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Bydureon

Last reviewed on RxList: 11/6/2017
Bydureon Side Effects Center

Last reviewed on RxList 11/06/2017

Bydureon (exenatide) is an incretin mimetic, which improves blood sugar control by mimicking the action of a hormone called glucagon-like peptide 1 (GLP-1), indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Common side effects of Bydureon include:

  • nausea (especially when you first start using Bydureon),
  • diarrhea,
  • headache,
  • vomiting,
  • constipation,
  • itching at the injection site,
  • a small bump (nodule) at the injection site, and
  • indigestion.

Serious side effects of Bydureon include:

  • swelling in your neck or throat (enlarged thyroid), hoarse voice, trouble swallowing or breathing;
  • swelling, weight gain, shortness of breath, urinating less than usual or not at all;
  • drowsiness, confusion, mood changes, increased thirst, diarrhea;
  • dull pain in your middle or lower back;
  • severe pain in your upper stomach spreading to your back; or
  • low blood sugar (headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery).

Bydureon (2 mg per dose) should be administered once every 7 days (weekly). The dose can be administered at any time of day, with or without meals. Bydureon may interact with chlorpropamide, glimepiride, glipizide, glyburide, tolazamide, tolbutamide, levothyroxine, lithium, lovastatin, pimozide, cyclosporine, sirolimus, tacrolimus, theophylline, blood thinners, ergot medicines, seizure medications, or heart or blood pressure medications. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant while using Bydureon; it is unknown if it will harm a fetus. It is unknown if Bydureon passes into breast milk or if it could harm a nursing baby. Breastfeeding while using Bydureon is not recommended.

Our Bydureon (exenatide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Bydureon Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • swelling in your neck or throat (enlarged thyroid), hoarse voice, trouble swallowing or breathing;
  • swelling, weight gain, feeling short of breath, urinating less than usual or not at all;
  • drowsiness, confusion, mood changes, increased thirst, diarrhea;
  • dull pain in your middle or lower back;
  • severe pain in your upper stomach spreading to your back, vomiting; or
  • low blood sugar (headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery).

Less serious side effects may include:

  • nausea, upset stomach, diarrhea or constipation;
  • weight loss; or
  • itching or a hard lump where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Bydureon (Exenatide)

Bydureon Professional Information

SIDE EFFECTS

The following serious adverse reactions are described below or elsewhere in the prescribing information:

Clinical Trial Experience

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 rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of BYDUREON was assessed in six comparator-controlled trials in patients who entered the studies not achieving adequate glycemic control on their current therapy. In a double-blind 26-week trial, patients on diet and exercise were treated with BYDUREON 2 mg once every 7 days (weekly), sitagliptin 100 mg daily, pioglitazone 45 mg daily, or metformin 2000 mg daily. In a double-blind 26-week trial, patients on metformin were treated with BYDUREON 2 mg once every 7 days (weekly), sitagliptin 100 mg daily, or pioglitazone 45 mg daily. In an open-label 26-week trial, patients on metformin or metformin plus sulfonylurea were treated with BYDUREON 2 mg once every 7 days (weekly) or optimized insulin glargine. In two open-label 24-to 30-week studies, patients on diet and exercise or metformin, a sulfonylurea, a thiazolidinedione, or combination of oral agents were treated with BYDUREON 2 mg once every 7 days (weekly) or BYETTA 10 mcg twice daily. In an open-label 26-week trial, patients on metformin, a sulfonylurea, metformin plus a sulfonylurea, or metformin plus pioglitazone were treated with BYDUREON 2 mg every 7 days (weekly) or liraglutide 1.8 mg once daily.

Common Adverse Reactions

Tables 1 and 2 summarize adverse reactions with an incidence ≥5% reported in the six comparator-controlled 24-to 30-week trials of BYDUREON used as monotherapy or as add-on to metformin, a sulfonylurea, a thiazolidinedione, or combination of these oral antidiabetic agents.

