Matching articles for "Auvi-Q"
An Epinephrine Nasal Spray (neffy) for Anaphylaxis
The Medical Letter on Drugs and Therapeutics • October 14, 2024; (Issue 1713)
The FDA has approved an epinephrine nasal spray
(neffy – ARS Pharma) for emergency treatment
of type 1 hypersensitivity reactions including
anaphylaxis in patients who weigh ≥30 kg. It is
the first...
The FDA has approved an epinephrine nasal spray
(neffy – ARS Pharma) for emergency treatment
of type 1 hypersensitivity reactions including
anaphylaxis in patients who weigh ≥30 kg. It is
the first noninjectable epinephrine product to be
approved for this indication.
Drugs Past Their Expiration Date
The Medical Letter on Drugs and Therapeutics • July 27, 2020; (Issue 1603)
Healthcare providers are often asked if drugs can
be used past their expiration date. Because of legal
restrictions and liability concerns, manufacturers do
not sanction such use and usually do not...
Healthcare providers are often asked if drugs can
be used past their expiration date. Because of legal
restrictions and liability concerns, manufacturers do
not sanction such use and usually do not comment
on the safety or effectiveness of their products beyond
the date on the label. Since our last article on this
subject, more data have become available.
An Epinephrine Prefilled Syringe (Symjepi) for Anaphylaxis
The Medical Letter on Drugs and Therapeutics • February 25, 2019; (Issue 1566)
The FDA has approved a manually
injected, single-dose, prefilled
epinephrine syringe (Symjepi –
Adamis/Sandoz) for emergency
treatment of anaphylaxis. The new
device is approved in 0.3- and
0.15-mg...
The FDA has approved a manually
injected, single-dose, prefilled
epinephrine syringe (Symjepi –
Adamis/Sandoz) for emergency
treatment of anaphylaxis. The new
device is approved in 0.3- and
0.15-mg strengths for treatment of
patients weighing ≥30 kg and 15 to
30 kg, respectively; only the 0.3-mg
strength is currently available.
According to Sandoz, Symjepi will be made available
first to institutions and later to the retail market.
In Brief: Auvi-Q Epinephrine Auto-Injector for Infants and Toddlers
The Medical Letter on Drugs and Therapeutics • May 21, 2018; (Issue 1547)
The FDA has approved a lower-dose epinephrine auto-injector (Auvi-Q 0.1 mg – Kaléo) for emergency treatment of anaphylaxis in children weighing 7.5-15 kg (16.5-33 lbs). It is the first epinephrine...
The FDA has approved a lower-dose epinephrine auto-injector (Auvi-Q 0.1 mg – Kaléo) for emergency treatment of anaphylaxis in children weighing 7.5-15 kg (16.5-33 lbs). It is the first epinephrine auto-injector to be approved for use in infants and toddlers weighing less than 15 kg. Previously, Auvi-Q and other epinephrine auto-injectors were only available in 0.15- and 0.3-mg strengths for patients weighing 15-30 kg or ≥30 kg, respectively.
The recommended dose of epinephrine for intramuscular (IM) or subcutaneous (SC) administration is 0.01 mg/kg. None of the previously available epinephrine auto-injectors provided a weight-appropriate dose for infants, so many physicians prescribed a 0.15-mg auto-injector off-label for this age group.2
The Auvi-Q device is about the length and width of a credit card and as thick as a cell phone. It has an automatic needle retraction system and a red safety guard at the needle-end of the device. Removal of the outer case initiates visual signals and an audio recording that provides step-by-step instructions and a 2-second countdown during the injection process.
