[18 April 2013]
Products Affected - Description
Pentacel Vaccine, Sanofi Pasteur
0.5 mL single dose vial, package of 5 (NDC 49281-0510-05)
Reason for the Shortage
Sanofi Pasteur states the reason for the shortage is manufacturing delay, which will reduce supplies below current demand.1,2
Available Products
There are no presentations fully available.
Estimated Resupply Dates
Pentacel is currently unavailable, but orders are being taken. Sanofi Pasteur estimates a release date of early-June 2013 for customers with past purchase history of Pentacel. The company estimates a release date of early-September 2013 for customers without a past purchase history.1
Safety
Ensure patients receive the adequate number of vaccinations as outlined by the Centers for Disease Control and Prevention (CDC) Recommended Immunization Schedules.3
Alternative Agents & Management
- Pentacel is labeled for active immunization against tetanus, diphtheria, pertussis, poliomyelitis and invasive Haemophilus influenzae type B as a 4-dose series in pediatric patients ages 6 weeks to 4 years old.4
- During this shortage, clinicians should use single component DTaP, IPV, and Hib vaccines or other combination vaccines to complete the recommended immunization schedule. For more information on using single component or combination vaccines for pediatric patients who have already received Pentacel doses, see online Guidance document from CDC.5
Related Shortages
References
- Sanofi Pasteur (personal communications). May 18, June 20, July 18, August 22, October 5, November 12, 2012; January 14, March 1, and April 1, 17, and 18, 2013.
- Sanofi Pasteur. Supply notification letter to health care providers (April 2012). Available online. Accessed May 18, 2012.
- Centers for Disease Control and Prevention (CDC). General Recommendations on Immunization, Recommendations of the Advisory Committee on Immunization Practice. MMWR Morb Mortal Wkly Rep. 2011 Jan 28;60(RR02):1-60. Available online. Accessed May 18, 2012.
- Sanofi Pasteur. Pentacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus and Haemophilus B Conjugate Vaccine) Suspension for Intramuscular Injection [product labeling]. Swiftwater, PA: Sanofi Pasteur; 2011.
- Department of Health and Human Services, Centers for Disease Control and Prevention. Guidance for vaccinating children during the 2012 Pentacel and Daptacel Shortage. Available online. Accessed May 18, 2012.
Updated
Updated April 18, 2013 by Michelle Wheeler, PharmD, Drug Information Specialist. Created May 18, 2012, by Jane Chandramouli, PharmD, Drug Information Specialist, Drug Information Service Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
Disclaimer
This information is provided through the support of Novation to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Novation, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Novation, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Novation, ASHP nor University of Utah endorses or recommends the use of any drug.
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