Table 1: Adverse Reactions Reported in ≥5% of BYDUREON-Treated Patients with Type 2 Diabetes Mellitus in Monotherapy Trial

26-Week Monotherapy Trial
  BYDUREON
2 mg
N = 248
%
Sitagliptin
100 mg
N = 163
%
Pioglitazone
30-45 (mean dose 40) mg
N = 163
%
Metformin
1000-2500 (mean dose 2077) mg
N = 246
%
Nausea 11.3 3.7 4.3 6.9
Diarrhea 10.9 5.5 3.7 12.6
Injection-site nodule 10.5 6.7 3.7 10.2
Constipation 8.5 2.5 1.8 3.3
Headache 8.1 9.2 8.0 12.2
Dyspepsia 7.3 1.8 4.9 3.3
N = number of intent-to-treat patients.

Table 2: Adverse Reactions Reported in ≥5% of BYDUREON-Treated Patients with Type 2 Diabetes Mellitus in 24-to 30-Week Add-On Combination Therapy Trials

26-Week Add-On to Metformin Trial
  BYDUREON
2 mg
N = 160
%
Sitagliptin
100 mg
N = 166
%
Pioglitazone
45 mg
N = 165
%
Nausea 24.4 9.6 4.8
Diarrhea 20.0 9.6 7.3
Vomiting 11.3 2.4 3.0
Headache 9.4 9.0 5.5
Constipation 6.3 3.6 1.2
Fatigue 5.6 0.6 3.0
Dyspepsia 5.0 3.6 2.4
Decreased appetite 5.0 1.2 0.0
Injection-site pruritus 5.0 4.8 1.2
26-Week Add-On to Metformin or Metformin + Sulfonylurea Trial
  BYDUREON
2 mg
N = 233
%
Insulin Glargine Titrated
N = 223
%
Nausea 12.9 1.3
Headache 9.9 7.6
Diarrhea 9.4 4.0
Injection-site nodule 6.0 0.0
30-Week Monotherapy or as Add-On to Metformin, a Sulfonylurea, a Thiazolidinedione, or Combination of Oral Agents Trial
  BYDUREON 2 mg
N = 148
%
BYETTA 10 mcg
N = 145
%
Nausea 27.0 33.8
Diarrhea 16.2 12.4
Vomiting 10.8 18.6
Injection-site pruritus 18.2 1.4
Constipation 10.1 6.2
Gastroenteritis viral 8.8 5.5
Gastroesophageal reflux disease 7.4 4.1
Dyspepsia 7.4 2.1
Injection-site erythema 7.4 0.0
Fatigue 6.1 3.4
Headache 6.1 4.8
Injection-site hematoma 5.4 11.0
24-Week Monotherapy or as Add-On to Metformin, a Sulfonylurea, a Thiazolidinedione, or Combination of Oral Agents Trial
  BYDUREON
2 mg
N = 129
%
BYETTA 10 mcg
N = 123
%
Nausea 14.0 35.0
Diarrhea 9.3 4.1
Injection-site erythema 5.4 2.4
26-Week Add-On to Metformin, a Sulfonylurea, Metformin + Sulfonylurea, or Metformin + Pioglitazone Trial
  BYDUREON 2 mg
N = 461
%
Injection-site nodule 10.4
Nausea 9.3
Diarrhea 6.1
N = number of intent-to-treat patients.
Note: Percentages are based on the number of intent-to-treat patients in each treatment group.
Patients in the sitagliptin, pioglitazone, and metformin treatment groups received weekly placebo injections.

Nausea was a common adverse reaction associated with initiation of treatment with BYDUREON and usually decreased over time.

Adverse Reactions Leading To Study Withdrawal

The incidence of withdrawal due to adverse reactions was 4.1% (N=57) for BYDUREON-treated patients, 4.9% (N=13) for BYETTA-treated patients, and 2.9% (N=46) for other comparator-treated patients in the six comparator-controlled 24-to 30-week trials. The most common classes of adverse reactions (0.5%) leading to withdrawal for BYDUREON-treated patients were, Gastrointestinal Disorders 1.6% (N=22) versus 4.1% (N=11) for BYETTA and 1.9% (N=30) for other comparators, and Administration Site Conditions 0.8% (N=11) versus 0.0% for BYETTA and 0.2% (N=3) for other comparators. The most frequent adverse reactions within each of these respective classes were, nausea 0.4% (N=6) for BYDUREON versus 1.5% (N=4) for BYETTA and 0.8% (N=12) for other comparators, and injection-site nodule, 0.4% (N=6) for BYDUREON versus 0.0% for BYETTA and 0.0% for other comparators.

