Dosing & Uses
Dosage Forms & Strengths
injectable suspension, autoinjector
- 2mg/0.85 mL (Bydureon BCise)
Type 2 Diabetes Mellitus
Indicated as adjunct to diet and exercise to improve glycemic control with type 2 diabetes mellitus (DM)
2 mg SC qWeek
Initiating therapy
- If starting Bydureon BCise in a patient already taking Byetta, discontinue Byetta
- Prior treatment with immediate- or extended-release exenatide product is not required when initiating Bydureon BCise therapy
- Discontinue any immediate- or extended-release exenatide product
- When wwitching from another extended-release exenatide product to Bydureon BCise, may initiate at next regularly scheduled dose
- When switching from immediate-release exenatide, patients may experience transient (~2-4 weeks) elevations in blood glucose concentrations
- Day of weekly administration can be changed if necessary, as long as the last dose was administered ≥3 days before new day of administration
Dosage Modifications
Hepatic impairment: Not studied
Renal impairment
- Pharmacokinetic studies indicated an increase in exposure in moderate and mild renally impaired patients as compared to patients with normal renal function
- Mild (eGFR >45 mL/min/1.73 m²): Monitor for adverse reactions that may lead to hypovolemia
- Severe (eGFR <45 mL/min/1.73 m²) or end-stage renal disease (ESRD): Not recommended
- Renal transplantation: Closely monitor for adverse reactions that may lead to hypovolemia
Dosing Considerations
Limitations of use
- Not recommended as first-line therapy for patients inadequately controlled on diet and exercise
- Not indicated for type 1 diabetes or diabetic ketoacidosis
- Bydureon BCise is an extended-release exenatide formulation; do not coadminister with other exenatide containing products
- Has not been studied in patients with history of pancreatitis; consider other antidiabetic therapies
Dosage Forms & Strengths
injectable suspension, autoinjector
- 2mg/0.85 mL (Bydureon BCise)
Type 2 Diabetes Mellitus
Indicated as adjunct to diet and exercise to improve glycemic control with type 2 diabetes mellitus (DM) in adults and children aged >10 years
<10 years: Safety and efficacy not established
≥10 years: 2 mg SC qWeek
Initiating therapy
- If starting Bydureon BCise in a patient already taking Byetta, discontinue Byetta
- Prior treatment with immediate- or extended-release exenatide product is not required when initiating Bydureon BCise therapy
- Discontinue any immediate- or extended-release exenatide product
- When wwitching from another extended-release exenatide product to Bydureon BCise, may initiate at next regularly scheduled dose
- When switching from immediate-release exenatide, patients may experience transient (~2-4 weeks) elevations in blood glucose concentrations
- Day of weekly administration can be changed if necessary, as long as the last dose was administered ≥3 days before new day of administration
Dosage Modifications
Hepatic impairment: Not studied
Renal impairment
- Pharmacokinetic studies indicated an increase in exposure in moderate and mild renally impaired patients as compared to patients with normal renal function
- Mild (eGFR >45 mL/min/1.73 m²): Monitor for adverse reactions that may lead to hypovolemia
- Severe (eGFR <45 mL/min/1.73 m²) or end-stage renal disease (ESRD): Not recommended
- Renal transplantation: Closely monitor for adverse reactions that may lead to hypovolemia
Dosing Considerations
Limitations of use
- Not recommended as first-line therapy for patients inadequately controlled on diet and exercise
- Not indicated for type 1 diabetes or diabetic ketoacidosis
- Bydureon BCise is an extended-release exenatide formulation; do not coadminister with other exenatide containing products
- Has not been studied in patients with history of pancreatitis; consider other antidiabetic therapies
Bydureon and Bydureon BCise
No differences in safety or efficacy were observed between these patients and younger patients
Because elderly patients are more likely to have decreased renal function, use caution
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (0)
Monitor Closely (104)
- acarbose
exenatide injectable suspension, acarbose. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Concurrent use may increase risk of hypoglycemia; monitor glucose levels.
- acetaminophen
exenatide injectable suspension will decrease the level or effect of acetaminophen by unspecified interaction mechanism. Use Caution/Monitor. To avoid potential interaction, give acetaminophen at least 1 hour before or 4 hours after exenatide injection.
- acetaminophen IV
exenatide injectable suspension will decrease the level or effect of acetaminophen IV by unspecified interaction mechanism. Use Caution/Monitor. To avoid potential interaction, give acetaminophen at least 1 hour before or 4 hours after exenatide injection.
- aripiprazole
aripiprazole, exenatide injectable suspension. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.
