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Sanofi Pasteur Full Prescribing Information
243 – Quadracel®
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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to
use Quadracel safely and effectively. See full prescribing
information for Quadracel.
Quadracel (Diphtheria and Tetanus Toxoids and Acellular
Pertussis Adsorbed and Inactivated Poliovirus Vaccine)
Suspension for Intramuscular Injection
Initial U.S. Approval: 2015
--------------------------- INDICATIONS AND USAGE---------------
Quadracel is a vaccine indicated for active immunization against
diphtheria, tetanus, pertussis and poliomyelitis. A single dose of
Quadracel is approved for use in children 4 through 6 years of age
as a fifth dose in the diphtheria, tetanus, pertussis vaccination
(DTaP) series, and as a fourth or fifth dose in the inactivated
poliovirus vaccination (IPV) series, in children who have received 4
doses of Pentacel and/or DAPTACEL vaccine. (1)
----------------------DOSAGE AND ADMINISTRATION----------
A single intramuscular injection of 0.5 mL. (2)
---------------------DOSAGE FORMS AND STRENGTHS---------
Suspension for injection, supplied in single dose (0.5 mL) vials. (3)
----------------------------CONTRAINDICATIONS-------------------
Severe allergic reaction (e.g., anaphylaxis) to any ingredient of
Quadracel, or following any diphtheria toxoid, tetanus toxoid,
pertussis-containing vaccine or inactivated poliovirus vaccine.
(4.1) (11)
Encephalopathy within 7 days of a previous pertussis- containing vaccine with no other identifiable cause. (4.2)
Progressive neurologic disorder until a treatment regimen has
been established and the condition has stabilized. (4.3)
-----------------------WARNINGS AND PRECAUTIONS-------
Carefully consider benefits and risks before administering
Quadracel to persons with a history of:
- fever ≥40.5°C (≥105°F), hypotonic-hyporesponsive episode
(HHE) or persistent, inconsolable crying lasting ≥3 hours
within 48 hours after a previous pertussis-containing
vaccine. (5.2)
- seizures within 3 days after a previous pertussis-containing
vaccine. (5.2)
If Guillain-Barré syndrome occurred within 6 weeks of receipt
of a prior vaccine containing tetanus toxoid, the decision to give
any tetanus toxoid-containing vaccine, including Quadracel,
should be based on careful consideration of the potential
benefits and possible risks. (5.3)
------------------------------ADVERSE REACTIONS--------------
In a clinical study, the most common solicited injection site
reactions were pain (>75%), increase in arm circumference (>65%),
erythema (>55%), and swelling (>40%). Common solicited
systemic reactions were myalgia (>50%), malaise (>35%), and
headache (>15%). (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact
Pharmacovigilance Department, Sanofi Pasteur Inc., Discovery
Drive, Swiftwater, PA 18370 at 1-800-822-2463 (1-800-
VACCINE) or VAERS at 1-800-822-7967 or
http://vaers.hhs.gov
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 01/2019
__________________________________________________________________________________________________________________
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.1 Hypersensitivity
4.2 Encephalopathy
4.3 Progressive Neurologic Disorder
5 WARNINGS AND PRECAUTIONS
5.1 Management of Acute Allergic Reactions
5.2 Adverse Reactions Following Prior Pertussis
Vaccination
5.3 Guillain-Barré Syndrome
5.4 Limitations of Vaccine Effectiveness
5.5 Altered Immunocompetence
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Concomitant Administration with Other Vaccines
7.2 Immunosuppressive Treatments
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
13 NON-CLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Immunogenicity
15 REFERENCES
16 HOW SUPPLIED STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage and Handling
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing
information are not listed.
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Sanofi Pasteur Full Prescribing Information
243 – Quadracel®
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1 FULL PRESCRIBING INFORMATION
2 1 INDICATIONS AND USAGE
Quadracel® 3 is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis
4 and poliomyelitis. A single dose of Quadracel is approved for use in children 4 through 6 years
5 of age as a fifth dose in the diphtheria, tetanus, pertussis vaccination (DTaP) series, and as a
6 fourth or fifth dose in the inactivated poliovirus vaccination (IPV) series, in children who have
received 4 doses of Pentacel® 7 [Diphtheria and Tetanus Toxoids and Acellular Pertussis
8 Vaccine Adsorbed, Inactivated Poliovirus and Haemophilus b conjugate (Tetanus Toxoid
Conjugate) Vaccine] and/or DAPTACEL® 9 (Diphtheria and Tetanus Toxoids and Acellular
10 Pertussis Vaccine Adsorbed).
11 2 DOSAGE AND ADMINISTRATION
12 For intramuscular use only.
13 Just before use, shake the vial well, until a uniform, white, cloudy suspension results.
14 Parenteral drug products should be inspected visually for particulate matter and discoloration
15 prior to administration, whenever solution and container permit. If either of these conditions
16 exist, the product should not be administered.
17 Using a sterile needle and syringe and aseptic technique, withdraw and administer a 0.5 mL
18 dose of Quadracel vaccine intramuscularly into the deltoid muscle of the upper arm.
19 Quadracel should not be combined through reconstitution or mixed with any other vaccine.
20 3 DOSAGE FORMS AND STRENGTHS
21 Quadracel is a suspension for injection in 0.5 mL single dose vials.