Auvi-Q should be injected IM into the anterolateral aspect of the thigh (through clothing, if necessary). After treatment with epinephrine, the patient should be taken to the nearest emergency department; anaphylaxis symptoms recur in up to 15% of patients hours after resolution of the initial symptoms.3
The needle length in the new 0.1-mg auto-injector is shorter than in other epinephrine auto-injectors. Use of a shorter needle decreases the risk of striking bone when administering a dose to a small child, but may result in SC rather than IM injection.4,5 Higher levels of epinephrine are obtained with IM injection than with SC injection.6
Auvi-Q 0.1 mg is supplied in a carton containing two single-use auto-injectors and a training device without a needle. The outer case protects the epinephrine solution from light; exposure to excessive heat or cold should be avoided. The shelf-life of the epinephrine in the auto-injector is 18 months. All three strengths of Auvi-Q are priced the same.
The recommended dose of epinephrine for intramuscular (IM) or subcutaneous (SC) administration is 0.01 mg/kg. None of the previously available epinephrine auto-injectors provided a weight-appropriate dose for infants, so many physicians prescribed a 0.15-mg auto-injector off-label for this age group.2
The Auvi-Q device is about the length and width of a credit card and as thick as a cell phone. It has an automatic needle retraction system and a red safety guard at the needle-end of the device. Removal of the outer case initiates visual signals and an audio recording that provides step-by-step instructions and a 2-second countdown during the injection process.
Auvi-Q should be injected IM into the anterolateral aspect of the thigh (through clothing, if necessary). After treatment with epinephrine, the patient should be taken to the nearest emergency department; anaphylaxis symptoms recur in up to 15% of patients hours after resolution of the initial symptoms.3
The needle length in the new 0.1-mg auto-injector is shorter than in other epinephrine auto-injectors. Use of a shorter needle decreases the risk of striking bone when administering a dose to a small child, but may result in SC rather than IM injection.4,5 Higher levels of epinephrine are obtained with IM injection than with SC injection.6
Auvi-Q 0.1 mg is supplied in a carton containing two single-use auto-injectors and a training device without a needle. The outer case protects the epinephrine solution from light; exposure to excessive heat or cold should be avoided. The shelf-life of the epinephrine in the auto-injector is 18 months. All three strengths of Auvi-Q are priced the same.
- Drugs for allergic disorders. Med Lett Drugs Ther 2017; 59:71.
- SH Sicherer and FER Simons et al. Epinephrine for first-aid management of anaphylaxis. Pediatrics 2017; 139:e20164006.
- S Lee et al. Update on biphasic anaphylaxis. Curr Opin Allergy Clin Immunol 2016; 16:346.
- H Kim et al. Inadequacy of current pediatric epinephrine autoinjector needle length for use in infants and toddlers. Ann Allergy Asthma Immunol 2017; 118:719.
- S Dreborg et al. Epinephrine auto-injector needle lengths: can both subcutaneous and periosteal/intraosseous injection be avoided? Ann Allergy Asthma Immunol 2018 Feb 27 (epub).
- FE Simons et al. Epinephrine absorption in children with a history of anaphylaxis. J Allergy Clin Immunol 1998; 101:33.
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Odactra - Sublingual Immunotherapy for House Dust Mite-Induced Allergic Rhinitis
The Medical Letter on Drugs and Therapeutics • February 26, 2018; (Issue 1541)
The FDA has approved Odactra (ALK), a sublingual
allergen extract, for immunotherapy in adults 18-65
years old with house dust mite (HDM)-induced allergic
rhinitis, with or without conjunctivitis. Odactra is...
The FDA has approved Odactra (ALK), a sublingual
allergen extract, for immunotherapy in adults 18-65
years old with house dust mite (HDM)-induced allergic
rhinitis, with or without conjunctivitis. Odactra is the
first sublingual allergen extract to be approved in the
US for this indication. Three other sublingual allergen
extracts were approved earlier (see Table 1).
Drugs for Allergic Disorders
The Medical Letter on Drugs and Therapeutics • May 8, 2017; (Issue 1520)
Allergic rhinitis can be classified as seasonal,
perennial, or episodic. It is often associated with
allergic conjunctivitis, rhinosinusitis, and asthma. H1-ANTIHISTAMINES — Oral – Oral...
Allergic rhinitis can be classified as seasonal,
perennial, or episodic. It is often associated with
allergic conjunctivitis, rhinosinusitis, and asthma.