- asenapine
asenapine, exenatide injectable suspension. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.
- atazanavir
atazanavir decreases effects of exenatide injectable suspension by Other (see comment). Use Caution/Monitor. Comment: Reports of hyperglycemia due to insulin resistance with protease inhibitors.
- azilsartan
azilsartan increases effects of exenatide injectable suspension by Other (see comment). Use Caution/Monitor. Comment: Angiotensin II receptor antagonists may enhance hypoglycemic effects of antidiabetic agents by improving insulin sensitivity. Monitor patients for changes in glycemic control.
- bazedoxifene/conjugated estrogens
bazedoxifene/conjugated estrogens decreases effects of exenatide injectable suspension by pharmacodynamic antagonism. Use Caution/Monitor. Estrogens may decrease hypoglycemic effects of antidiabetics by impairing glucose tolerance. Monitor for glycemic control in diabetic patients.
- benazepril
benazepril increases effects of exenatide injectable suspension by Other (see comment). Use Caution/Monitor. Comment: ACE inhibitors may increase hypoglycemic effect. Monitor glycemic control especially during the first month of treatment with an ACE inhibitor.
- betamethasone
betamethasone decreases effects of exenatide injectable suspension by pharmacodynamic antagonism. Use Caution/Monitor. Corticosteroids may diminish hypoglycemic effect of antidiabetic agents. Monitor blood glucose levels carefully.
- candesartan
candesartan increases effects of exenatide injectable suspension by Other (see comment). Use Caution/Monitor. Comment: Angiotensin II receptor antagonists may enhance hypoglycemic effects of antidiabetic agents by improving insulin sensitivity. Monitor patients for changes in glycemic control.
- captopril
captopril increases effects of exenatide injectable suspension by Other (see comment). Use Caution/Monitor. Comment: ACE inhibitors may increase hypoglycemic effect. Monitor glycemic control especially during the first month of treatment with an ACE inhibitor.
- chlorothiazide
chlorothiazide decreases effects of exenatide injectable suspension by pharmacodynamic antagonism. Use Caution/Monitor. Thiazide diuretics can decrease insulin sensitivity thereby leading to glucose intolerance and hyperglycemia. Monitor glycemic control especially when initiating, discontinuing, or increasing thiazide diuretic dose.
- chlorpropamide
exenatide injectable suspension, chlorpropamide. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of hypoglycemia when exenatide is used in combination with agents that induce hypoglycemia. Consider lowering dose of sulfonylureas to reduce risk of hypoglycemia.
- chlorthalidone
chlorthalidone decreases effects of exenatide injectable suspension by pharmacodynamic antagonism. Use Caution/Monitor. Thiazide diuretics can decrease insulin sensitivity thereby leading to glucose intolerance and hyperglycemia. Monitor glycemic control especially when initiating, discontinuing, or increasing thiazide diuretic dose.
- cinnamon
cinnamon increases effects of exenatide injectable suspension by pharmacodynamic synergism. Use Caution/Monitor. Potential for hypoglycemia.
- clozapine
clozapine, exenatide injectable suspension. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.
- conjugated estrogens
conjugated estrogens decreases effects of exenatide injectable suspension by pharmacodynamic antagonism. Use Caution/Monitor. Estrogens may decrease hypoglycemic effects of antidiabetics by impairing glucose tolerance. Monitor for glycemic control in diabetic patients.
- conjugated estrogens, vaginal
conjugated estrogens, vaginal decreases effects of exenatide injectable suspension by pharmacodynamic antagonism. Use Caution/Monitor. Estrogens may decrease hypoglycemic effects of antidiabetics by impairing glucose tolerance. Monitor for glycemic control in diabetic patients.
- cortisone
cortisone decreases effects of exenatide injectable suspension by pharmacodynamic antagonism. Use Caution/Monitor. Corticosteroids may diminish hypoglycemic effect of antidiabetic agents. Monitor blood glucose levels carefully.
- darunavir
darunavir decreases effects of exenatide injectable suspension by Other (see comment). Use Caution/Monitor. Comment: Reports of hyperglycemia due to insulin resistance with protease inhibitors.
- desogestrel
desogestrel, exenatide injectable suspension. Other (see comment). Use Caution/Monitor. Comment: Oral contraceptives may decrease hypoglycemic effects of antidiabetics by impairing glucose tolerance. The effect of exenatide to slow gastric emptying may reduce the extent and rate of oral medications that require rapid GI absorption. Advise patients to take oral contraceptives at least 1 hr before exenatide.
