INDICATIONS
AND USAGE
GVOKE is an
antihypoglycemic agent indicated for the treatment of severe hypoglycemia in
pediatric and adult patients with diabetes ages 2 years and above.
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full Prescribing
Information for Gvoke.
DOSAGE
AND ADMINISTRATION
· GVOKE auto-injector and pre-filled syringe are for
subcutaneous injection only
· The recommended dose for adults and pediatric
patients aged 12 years and older is 1 mg
· The recommended dose for pediatric patients aged 2
to under 12 years of age is weight dependent:
·
For pediatric patients who weigh less than 45 kg,
the recommended dose is 0.5 mg GVOKE
·
For pediatric patients who weigh 45 kg or greater,
the recommended dose is 1 mg GVOKE
· Administer GVOKE according to the printed
instructions on the foil pouch label, carton, or the Instructions for Use
· Visually inspect GVOKE prior to administration. The
solution should appear clear and colorless to pale yellow and be free of
particles. If the solution is discolored or contains particulate matter, do not
use
· Administer the injection in the lower abdomen, outer
thigh, or outer upper arm
· Call for emergency assistance immediately after
administering the dose
· When the patient has responded to treatment, give
oral carbohydrates
· Do not attempt to reuse GVOKE. Each GVOKE device
contains a single dose of glucagon and cannot be reused
· If there has been no response after 15 minutes, an
additional weight appropriate dose of GVOKE from a new device may be
administered while waiting for emergency assistance
DOSAGE FORMS AND
STRENGTHS
Injection:
·
0.5
mg/0.1 mL single-dose pre-filled HypoPen auto-injector
·
1
mg/0.2 mL single-dose pre-filled HypoPen auto-injector
·
0.5
mg/0.1 mL single-dose pre-filled syringe
·
1
mg/0.2 mL single-dose pre-filled syringe
Please see
full Prescribing
Information for Gvoke.
CONTRAINDICATIONS
·
Pheochromocytoma
·
Insulinoma
·
Known
hypersensitivity to glucagon or to any of the excipients
Please see
full Prescribing
Information for Gvoke.
WARNINGS
AND PRECAUTIONS
· Catecholamine Release in Patients with
Pheochromocytoma: Contraindicated in patients with pheochromocytoma
because GVOKE may stimulate the release of catecholamines from the tumor.
· Hypoglycemia in Patients with Insulinoma: In patients
with insulinoma, administration may produce an initial increase in blood glucose;
however, GVOKE may stimulate exaggerated insulin release from an insulinoma and
cause hypoglycemia. If a patient develops symptoms of hypoglycemia after a dose
of GVOKE, give glucose orally or intravenously.
· Hypersensitivity and Allergic Reactions: Allergic
reactions have been reported and include generalized rash, and in some cases
anaphylactic shock with breathing difficulties, and hypotension.
· Lack of Efficacy in Patients with Decreased Hepatic
Glycogen: GVOKE is effective in treating hypoglycemia only if sufficient hepatic
glycogen is present. Patients in states of starvation, with adrenal
insufficiency or chronic hypoglycemia may not have adequate levels of hepatic
glycogen for GVOKE to be effective. Patients with these conditions should be treated
with glucose.
· Necrolytic Migratory Erythema (NME): a skin rash,
has been reported postmarketing following continuous glucagon infusion and
resolved with discontinuation of the glucagon. Should NME occur, consider
whether the benefits of continuous glucagon infusion outweigh the risks.
· Hypoglycemia in Patients with Glucagonoma: Glucagon
administered to patients with glucagonoma may cause secondary hypoglycemia.
Test patients suspected of having glucagonoma for blood levels of glucagon
prior to treatment, and monitor blood glucose levels during treatment. If a
patient develops hypoglycemia, give glucose orally or intravenously.
Please see full Prescribing
Information for
Gvoke.
ADVERSE
REACTIONS
· Most common adverse reactions (incidence 2% or
greater) reported were:
· Adults—nausea, vomiting, injection site edema raised
1 mm or greater, and headache
· Pediatric Patients—nausea, hypoglycemia, vomiting,
headache, abdominal pain, hyperglycemia, injection site discomfort and
reaction, and urticaria
To report SUSPECTED
ADVERSE REACTIONS, contact Xeris Pharmaceuticals at toll-free 1-877-937-4737 or
FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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see full Prescribing
Information for Gvoke.
