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Byetta

Byetta (Exenatide Injection) side effects drug center

 

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SIDE EFFECTS

 

Byetta Side Effects Center

What Is Byetta?

Byetta (exenatide) is an injectable diabetes medicine that helps control blood sugar levels. Exenatide is used to treat type 2 (non-insulin dependent) diabetes.

What Are Side Effects of Byetta?

Side effects of Byetta include:

Although Byetta by itself usually does not cause low blood sugar (hypoglycemia), low blood sugar may occur if this drug is prescribed with other anti-diabetic medications. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet.

Dosage for Byetta

Byetta is administered as a subcutaneous injection, and should be initiated at a 5 mcg dose administered twice daily at any time within the 60-minute period before the morning and evening meals.

What Drugs, Substances, or Supplements Interact with Byetta?

Byetta may interact with:

Tell your doctor all medications and supplements you use.

Byetta During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant while using Byetta; it is unknown it will harm a fetus. Byetta can make birth control pills less effective. If you take birth control pills, take your pill at least 1 hour before your Byetta injection. It is unknown if Byetta passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Additional Information

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

 

Byetta Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives, itching; rapid heartbeats; difficult breathing; feeling light-headed; 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 Byetta 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:

  • 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, nausea, 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; or
  • itching or a small bump 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 Byetta (Exenatide Injection)

 

Byetta Professional Information

SIDE EFFECTS

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

  • Never Share a BYETTA Pen Between Patients [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]

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.

Hypoglycemia

Table 1 summarizes the incidence and rate of hypoglycemia with BYETTA in six placebo-controlled clinical trials.

Table 1: Incidence (%) and Rate of Hypoglycemia when BYETTA was used as Monotherapy or with Concomitant Antidiabetic Therapy in Six Placebo-Controlled Clinical Trials*

Placebo BID BYETTA 5 mcg BID BYETTA 10 mcg BID
Monotherapy (24 Weeks)
N 77 77 78
% Overall 1.3% 5.2% 3.8%
Rate (episodes/patient-year) 0.03 0.21 0.52
% Severe 0.0% 0.0% 0.0%
With Metformin (30 Weeks)
N 113 110 113
% Overall 5.3% 4.5% 5.3%
Rate (episodes/patient-year) 0.12 0.13 0.12
% Severe 0.0% 0.0% 0.0%
With a Sulfonylurea (30 Weeks)
N 123 125 129
% Overall 3.3% 14.4% 35.7%
Rate (episodes/patient-year) 0.07 0.64 1.61
% Severe 0.0% 0.0% 0.0%
With Metformin and a Sulfonylurea (30 Weeks)
N 247 245 241
% Overall 12.6% 19.2% 27.8%
Rate (episodes/patient-year) 0.58 0.78 1.71
% Severe 0.0% 0.4% 0.0%
With a Thiazolidinedione (16 Weeks)
N 112 not evaluated 121
% Overall 7.1% not evaluated 10.7%
Rate (episodes/patient-years) 0.56 not evaluated 0.98
% Severe 0.0% not evaluated 0.0%
With Insulin Glargine with or without Metformin and/or Thiazolidinedione (30 Weeks)†
N 122 not evaluated 137
% Overall 29.5% not evaluated 24.8%
Rate (episodes/patient-years) 1.58 not evaluated 1.61
% Severe 0.8% not evaluated 0.0%
* A hypoglycemic episode was recorded if a patient reported symptoms of hypoglycemia with or without a blood glucose value consistent with hypoglycemia. Severe hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring the assistance of another person and associated with either a documented blood glucose value <54 mg/dL or prompt recovery after treatment for hypoglycemia.
† When BYETTA was initiated in combination with insulin glargine, the dose of insulin glargine was decreased by 20% in patients with an HbA1c ≤8.0% to minimize the risk of hypoglycemia. See Table 9 for insulin dose titration algorithm.
N = number of Intent-to-Treat subjects in each treatment group.

Immunogenicity

Antibodies were assessed in 90% of subjects in the 30-week, 24-week, and 16-week studies of BYETTA. In the 30-week controlled trials of BYETTA add-on to metformin and/or sulfonylurea, antibodies were assessed at 2-to 6-week intervals. The mean antibody titer peaked at Week 6 and was reduced by 55% by Week 30. Three hundred and sixty patients (38%) had low titer antibodies (<625) to exenatide at 30 weeks. The level of glycemic control (HbA1c) in these patients was generally comparable to that observed in the 534 patients (56%) without antibody titers. An additional 59 patients (6%) had higher titer antibodies (≥625) at 30 weeks. Of these patients, 32 (3% overall) had an attenuated glycemic response to BYETTA; the remaining 27 (3% overall) had a glycemic response comparable to that of patients without antibodies.