- dexamethasone
dexamethasone decreases effects of exenatide injectable suspension by pharmacodynamic antagonism. Use Caution/Monitor. Corticosteroids may diminish hypoglycemic effect of antidiabetic agents. Monitor blood glucose levels carefully.
- drospirenone
drospirenone, exenatide injectable suspension. Other (see comment). Use Caution/Monitor. Comment: Oral contraceptives may decrease hypoglycemic effects of antidiabetics by impairing glucose tolerance. The effect of exenatide to slow gastric emptying may reduce the extent and rate of oral medications that require rapid GI absorption. Advise patients to take oral contraceptives at least 1 hr before exenatide.
- enalapril
enalapril increases effects of exenatide injectable suspension by Other (see comment). Use Caution/Monitor. Comment: ACE inhibitors may increase hypoglycemic effect. Monitor glycemic control especially during the first month of treatment with an ACE inhibitor.
- eprosartan
eprosartan increases effects of exenatide injectable suspension by Other (see comment). Use Caution/Monitor. Comment: Angiotensin II receptor antagonists may enhance hypoglycemic effects of antidiabetic agents by improving insulin sensitivity. Monitor patients for changes in glycemic control.
- estradiol
estradiol, exenatide injectable suspension. Other (see comment). Use Caution/Monitor. Comment: Oral contraceptives may decrease hypoglycemic effects of antidiabetics by impairing glucose tolerance. The effect of exenatide to slow gastric emptying may reduce the extent and rate of oral medications that require rapid GI absorption. Advise patients to take oral contraceptives at least 1 hr before exenatide.
- estradiol combos
estradiol combos, exenatide injectable suspension. Other (see comment). Use Caution/Monitor. Comment: Oral contraceptives may decrease hypoglycemic effects of antidiabetics by impairing glucose tolerance. The effect of exenatide to slow gastric emptying may reduce the extent and rate of oral medications that require rapid GI absorption. Advise patients to take oral contraceptives at least 1 hr before exenatide.
- estrogens conjugated synthetic
estrogens conjugated synthetic decreases effects of exenatide injectable suspension by pharmacodynamic antagonism. Use Caution/Monitor. Estrogens may decrease hypoglycemic effects of antidiabetics by impairing glucose tolerance. Monitor for glycemic control in diabetic patients.
- estrogens esterified
estrogens esterified decreases effects of exenatide injectable suspension by pharmacodynamic antagonism. Use Caution/Monitor. Estrogens may decrease hypoglycemic effects of antidiabetics by impairing glucose tolerance. Monitor for glycemic control in diabetic patients.
- estropipate
estropipate decreases effects of exenatide injectable suspension by pharmacodynamic antagonism. Use Caution/Monitor. Estrogens may decrease hypoglycemic effects of antidiabetics by impairing glucose tolerance. Monitor for glycemic control in diabetic patients.
- ethinylestradiol
ethinylestradiol, exenatide injectable suspension. Other (see comment). Use Caution/Monitor. Comment: Oral contraceptives may decrease hypoglycemic effects of antidiabetics by impairing glucose tolerance. The effect of exenatide to slow gastric emptying may reduce the extent and rate of oral medications that require rapid GI absorption. Advise patients to take oral contraceptives at least 1 hr before exenatide.
- etonogestrel
etonogestrel decreases effects of exenatide injectable suspension by pharmacodynamic antagonism. Use Caution/Monitor. Estrogens may decrease hypoglycemic effects of antidiabetics by impairing glucose tolerance. Monitor for glycemic control in diabetic patients.
- fludrocortisone
fludrocortisone decreases effects of exenatide injectable suspension by pharmacodynamic antagonism. Use Caution/Monitor. Corticosteroids may diminish hypoglycemic effect of antidiabetic agents. Monitor blood glucose levels carefully.
- fosamprenavir
fosamprenavir decreases effects of exenatide injectable suspension by Other (see comment). Use Caution/Monitor. Comment: Reports of hyperglycemia due to insulin resistance with protease inhibitors.
- fosinopril
fosinopril increases effects of exenatide injectable suspension by Other (see comment). Use Caution/Monitor. Comment: ACE inhibitors may increase hypoglycemic effect. Monitor glycemic control especially during the first month of treatment with an ACE inhibitor.
- glimepiride
exenatide injectable suspension, glimepiride. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of hypoglycemia when exenatide is used in combination with agents that induce hypoglycemia. Consider lowering dose of sulfonylureas to reduce risk of hypoglycemia.
- glipizide
exenatide injectable suspension, glipizide. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of hypoglycemia when exenatide is used in combination with agents that induce hypoglycemia. Consider lowering dose of sulfonylureas to reduce risk of hypoglycemia.