H1-ANTIHISTAMINES — Oral – Oral second-generation H1-antihistamines are the preferred first-line treatment for relief of the itching, sneezing, and rhinorrhea that characterize mild-to-moderate allergic rhinitis. They are less effective for nasal congestion.
H1-ANTIHISTAMINES — Oral – Oral second-generation H1-antihistamines are the preferred first-line treatment for relief of the itching, sneezing, and rhinorrhea that characterize mild-to-moderate allergic rhinitis. They are less effective for nasal congestion.
Auvi-Q Epinephrine Auto-Injector Returns
The Medical Letter on Drugs and Therapeutics • February 27, 2017; (Issue 1515)
Auvi-Q (Kaléo; previously manufactured and
marketed by Sanofi), the epinephrine auto-injector
approved by the FDA in 2012 for emergency treatment
of anaphylaxis and voluntarily withdrawn in 2015
due to...
Auvi-Q (Kaléo; previously manufactured and
marketed by Sanofi), the epinephrine auto-injector
approved by the FDA in 2012 for emergency treatment
of anaphylaxis and voluntarily withdrawn in 2015
due to potential inaccurate dosage delivery, has
become available once more. According to Kaléo,
improvements in the manufacturing process have
addressed the concerns that led to its recall.
In Brief: Epinephrine Auto-Injectors for Anaphylaxis (online only)
The Medical Letter on Drugs and Therapeutics • September 12, 2016; (Issue 1503)
News about recent price increases for EpiPen and EpiPen Jr (Mylan) may have patients asking about other options for emergency treatment of anaphylaxis. Adrenaclick and its generic equivalent (epinephrine...
News about recent price increases for EpiPen and EpiPen Jr (Mylan) may have patients asking about other options for emergency treatment of anaphylaxis. Adrenaclick and its generic equivalent (epinephrine injection auto-injector) are the only other epinephrine auto-injectors currently available in the US. According to Impax (the manufacturer of both the brand and generic products), Adrenaclick is no longer being manufactured; the generic product will continue to be marketed after supplies of Adrenaclick are depleted. Auvi-Q (Sanofi), an epinephrine auto-injector that was approved by the FDA in 2013, was removed from the market in 2015 due to inconsistencies in delivery of epinephrine doses, including failure to deliver the drug.1
Adrenaclick and its generic equivalent are similar to EpiPen and EpiPen Jr in size and functionality, but they are not considered interchangeable with the EpiPen products due to differences in device design and instructions for use. One pack (two auto-injectors) of EpiPen or EpiPen Jr costs $608.60. One pack of Impax's generic auto-injectors costs $395.20.2
According to Mylan, generic versions of EpiPen and EpiPen Jr will soon become available at about half the cost of the brand-name products.
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Adrenaclick and its generic equivalent are similar to EpiPen and EpiPen Jr in size and functionality, but they are not considered interchangeable with the EpiPen products due to differences in device design and instructions for use. One pack (two auto-injectors) of EpiPen or EpiPen Jr costs $608.60. One pack of Impax's generic auto-injectors costs $395.20.2
According to Mylan, generic versions of EpiPen and EpiPen Jr will soon become available at about half the cost of the brand-name products.
- FDA. Updated: Sanofi US issues voluntary nationwide recall of all Auvi-Q due to potential inaccurate dosage delivery. Available at www.fda.gov. Accessed September 1, 2016.
- Approximate WAC. WAC = wholesaler acquisition cost or manufacturer's published price to wholesalers; WAC represents a published catalogue or list price and may not represent an actual transactional price. Source: AnalySource® Monthly. August 5, 2016. Reprinted with permission by First Databank, Inc. All rights reserved. ©2016. www.fdbhealth.com/policies/drug-pricing-policy.
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Drugs Past Their Expiration Date
The Medical Letter on Drugs and Therapeutics • December 7, 2015; (Issue 1483)
Healthcare providers are often asked if drugs can
be used past their expiration date. Because of legal
restrictions and liability concerns, manufacturers do
not sanction such use and usually do not even...
