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. HIGHLIGHTS OF PRESCRIBING INFORMATION -----------------------WARNINGS AND PRECAUTIONS------------------------ These highlights do not include all the information needed to use • Carefully consider benefits and risks before administering VAXELIS to VAXELIS safely and effectively. See full prescribing information for persons with a history of: VAXELIS. - fever ≥40.5°C (≥105°F), hypotonic-hyporesponsive episode (HHE) or VAXELISTM (Diphtheria and Tetanus Toxoids and Acellular Pertussis, persistent, inconsolable crying lasting ≥3 hours within 48 hours after a Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B previous pertussis-containing vaccine. (5.2) Vaccine) - seizures within 3 days after a previous pertussis-containing vaccine. (5.2) Suspension for Intramuscular Injection Initial U.S. Approval: 2018 • If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk for Guillain-Barré syndrome ----------------------------RECENT MAJOR CHANGES ------------------------ may be increased following VAXELIS. (5.3) Dosage and Administration (2.2) 09/2020 • Apnea following intramuscular vaccination has been observed in some ----------------------------INDICATIONS AND USAGE--------------------------- infants born prematurely. The decision about when to administer an VAXELIS is a vaccine indicated for active immunization to prevent intramuscular vaccine, including VAXELIS, to an infant born prematurely diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease should be based on consideration of the individual infant’s medical status due to Haemophilus influenzae type b.