- glyburide
exenatide injectable suspension, glyburide. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of hypoglycemia when exenatide is used in combination with agents that induce hypoglycemia. Consider lowering dose of sulfonylureas to reduce risk of hypoglycemia.
- hydrochlorothiazide
hydrochlorothiazide decreases effects of exenatide injectable suspension by pharmacodynamic antagonism. Use Caution/Monitor. Thiazide diuretics can decrease insulin sensitivity thereby leading to glucose intolerance and hyperglycemia. Monitor glycemic control especially when initiating, discontinuing, or increasing thiazide diuretic dose.
- hydrocortisone
hydrocortisone decreases effects of exenatide injectable suspension by pharmacodynamic antagonism. Use Caution/Monitor. Corticosteroids may diminish hypoglycemic effect of antidiabetic agents. Monitor blood glucose levels carefully.
- ifosfamide
ifosfamide, exenatide injectable suspension. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Use Caution/Monitor. Monitor renal function.
- iloperidone
iloperidone, exenatide injectable suspension. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.
- indapamide
indapamide decreases effects of exenatide injectable suspension by pharmacodynamic antagonism. Use Caution/Monitor. Thiazide diuretics can decrease insulin sensitivity thereby leading to glucose intolerance and hyperglycemia. Monitor glycemic control especially when initiating, discontinuing, or increasing thiazide diuretic dose.
- indinavir
indinavir decreases effects of exenatide injectable suspension by Other (see comment). Use Caution/Monitor. Comment: Reports of hyperglycemia due to insulin resistance with protease inhibitors.
- insulin aspart
exenatide injectable suspension, insulin aspart. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- insulin aspart protamine/insulin aspart
exenatide injectable suspension, insulin aspart protamine/insulin aspart. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- insulin degludec
exenatide injectable suspension, insulin degludec. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- insulin degludec/insulin aspart
exenatide injectable suspension, insulin degludec/insulin aspart. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- insulin detemir
exenatide injectable suspension, insulin detemir. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- insulin glargine
exenatide injectable suspension, insulin glargine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- insulin glulisine
exenatide injectable suspension, insulin glulisine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- insulin inhaled
exenatide injectable suspension, insulin inhaled. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- insulin isophane human/insulin regular human
exenatide injectable suspension, insulin isophane human/insulin regular human. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- insulin lispro
exenatide injectable suspension, insulin lispro. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- insulin lispro protamine/insulin lispro
exenatide injectable suspension, insulin lispro protamine/insulin lispro. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- insulin NPH
exenatide injectable suspension, insulin NPH. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- insulin regular human
exenatide injectable suspension, insulin regular human. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- irbesartan
irbesartan increases effects of exenatide injectable suspension by Other (see comment). Use Caution/Monitor. Comment: Angiotensin II receptor antagonists may enhance hypoglycemic effects of antidiabetic agents by improving insulin sensitivity. Monitor patients for changes in glycemic control.
- levonorgestrel oral
levonorgestrel oral, exenatide injectable suspension. Other (see comment). Use Caution/Monitor. Comment: Oral contraceptives may decrease hypoglycemic effects of antidiabetics by impairing glucose tolerance. The effect of exenatide to slow gastric emptying may reduce the extent and rate of oral medications that require rapid GI absorption. Advise patients to take oral contraceptives at least 1 hr before exenatide.
- lisinopril
lisinopril increases effects of exenatide injectable suspension by Other (see comment). Use Caution/Monitor. Comment: ACE inhibitors may increase hypoglycemic effect. Monitor glycemic control especially during the first month of treatment with an ACE inhibitor.
- lonapegsomatropin
lonapegsomatropin decreases effects of exenatide injectable suspension by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- lopinavir
lopinavir decreases effects of exenatide injectable suspension by Other (see comment). Use Caution/Monitor. Comment: Reports of hyperglycemia due to insulin resistance with protease inhibitors.
- losartan
losartan increases effects of exenatide injectable suspension by Other (see comment). Use Caution/Monitor. Comment: Angiotensin II receptor antagonists may enhance hypoglycemic effects of antidiabetic agents by improving insulin sensitivity. Monitor patients for changes in glycemic control.
- lurasidone
lurasidone, exenatide injectable suspension. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.
- medroxyprogesterone
medroxyprogesterone decreases effects of exenatide injectable suspension by pharmacodynamic antagonism. Use Caution/Monitor. Estrogens may decrease hypoglycemic effects of antidiabetics by impairing glucose tolerance. Monitor for glycemic control in diabetic patients.
