H
IGHLIGHTS OF PRESCRIBING INFORMATION
Thes
e highlights do not include all the information needed to use
AUVI-Q® sa
fely and effectively. See full prescribing information for
AUVI-Q.
AUVI-Q® (e
pinephrine injection, USP) 0.3 mg, 0.15 mg, 0.1 mg
Auto-Inj
ector, for intramuscular or subcutaneous use
Initia
l U.S. Approval: 1939
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--------------------
-
------
RECE
NT MAJOR CHANGES
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---------------------
• Do
s
ag
e and Administration (2)
11/2
017
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--------------------------
INDI
CATIONS AND USAGE
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-------------------------
AUVI-Q co
ntains epinephrine, a n
on-selectiv
e alpha and beta
-ad
renergic
rece
ptor agonist, indicated in the emergency treatment of allergic reactions
(T
ype I) including anaphylaxis. (1)
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--------------------
DO
SAGE AND ADMINISTRATION
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---------------------
• Patien
ts greater than or equal to 30 kg (66 lbs):
AUVI-Q 0
.3 mg (2)
• Patien
ts 15 to 30 kg (33 to
6
6 lbs):
AUVI-Q 0
.15 mg (2)
• Patien
ts
7.5 to 1
5 kg (16
.5 to
3
3 lbs):
AUV
I
-Q 0
.1 mg (2)
Inject A
UVI
-Q in
tramuscularly or subcutaneously into the anterolateral aspect of the
th
igh, through clothing if necessary.
E
ach device is a single
-u
se injection.
(2
)
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-------------------
DO
SAGE FORMS AND STRENGTHS
-
---------------------
• Injectio
n, 0.3 mg: 0.3 mg/0.3 mL
ep
inephrine injection, USP, pre
-f
illed
au
to
-in
jector (3)
• Injectio
n, 0.15 mg: 0.15 mg/0.15 mL epinephrine injection, USP, pre
-
f
illed auto
-in
jector (3)
• Injectio
n, 0.1 mg: 0.1 mg/0.1 mL epinephrine injection, USP, pre
-f
illed
au
to
-in
jector (3)
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------------
--
---------------
C
ONTRAINDICATIONS
-
-----------------------------
No
ne
. (4)
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---------------------
WARNIN
GS AND PRECAUTIONS
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----------------------
• In co
njunction with use, seek immediate medical or hospital care.
(5.1
)
• Do
not inject intravenously, into
b
uttock, or into digits, hands, or feet. (5.2)
• To
minimize the risk of injection
-related
injury, instruct caregivers to hold
th
e child’s leg firmly in place and limit movement prior to and during
in
jection when administering to young children
o
r infants
. (5.2
)
• Rare
cases of serious skin and soft tissue infections have been reported
f
ollowing epinephrine injection.
Ad
vise patients to seek medical care if they
d
evelop signs or symptoms of infection at the epinephrine injection site. (5.3)
• The p
resence of a
su
lfite in this product should not deter use. (5.
4)
• Ad
minister with caution in patients with heart disease; may aggravate angina
p
ectoris or produce ventricular arrhythmias. (5.
5)
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----------------------------
AD
VERSE REACTIONS
-
--------------------------
-
---
Ad
verse reactions to epinephrine include anxiety, apprehensiveness,
restless
ness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea
an
d vomiting, headache, and/or respiratory difficulties. (6)
To
report SUSPECTED ADVERSE REACTIONS, contact kaleo, Inc. at
1-844-8
28
-8
742 or FDA at 1
-800-F
DA
-1
088 or
w
ww.fda.gov/medwatch
.
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----------------------------
DR
UG INTERACTIONS
-
------------------------------
• Card
iac glycosides or diuretics: observe for development of cardiac
arr
hythmias. (7)
• Tr
icyclic antidepressants, monoamine oxidase inhibitors, levothyroxine
so
dium, and certain antihistamines: potentiate effects of epinephrine. (7)
• Beta-ad
renergic blocking
d
rugs: antagonize cardiostimulating and
b
ronchodilating effects of epinephrine. (7)
• Alp
ha
-ad
renergic blocking drugs: antagonize vasoconstricting and
h
ypertensive effects of epinephrine. (7)
• Er
got alkaloids: may reverse the pressor effects of epinephrine. (
7)
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----------------------
USE IN
SPECIFIC POPULATIONS
--
---------------
• E
lderly patients may be at greater risk of developing adverse reactions. (5.
5, 8
.5)
See
17 for PATIENT COUNSELING INFORMATION and FDA
-
a
pproved patient labeling
Rev
ised:
11/2017
_
____________________________________________________________________________________________________________________________
_
__
FULL P
RESCRIBING INFORMATION: CONTENTS*
1 INDI
CATIONS AND USAGE
2 DO
SAGE
AND
ADMINISTRATION
3 DO
SAGE FORMS AND STRENGTHS
4 CO
NTRAINDICATIONS
5 WARNIN
GS AND PRECAUTIONS
5
.1
E
mergency Treatment
5
.2
Injectio
n
-related C
omplications
5
.3
Seriou
s Infections at the Injection Site
5.4 Allergic Rea
ctions Associated with Sulfite
5.5 Diseas
e Interactions
6 ADVERSE
REACTIONS
7 DRU
G INTERACTIONS
8 USE IN S
PECIFIC POPULATIONS
8
.1
Pregn
ancy
8
.3 Nursing Mothers
8
.4 Pediatric Use
8
.5 Geriatric Use
10 O
VERDOSAGE
11 DESCRI
PTION
12 CLI
NICAL PHARMACOLOGY
1
2.1
Mechan
ism of Action
1
2.2
Ph
armacodynamics
13 NO
NCLINICAL TOXICOLOGY
1
3.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
16 H
OW SUPPLIED/STORAGE AND HANDLING
1
6.1
Ho
w Supplied
1
6.2
Sto
rage and Handling
17 PATIE
NT COUNSELING INFORMATION
*
Sections or
su
bsections omitted from the full prescribing information are not
listed
.
Reference ID: 4183363