Prescribing Information | Safety Information

Pentacel vaccine is the only combination of DTaP, IPV, and Hib vaccine.1 It provides proven pertussis protection in 4 doses so you don't have to switch vaccines for the 15-18 month visit.1 (Children should receive a DTaP booster at 4-6 years of age.2) Pentacel vaccine also saves a shot at the crowded toddler visit and helps maximize shot savings within the first 2 years of life.3

To minimize the number of injections children receive, the Advisory Committee on Immunization Practices generally prefers the use of combination vaccines.19

How does Pentacel vaccine impact immunization? 
Pentacel vaccine can save shots, helping to reduce discomfort for both baby and mom. It can also help to increase compliance at the fourth dose at 15-18 months of age—a visit that is easy to fall behind on, or miss.3,4 In fact, a 2009 National Immunization Survey showed that by 24 months of age, 1 in 5 children did not receive all 4 recommended doses of DTaP vaccine.5

Why switch to Pentacel vaccine? 
Pentacel vaccine is a 4-dose vaccine that completes the primary DTaP, Hib, and polio immunization series at 15-18 months of age (with a DTaP and polio booster at 4-6 years of age).1,2

•	You do not need to switch DTaP vaccines at the fourth dose
•	Using the same vaccine at all 4 doses of the primary series can reduce the potential for choosing the wrong vaccine, makes inventory and ordering easier, and can save refrigerator space

What is the advantage of administering Pentacel vaccine at the fourth dose? 
When you administer Pentacel vaccine at the fourth dose, you complete the DTaP primary series, provide a Hib booster dose, and eliminate a shot.1 This is important because the 15-18 month visit is crowded with immunizations.

How does Pentacel vaccine help protect against pertussis? 
Pentacel vaccine offers protection against pertussis with comparable immunogenicity to separately administered DAPTACEL vaccine.1

Learn more about the pertussis protection of Pentacel vaccine.

How does Pentacel vaccine compare to DAPTACEL vaccine? 
Pentacel vaccine helps protect against diphtheria, tetanus, pertussis, Hib, and polio in a 4-dose series at 2, 4, 6, and 15-18 months of age, with a fifth dose of DTaP at 4-6 years of age.1,2

DAPTACEL vaccine helps protect against diphtheria, tetanus, and pertussis, and is indicated as a 5-dose series in children 6 weeks through 6 years of age.7 DAPTACEL vaccine may be used for the fifth dose following the 4-dose Pentacel vaccine series.

Learn more about the pertussis protection of Pentacel vaccine.

How safe is Pentacel vaccine? 
Pentacel vaccine safety was established in a population of over 5000 infants 2 to 18 months of age who received at least 1 dose of Pentacel vaccine.1

•	In clinical trials, most cases of fever reported were mild to moderate1,3
•	The most common local and systemic adverse reactions to Pentacel vaccine include injection site redness, swelling, and tenderness; fever, fussiness, and crying1

How do I record Pentacel vaccine lot numbers? 
If you store the Pentacel vaccine vials in their original carton until the time of use, the lot number on the carton can be recorded singly. The powdered Hib vaccine component vial with the green cap has the same lot number as the Pentacel vaccine carton. Recording this number from either location supports manufacturing traceability in the event of a product recall or an adverse reaction.

If you store the Pentacel vaccine components outside the carton, please record lot numbers from both the Hib component vial and the DTaP-IPV component vial. The DTaP-IPV vial with the blue cap and magenta half circle has a different lot number.

If you store Pentacel vaccine in the original packaging, simply record the lot number from the carton.

How can I transition patients to Pentacel vaccine? 
An interactive immunization schedule is available to help make integrating Pentacel vaccine into your immunization schedule as easy as possible.2

The interactive tool is adapted from the recommended CDCd childhood immunization schedule to help you:

•	Start newborn patients on Pentacel vaccine at the appropriate time
•	Continue the DTaP, IPV, and Hib immunization series for previously vaccinated patients

"The CDC tells us that you can transition to another vaccine should you not have that original vaccine in your office any longer. Any office that is already using DAPTACEL vaccine can convert immediately to Pentacel vaccine."4
—Judith Coates, RN, Director of Immunization Initiatives, sanofi pasteur

How do I reconstitute Pentacel vaccine? 
Reconstitution is quick and easy. Simply mix the DTaP-IPV and Hib components together to make Pentacel vaccine.1 It takes just a few seconds to reconstitute Pentacel vaccine, which provides protection and comparable immunogenicity to DAPTACEL, ActHIB, and IPOL vaccines, simplifies the immunization schedule, and demonstrates proven safety.1-3,8-10

Watch the short video about reconstitution or download the reconstitution instructions pdf. Watch or download now.

How does Pentacel vaccine make inventory management easier? 
There are fewer vaccines to store when you use the Pentacel combination vaccine for all 4 doses. Learn other ways to simplify vaccine inventory management.

How should I enter the lot information into my state registry or Electronic Medical Record (EMR)? 
State registries and EMR may vary. For guidance on recording lot number information—such as recording separate lot numbers—please contact your state or EMR provider.

Watch the Pentacel vaccine Storage and Handling video.

Indication 
Pentacel vaccine is indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to Haemophilus influenzae type b. Pentacel vaccine is approved for use as a 4-dose series in children 6 weeks through 4 years of age (prior to fifth birthday).

Safety Information
The most common local and systemic adverse reactions to Pentacel vaccine include injection site redness, swelling, and tenderness; fever, fussiness, and crying. Other adverse reactions may occur. Known systemic hypersensitivity reaction to any component of Pentacel vaccine or a life-threatening reaction after previous administration of the vaccine or a vaccine containing the same substances are contraindications to vaccination.

The decision to give Pentacel vaccine should be based on the potential benefits and risks; if Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid; or if adverse events have occurred in temporal relation to receipt of pertussis-containing vaccine. Encephalopathy within 7 days of administration of a previous dose of a pertussis-containing vaccine or a progressive neurologic disorder is a contraindication. Vaccination with Pentacel vaccine may not protect all individuals.

Before administering Pentacel vaccine, please see the full Prescribing Information.

Pentacel vaccine is manufactured by Sanofi Pasteur Limited and Sanofi Pasteur SA and distributed by Sanofi Pasteur Inc.