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Bydureon Bcise

Last reviewed on RxList: 12/10/2020
Bydureon Bcise Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Bydureon Bcise?

Bydureon Bcise (exenatide extended-release) is a glucagon-like peptide-1 (GLP-1) receptor agonist 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 Bcise?

Common side effects of Bydureon Bcise include :

  • injection site reactions (nodules, itching, redness),
  • nausea,
  • headache,
  • diarrhea,
  • vomiting,
  • dizziness,
  • and constipation.

Dosage for Bydureon Bcise

The dose of Bydureon Bcise is 2 mg administered by subcutaneous injection once every seven days (weekly), at any time of day and with or without meals.

What Drugs, Substances, or Supplements Interact with Bydureon Bcise?

Bydureon Bcise may interact with:

  • other medications taken orally at the same time,
  • warfarin, and
  • insulin secretagogues or
  • insulin

Tell your doctor all medications and supplements you use.

Bydureon Bcise During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Bydureon Bcise; it may harm a fetus. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy. It is unknown if Bydureon Bcise passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Bydureon Bcise (exenatide extended-release) Injectable Suspension, for Subcutaneous Use 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.

SLIDESHOW

Type 2 Diabetes: Signs, Symptoms, Treatments See Slideshow
Bydureon Bcise Consumer Information

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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;
  • swelling in your neck or throat (enlarged thyroid), hoarse voice, trouble swallowing or breathing;
  • 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--little or no urination, painful or difficult urination, swelling in your feet or ankles, 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 Bcise (Exenatide Extended-Release Injectable Suspension)

QUESTION

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

SIDE EFFECTS

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

  • Risk of Thyroid C-cell Tumors [see WARNINGS AND PRECAUTIONS]
  • Acute Pancreatitis [see WARNINGS AND PRECAUTIONS]
  • Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin [see WARNINGS AND PRECAUTIONS]
  • Acute Kidney Injury [see WARNINGS AND PRECAUTIONS]
  • Gastrointestinal Disease [see WARNINGS AND PRECAUTIONS]
  • Immunogenicity [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity [see WARNINGS AND PRECAUTIONS]
  • Drug-Induced Thrombocytopenia [see WARNINGS AND PRECAUTIONS]
  • Injection-Site Reactions [see WARNINGS AND PRECAUTIONS]
  • Acute Gallbladder Disease [see WARNINGS AND PRECAUTIONS]

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 data in this section are derived from pooled data from the controlled period of the 2 comparator-controlled trials as well as data from the extension phase of one of these trials [see Clinical Studies]. There were 410 patients exposed to BYDUREON BCISE 2 mg for 28 weeks during the controlled phases, and an additional 116 patients exposed to BYDUREON BCISE 2 mg during an uncontrolled extension for an additional 24 weeks. Overall, there were 526 patients exposed to BYDUREON BCISE 2 mg with a mean duration of exposure of 35 weeks in the controlled and extension phases of the two trials. Across the treatment arms in the controlled periods, the mean age of patients was 55 years, 2% were 75 years or older and 59% were male. The population in these studies was 78% White, 15% Black or African American, 5% Asian; 1% American Indian or Alaska Native; <1 % were Native Hawaiian or Pacific Islander; and <1% were other races. This population included 42% of Hispanic or Latino ethnicity. At baseline, the population had diabetes for an average of 8.3 years and had a mean HbA1c of 8.5%. Baseline estimated renal function was normal or mildly impaired (eGFR ≥60 mL/min/1.73 m²) in 93% of the pooled study populations.

Common Adverse Reactions

Table 1 summarizes the adverse reactions with an incidence ≥5% occurring in BYDUREON BCISE-treated patients in the pooled data from the controlled and extension phases, including 10 weeks of follow-up, of the two comparator-controlled 28-week clinical trials. Adverse reactions were identified based on known adverse reactions associated with BYDUREON.

Table 1: Adverse Reactions Reported in ≥5% of BYDUREON BCISE-Treated Patients from Pooled Clinical Trial Data in Patients with Type 2 Diabetes Mellitus

BYDUREON BCISE 2 mg
N = 526 %
Injection site nodule10.5
Nausea8.2
Note: Percentages are based on the number of patients who were randomized and received at least one dose of BYDUREON BCISE.

Nausea was a common adverse reaction associated with initiation of treatment with BYDUREON BCISE and usually decreased over time with continued use. The incidence of nausea and/or vomiting was 2% in the first week of therapy compared to 1% in the 4th week of therapy.

Less Common Adverse Reactions

Adverse reactions that occurred in >2% and <5% of patients receiving BYDUREON BCISE during the controlled and extension phases, including 10 weeks of follow-up, of the two comparator-controlled 28-week clinical trials include: headache (4.4%), diarrhea (4.0%), vomiting (3.4%), injection site pruritus (3.2%), dizziness (2.5%), injection site erythema (2.3%), constipation (2.1%).

