitant Administration with Other Vaccines

    • In the US clinical trial (Study M5I02), Quadracel was administered concomitantly with 1 or more of the following US-licensed vaccines: MMR vaccines and varicella vaccine.

    • When Quadracel is given at the same time as another injectable vaccine(s), the vaccines should be administered with different syringes and at different injection sites.

    Immunosuppressive Treatments

    • Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to Quadracel.

    Quadracel Adverse Reactions

    Adverse Reactions

    Inj site reactions (eg, pain, increase in arm circumference, erythema, swelling), mylagia, malaise, headache, fever.

    Quadracel Clinical Trials

    Clinical Trials

    Immunogenicity - Study M5I02

    • The immunogenicity of Quadracel was evaluated in children 4 through 6 years of age. Patients received either Quadracel (n=263) or Daptacel + IPOL (n=253) as the 5th dose in the diphtheria, tetanus, and pertussis vaccination series and the 4th or 5th dose in the inactivated poliovirus vaccination series. Patients also received their second dose of MMR and Varicella vaccines, concomitantly.

    • Antibody levels to diphtheria, tetanus, pertussis (PT, FHA, PRN and FIM) and poliovirus antigens were measured in sera obtained immediately prior to vaccination and 28 days after vaccination. Booster response rates and antibody GMCs/GMTs following Quadracel vaccination were compared to those after DAPTACEL + IPOL vaccination.

    • Quadracel was non-inferior to Daptacel + IPOL vaccines administered concomitantly at separate sites based on post-vaccination antibody booster response rates and GMCs/GMTs to diphtheria and tetanus.

    • Quadracel was non-inferior to Daptacel + IPOL based on the post-vaccination booster response rates and GMCs for all pertussis antigens.

    • Quadracel was non-inferior to Daptacel + IPOL based on the post-vaccination booster response rates and GMTss for all polio types 1, 2, and 3.

    Quadracel Note

    Not Applicable

    Quadracel Patient Counseling

    Patient Counseling

    Inform the parent or guardian of the following: 

    • The potential benefits and risks of immunization with Quadracel. 

    • The common adverse reactions that have occurred following administration of Quadracel or other vaccines containing similar components. 

    • Other adverse reactions can occur. Call healthcare provider with any adverse reactions of concern.

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