- mestranol
mestranol, exenatide injectable suspension. Other (see comment). Use Caution/Monitor. Comment: Oral contraceptives may decrease hypoglycemic effects of antidiabetics by impairing glucose tolerance. The effect of exenatide to slow gastric emptying may reduce the extent and rate of oral medications that require rapid GI absorption. Advise patients to take oral contraceptives at least 1 hr before exenatide.
- metformin
exenatide injectable suspension, metformin. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Concurrent use may increase risk of hypoglycemia; monitor glucose levels.
- methyclothiazide
methyclothiazide decreases effects of exenatide injectable suspension by pharmacodynamic antagonism. Use Caution/Monitor. Thiazide diuretics can decrease insulin sensitivity thereby leading to glucose intolerance and hyperglycemia. Monitor glycemic control especially when initiating, discontinuing, or increasing thiazide diuretic dose.
- methylprednisolone
methylprednisolone decreases effects of exenatide injectable suspension by pharmacodynamic antagonism. Use Caution/Monitor. Corticosteroids may diminish hypoglycemic effect of antidiabetic agents. Monitor blood glucose levels carefully.
- metolazone
metolazone decreases effects of exenatide injectable suspension by pharmacodynamic antagonism. Use Caution/Monitor. Thiazide diuretics can decrease insulin sensitivity thereby leading to glucose intolerance and hyperglycemia. Monitor glycemic control especially when initiating, discontinuing, or increasing thiazide diuretic dose.
- miglitol
exenatide injectable suspension, miglitol. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Concurrent use may increase risk of hypoglycemia; monitor glucose levels.
- moexipril
moexipril increases effects of exenatide injectable suspension by Other (see comment). Use Caution/Monitor. Comment: ACE inhibitors may increase hypoglycemic effect. Monitor glycemic control especially during the first month of treatment with an ACE inhibitor.
- nateglinide
exenatide injectable suspension, nateglinide. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Concurrent use may increase risk of hypoglycemia; monitor glucose levels.
- nelfinavir
nelfinavir decreases effects of exenatide injectable suspension by Other (see comment). Use Caution/Monitor. Comment: Reports of hyperglycemia due to insulin resistance with protease inhibitors.
- norethindrone acetate
norethindrone acetate, exenatide injectable suspension. Other (see comment). Use Caution/Monitor. Comment: Oral contraceptives may decrease hypoglycemic effects of antidiabetics by impairing glucose tolerance. The effect of exenatide to slow gastric emptying may reduce the extent and rate of oral medications that require rapid GI absorption. Advise patients to take oral contraceptives at least 1 hr before exenatide.
- olanzapine
olanzapine, exenatide injectable suspension. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.
- olmesartan
olmesartan increases effects of exenatide injectable suspension by Other (see comment). Use Caution/Monitor. Comment: Angiotensin II receptor antagonists may enhance hypoglycemic effects of antidiabetic agents by improving insulin sensitivity. Monitor patients for changes in glycemic control.
- paliperidone
paliperidone, exenatide injectable suspension. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.
- perindopril
perindopril increases effects of exenatide injectable suspension by Other (see comment). Use Caution/Monitor. Comment: ACE inhibitors may increase hypoglycemic effect. Monitor glycemic control especially during the first month of treatment with an ACE inhibitor.
- pioglitazone
exenatide injectable suspension, pioglitazone. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Concurrent use may increase risk of hypoglycemia; monitor glucose levels.
- prednisolone
prednisolone decreases effects of exenatide injectable suspension by pharmacodynamic antagonism. Use Caution/Monitor. Corticosteroids may diminish hypoglycemic effect of antidiabetic agents. Monitor blood glucose levels carefully.
- prednisone
prednisone decreases effects of exenatide injectable suspension by pharmacodynamic antagonism. Use Caution/Monitor. Corticosteroids may diminish hypoglycemic effect of antidiabetic agents. Monitor blood glucose levels carefully.
- quetiapine
quetiapine, exenatide injectable suspension. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.
- quinapril
quinapril increases effects of exenatide injectable suspension by Other (see comment). Use Caution/Monitor. Comment: ACE inhibitors may increase hypoglycemic effect. Monitor glycemic control especially during the first month of treatment with an ACE inhibitor.
- ramipril
ramipril increases effects of exenatide injectable suspension by Other (see comment). Use Caution/Monitor. Comment: ACE inhibitors may increase hypoglycemic effect. Monitor glycemic control especially during the first month of treatment with an ACE inhibitor.
- repaglinide
exenatide injectable suspension, repaglinide. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Concurrent use may increase risk of hypoglycemia; monitor glucose levels.
