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epinephrine autoinjector (Epipen, Symjepi)
Indications:
- history of serious allergic reaction & risk of re-exposure
- use immediately at onset of symptoms of anaphylaxis
Dosage: (administration)
1) inject into outer thigh, hold for 10 seconds, massage
2) no need to remove clothing
3) SEEK MEDICAL ATTENTION AFTER USING
4) up to 20% of patients get a 2nd dose to treat anaphylaxis [4]
epinephrine: 0.15 mg/dose, 0.3 mg/dose
Storage:
1) keep in container, epinephrine is degraded by light & heat
2) glove box in car NOT recommended
3) do NOT refrigerate (auto-injector may malfunction)
- Epipens still work after freezing for 24 hours [17]
4) replace if solution turns brown or precipitates
Black cap houses needle, do NOT try to take it off [2]
Pharmacokinetics:
- effects start to wear off after 10-20 minutes
Adverse effects:
- lacerations
- embedded needles [5]
- inaccurate dosage delivery [6]
- failure of autoinjector to activate [12]
Notes:
- cost of 2-pack > $600 [7,8]
- generic to be released at cost of 2-pack = $300 [8]
- 1st generic Epipen FDA-approved Aug 16, 2018 [15]
- recall of select lots of EpiPen, including lots distributed in the U.S. (2017) [12]
- dose available 50 months after expiration would still provide a beneficial pharmacologic response [13]
- FDA extends epiration date of 0.3 mg doses (Mylan) [16]
Related
anaphylaxis
insect sting or anaphylaxis kit (Ana-Kit)
General
device (medical device)
References
- Prescriber's Letter 11(3):13 2004
Detail-Document#: 200303
(subscription needed) http://www.prescribersletter.com
- Prescriber's Letter 14(1): 2007
Medication Errors due to Medication Delivery Devices
Detail-Document#: 230113
(subscription needed) http://www.prescribersletter.com
- Prescriber's Letter 16(9): 2009
COMMENTARY: Epinephrine Auto-Injectors and Needle Length:
Can They Deliver an Intramuscular Dose?
GUIDELINES: Diagnosis and Management of Anaphylaxis
(AAAAI/ACAAI/JCAAI, 2005 Update)
Detail-Document#: 250904
(subscription needed) http://www.prescribersletter.com
- Prescriber's Letter 17(6): 2010
COMMENTARY: Self-injected Epinephrine in the Outpatient
Treatment of Anaphylaxis
GUIDELINES: American Academy of Allergy, Asthma and Immunology:
The Diagnosis and Management of Anaphylaxis
Detail-Document#: 260602
- Brown JC, Tuuri RE, Akhter S et al
Lacerations and Embedded Needles Caused by Epinephrine Autoinjector
Use in Children.
Pediatrics. Oct 2015
http://www.annemergmed.com/article/S0196-0644%2815%2900588-0/pdf
- FDA Safety Alert. Oct 29, 2015
Auvi-Q (epinephrine injection, USP): Recall - Potential
Inaccurate Dosage Delivery.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm470010.htm
- Orciari Herman A, Sofair A, Chavey WE
EpiPen Costs Lowered for Some
Physician's First Watch, Aug 26, 2016
David G. Fairchild, MD, MPH, Editor-in-Chief
Massachusetts Medical Society
http://www.jwatch.org
- Mylan News Release. Aug. 25, 2016
Mylan Taking Immediate Action to Further Enhance Access
to EpiPen (Epinephrine Injection, USP) Auto-Injector.
http://newsroom.mylan.com/2016-08-25-Mylan-Taking-Immediate-Action-to-Further-Enhance-Access-to-EpiPen-Epinephrine-Injection-USP-Auto-Injector
- Mylan News Release. Aug. 29, 2016
Mylan to Launch First Generic to EpiPen Auto-Injector at a
List Price of $300 per Two-Pack Carton, a More than 50%
Discount to the Brand Product.
http://newsroom.mylan.com/2016-08-29-Mylan-to-Launch-First-Generic-to-EpiPen-Auto-Injector-at-a-List-Price-of-300-per-Two-Pack-Carton-a-More-than-50-Discount-to-the-Brand-Product
- KALEO ANNOUNCES 2017 U.S. RETURN OF AUVI-Q (EPINEPHRINE
INJECTION, USP) AUTO-INJECTOR FOR LIFE-THREATENING ALLERGIC REACTIONS.
PR Newswire, RICHMOND, VA. October 26, 2016
http://www.multivu.com/players/English/7940951-auvi-q-epinephrine-auto-injector-comeback/
- KALEO ANNOUNCES U.S. AVAILABILITY AND PRICING TO PATIENTS OF
AUVI-Q (Epinephrine Injection, USP) AUTO-INJECTOR, FOR LIFE-
THREATENING ALLERGIC REACTIONS.
PR Newswire, RICHMOND, VA. January 19, 2017
- Coukell A, Shih C, Reese E
Beyond EpiPen: Prices of Lifesaving Epinephrine Products Soar
Competition has failed to drive down prices, leaving
policymakers demanding answers.
The Pew Charitable Trusts Research & Analysis Sept 22, 2016
http://www.pewtrusts.org/en/research-and-analysis/analysis/2016/09/22/beyond-epipen-prices-of-lifesaving-epinephrine-products-soar
- EpiPen Maker Mylan Hit With Class-Action Lawsuit
PR Newswire, Houston Tx. October 26, 2016
http://www.prnewswire.com/news-releases/epipen-maker-mylan-hit-with-class-action-lawsuit-300351794.html
- FDA Safety Alert. March 31, 2017
EpiPen and and EpiPen Jr Auto-Injector: Recall - Failure to
Activate Device.
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm550165.htm
- Cantrell FL, Cantrell P, Wen A, Gerona R
Epinephrine Concentrations in EpiPens After the Expiration Date.
Ann Intern Med. 2017. May 9.
PMID: 28492859
http://annals.org/aim/article/2625390/epinephrine-concentrations-epipens-after-expiration-date
- Brooks M
FDA Approves New Epinephrine Prefilled Syringe
Medscape - Jun 16, 2017.
http://www.medscape.com/viewarticle/881731
- FDA News Release. Aug 16, 2018
FDA approves first generic version of EpiPen.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm617173.htm
- Brooks M
FDA Extends Some EpiPen Expiration Dates to Fight Shortages.
Medscape - Aug 21, 2018.
https://www.medscape.com/viewarticle/901002
- Boyles S
EpiPens Still Work After Freezing.
Devices still fired after being frozen for 24 hours in study.
MedPage Today. November 20, 2018
https://www.medpagetoday.com/meetingcoverage/acaai/76458
- Weir A et al.
Epinephrine auto-injectors for anaphylaxis: a review of the clinical
effectiveness, cost-effectiveness, and guidelines [Internet]. Ottawa (ON):
Canadian Agency for Drugs and Technologies in Health; 2020 Apr 24.
PMID: 33074635
Bookshelf ID: NBK563019
Components
epinephrine; adrenaline (Sus-Phrine, Vapronefrin, Epifrin, Glaucon, Auvi-Q, Allerject)