Hypoglycemia

Table 3 summarizes the incidence of minor hypoglycemia in the six comparator-controlled 24-to 30week trials of BYDUREON used as monotherapy or as add-on to metformin, a sulfonylurea, a thiazolidinedione, or combination of these oral antidiabetic agents. In these trials, an event was classified as minor hypoglycemia if there were symptoms of hypoglycemia with a concomitant glucose <54 mg/dL and the patient was able to self-treat.

Table 3: Incidence (% of Subjects) of Minor Hypoglycemia in Clinical Trials in Patients with Type 2 Diabetes Mellitus

26-Week Monotherapy Trial
BYDUREON 2 mg (N = 248) 2.0%
Sitagliptin 100 mg (N = 163) 0.0%
Pioglitazone 30-45 (mean dose 40) mg (N = 163) 0.0%
Metformin 1000-2500 (mean dose 2077) mg (N = 246) 0.0%
26-Week Add-On to Metformin Trial
BYDUREON 2 mg (N = 160) 1.3%
Sitagliptin 100 mg (N = 166) 3.0%
Pioglitazone 45 mg (N = 165) 1.2%
26-Week Add-On to Metformin or Metformin + Sulfonylurea Trial
With Concomitant Sulfonylurea Use (N = 136)
BYDUREON 2 mg (N = 70) 20.0%
Titrated Insulin Glargine (N = 66) 43.9%
Without Concomitant Sulfonylurea Use (N = 320)
BYDUREON 2 mg (N = 163) 3.7%
Titrated Insulin Glargine (N = 157) 19.1%
24-Week Monotherapy or Add-On to Metformin, a Sulfonylurea, a Thiazolidinedione, or Combination of Oral Agents Trial
With Concomitant Sulfonylurea Use (N = 74)
BYDUREON 2 mg (N = 40) 12.5%
BYETTA 10 mcg (N = 34) 11.8%
Without Concomitant Sulfonylurea Use (N = 178)
BYDUREON 2 mg (N = 89) 0.0%
BYETTA 10 mcg (N = 89) 0.0%
30-Week Monotherapy or Add-On to Metformin, a Sulfonylurea, a Thiazolidinedione, or Combination of Oral Agents Trial
With Concomitant Sulfonylurea Use (N = 107)
BYDUREON 2 mg (N = 55) 14.5%
BYETTA 10 mcg (N = 52) 15.4%
Without Concomitant Sulfonylurea Use (N = 186)
BYDUREON 2 mg (N = 93) 0.0%
BYETTA 10 mcg (N = 93) 1.1%
26-Week as Add-On to Metformin, a Sulfonylurea, Metformin + Sulfonylurea, or Metformin + Pioglitazone Trial
With Concomitant Sulfonylurea Use (N = 590)
BYDUREON 2 mg (N = 294) 15.3%
Without Concomitant Sulfonylurea Use (N = 321)
BYDUREON 2 mg (N = 167) 3.6%
N = number of intent-to-treat patients.
Note: Percentages are based on the number of intent-to-treat patients in each treatment group.
Reported event that has symptoms consistent with hypoglycemia with a concomitant glucose <54 mg/dL and the patient was able to self-treat.
Insulin glargine was dosed to a target fasting glucose concentration of 72 to 100 mg/dL. The mean dose of insulin glargine was 10 units/day at baseline and 31 units/day at endpoint.

