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Prescribing Information
 
Patient Information
For US Health Care Professionals
Prescribing Information
Patient Information

Indication and Usage for VAXELIS™

VAXELIS is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to

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 (Hib). VAXELIS is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday).


Supply Available June 2021

VAXELIS Is the First-And-Only Hexavalent Vaccine Approved by the FDA1

VAXELIS helps simplify the execution of the infant vaccination schedule with 2 to 3 fewer shots2-5

VAXELIS™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine) Reduces the Total Number of Injections Needed Within the First 6 Months

Reduces the total number of injections needed within the first 6 months2-5

VAXELIS™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine) Helps Protect Against 6 Diseases in a Single Shot

Helps protect against 6 diseases in a single shota

VAXELIS™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine) Simplifies the Administration of the Infant Vaccine Series

Helps to simplify the administration of the infant vaccine series2-5

VAXELIS™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine) May Help Improve Efficiency and Reduce Administrative Tasks

May help improve efficiency and reduce administrative tasks6

aVAXELIS helps to prevent the diseases caused by diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and Haemophilus influenzae type b (Hib).

 
 
 
 
 
 

Supply Available

June 2021

Ready to reserve VAXELIS? Be one of the first to place your reservation

At this time, reservations can only be made directly on VaccineShoppe.com. Reservations prior to June 2021 are not available through distributors or wholesalers. If you prefer to purchase through a distributor or wholesaler, please contact your distributor or wholesaler to inform them of your intent and timing to purchase VAXELIS.


Indication for VAXELIS

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 (Hib). VAXELIS is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday).

Important Safety Information for VAXELIS

  • Do not administer VAXELIS to anyone with a history of severe allergic reaction 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 Hib vaccine.
  • Do not administer VAXELIS to anyone with a history of encephalopathy within 7 days of a pertussis-containing vaccine with no other identifiable cause.
  • Do not administer VAXELIS to anyone with a history of progressive neurologic disorder until a treatment regimen has been established and the condition has stabilized.
  • 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; and/or seizures within 3 days after a previous pertussis-containing vaccine.
  • 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.
  • Apnea following intramuscular vaccination has been observed in some infants born prematurely. Consider the individual infant’s medical status and potential benefits and possible risks of intramuscular vaccination in deciding when to administer VAXELIS to an infant born prematurely.
  • Vaccination with VAXELIS may not protect all individuals.
  • The solicited adverse reactions 0-5 days 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%).

Before administering VAXELIS, please read the accompanying Prescribing Information.

The Patient Information also is available.

References

  1. 1. Oliver SE, Moore KL. Licensure of a diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, Haemophilus influenzae type b conjugate, and hepatitis B vaccine, and guidance for use in infants. MMWR Morb Mortal Wkly Rep. 2020;69(5):136–139. doi.org/10.15585/mmwr.mm6905a5
  2. 2. Pentacel. Prescribing Information. Sanofi Pasteur; 2020. Accessed January 22, 2021. https://www.vaccineshoppe.com/image.cfm?doc_id=13799&image_type=product_pdf
  3. 3. Pentacel. Prescribing Information. Sanofi Pasteur; 2019. Accessed January 22, 2021. https://www.vaccineshoppe.com/mailing/VSH/PIs%20&%20SDS/PI/dtppv-fplr-sl-dec19.pdf
  4. 4. PEDIARIX. Prescribing Information. GlaxoSmithKline, Inc.; 2019. Accessed January 22, 2021. https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Pediarix/pdf/PEDIARIX.PDF
  5. 5. Recommended child and adolescent immunization schedule for ages 18 years or younger, United States, 2021. Centers for Disease Control and Prevention. Updated February 11, 2021. Accessed February 12, 2021. https://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf
  6. 6. Pellissier JM, Coplan PM, Jackson LA, May JE. The effect of additional shots on the vaccine administration process: results of a time-motion study in 2 settings. Am J Manag Care. 2000;6(9):1038–1044.

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