- risperidone
risperidone, exenatide injectable suspension. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.
- ritonavir
ritonavir decreases effects of exenatide injectable suspension by Other (see comment). Use Caution/Monitor. Comment: Reports of hyperglycemia due to insulin resistance with protease inhibitors.
- rosiglitazone
exenatide injectable suspension, rosiglitazone. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Concurrent use may increase risk of hypoglycemia; monitor glucose levels.
- sacubitril/valsartan
sacubitril/valsartan increases effects of exenatide injectable suspension by Other (see comment). Use Caution/Monitor. Comment: Angiotensin II receptor antagonists may enhance hypoglycemic effects of antidiabetic agents by improving insulin sensitivity. Monitor patients for changes in glycemic control.
- saquinavir
saquinavir decreases effects of exenatide injectable suspension by Other (see comment). Use Caution/Monitor. Comment: Reports of hyperglycemia due to insulin resistance with protease inhibitors.
- saxagliptin
exenatide injectable suspension, saxagliptin. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Concurrent use may increase risk of hypoglycemia; monitor glucose levels.
- sitagliptin
exenatide injectable suspension, sitagliptin. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Concurrent use may increase risk of hypoglycemia; monitor glucose levels.
- somapacitan
somapacitan decreases effects of exenatide injectable suspension by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- telmisartan
telmisartan increases effects of exenatide injectable suspension by Other (see comment). Use Caution/Monitor. Comment: Angiotensin II receptor antagonists may enhance hypoglycemic effects of antidiabetic agents by improving insulin sensitivity. Monitor patients for changes in glycemic control.
- tesamorelin
tesamorelin will decrease the level or effect of exenatide injectable suspension by altering metabolism. Modify Therapy/Monitor Closely. Monitor glucose levels
- tipranavir
tipranavir decreases effects of exenatide injectable suspension by Other (see comment). Use Caution/Monitor. Comment: Reports of hyperglycemia due to insulin resistance with protease inhibitors.
- tolazamide
exenatide injectable suspension, tolazamide. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of hypoglycemia when exenatide is used in combination with agents that induce hypoglycemia. Consider lowering dose of sulfonylureas to reduce risk of hypoglycemia.
- tolbutamide
exenatide injectable suspension, tolbutamide. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of hypoglycemia when exenatide is used in combination with agents that induce hypoglycemia. Consider lowering dose of sulfonylureas to reduce risk of hypoglycemia.
- triamcinolone acetonide injectable suspension
triamcinolone acetonide injectable suspension decreases effects of exenatide injectable suspension by pharmacodynamic antagonism. Use Caution/Monitor. Corticosteroids may diminish hypoglycemic effect of antidiabetic agents. Monitor blood glucose levels carefully.
- valsartan
valsartan increases effects of exenatide injectable suspension by Other (see comment). Use Caution/Monitor. Comment: Angiotensin II receptor antagonists may enhance hypoglycemic effects of antidiabetic agents by improving insulin sensitivity. Monitor patients for changes in glycemic control.
- warfarin
exenatide injectable suspension increases effects of warfarin by unspecified interaction mechanism. Use Caution/Monitor.
- ziprasidone
ziprasidone, exenatide injectable suspension. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.
Minor (3)
- acetaminophen rectal
exenatide injectable suspension decreases levels of acetaminophen rectal by unspecified interaction mechanism. Minor/Significance Unknown.
- digoxin
exenatide injectable suspension decreases levels of digoxin by unspecified interaction mechanism. Minor/Significance Unknown.
- lovastatin
exenatide injectable suspension decreases levels of lovastatin by unspecified interaction mechanism. Minor/Significance Unknown.