Injection-Site Adverse Reactions

In the five comparator-controlled 24-to 30-week trials, injection-site reactions were observed more frequently in patients treated with BYDUREON (17.1%) than in patients treated with BYETTA (12.7%), titrated insulin glargine (1.8%), or those patients who received placebo injections (sitagliptin (10.6%), pioglitazone (6.4%), and metformin (13.0%) treatment groups). These reactions for patients treated with BYDUREON were more commonly observed in antibody-positive patients (14.2%) compared with antibody-negative patients (3.1%), with a greater incidence in those with higher titer antibodies [see WARNINGS AND PRECAUTIONS]. Incidence of injection-site reactions for patients treated with BYETTA was similar for antibody-positive patients (5.8%) and antibody-negative patients (7.0%). One percent of patients treated with BYDUREON withdrew due to injection-site adverse reactions (injection-site mass, injection-site nodule, injection-site pruritus, and injection-site reaction).

Subcutaneous injection-site nodules may occur with the use of BYDUREON. In a separate 15-week study in which information on nodules were collected and analyzed, 24 out of 31 subjects (77%) experienced at least 1 injection-site nodule during treatment; 2 subjects (6.5%) reported accompanying localized symptoms. The mean duration of events was 27 days. The formation of subcutaneous nodules is consistent with the known properties of the microspheres used in BYDUREON.

Increase In Heart Rate

Increases in heart rate from baseline ranging from 1.5 to 4.5 beats per minute have been observed in comparator-controlled clinical trials. The long-term effects of the increase in heart rate have not been established.

Other Adverse Reactions

The following adverse reactions were also reported in three 30-week controlled trials of BYETTA (N=963) add-on to metformin and/or sulfonylurea, with an incidence of ≥1% and reported more frequently than with placebo: feeling jittery (9% BYETTA, 4% placebo), dizziness (9% BYETTA, 6% placebo), asthenia (4% BYETTA, 2% placebo), and hyperhidrosis (3% BYETTA, 1% placebo).

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, the incidence of antibodies to exenatide cannot be directly compared with the incidence of antibodies with other products.

Anti-exenatide antibodies were measured at prespecified intervals (4-14 weeks) in all BYDUREON-treated patients (N=918) in the five comparator-controlled studies of BYDUREON. In these five trials, 452 BYDUREON-treated patients (49%) had low titer antibodies (≤125) to exenatide at any time during the trials and 405 BYDUREON-treated patients (45%) had low titer antibodies to exenatide at study endpoint (24-30 weeks). The level of glycemic control in these patients was generally comparable to that observed in the 379 BYDUREON-treated patients (43%) without antibody titers. An additional 107 BYDUREON-treated patients (12%) had higher titer antibodies at endpoint. Of these patients, 50 (6% overall) had an attenuated glycemic response to BYDUREON (<0.7% reduction in HbA1c); the remaining 57 (6% overall) had a glycemic response comparable to that of patients without antibodies [see WARNINGS AND PRECAUTIONS]. In the 30-week trial in which anti-exenatide antibody assessments were performed at baseline and at 4-week intervals from week 6 to week 30, the mean anti-exenatide antibody titer in the BYDUREON-treated patients peaked at week 6 then declined by 56% from this peak by week 30.

A total of 246 patients with antibodies to exenatide in the BYETTA and BYDUREON clinical trials were tested for the presence of cross-reactive antibodies to GLP-1 and/or glucagon. No treatment-emergent cross-reactive antibodies were observed across the range of titers.

Postmarketing Experience

The following additional adverse reactions have been reported during post-approval use of another formulation of exenatide. 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.

Allergy/Hypersensitivity: injection-site reactions, generalized pruritus and/or urticaria, macular or papular rash, angioedema; anaphylactic reaction.

Drug Interactions: increased international normalized ratio (INR), sometimes associated with bleeding, with concomitant warfarin use [see DRUG INTERACTIONS].

Gastrointestinal: nausea, vomiting, and/or diarrhea resulting in dehydration; abdominal distension, abdominal pain, eructation, constipation, flatulence, acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death [see INDICATIONS.]

Neurologic: dysgeusia; somnolence

Renal and Urinary Disorders: altered renal function, including increased serum creatinine, renal impairment, worsened chronic renal failure or acute renal failure (sometimes requiring hemodialysis), kidney transplant and kidney transplant dysfunction.

Skin and Subcutaneous Tissue Disorders: alopecia

Read the entire FDA prescribing information for Bydureon (Exenatide)

Related Resources for Bydureon

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