Approved Drug Label (PDF)
5
Warnings and Precautions
5.10 Pulmonary Aspiration During General Anesthesia or Deep
Sedation
Newly
added subsection:
BYETTA
delays gastric emptying [see Clinical
Pharmacology (12.2)]. There have been rare postmarketing reports of
pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing
elective surgeries or procedures requiring general anesthesia or deep sedation
who had residual gastric contents despite reported adherence to preoperative
fasting recommendations.
Available
data are insufficient to inform recommendations to mitigate the risk of
pulmonary aspiration during general anesthesia or deep sedation in patients
taking BYETTA, including whether modifying preoperative fasting recommendations
or temporarily discontinuing BYETTA could reduce the incidence of retained
gastric contents. Instruct patients to inform healthcare providers prior to any
planned surgeries or procedures if they are taking BYETTA.
6
Adverse Reactions
Addition of the
following to the bulleted line listing:
- Pulmonary
Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions (5.10)]
6.2 Postmarketing
Experience
Newly
added information:
…
Pulmonary: Pulmonary
aspiration has occurred in patients receiving GLP-1 receptor agonists
undergoing elective surgeries or procedures requiring general anesthesia or
deep sedation.
…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING
INFORMATION
Newly added information:
…
Pulmonary
Aspiration During General Anesthesia or Deep Sedation
Inform
patients that BYETTA may cause their stomach to empty more slowly which may
lead to complications with anesthesia or deep sedation during planned surgeries
or procedures. Instruct patients to inform healthcare providers prior to any
planned surgeries or procedures if they are taking BYETTA [see Warnings and Precautions (5.10)].
…
MEDICATION GUIDE
Additions and/or revisions underlined:
Before taking
BYETTA, tell your healthcare provider about all of your medical conditions,
including if you:
…
- are scheduled to have surgery or other procedures that
use anesthesia or deep sleepiness (deep sedation).
…
What are the
possible side effects of BYETTA?
BYETTA may cause
serious side effects, including:
…
Approved Drug Label (PDF)
6
Adverse Reactions
6.2 Postmarketing Experience
Additions and revisions underlined:
Gastrointestinal:
nausea, vomiting, and/or diarrhea resulting in dehydration; abdominal
distension, abdominal pain, eructation, constipation, flatulence, ileus,
acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death [see Indications and Usage (1)].
Approved Drug Label (PDF)
5
Warnings and Precautions
5.9 Acute Gallbladder Disease
Newly added
subsection:
Acute events
of gallbladder disease
such as cholelithiasis or cholecystitis have been reported
in GLP-1 receptor agonist trials and postmarketing. In a clinical study
with exenatide, 1.9% of exenatide-treated patients and 1.4% of placebo-treated
patients reported an acute event of gallbladder disease, such as cholelithiasis
or cholecystitis. If cholelithiasis is suspected, gallbladder studies and
appropriate clinical follow-up are indicated.
6
Adverse Reactions
Addition of the
following to the bulleted line listing:
6.1 Clinical Trials Experience
Additions and/or
revisions underlined:
…
Cholelithiasis and cholecystitis
In a clinical study with exenatide, 1.9% of exenatide-treated patients and 1.4% of placebo-treated patients reported an
acute event of gallbladder disease, such as cholelithiasis or cholecystitis.
…
6.2 Postmarketing Experience
Additions and/or
revisions underlined:
…
Hepatobiliary:
cholecystitis, cholelithiasis requiring cholecystectomy.
…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Additions and/or
revisions underlined:
…
…
PATIENT COUNSELING INFORMATION
Additions and/or
revisions underlined:
…
Acute Gallbladder Disease
Inform patients
of the potential risk for cholelithiasis or cholecystitis. Instruct
patients to contact their physician if cholelithiasis
or cholecystitis is suspected for appropriate clinical follow-up [see Warnings and Precautions (5.9)].
…
Approved Drug Label (PDF)
8
Use in Specific Populations
8.4 Pediatric Use
Additions
and/or revisions underlined:
The safety and effectiveness of BYETTA have not been established in
pediatric patients.
