Diphtheria Prophylaxis, Tetanus Prophylaxis, Pertussis Prophylaxis, Poliomyelitis Prophylaxis, Hepatitis B Prophylaxis, Haemophilus influenzae Prophylaxis
Vaxelis is a hexavalent combination vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b in children from 6 weeks through 4 years of age (prior to the 5th birthday). VAXELIS is supplied in a single dose vial (NDC 63361-245-58) in packages of 10 vials (NDC 63361-245-10).
The vial stopper is not made with natural rubber latex.
16.2 Storage and Handling
VAXELIS should be stored at 2�C to 8�C (36�F 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. These highlights do not include all the information needed to use VAXELIS safely and effectively. See full prescribing information for VAXELIS.
VAXELIS� (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine)
Suspension for Intramuscular Injection
Initial U.S. Approval: 2018
INDICATIONS AND USAGE
VAXELIS is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b. VAXELIS is approved for use as a 3-dose series in children from 6 weeks through 4 years of age (prior to the 5th birthday). (1)
DOSAGE AND ADMINISTRATION
The 3-dose immunization series consists of a 0.5 mL intramuscular injection, administered at 2, 4, and 6 months of age. (2.1)
DOSAGE FORMS AND STRENGTHS
Suspension for injection (0.5 mL dose) supplied in single dose vials. (3)
CONTRAINDICATIONS
Severe allergic reaction (e.g., anaphylaxis) to a previous dose of VAXELIS, any ingredient of VAXELIS, or any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, or Haemophilus influenzae type b vaccine. (4.1)
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 VAXELIS to persons with a history of:
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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)
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seizures within 3 days after a previous pertussis-containing vaccine. (5.2)
If Guillain-Barr� syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk for Guillain-Barr� syndrome may be increased following VAXELIS. (5.3)
Apnea following intramuscular vaccination has been observed in some infants born prematurely. The decision about when to administer an intramuscular vaccine, including VAXELIS, to an infant born prematurely should be based on consideration of the individual infant's medical status and the potential benefits and possible risks of vaccination. (5.5)
Urine antigen detection may not have definitive diagnostic value in suspected H. influenzae type b disease following vaccination with VAXELIS. (5.7) (7.1)
ADVERSE REACTIONS
The solicited adverse reactions following any dose were irritability (?55%), crying (?45%), injection site pain (?44%), somnolence (?40%), injection site erythema (?25%), decreased appetite (?23%), fever ?38.0�C (?19%), injection site swelling (?18%), and vomiting (?9%). (6)
To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or VAERS at 1-800-822-7967 and https://vaers.hhs.gov.
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 12/2018