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Bydureon

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Bydureon

Bydureon

Bydureon Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Bydureon (exenatide) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Bydureon is the first once-weekly treatment for type 2 diabetes, the most common form of diabetes. This drug caused certain kinds of thyroid tumors in rats at clinically relevant exposures in testing, and should not be used in people with a personal or family history of thyroid cancer.

Bydureon is a long-acting form of the medication contained in Byetta. Do not use Bydureon and Byetta together . Bydureon should be administered as 2 mg by subcutaneous injection once every seven days (weekly), at any time of day and with or without meals.

It is not known if Bydureon is harmful to unborn babies. Women should alert their doctors if they become pregnant while taking Bydureon. It is also not known if Bydureon passes into breast milk. The patient and the healthcare provider should decide if Bydureon will be taken, or if the patient will breastfeed.

Our Bydureon 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.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Bydureon FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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 five 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.

Withdrawals

The incidence of withdrawal due to adverse events was 4.9% (N=45) for BYDUREON-treated patients, 4.9% (N=13) for BYETTA-treated patients, and 2.0% (N=23) for other comparator-treated patients in the five comparator-controlled 24-to 30-week trials. The most common adverse reactions leading to withdrawal for BYDUREON-treated patients were nausea 0.5% (N=5) versus 1.5% (N=4) for BYETTA and 0.3% (N=3) for other comparators, injection-site nodule 0.5% (N=5) versus 0.0% for BYETTA and 0.0% for other comparators, diarrhea 0.3% (N=3) versus 0.4% (N=1) for BYETTA and 0.3% (N=3) for other comparators, injection-site reaction 0.2% (N=2) versus 0.0% for BYETTA and 0.0% for other comparators, and headache 0.2% (N=2) versus 0.0% for BYETTA and 0.0% for other comparators.

Hypoglycemia

Table 1 summarizes the incidence and rate of minor hypoglycemia in the five 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. 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 1: Incidence (% of Subjects) and Rate (Episodes/Subject Year) of Minor† Hypoglycemia in the Monotherapy Trial and in the Combination Therapy Trials

26-Week Monotherapy Trial
BYDUREON 2 mg (N = 248) 2.0% (0.05)
Sitagliptin 100 mg (N = 163) 0.0% (0.00)
Pioglitazone 45 mg (N = 163) 0.0% (0.00)
Metformin 2000 mg QD (N = 246) 0.0% (0.00)
26-Week Add-On to Metformin Trial
BYDUREON 2 mg (N = 160) 1.3% (0.03)
Sitagliptin 100 mg (N = 166) 3.0% (0.12)
Pioglitazone 45 mg (N = 165) 1.2% (0.03)
26-Week Add-On to Metformin or Metformin + Sulfonylurea Trial
With Concomitant Sulfonylurea Use (N = 136)
BYDUREON 2 mg (N = 70) 20.0% (1.11)
Titrated Insulin Glargine (N = 66) 43.9% (2.87)
Without Concomitant Sulfonylurea Use (N = 320)
BYDUREON 2 mg (N = 163) 3.7% (0.11)
Titrated Insulin Glargine^ (N = 157) 19.1% (0.64)
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% (0.72)
BYETTA 10 mcg (N = 34) 11.8% (0.31)
Without Concomitant Sulfonylurea Use (N = 178)
BYDUREON 2 mg (N = 89) 0.0% (0.00)
BYETTA 10 mcg (N = 89) 0.0% (0.00)
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% (0.55)
BYETTA 10 mcg (N = 52) 15.4% (0.37)
Without Concomitant Sulfonylurea Use (N = 186)
BYDUREON 2 mg (N = 93) 0.0% (0.00)
BYETTA 10 mcg (N = 93) 1.1% (0.02)
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.

There were no reported events of major hypoglycemia in these five comparator-controlled 24-to 30-week trials. Major hypoglycemia was defined as loss of consciousness, seizure, or coma (or other mental status change consistent with neuroglycopenia in the judgment of the investigator or physician) which resolved after administration of glucagon or glucose or required third-party assistance to resolve because of severe impairment in consciousness or behavior. Patients were to have a concomitant glucose < 54 mg/dL.

Immunogenicity

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.

Other Adverse Reactions

BYDUREON

Tables 2 and 3 summarize adverse reactions with an incidence ≥ 5% reported in the five 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 2: Treatment-Emergent Adverse Reactions Reported in ≥ 5% of BYDUREON-Treated Patients in Monotherapy Trial

26-Week Monotherapy Trial
  BYDUREON 2 mg
N = 248 %
Sitagliptin 100 mg
N = 163 %
Pioglitazone 45 mg
N = 163 %
Metformin 2000 mg
N = 246 %
Nausea 11.3 3.7 4.3 6.9
Diarrhea 10.9 5.5 3.7 12.6
f 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 3: Treatment-Emergent Adverse Reactions Reported in ≥ 5% of BYDUREON-Treated Patients in 24to 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  
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 the most common adverse reaction associated with initiation of treatment with BYDUREON, and usually decreased over time.

Injection-Site 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 nodules is consistent with the known properties of the microspheres used in BYDUREON.

BYETTA

In three 30-week controlled trials of BYETTA (N=963) add-on to metformin and/or sulfonylurea, adverse reactions (excluding hypoglycemia) with an incidence of ≥ 1% and reported more frequently than with placebo included nausea (44% BYETTA, 18% placebo), vomiting (13% BYETTA, 4% placebo), diarrhea (13% BYETTA, 6% placebo), feeling jittery (9% BYETTA, 4% placebo), dizziness (9% BYETTA, 6% placebo), headache (9% BYETTA, 6% placebo), dyspepsia (6% BYETTA, 3% placebo), asthenia (4% BYETTA, 2% placebo), gastroesophageal reflux (3% BYETTA, 1% placebo), hyperhidrosis (3% BYETTA, 1% placebo), and decreased appetite (1% BYETTA, < 1% placebo). Similar types of adverse reactions were observed in 24-week and 16-week controlled trials of BYETTA used as monotherapy or as add-on to a thiazolidinedione, with or without metformin, respectively.

Postmarketing Experience

BYDUREON

Allergy/Hypersensitivity: injection-site reactions [see WARNINGS AND PRECAUTIONS].

BYETTA

The following additional adverse reactions have been reported during postapproval use of BYETTA. 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 [see WARNINGS AND PRECAUTIONS].

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 AND USAGE and WARNINGS AND PRECAUTIONS].

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 [see WARNINGS AND PRECAUTIONS].

Skin and Subcutaneous Tissue Disorders: alopecia

Read the entire FDA prescribing information for Bydureon (Exenatide) »

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