Effectiveness
of BYETTA was not demonstrated in a randomized, double-blind, placebo-
controlled study conducted in 120 pediatric patients (78 received BYETTA and 42
received placebo) aged 10 to 17 years with type 2 diabetes mellitus.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Additions
and/or revisions underlined:
Acute Pancreatitis
Inform patients
that persistent severe abdominal pain that may radiate to the back and which
may
or may not be
accompanied by vomiting, is the hallmark symptom of acute pancreatitis …
Approved Drug Label (PDF)
4
Contraindications
Additions and/or revisions underlined:
BYETTA is
contraindicated in patients with:
5
Warnings and Precautions
Additions and/or
revisions underlined:
5.3 Hypoglycemia with
Concomitant Use of Insulin Secretagogues or Insulin
Patients receiving
BYETTA in combination with an insulin secretagogue (e.g., sulfonylurea) or
insulin may have an increased risk of hypoglycemia including severe
hypoglycemia
[see Adverse Reactions (6) and Drug Interactions (7.2)].
The risk of
hypoglycemia may be lowered by a reduction in the dose of
sulfonylurea (or other concomitantly administered insulin secretagogue) or
insulin. Inform patients using these concomitant medications of the risk of
hypoglycemia and
educate
them
on the signs and symptoms of hypoglycemia.
6
Adverse Reactions
Additions and/or
revisions underlined:
6.2 Postmarketing
Experience
Metabolic:
Severe
hypoglycemia with concomitant use of sulfonylurea or insulin
Neurologic:
dysgeusia;
somnolence
7
Drug Interactions
Newly added
subsection:
7.2 Concomitant
Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin
When initiating
BYETTA, consider reducing the dose of concomitantly administered insulin
secretagogues (such as sulfonylureas) or insulin to reduce the risk of
hypoglycemia [see Warnings and
Precautions (5.3) and Adverse Reactions (6)].
8
Use in Specific Populations
8.5 Geriatric Use
Additions and/or
revisions underlined:
Population
pharmacokinetic analysis of patients ranging from 22 to 73 years of age
suggests that age does not influence the pharmacokinetic properties of
exenatide [see
Clinical Pharmacology (12.3)]. BYETTA was studied in 282 patients 65 years of age
or older …
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 (Medication Guide and Instructions
for Use).
Hypoglycemia
with Concomitant Use of Insulin Secretagogues or Insulin
Inform patients
that
the risk of hypoglycemia is increased when BYETTA is used in combination with an
agent that induces hypoglycemia, such as a sulfonylurea or insulin. Educate
patients on the signs and symptoms of hypoglycemia [see Warnings and Precautions (5.3)].
Acute
Kidney Injury
Inform patients treated
with BYETTA of the potential risk for worsening renal function …
Approved Drug Label (PDF)
4
Contraindications
Addition
of the following bullet point underlined:
BYETTA is contraindicated in patients
with:
A history of drug-induced immune-mediated
thrombocytopenia from exenatide products. Serious bleeding, which may be fatal,
from drug-induced immune-mediated thrombocytopenia has been reported with
exenatide use [see Warnings and
Precautions (5.8)].
5
Warnings and Precautions
Additions and/or
revisions underlined:
5.4 Acute Kidney
Injury
…
Reversibility of altered renal function has been observed in many cases with
supportive treatment and discontinuation of potentially causative agents,
including BYETTA. Exenatide has not been found to be directly nephrotoxic in
preclinical or clinical studies.
BYETTA
is not recommended
in patients with severe renal impairment (creatinine clearance
<30
mL/min) or end-stage renal disease and should be used with caution in patients
with renal transplantation [see Use in Specific
Populations (8.6)]. Because BYETTA may
induce nausea and vomiting with transient hypovolemia, treatment may worsen
renal function. Caution should be applied when initiating or escalating
doses of BYETTA from 5 to 10 mcg in patients with moderate renal impairment
(creatinine clearance 30-50 mL/min).