In the 16-week trial of BYETTA add-on to thiazolidinediones, with or without metformin, 36 patients (31%) had low titer antibodies to exenatide at 16 weeks. The level of glycemic control in these patients was generally comparable to that observed in the 69 patients (60%) without antibody titer. An additional 10 patients (9%) had higher titer antibodies at 16 weeks. Of these patients, 4 (4% overall) had an attenuated glycemic response to BYETTA; the remaining 6 (5% overall) had a glycemic response comparable to that of patients without antibodies .

In the 24-week trial of BYETTA used as monotherapy, 40 patients (28%) had low titer antibodies to exenatide at 24 weeks. The level of glycemic control in these patients was generally comparable to that observed in the 101 patients (70%) without antibody titers. An additional 3 patients (2%) had higher titer antibodies at 24 weeks. Of these patients, 1 (1% overall) had an attenuated glycemic response to BYETTA; the remaining 2 (1% overall) had a glycemic response comparable to that of patients without antibodies.

Antibodies to exenatide were not assessed in the 30-week placebo-controlled trial of BYETTA used in combination with insulin glargine.

In the 30-week comparator-controlled trial of BYETTA used in combination with insulin glargine and metformin, 60 patients (20%) had low titer antibodies to exenatide at 30 weeks. The level of glycemic control in these patients was generally comparable to that observed in the 234 patients (77%) without antibody titers. An additional 10 patients (3%) had higher titer antibodies at 30 weeks. Of these patients, 2 (1% overall) had an attenuated glycemic response to BYETTA; the remaining 8 (3% overall) had a glycemic response comparable to that of patients without antibodies.

Two hundred and ten patients with antibodies to exenatide in the BYETTA 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

Monotherapy

For the 24-week placebo-controlled study of BYETTA used as a monotherapy, Table 2 summarizes adverse reactions (excluding hypoglycemia) occurring with an incidence ≥2% and occurring more frequently in BYETTA-treated patients compared with placebo-treated patients.

Table 2: Treatment-Emergent Adverse Reactions ≥2% Incidence with BYETTA used as Monotherapy (excluding Hypoglycemia)*

Monotherapy Placebo BID
N=77 %		 All BYETTA BID
N=155 %
Nausea 0 8
Vomiting 0 4
Dyspepsia 0 3
* In a 24-week placebo-controlled trial.
BID = twice daily.

Adverse reactions reported in ≥1.0% to <2.0% of patients receiving BYETTA and reported more frequently than with placebo included decreased appetite, diarrhea, and dizziness. The most frequently reported adverse reaction associated with BYETTA, nausea, occurred in a dose-dependent fashion.

Two of the 155 patients treated with BYETTA withdrew due to adverse reactions of headache and nausea. No placebo-treated patients withdrew due to adverse reactions.

Combination Therapy

Add-On To Metformin And/Or Sulfonylurea

In the three 30-week controlled trials of BYETTA add-on to metformin and/or sulfonylurea, adverse reactions (excluding hypoglycemia) with an incidence ≥2% and occurring more frequently in BYETTA-treated patients compared with placebo-treated patients are summarized in Table 3.

Table 3: Treatment-Emergent Adverse Reactions ≥2% Incidence and Greater Incidence with BYETTA Treatment used with Metformin and/or a Sulfonylurea (excluding Hypoglycemia)*

Placebo BID
N=483 %		 All BYETTA
BID
N=963 %
Nausea 18 44
Vomiting 4 13
Diarrhea 6 13
Feeling Jittery 4 9
Dizziness 6 9
Headache 6 9
Dyspepsia 3 6
Asthenia 2 4
Gastroesophageal Reflux Disease 1 3
Hyperhidrosis 1 3
* In three 30-week placebo-controlled clinical trials.
BID = twice daily.

Adverse reactions reported in ≥1.0% to <2.0% of patients receiving BYETTA and reported more frequently than with placebo included decreased appetite. Nausea was the most frequently reported adverse reaction and occurred in a dose-dependent fashion. With continued therapy, the frequency and severity decreased over time in most of the patients who initially experienced nausea. Patients in the long-term uncontrolled open-label extension studies at 52 weeks reported no new types of adverse reactions than those observed in the 30-week controlled trials.