Adverse Reactions Leading To Discontinuation Of Therapy

The incidence of discontinuation of therapy due to adverse reactions was 3.9% for BYDUREON BCISE-treated patients in the two comparator-controlled 28-week trials. The most common classes of adverse reactions leading to discontinuation of therapy for BYDUREON BCISE-treated patients were Gastrointestinal Disorders 2.0% and General Disorders and Administration Site Conditions 1.2%. For BYDUREON BCISE-treated patients, the most frequent adverse reactions leading to discontinuation of therapy within each of these respective classes were diarrhea (0.7%), nausea (0.7%), vomiting (0.5%) and injection-site nodule (0.5%).

Other Adverse Reactions

Hypoglycemia

Table 2 summarizes the incidence of glucose level <54 mg/dL regardless of hypoglycemia clinical symptoms and the incidence of severe hypoglycemia in the two comparator-controlled 28-week trials of BYDUREON BCISE.

Table 2: Incidence (% of Subjects) of Hypoglycemia (glucose <54 mg/dL) and Severe Hypoglycemia in Clinical Trials in Patients with Type 2 Diabetes Mellitus

Incidence of Hypoglycemia (glucose <54 mg/dL)
Mono-or Combination Therapy with One or Two OADs Trial (28 weeks)
With Concomitant Sulfonylurea Use
BYDUREON BCISE 2 mg (N=88)25.0%
Without Concomitant Sulfonylurea Use
BYDUREON BCISE 2 mg (N=141)2.1%
Add-On to Metformin Trial (28 weeks)
All treated subjects
BYDUREON BCISE 2 mg (N=181)0.0%
Incidence of Severe Hypoglycemia
Mono-or Combination Therapy with One or Two OADs Trial (28 weeks)
With Concomitant Sulfonylurea Use
BYDUREON BCISE 2 mg (N=88)2.3%
Without Concomitant Sulfonylurea Use
BYDUREON BCISE 2 mg (N=141)0.7%
Add-On to Metformin Trial (28 weeks)
All treated subjects
BYDUREON BCISE 2 mg (N=181)0.0%
Note: N and percentages are based on the number of patients who were randomized and received at least one dose of BYDUREON BCISE.

Severe hypoglycemia was defined as clinical symptoms that were considered to result from hypoglycemia in which the patient required the assistance of another person and associated with recovery after oral carbohydrates, intravenous glucose or glucagon administration if no plasma glucose was available.

Injection-Site Adverse Reactions

In the two comparator-controlled 28-week trials, injection site reactions (including injection site nodule, injection site pruritus, injection site bruising) were observed in 23.9% of patients treated with BYDUREON BCISE. The formation of subcutaneous nodules is consistent with the properties of the microspheres used in BYDUREON BCISE.

Increase in Heart Rate

In clinical trials of BYDUREON BCISE the mean increase from baseline in heart rate was 2.4 beats per minute.

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, comparison of the incidence of antibodies to exenatide in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.

Anti-exenatide antibodies were measured at prespecified intervals in the two comparator-controlled studies, and evaluable anti-exenatide antibody measurements were available from 393 BYDUREON BCISE-treated patients. In these trials 40.2% of these patients developed low titer antibodies to exenatide and approximately 33.8% of patients developed high titer antibodies at any time during the studies. The percentage of patients with positive antibody titers peaked at approximately Weeks 8-16 of dosing and then diminished over time.

Change in HbA1c from baseline in patients with low titer antibodies at the last visit was generally comparable to that observed in antibody-negative patients at the last visit. However, patients with higher titer antibodies may have an attenuated HbA1c response.

Amongst BYDUREON BCISE-treated patients evaluable for antibodies (N=393), the incidence of potentially immunogenic injection site reactions (most commonly injection site nodule) during the 28-week studies was approximately 19.6%. These reactions were less commonly observed in antibody-negative patients (15.7%) and patients with low titer antibodies (16.3%) compared with those with high titer antibodies (27.2%).

Evaluation of anti-exenatide antibodies in select patients with high-titer antibodies have demonstrated the potential for development of antibodies cross-reactive with endogenous GLP-1 and glucagon, but the clinical significance of these antibodies is not currently known. In the BYDUREON BCISE clinical trials, 133 patients developed high titer antibodies to exenatide and 118 of these patients had samples and data for the cross-reactivity assay; one patient (0.8%) developed cross-reactive antibodies to GLP-1 and/or glucagon. No information regarding the presence of neutralizing antibodies is currently available.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of BYDUREON BCISE or other formulations of exenatide. Because these reactions are reported voluntarily from a population of uncertain size, it is not always 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.

Blood and Lymphatic Systems: drug-induced thrombocytopenia [see WARNINGS AND PRECAUTIONS]

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

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 Bcise (Exenatide Extended-Release Injectable Suspension)

Related Resources for Bydureon Bcise

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

SLIDESHOW

Type 2 Diabetes: Signs, Symptoms, Treatments See Slideshow

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