5.7
Hypersensitivity
There have been postmarketing reports of
serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) in
patients treated with BYETTA. If a hypersensitivity reaction occurs, the
patient should discontinue BYETTA and other suspect medications and promptly
seek medical advice. Inform and closely monitor patients with a history of anaphylaxis
or angioedema with another
GLP-1 receptor agonist for allergic
reactions, because it is unknown whether such patients will be
predisposed to anaphylaxis with BYETTA [see Adverse Reactions (6.2)].
Newly added
subsection:
5.8 Drug-Induced Thrombocytopenia
Serious
bleeding, which may be fatal, from drug-induced immune-mediated
thrombocytopenia has been reported in the postmarketing setting with exenatide
use. Drug-induced thrombocytopenia is an immune-mediated reaction, with
exenatide-dependent anti-platelet antibodies. In the presence of exenatide,
these antibodies cause platelet destruction. If drug-induced
thrombocytopenia is suspected, discontinue BYETTA immediately and do not
re-expose the patient to exenatide [see Adverse Reactions
(6.2)].
6
Adverse Reactions
Addition of the
following bulleted line listings:
The
following serious adverse reactions are described below or elsewhere in the
prescribing information:
6.2 Postmarketing
Experience
Additions and/or
revisions underlined:
The
following additional adverse reactions have been reported during postapproval
use of BYETTA or other exenatide formulations. Because these events 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.
Blood and
Lymphatic Systems: drug-induced thrombocytopenia [see Warnings
and Precautions (5.8)].
8
Use in Specific Populations
8.6 Renal Impairment
Additions and/or
revisions underlined:
BYETTA
is not recommended for use in patients with end-stage renal disease or severe
renal impairment (creatinine clearance <30 mL/min) and should be used with
caution in patients with renal transplantation. In patients with end-stage
renal disease receiving dialysis, single doses of BYETTA 5 mcg were not
well-tolerated due to gastrointestinal side effects.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Who
should not use BYETTA?
Do
not use BYETTA if:
Addition of the following second bullet point underlined:
What are the
possible side effects of BYETTA?
BYETTA may cause
serious side effects, including:
Newly added bullet
point:
BYETTA
causes stomach problems or will cause your stomach problems to worsen.
Low blood platelet count (drug-induced
thrombocytopenia). BYETTA
may cause the number of platelets in your blood to be reduced. When your
platelet count is too low, your body cannot form blood clots. You could have
serious bleeding that could lead to death. Stop using BYETTA and call your
healthcare provider right away if you have unusual bleeding or bruising.
PATIENT COUNSELING INFORMATION
Newly added
information:
Risk
of Drug-Induced Thrombocytopenia
Inform
patients that drug-induced immune-mediated thrombocytopenia has been reported
during
use
of exenatide. Inform patients that if symptoms of thrombocytopenia occur, stop
taking
BYETTA
and seek medical advice promptly [see Warnings and Precautions (5.8)].
Approved Drug Label (PDF)
8
Use in Specific Populations
8.1 Pregnancy
(Pregnancy and
Lactation Labeling Rule (PLLR) Conversion; Extensive changes – please refer to
labeling)
8.2 Lactation
(Pregnancy and
Lactation Labeling Rule (PLLR) Conversion; Additions and/or revisions are underlined)
Risk Summary
There is no information regarding
the presence of BYETTA, in human milk,
the effects of BYETTA on the breastfed infant, or the effects of BYETTA on milk
production. Exenatide was present in the milk of lactating mice. However, due to
species-specific differences in lactation physiology, the clinical relevance of
these data is not clear. The developmental and health
benefits of breastfeeding should be considered
along with the mother’s clinical
need for
BYETTA and any potential adverse effects on the
breastfed child from BYETTA or from the underlying maternal condition.
Data
In lactating mice subcutaneously injected twice a
day with exenatide, the concentration of exenatide in
milk was up to 2.5% of the concentration in
maternal plasma.
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