The most common adverse reactions leading to withdrawal for BYETTA-treated patients were nausea (3% of patients) and vomiting (1%). For placebo-treated patients, <1% withdrew due to nausea and none due to vomiting.

Add-On To Thiazolidinedione With Or Without Metformin

For the 16-week placebo-controlled study of BYETTA add-on to a thiazolidinedione, with or without metformin, Table 4 summarizes the adverse reactions (excluding hypoglycemia) with an incidence of ≥2% and occurring more frequently in BYETTA-treated patients compared with placebo-treated patients.

Table 4: Treatment-Emergent Adverse Reactions ≥2% Incidence with BYETTA used with a Thiazolidinedione (TZD), with or without Metformin (MET) (excluding Hypoglycemia)*

With a TZD or TZD/MET Placebo
N=112 %		 All BYETTA BID
N=121 %
Nausea 15 40
Vomiting 1 13
Dyspepsia 1 7
Diarrhea 3 6
Gastroesophageal Reflux Disease 0 3
* In a 16-week placebo-controlled clinical trial.
BID = twice daily.

Adverse reactions reported in ≥1.0% to <2.0% of patients receiving BYETTA and reported more frequently than with placebo included decreased appetite. Chills (n=4) and injection-site reactions (n=2) occurred only in BYETTA-treated patients. The two patients who reported an injection-site reaction had high titers of antibodies to exenatide. Two serious adverse events (chest pain and chronic hypersensitivity pneumonitis) were reported in the BYETTA arm. No serious adverse events were reported in the placebo arm.

The most common adverse reactions leading to withdrawal for BYETTA-treated patients were nausea (9%) and vomiting (5%). For placebo-treated patients, <1% withdrew due to nausea.

Add-On To Insulin Glargine With Or Without Metformin And/Or Thiazolidinedione (Placebo-Controlled)

For the 30-week placebo-controlled study of BYETTA as add-on to insulin glargine with or without oral antihyperglycemic medications, Table 5 summarizes adverse reactions (excluding hypoglycemia) occurring with an incidence ≥2% and occurring more frequently in BYETTA-treated patients compared with placebo-treated patients.

Table 5: Treatment-Emergent Adverse Reactions ≥2% Incidence with BYETTA used with Insulin Glargine with or without Oral Antihyperglycemic Medications (excluding Hypoglycemia)*

With Insulin Glargine Placebo
N=122 %		 All BYETTA BID
N=137 %
Nausea 8 41
Vomiting 4 18
Diarrhea 8 18
Headache 4 14
Constipation 2 10
Dyspepsia 2 7
Asthenia 1 5
Abdominal Distension 1 4
Decreased Appetite 0 3
Flatulence 1 2
Gastroesophageal Reflux Disease 1 2
* In a 30-week placebo-controlled clinical trial.
BID = twice daily.

The most frequently reported adverse reactions leading to withdrawal for BYETTA-treated patients were nausea (5.1%) and vomiting (2.9%). No placebo-treated patients withdrew due to nausea or vomiting.

Postmarketing Experience

The following additional adverse reactions have been reported during post-approval 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.

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

Blood and Lymphatic Systems: drug-induced thrombocytopenia.

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

Metabolic: Severe hypoglycemia with concomitant use of sulfonylurea or insulin 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

Orally Administered Drugs

The effect of BYETTA to slow gastric emptying can reduce the extent and rate of absorption of orally administered drugs. BYETTA should be used with caution in patients receiving oral medications that have narrow therapeutic index or require rapid gastrointestinal absorption [see ADVERSE REACTIONS]. For oral medications that are dependent on threshold concentrations for efficacy, such as contraceptives and antibiotics, patients should be advised to take those drugs at least 1 hour before BYETTA injection. If such drugs are to be administered with food, patients should be advised to take them with a meal or snack when BYETTA is not administered [see CLINICAL PHARMACOLOGY].

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 and ADVERSE REACTIONS].

Warfarin

There are postmarketing reports of increased INR sometimes associated with bleeding, with concomitant use of warfarin and BYETTA [see ADVERSE REACTIONS]. In a drug interaction study, BYETTA did not have a significant effect on INR [see CLINICAL PHARMACOLOGY]. In patients taking warfarin, prothrombin time should be monitored more frequently after initiation or alteration of BYETTA therapy. Once a stable prothrombin time has been documented, prothrombin times can be monitored at the intervals usually recommended for patients on warfarin.

Read the entire FDA prescribing information for Byetta (Exenatide Injection)

&Copy; Byetta Patient Information is supplied by Cerner Multum, Inc. and Byetta Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.