DRUG
INTERACTIONS
· Beta-blockers: Patients taking beta-blockers may have
a transient increase in pulse and blood pressure.
· Indomethacin: In patients taking indomethacin GVOKE
may lose its ability to raise glucose or may produce hypoglycemia.
· Warfarin: GVOKE may increase the anticoagulant
effect of warfarin.
Please see
full Prescribing
Information for Gvoke.
Hypoglycemic
disorder
E08.64 Diabetes
mellitus due to underlying condition with hypoglycemia
E08.649 Diabetes
mellitus due to underlying condition with hypoglycemia
without coma
E09.64 Drug or chemical induced diabetes mellitus
with hypoglycemia
E09.649 Drug
or chemical induced diabetes mellitus with hypoglycemia
without coma
E10.64 Type 1 diabetes mellitus with hypoglycemia
E10.649 Type 1
diabetes mellitus with hypoglycemia without coma
E11.64 Type 2
diabetes mellitus with hypoglycemia
E11.649 Type 2 diabetes mellitus with hypoglycemia
without coma
E13.64 Other specified diabetes mellitus with
hypoglycemia
E13.649 Other specified diabetes mellitus with
hypoglycemia without coma
E16.0 Drug-induced
hypoglycemia without coma
E16.1 Other
hypoglycemia
E16.2 Hypoglycemia,
unspecified
P70.3 Iatrogenic
neonatal hypoglycemia
P70.4 Other
neonatal hypoglycemia
US-GVK-20-00148 09/20
Please see full Prescribing Information
INDICATION AND
IMPORTANT SAFETY INFORMATION
INDICATION
GVOKE is indicated for
the treatment of severe hypoglycemia in adult and pediatric patients with
diabetes ages 2 years and above.
IMPORTANT
SAFETY INFORMATION
Contraindications
GVOKE is contraindicated
in patients with pheochromocytoma, insulinoma, and known hypersensitivity to
glucagon or to any of the excipients in GVOKE. Allergic reactions have been
reported with glucagon and include anaphylactic shock with breathing
difficulties and hypotension.
Warnings
and Precautions
GVOKE is contraindicated
in patients with pheochromocytoma because glucagon may stimulate the release of
catecholamines from the tumor. If the patient develops a dramatic increase in
blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to
10 mg of phentolamine mesylate, administered intravenously, has been shown to
be effective in lowering blood pressure.
In patients with
insulinoma, administration of glucagon may produce an initial increase in blood
glucose; however, GVOKE administration may directly or indirectly (through an
initial rise in blood glucose) stimulate exaggerated insulin release from an
insulinoma and cause hypoglycemia. GVOKE is contraindicated in patients with
insulinoma. If a patient develops symptoms of hypoglycemia after a dose of
GVOKE, give glucose orally or intravenously.
Allergic reactions have
been reported with glucagon. These include generalized rash, and in some cases,
anaphylactic shock with breathing difficulties and hypotension. GVOKE is
contraindicated in patients with a prior hypersensitivity reaction.
GVOKE is effective in
treating hypoglycemia only if sufficient hepatic glycogen is present. Patients
in states of starvation, with adrenal insufficiency or chronic hypoglycemia,
may not have adequate levels of hepatic glycogen for GVOKE administration to be
effective. Patients with these conditions should be treated with glucose.
Necrolytic
migratory erythema (NME), a skin rash commonly associated with glucagonomas has
been reported postmarketing following continuous glucagon infusion and resolved
with discontinuation of the glucagon. Should NME occur, consider whether the
benefits of continuous glucagon infusion outweigh the risks. Glucagon
administered to patients with glucagonoma may cause secondary hypoglycemia.
Adverse
Reactions
Most common (≥5%)
adverse reactions associated with GVOKE are nausea, vomiting, injection site
edema (raised 1 mm or greater), and hypoglycemia.
Drug
Interactions
Patients taking
beta-blockers may have a transient increase in pulse and blood pressure when given
GVOKE. In patients taking indomethacin, GVOKE may lose its ability to raise
blood glucose or may even produce hypoglycemia. GVOKE may increase the anticoagulant
effect of warfarin.