RxPRODUCT NEWS: PROFILE: Boostrix (diphtheria-tetanus-acellular pertussis vaccine)

Pharmacy Times
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Boostrix—a booster vaccine combiningTetanus Toxoid, ReducedDiphtheria Toxoid, and AcellularPertussis, Adsorbed—has receivedFDA approval for use in children andadolescents 10 to 18 years old. Boostrix,produced by GlaxoSmithKline, isthe first pertussis vaccine in the UnitedStates for children >7 years old.1

Most people are vaccinated duringchildhood from diphtheria, tetanus,and pertussis with a combination vaccine(DTaP). The DTaP vaccinationseries is completed around age 5.2,3Although regular boosters of tetanusand diphtheria are required and availableas a combination vaccine (Td),additional vaccination for pertussishas not been available. Immunitybegins to fade 5 to 10 years afterimmunization, leaving the adolescentpopulation especially susceptible topertussis infections.1

Adolescents with pertussis, oftenundiagnosed due to its less-symptomaticpresentation, often act as a host to thedisease. Bordetella pertussis, the organismresponsible for the disease, is highly contagiousand easily transmitted throughairborne droplets in sneezes or coughs.In infants, who have not yet developedthe immune system to ward off suchinfections, pertussis can be deadly.1

Pertussis, also known as "whoopingcough,"typically presents similarly tothe common cold; patients may complainof mild fever, runny nose, andcoughing. As the disease progresses,the cough usually becomes severe andexhibits as a classic high-pitched"whooping"sound. Adolescent patients,however, generally do notdevelop the "whooping"noise associatedwith pertussis.1

Diphtheria usually presents asmalaise, sore throat, and low-gradefever. Later in the disease, a membranemay form over the airway, creating respiratoryobstruction. Five percent to10% of individuals infected with diphtheriadie from the disease; this raterises to up to 20% in patients <5 and>40 years old.

Tetanus is caused by bacteria typicallyfound in soil and manure. Initialsymptoms include lockjaw, neck andabdomen stiffness, and difficulty swallowing.Later symptoms include fever,elevated blood pressure, and severemuscle spasms.

Clinical Trials

A US phase 3 clinical trial of Boostrixinvolving ~3000 patients aged 10 to 18years demonstrated Boostrix to be ofcomparable safety and efficacy to analready-approved Td [Tetanus andDiphtheria Toxoids for Adult Use] vaccine.Antipertussis antibodies in theBoostrix patients were found to benoninferior to levels in infants vaccinatedwith the standard DTaP vaccine.1

An observer-blinded, randomized,controlled, multicenter clinical trial of4114 patients aged 10 to 18 years comparedvaccination with either 1 dose ofBoostrix or an adult Td vaccine. Serologyreports established that bothgroups obtained antidiphtheria andantitetanus levels that indicatedimmunity. The Boostrix group, however,demonstrated antipertussis levelssimilar to those in vaccinated infantswith established pertussis immunity.1

Warnings, Precautions, andAdverse Events

Use as a primary vaccination hasnot yet been established. Boostrixshould not be given to anyone with ahistory of hypersensitivity to any vaccinecontaining tetanus toxoid, diphtheriatoxoid, or pertussis. Encephalopathy,progressive neurologicdisorder, and uncontrolled epilepsyare contraindications for the administrationof Boostrix. Additional cautionshould be used in patients experiencingfever >105ºF, collapse, shock, orinconsolable crying within 48 hours ofadministration or seizures within 3days of administration.4

Pain, redness, and swelling at thesite of injection were the most commonlocal reactions to Boostrix. Systemicadverse effects included headacheand fatigue.4

Dosage and Administration

Boostrix should be administered tothe deltoid muscle as a 0.5-mL intramuscularinjection. It never should beadministered intravenously or subcutaneously.

Dr. Holmberg is a pharmacist with PhoenixChildren's Hospital, Phoenix, Ariz.

For a list of references, send astamped, self-addressed envelope to:References Department, Attn. A. Stahl,Pharmacy Times, 241 Forsgate Drive,Jamesburg, NJ 08831; or send an e-mailrequest to: astahl@ascendmedia.com.

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