Hiberix® Clinical Training Presented by Joanna Briggs, R.N. Clinical/Quality &Compliance Coordinator Immunization Section Community and Public Health Division Update on Haemophilus influenzae type b (Hib) Vaccine Shortage • National Hib shortage began in late 2007. • As of October 2009, all Hib vaccines are allocated to Immunization grantees by the Centers for Disease Control and Prevention (CDC). • Hib vaccine allocations will continue until there is adequate Hib vaccine supply. Hib Vaccines -- Differences and Guidelines • PedvaxHIB® (Merck) – Schedule: • 2 doses at least 4 weeks apart (8 weeks preferred). Series should not be started earlier than 6 weeks of age. • Currently, the limited supply of PedvaxHIB® allocated to Wyoming is being shipped directly to Indian Health Services. • ActHIB® (sanofi pasteur) – Schedule: • 3 doses at least 4 weeks apart (8 weeks preferred). Series should not be started earlier than 6 weeks of age. • Pentacel® (sanofi pasteur) includes: – DTaP (Daptacel®) – IPV (IPOL®) – Hib (ActHIB®) • Series is 3 doses at age 2 months, 4 months, 6 months and 12-15 months. • Hiberix® (GSK) • Hiberix® (GSK) – cont. Prescribing Information • Indication and Usage: – Booster dose for the prevention of Haemophilus influenzae type b for children 15 months through 4 years of age (prior to the 5th birthday). – Use only as a booster doses in children who have received a primary series. (Primary series: ActHIB=3 doses; PedvaxHib=2 doses; Pentacel=3 doses.) – Inspect vials and syringes before reconstituting and then only administered a clear and colorless reconstituted solution. • Shake solution vigorously before injecting. • As of October 2009, all children under age 5 years need a completed series of Hib that includes a booster. • Additional information for providers who serve American Indian and Alaska Native children is available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm56d1219a1.htm. • Applicable codes for Hiberix: – WyIR code: PRP-T -- CPT code -- 90648 CVX code -- 48 Safety Information • In clinical studies, adverse events in children receiving Hiberix® included: – Pain and redness at injection site; fever; fussiness; loss of appetite; and restlessness. • Severe allergic reaction (eg, anaphylaxis) after previous dose of any Hib or tetanus toxoid-containing vaccine or component is a contraindication. Additional Resources • CDC’s Morbidity and Mortality Weekly Report (MMWR), dated September 18, 2009 – http://www.cdc.gov/mmwr/preview/mmwrhtml/m m5836a5.htm • Hiberix® Package Insert – http://www.fda.gov/downloads/BiologicsBloodV accines/Vaccines/ApprovedProducts/UCM17953 0.pdf • Hiberix® Web Site: – http://www.hiberix.com/ Please answer these questions on a blank piece of paper and fax your answers to 307-673-5368. Please include your name and PIN on the fax cover sheet – and indicate “Hiberix training competency” on your fax cover sheet. Once received, Hiberix shipments can be authorized. 1. The antigen contained in Hiberix® is ___________. 2. Hiberix® should never be administered after age __________ or before ________ months. 3. Hib booster doses are authorized for all children as of October 2009. TRUE FALSE 4. Adverse events in children receiving Hiberix include: a. ___________ b.______________ c.______________ . 5. Diluents (saline) may be exchanged with other vaccines needing reconstituted. TRUE FALSE 6. Hiberix® lyophilized power should be stored in the ______________ and protected from ____________ .
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