Approved Drug Label (PDF)
4
Contraindications
Additions and/or
revisions underlined:
Glucagon for Injection
is contraindicated
in patients with:
· Pheochromocytoma
· Insulinoma because of the risk of
hypoglycemia
· Known hypersensitivity to
glucagon or any of
the excipients in Glucagon
for Injection. Allergic reactions
have been reported with glucagon
and include anaphylactic shock with
breathing difficulties and hypotension
· Glucagonoma
because of risk of
hypoglycemia when used as a
diagnostic aid
5
Warnings and Precautions
Additions and/or
revisions underlined:
Catecholamine Release in Patients
with Pheochromocytoma
Glucagon
for Injection
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.
Hypoglycemia in Patients
with Insulinoma
In
patients with insulinoma, administration of glucagon may produce
an initial increase in blood glucose;
however, Glucagon for Injection administration
may directly or indirectly (through an
initial rise in blood glucose) stimulate exaggerated insulin release from
an insulinoma and cause hypoglycemia. Glucagon for Injection is contraindicated
in patients with insulinoma . If a patient develops symptoms of hypoglycemia after a dose of Glucagon for Injection, give glucose
orally or intravenously.
Hypersensitivity
and Allergic Reactions
Newly added
section:
Allergic
reactions have been reported with glucagon, these include
generalized rash, and
in some cases anaphylactic shock
with breathing difficulties and hypotension. Glucagon for Injection is contraindicated in patients with a prior hypersensitivity reaction.
Lack of Efficacy
in Patients
with Decreased Hepatic Glycogen
Newly added
section:
Glucagon
for Injection
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 Glucagon
for Injection administration
to be effective. Patients
with these conditions should be treated with glucose.
Necrolytic Migratory
Erythema
Newly added
section:
Necrolytic
migratory erythema (NME), a skin
rash commonly associated
with glucagonomas (glucagon- producing tumors) and characterized
by
scaly, pruritic erythematous plaques, bullae, and
erosions, has been reported postmarketing following continuous glucagon
infusion. NME lesions may affect
the face, groin, perineum and legs or be more widespread. In the reported
cases NME resolved with discontinuation of the glucagon,
and treatment with corticosteroids
was not effective. Should NME occur, consider
whether the benefits of continuous
glucagon infusion outweigh the risks.
Hyperglycemia in Patients with Diabetes Mellitus
when Used as a Diagnostic Aid
Additions and/or
revisions underlined:
Treatment
with Glucagon for Injection in patients with diabetes mellitus
may cause hyperglycemia. Monitor diabetic
patients for changes
in blood glucose levels during treatment and treat if indicated.
Blood Pressure and Heart Rate Increase in Patients with Cardiac
Disease when Used as a
Diagnostic Aid
Additions and/or
revisions underlined:
Glucagon
for Injection
may
increase myocardial oxygen demand, blood pressure, and pulse rate which may be life-threatening in patients
with cardiac disease. Cardiac monitoring is recommended in patients with
cardiac disease during
use of Glucagon for Injection
as a diagnostic aid, and
an increase
in blood pressure and
pulse rate may require therapy.
Hypoglycemia in Patients
with Glucagonoma
Newly added
section:
Glucagon
administered to patients with glucagonoma may cause secondary hyoplycemia.
Glucagon for Injection is contraindicated in patients with glucagonoma when used as a diagnostic aid. Test patients
suspected of having glucagonoma
for blood levels of glucagon prior
to treatment, and monitor for changes in blood glucose levels during treatment. If a patient
develops symptoms of hypoglycemia after a dose of Glucagon
for Injection,
give glucose orally or intravenously.
6
Adverse Reactions
Additions and/or
revisions underlined:
The following important adverse reactions are described below and
elsewhere in the labeling:
· Hypersensitivity and Allergic Reactions
· Necrolytic Migratory Erythema
· Hyperglycemia
in Patients
with Diabetes Mellitus when Used as
a Diagnostic Aid
· Blood Pressure
and Heart Rate Increase in Patients with Cardiac Disease when Used as a Diagnostic Aid
Clinical Studies Experience
Additions and/or
revisions underlined:
Because
clinical trials are conducted under widely varying conditions,
adverse reaction rates observed
in the clinical trials of a drug cannot
be directly compared to the rates
in clinical trials of another drug and may not reflect
the rates observed in practice.
