AUVI-Q RECALLED

By DIEN VU11/3/2015

What is an Auvi-Q?• An Epinephrine prefilled auto-injector

– Indicated for emergency treatment of allergic reaction (Type 1 hypersensitivity) including anaphylaxis, stinging/biting insects, foods, drugs, idiopathic anaphylaxis, or exercise-induced anaphylaxis.

• Two strengths available: – Weight ≥ 30 kg (66 lbs): 0.3 mg– Weight 15-30 mg (33-66 lbs): 0.15 mg

• Each device is a single-use injection• A box comes with 2 auto-injectors and 1 trainer

How to use Auvi-Q? • Intended for immediate self-administration as

emergency while waiting for medical care.• Included audible voice instructions, beeps and LED

lights cues for use. • Inject into the outer of the thigh, through clothing if

necessary.

Why is Auvi-Q being recalled?

• Included lot numbers 2081278 through 3037230, which expire Oct 2015 through December 2016.

What are the consequences?

• Anaphylaxis is a life-threatening allergic reaction• If dose is delivered incorrectly, patient could suffer

significant health consequences, including death

Where did it happen?

• As of October 26, 2015, 26 case reports were sent to Sanofi throughout the US and Canada.

• However, it is only suspected device malfunction. There is no confirmation yet.

• Patient reported symptoms of hypersensitivity reaction, but none of the cases were fatal.

How does this incident affect treatment decision?

• Auvi-Q was recently approved by FDA in 2012• Patient can switch back to traditional EpiPen

• EpiPen– Not impacted by the recall– Same treatment dose (0.3mg, 0.15mg epinephrine)– Same packaging: 2 auto-injectors, 1 trainer– No audio guides like Auvi-Q

• Pharmacist is always your best friend to train you how to use an EpiPen

Patient EducationAuvi-Q

EpiPen

Reference

• 1. https://www.auvi-q.com/ Accessed 11/3/2015

• 2. https://www.epipen.com/en/prescribing-information#Patient. Accessed 11/3/2015

QUESTION?

THANK YOU.HOPE YOU LEARNED SOMETHING TODAY.