Healthcare providers are often asked if drugs can
be used past their expiration date. Because of legal
restrictions and liability concerns, manufacturers do
not sanction such use and usually do not even comment
on the safety or effectiveness of their products
beyond the date on the label. Since our last publication
on this subject, more data have become available.
Drugs for Allergic Disorders
The Medical Letter on Drugs and Therapeutics • May 1, 2013; (Issue 129)
The use of drugs to prevent and control symptoms of
allergic disorders can be optimized when patients
avoid exposure to specific allergens and/or environmental
conditions that trigger or worsen their...
The use of drugs to prevent and control symptoms of
allergic disorders can be optimized when patients
avoid exposure to specific allergens and/or environmental
conditions that trigger or worsen their symptoms.
In Brief: Auvi-Q - A New Epinephrine Auto-Injector
The Medical Letter on Drugs and Therapeutics • February 18, 2013; (Issue 1410)
A new epinephrine auto-injector is available in the US (Auvi-Q – Sanofi; Allerject in Canada) for emergency treatment of anaphylaxis. The new device is about the length and width of a credit card and as thick...
A new epinephrine auto-injector is available in the US (Auvi-Q – Sanofi; Allerject in Canada) for emergency treatment of anaphylaxis. The new device is about the length and width of a credit card and as thick as a smartphone. It has a retractable needle system and a red safety guard located at the same end as the needle. Activation of the device by removing the outer case initiates an audio voice recording that provides step-by-step instructions and a 5-second countdown during the injection. The shelf-life of the epinephrine in the auto-injector is 18 months; the shelf-life of the battery is longer.
Auvi-Q’s needle length, gauge and injection force are similar to those of EpiPen. A randomized, crossover, bioavailability study found that injection of epinephrine 0.3 mg from Auvi-Q and EpiPen resulted in similar peak epinephrine levels and total epinephrine exposure.1 Like EpiPen, Auvi-Q is available in 2 doses: 0.15 mg (for children weighing 15-30 kg) and 0.3 mg. The cost for 2 Auvi-Qs containing either 0.15 mg or 0.3 mg is $241, compared to $240.66 for an EpiPen Jr or EpiPen 2-Pak.2
CONCLUSION — Auvi-Q is a new, smaller epinephrine auto-injector that provides audio instructions as it is being used. It appears to be more convenient to carry and easier to use than EpiPen.
1. ES Edwards et al. J Allergy Clin Immunol 2012;129:AB179, abstract 678.
2. Wholesale acquisition cost (WAC). Source: $ource® Monthly (Selected from FDB MedKnowledge™) February 5, 2013. Reprinted with permission by FDB, Inc. All rights reserved. ©2013. www.fdbhealth.com/policies/drug-pricing-policy. Actual retail prices may vary.
Download complete U.S. English article
Auvi-Q’s needle length, gauge and injection force are similar to those of EpiPen. A randomized, crossover, bioavailability study found that injection of epinephrine 0.3 mg from Auvi-Q and EpiPen resulted in similar peak epinephrine levels and total epinephrine exposure.1 Like EpiPen, Auvi-Q is available in 2 doses: 0.15 mg (for children weighing 15-30 kg) and 0.3 mg. The cost for 2 Auvi-Qs containing either 0.15 mg or 0.3 mg is $241, compared to $240.66 for an EpiPen Jr or EpiPen 2-Pak.2
CONCLUSION — Auvi-Q is a new, smaller epinephrine auto-injector that provides audio instructions as it is being used. It appears to be more convenient to carry and easier to use than EpiPen.
1. ES Edwards et al. J Allergy Clin Immunol 2012;129:AB179, abstract 678.
2. Wholesale acquisition cost (WAC). Source: $ource® Monthly (Selected from FDB MedKnowledge™) February 5, 2013. Reprinted with permission by FDB, Inc. All rights reserved. ©2013. www.fdbhealth.com/policies/drug-pricing-policy. Actual retail prices may vary.
Download complete U.S. English article