In a randomized single-blind clinical
study of Glucagon for Injection,
29 healthy subjects received a single dose of 1 mg Glucagon for Injection intramuscularly.
Table 1 shows the most common adverse reactions
that were not present at baseline and
occurred in at least 5% of
patients.
Change in title of table:
Table 1: Adverse Reactions Occuring in > 5% of Healthy
Subjects Who Received Glucagon
for Injection Intramuscularly
Newly added information:
In a randomized,
single-blind clinical study of Glucagon
for
Injection, 31 healthy subjects
received a single dose of 1 mg Glucagon
for Injection subcutaneously. Table 2 shows the most common
adverse reactions that were not present
at baseline and occurred in at least 5% of patients.
Change
in title of table:
Table 2: Adverse
Reactions Occurring >5% in Healthy Subjects Who Received Glucagon for Injection
Subcutaneously
Newly added information:
Other Adverse Reactions
Hypertension and tachycardia have occurred with glucagon
treatment
Postmarketing Experience
Newly added section:
Additional adverse reactions have been
identified during post-approval use of glucagon. Because
these reactions are reported
voluntarily from a population of uncertain size, it is generally not possible to reliably estimate
their frequency or establish
a causal relationship to drug exposure.
-hypoglycemia and hypoglycemic coma. Patients taking indomethacin may be more likely to experience hypoglycemia following glucagon administration.
-Necrolytic migratory erythema
(NME) cases have been reported
postmarketing in patients receiving
continuous infusion of glucagon.
8
Use in Specific Populations
PLLR conversion
for below 2 subsections; as below:
Pregnancy
Risk Summary
Available
data from case reports
and a small number of observational studies with glucagon use in pregnant women over decades of use have not identified a drug-associated risk
of major birth defects, miscarriage or adverse maternal or fetal outcomes. Multiple
small studies have demonstrated a lack of transfer
of pancreatic glucagon across the human placental barrier during early
gestation. In
rat and rabbit reproduction
studies, no embryofetal toxicity was observed
with glucagon administered by injection
during the period of organogenesis
at doses representing up to
100 and 200 times the human dose, respectively,
based on body surface area (mg/m2).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects
and miscarriage in clinically
recognized pregnancies is 2%-4% and 15%-20%,
respectively.
Data
Animal Data
In rats and rabbits
given glucagon by injection at doses of 0.4, 2.0, and 10 mg/kg (up to 100 and 200 times
the human dose based on mg/m2 for rats and rabbits, respectively) there
was no evidence of increased
malformations or embryofetal lethality.
Lactation
Risk
Summary
There is no information available
on the presence of glucagon
in human or animal milk, the
effects of glucagon
on the breastfed child or
the effects
of glucagon on milk production.
However, glucagon is a peptide and would be expected
to be broken down to its constituent
amino acids in the infant's digestive tract and is therefore, unlikely to cause harm to an exposed
infant.
Pediatric Use
Additions and/or
revisions underlined:
The safety and effectiveness
of Glucagon for Injection
for the treatment of severe hypoglycemia
in pediatric patients with diabetes
have been established.
Safety and
effectiveness for use as a diagnostic aid during radiologic examinations to temporarily inhibit
movement of the gastrointestinal
tract in pediatric patients
have not been established.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Additions and/or
revisions underlined:
Advise the patient to read the FDA-approved
patient labeling (Patient Information
and
Instructions for Use).
Recognition of Severe Hypoglycemia
Inform
patient and family members or caregivers on how to recognize the signs and
symptoms of severe hypoglycemia and the risks of prolonged hypoglycemia.
Administration
Review
the Patient Information and Instructions for Use with the patient and family members
or caregivers.
Serious Hypersensitivity
Inform
patients that allergic reactions
can occur with Glucagon for Injection. Advise
patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity
reactions.
PATIENT INFORMATION
Newly added section; please
refer to label for complete information.
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