Clinical Information
Gen. Code and Des.
81737 dip,pert(a)tet/hepB/pol/Hib/PF INTRAMUSC SYRINGE 15-5-10
GCN and Des.
48936 dip,pert(a)tet/hepB/pol/Hib/PF INTRAMUSC SYRINGE 15-5-10
Strength
Dose Form
SYRINGE (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
80080000 TOXOIDS
80120000 VACCINES
Active Ingredients
3036 poliomyelitis vaccine,killed
4076 diphtheria,pertussis(acell),tetanus pedi vaccine
9870 preservative free
6319 Haemophilus B polysach conjugat with meningococcal
8320 hepatitis B virus vaccine, recombinant
Inactive Ingredients
2551 polysorbates 9005645
9283 beef derived (bovine)
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, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B 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) available in single-dose vials and prefilled syringes. (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:
-
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 risk for Guillain-Barré 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 Sanofi Pasteur Inc., at 1-800-822-2463 (1-800-VACCINE) or VAERS at 1-800-822-7967 and https://vaers.hhs.gov.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 10/2022