Adverse Effects
>10%
Injection site nodule (10.5%)
1-10%
Nausea (8.2%)
Headache (4.4%)
Diarrhea (4%)
Vomiting (3.4%)
Injection site pruritus (3.2%)
Dizziness (2.5%)
Injection site erythema (2.3%)
Constipation (2.1%)
Postmarketing Reports
Allergy/hypersensitivity: Injection-site reactions, generalized pruritus and/or urticaria, macular or papular rash, abscess, cellulitis, necrosis without subcutaneous nodules, angioedema; anaphylactic reaction
Drug interactions: Increased INR sometimes associated with bleeding, with concomitant warfarin
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
Hepatobiliary: Cholecystitis, cholelithiasis requiring cholecystectomy
Neurologic: Dysgeusia; somnolence
Increased heart rate
Renal and urinary disorders: Altered renal function (eg, 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
Warnings
Black Box Warnings
Risk of thyroid C-cell tumors
- Exenatide extended-release causes an increased incidence in thyroid C-cell tumors at clinically relevant exposures in rats compared to controls; unknown whether this risk for medullary thyroid carcinoma (MTC) exists in humans, as human relevance could not be determined by clinical or nonclinical studies
- Contraindicated in patients with a personal or family history of MTC and in patients with multiple endocrine neoplasia syndrome type 2 (MEN 2)
- Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value in patients treated with exenatide injectable suspension
- Counsel patients regarding the potential risk of MTC and symptoms (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness) of thyroid tumors
Contraindications
Hypersensitivity to exenatide or to any of the product components
Personal or family history of medullary thyroid carcinoma or in patients with multiple endocrine neoplasia syndrome type 2 (see Black Box Warnings)
Cautions
Avoid concurrent use of extended release (Bydureon BCise) and immediate release xenatide (Byetta) formulations
Serious injection-site reactions (eg, abscess, cellulitis, and necrosis) reported, with or without SC nodules; some required surgical intervention
Thyroid C-cell tumors in animals observed; human relevance unknown (see Black Box Warnings)
Pancreatitis reported, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis; discontinue promptly if pancreatitis is suspected; do not resume therapy unless alternative etiology of pancreatitis is confirmed; consider alternative antidiabetic therapy in patients with history of pancreatitis
Reports of serious hypersensitivity reactions (eg, anaphylaxis and angioedema); inform and closely monitor patients with a history of anaphylaxis or angioedema with another GLP-1 receptor agonist for allergic reactions; it is unknown whether such patients will be predisposed to anaphylaxis (see Contraindications)
Antibodies to exenatide following treatment may develop; anti-exenatide antibodies were measured in controlled studies; patients with higher titer antibodies may have an attenuated HbA1c response; if glycemic control worsens, consider alternative antidiabetic therapy
Not recommended with severe gastrointestinal disease (eg, gastroparesis)
Evaluate patient further if serum calcitonin is measured and found to be elevated
Evaluate further patients with thyroid nodules noted on physical examination or neck imaging
There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction
Pen shaped injection devices should not be used by more than one person, even if needle is changed as it increases risk of infection
Not for use in patients with type 1 diabetes mellitus or diabetic ketoacidosis
Acute events of gallbladder disease reported in GLP-1 receptor agonist trials; if cholelithiasis suspected, gallbladder studies and appropriate clinical follow-up indicated
Use caution when initiating therapy in geriatric patients; they are more likely to have decreased kidney function
Acute kidney injury
- Renal impairment reported, including some instances requiring hemodialysis and kidney transplantation; not recommended if severe renal impairment or ESRD exist
- Caution in patients with renal transplantation or moderate renal impairment
- There is increase in drug exposure in those with mild and moderate renal impairment as compared to patients with normal kidney function
- Not recommended for use in patients with severe renal impairment (creatinine clearance <30 mL/min) or end-stage renal disease; should be used with caution in patients with renal transplantation
- Therapy may induce nausea and vomiting with transient hypovolemia and may worsen renal function; not recommended for use in patients with an eGFR below 45mL/min/1.73 m²
Drug interactions overview
- Use caution when administering oral medications with Bydureon and Bydureon BCise where a slower rate of oral absorption may be clinically meaningful
- Postmarketing reports for exenatide of increased INR with concomitant use of warfarin, sometimes associated with bleeding; monitor INR
- Risk of hypoglycemia is increased when exenatide is used in combination with insulin secretagogues (eg, sulfonylureas) or insulin; lower dose of the secretagogue or insulin to reduce risk of hypoglycemia; inform patients using these concomitant medications of risk of hypoglycemia and educate them on signs and symptoms of hypoglycemia
Pregnancy & Lactation
Pregnancy
Limited data with exenatide in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage
Based on animal reproduction studies, there may be risks to the fetus from exposure to exenatide injection during pregnancy
Use exenatide injection during pregnancy only if the potential benefit justifies the potential risk to the fetus
Animal reproduction studies identified increased adverse fetal and neonatal outcomes from exposure to exenatide extended-release during pregnancy or from exposure to exenatide during pregnancy and lactation, in association with maternal effects
