Bydureon

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 6/24/2022
Bydureon Side Effects Center

What Is Bydureon?

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.

What Are Side Effects of Bydureon?

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).

Call your doctor at once if you have the following serious side effects:

  • blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
  • low levels of sodium in the body with severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady; or
  • severe nervous system reaction with very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out.

Dosage for Bydureon

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.

What Drugs, Substances, or Supplements Interact with Bydureon?

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.

Bydureon During Pregnancy and Breastfeeding

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.

Additional Information

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.

QUESTION

______________ is another term for type 2 diabetes. See Answer
Bydureon Consumer Information

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

Some people using exenatide have had serious or fatal bleeding caused by low levels of platelets (blood cells that help your blood to clot). Stop using Bydureon and call your doctor right away if you have unusual bleeding or bruising.

Stop using this medicine and call your doctor at once if you have:

  • severe ongoing nausea and vomiting;
  • pain, warmth, swelling, an open wound or scab, or other skin changes where the injection was given;
  • easy bruising, unusual bleeding, purple or red spots under your skin;
  • signs of a thyroid tumor--swelling or a lump in your neck, trouble swallowing, a hoarse voice, feeling short of breath;
  • pancreas or gallbladder problems--pain in your upper stomach spreading to your back, nausea and vomiting, fever, fast heart rate, yellowing of your skin or eyes;
  • low blood sugar--headache, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky; or
  • kidney problems--swelling, urinating less, feeling tired or short of breath.

Common side effects may include:

  • indigestion, nausea, vomiting, diarrhea, constipation;
  • headache; or
  • itching or a small bump where an injection was given.

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)

SLIDESHOW

Type 2 Diabetes: Signs, Symptoms, Treatments See Slideshow
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 data presented below are derived from six comparator-controlled trials of BYDUREON in patients who entered the studies not achieving adequate glycemic control on their current therapy [see Clinical Studies]. 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 comparatorcontrolled 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.
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.

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 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.

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 BYDUREONtreated patients (N=918) in five of the 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

DRUG INTERACTIONS

Table 4: Clinically Relevant Interactions Affecting Drugs Co-Administered with BYDUREON and Other Exenatide-Containing Products

Orally Administered Drugs (e.g., acetaminophen)
Clinical Impact Exenatide slows gastric emptying. Therefore, BYDUREON has the potential to reduce the rate of absorption of orally administered drugs [see CLINICAL PHARMACOLOGY].
Intervention Use caution when administering oral medications with BYDUREON where a slower rate of oral absorption may be clinically meaningful.
Warfarin
Clinical Impact BYDUREON has not been studied with warfarin. However, in a drug interaction study, BYETTA did not have a significant effect on INR [see CLINICAL PHARMACOLOGY]. There have been postmarketing reports for exenatide of increased INR with concomitant use of warfarin, sometimes associated with bleeding [see ADVERSE REACTIONS].
Intervention In patients taking warfarin, the INR should be monitored more frequently after initiating BYDUREON. Once a stable INR has been documented, the INR can be monitored at the intervals usually recommended for patients on warfarin.
Concomitant Use of Insulin Secretagogues or Insulin
Clinical Impact Exenatide promotes insulin release from pancreatic beta-cells in the presence of elevated glucose concentrations. The risk of hypoglycemia is increased when exenatide is used in combination with insulin secretagogues (e.g., sulfonylureas) or insulin [see ADVERSE REACTIONS].
Intervention Patients may require a lower dose of the secretagogue or insulin to reduce the risk of hypoglycemia in this setting.

Read the entire FDA prescribing information for Bydureon (Exenatide)

© Bydureon Patient Information is supplied by Cerner Multum, Inc. and Bydureon Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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