Individuals using assistive technology may not be able to fully access the information contained in this file. For assistance, please send an e-mail to: [email protected] and include 508 Accommodation and the title of the document in the subject line of your e-mail. Sanofi Pasteur Full Prescribing Information 243 – Quadracel® HIGHLIGHTS OF PRESCRIBING INFORMATION • Progressive neurologic disorder until a treatment regimen has been These highlights do not include all the information needed to use established and the condition has stabilized. (4.3) Quadracel safely and effectively. See full prescribing information for -----------------------WARNINGS AND PRECAUTIONS------------------------ Quadracel. • Carefully consider benefits and risks before administering Quadracel to Quadracel (Diphtheria and Tetanus Toxoids and Acellular Pertussis persons with a history of: Adsorbed and Inactivated Poliovirus Vaccine) - fever ≥40.5°C (≥105°F), hypotonic-hyporesponsive episode (HHE) or Suspension for Intramuscular Injection persistent, inconsolable crying lasting ≥3 hours within 48 hours after a Initial U.S. Approval: 2015 previous pertussis-containing vaccine. (5.2) - seizures within 3 days after a previous pertussis-containing vaccine. ----------------------------INDICATIONS AND USAGE--------------------------- (5.2) Quadracel is a vaccine indicated for active immunization against diphtheria, • If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior tetanus, pertussis and poliomyelitis. A single dose of Quadracel is approved vaccine containing tetanus toxoid, the decision to give any tetanus toxoid- for use in children 4 through 6 years of age as a fifth dose in the diphtheria, containing vaccine, including Quadracel, should be based on careful tetanus, pertussis vaccination (DTaP) series, and as a fourth or fifth dose in consideration of the potential benefits and possible risks. (5.3) the inactivated poliovirus vaccination (IPV) series, in children who have received 4 doses of Pentacel and/or DAPTACEL vaccine. (1) ------------------------------ADVERSE REACTIONS------------------------------- In a clinical study, the most common solicited injection site reactions were ----------------------DOSAGE AND ADMINISTRATION----------------------- pain (>75%), increase in arm circumference (>65%), erythema (>55%), and A single intramuscular injection of 0.5 mL. (2) swelling (>40%). Common solicited systemic reactions were myalgia (>50%), ---------------------DOSAGE FORMS AND STRENGTHS---------------------- malaise (>35%), and headache (>15%). (6.1) Suspension for injection, supplied in single dose (0.5 mL) vials. (3) To report SUSPECTED ADVERSE REACTIONS, contact ---------------------------CONTRAINDICATIONS---------------------------------- Pharmacovigilance Department, Sanofi Pasteur Inc., Discovery Drive, • Severe allergic reaction (e.g., anaphylaxis) to any ingredient of Quadracel, Swiftwater, PA 18370 at 1-800-822-2463 (1-800-VACCINE) or VAERS at or following any diphtheria toxoid, tetanus toxoid, pertussis-containing 1-800-822-7967 or http://vaers.hhs.gov vaccine or inactivated poliovirus vaccine. (4.1) (11) See 17 for PATIENT COUNSELING INFORMATION. • Encephalopathy within 7 days of a previous pertussis-containing vaccine with no other identifiable cause. (4.2) Revised: XX02/20202021 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 8 USE IN SPECIFIC POPULATIONS 2 DOSAGE AND ADMINISTRATION 8.4 Pediatric Use 3 DOSAGE FORMS AND STRENGTHS 11 DESCRIPTION 4 CONTRAINDICATIONS 12 CLINICAL PHARMACOLOGY 4.1 Hypersensitivity 12.1 Mechanism of Action 4.2 Encephalopathy 4.3 Progressive Neurologic Disorder 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5 WARNINGS AND PRECAUTIONS 5.1 Management of Acute Allergic Reactions 14 CLINICAL STUDIES 5.2 Adverse Reactions Following Prior Pertussis Vaccination 14.1 Immunogenicity 5.3 Guillain-Barré Syndrome 15 REFERENCES 5.4 Limitations of Vaccine Effectiveness 5.5 Altered Immunocompetence 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied 6 ADVERSE REACTIONS 16.2 Storage and Handling 6.1 Clinical Trials Experience 6.2 Postmarketing Experience 17 PATIENT COUNSELING INFORMATION 7 DRUG INTERACTIONS * Sections or subsections omitted from the full prescribing information are 7.1 Concomitant Administration with Other Vaccines not listed. 7.2 Immunosuppressive Treatments 1 Sanofi Pasteur Full Prescribing Information 243 – Quadracel® FULL PRESCRIBING INFORMATION 1 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® [Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus and Haemophilus b conjugate (Tetanus Toxoid Conjugate) Vaccine] and/or DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed). 2 DOSAGE AND ADMINISTRATION For intramuscular use only. Just before use, shake the vial well, until a uniform, white, cloudy suspension results. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exist, the product should not be administered. Using a sterile needle and syringe and aseptic technique, withdraw and administer a 0.5 mL dose of Quadracel vaccine intramuscularly into the deltoid muscle of the upper arm. Discard unused portion. Quadracel should not be combined through reconstitution or mixed with any other vaccine. 3 DOSAGE FORMS AND STRENGTHS Quadracel is a suspension for injection in 0.5 mL single-dose vials. 4 CONTRAINDICATIONS 4.1 Hypersensitivity Severe allergic reaction (e.g., anaphylaxis) to any ingredient of Quadracel [see Description (11)] or following any diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, or inactivated poliovirus vaccine, is a contraindication to administration of Quadracel. 4.2 Encephalopathy Encephalopathy (e.g., 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 is a contraindication to administration of any pertussis-containing vaccine, including Quadracel. 4.3 Progressive Neurologic Disorder Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy is a contraindication to administration of any pertussis-containing vaccine including Quadracel. Pertussis vaccine should not be administered to individuals with such conditions until a treatment regimen has been established and the condition has stabilized. 2 Sanofi Pasteur Full Prescribing Information 243 – Quadracel® 5 WARNINGS AND PRECAUTIONS 5.1 Management of Acute Allergic Reactions Epinephrine hydrochloride solution (1:1,000) and other appropriate agents and equipment must be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs. 5.2 Adverse Reactions Following Prior Pertussis Vaccination If any of the following events have occurred within the specified period after administration of a pertussis vaccine, the decision to administer Quadracel should be based on careful consideration of benefits and risks. • 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 ≥3 hours within 48 hours. • Seizures with or without fever within 3 days. 5.3 Guillain-Barré Syndrome If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the decision to give any vaccine containing tetanus toxoid, including Quadracel, should be based on careful consideration of the potential benefits and possible risks. 5.4 Limitations of Vaccine Effectiveness Vaccination with Quadracel may not protect all individuals. 5.5 Altered Immunocompetence If Quadracel is administered to immunocompromised persons, including persons receiving immunosuppressive therapy, the expected immune response may not be obtained. [See Drug Interactions (7.2).] 6 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 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to vaccine use and for approximating rates of those events. In a randomized, controlled, multicenter study conducted in the US and Puerto Rico (Study M5I02; ClinicalTrials.gov Identifier: NCT01346293), 3,372 children, 4 to 6 years of age, who had received 4 doses of DAPTACEL and/or Pentacel vaccine(s) received