Lactation
There is no information on the presence of exenatide, in human milk, the effects of exenatide on the breastfed infant, or the effects of exenatide on milk production
Exenatide was present in the milk of lactating mice; exenatide concentration in milk was up to 2.5% of the concentration in maternal plasma after administering SC injection twice a day
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Glucagon-like peptide-1 (GLP-1) agonist
Incretins, such as GLP-1, enhance glucose-dependent insulin secretion by pancreatic beta-cells, suppresses inappropriately elevated glucagon secretion, and slows gastric emptying
Absorption
Peak plasma concentration, steady-state: 208 pg/mL
Distribution
Vd: 28.3 L
Elimination
Renal clearance: 9.1 L/hr
Excretion: Predominantly urine
Administration
SC Preparation
Bydureon BCise
- Remove autoinjector from the refrigerator 15 minutes prior to resuspending the suspension
- Shake vigorously for at least 15 seconds
- Drug should appear as an opaque, white to off-white suspension (autoinjector contains microspheres which appear as white to off-white particles)
- Visually inspect for particulate matter and discoloration prior to administration
- Do not use if foreign particulate matter is present or if discoloration is observed
SC Administration
SC use only
Use immediately after autoinjector is prepared
Administer as SC injection in abdomen, thigh or upper arm region
Rotate injection sites each week when injecting in the same region
Do not administer IV or IM
Administer with or without meals
Administration with basal insulin
- Always administer exenatide and basal insulin as separate injections; do not mix these medications together into a single injection
- It is acceptable to inject exenatide and basal insulin in the same body region, but the injections should not be adjacent to each other
Missed dose
- Missed dose and next dose is due at least 3 days later: Administer dose as soon as possible; resume usual dosing schedule of qWeek thereafter
- Missed dose and next dose is due 1 or 2 days later: Do not administer missed dose; resume next regularly scheduled dose
Storage
Keep out of reach of children
Unopened autoinjectors
- Refrigerate at 36-46°F (2-8°C); do not freeze; do not use if suspension has been frozen
- Protect from light If needed, can be kept at room temperature (not to exceed 77°F [25°C]) for no more than a total of 4 weeks
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Bydureon BCise subcutaneous - | 2 mg/0.85 mL syringe |  | |
| Bydureon BCise subcutaneous - | 2 mg/0.85 mL syringe |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
exenatide microspheres subcutaneous
EXENATIDE EXTENDED-RELEASE - INJECTION
(ex-EN-a-tide)
COMMON BRAND NAME(S): Bydureon
WARNING: This medication can cause a certain type of thyroid tumor (thyroid C-cell tumors) in rats. It is unknown if this medication can cause similar tumors in humans. Talk with your doctor about the benefits and risks of treatment with this medication. Do not use this medication if you have a personal/family history of a certain type of cancer (medullary thyroid carcinoma) or a certain inherited disease (multiple endocrine neoplasia syndrome type 2 or MEN 2). While using this medication, tell your doctor right away if you notice any signs of thyroid tumors, including an unusual growth or lump in the neck, difficulty swallowing, shortness of breath, unusual/lasting hoarseness.
USES: Exenatide is used either alone or with other medications, and with a proper diet and exercise program, to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke.Exenatide is similar to a natural hormone in your body (incretin). It works by causing insulin release in response to high sugar (such as after a meal) and decreasing the amount of sugar your liver makes.Exenatide is not a substitute for insulin if you require insulin treatment.
HOW TO USE: Read the Medication Guide and the Instructions For Use Leaflet provided by your pharmacist before you start using exenatide and each time you get a refill. Learn all preparation and usage instructions. If you have any questions, ask your doctor or pharmacist.Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each week to lessen injury under the skin.Inject this medication under the skin in the thigh, abdomen, or upper arm as directed by your doctor, usually once every 7 days. It may be used with or without meals.If you are using insulin at the same time as exenatide, give exenatide and insulin as separate injections. Do not mix them. You may inject these medications in the same area of the body, but the injection sites should not be next to each other.Use this medication regularly to get the most benefit from it. Remember to use it every 7 days. It may help to mark your calendar with a reminder. Carefully follow the medication treatment plan, meal plan, and exercise program your doctor has recommended.Learn how to store and discard medical supplies safely. Consult your pharmacist.Tell your doctor if your condition does not improve or if it worsens (such as if your blood sugar remains high or increases).
SIDE EFFECTS: See also Warning section.Swelling/redness/itching at the injection site, tiredness, nausea, vomiting, diarrhea, constipation, or stomach upset may occur. Nausea usually lessens as you continue to use exenatide. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: signs of kidney problems (such as change in the amount of urine), severe injection-site reactions (such as blisters, open wound, severe pain/swelling), easy bruising/bleeding.Get medical help right away if you have any very serious side effects, including: signs of pancreas or gallbladder disease (such as nausea/vomiting that doesn't stop, severe stomach/abdominal pain).Although exenatide by itself usually does not cause low blood sugar (hypoglycemia), low blood sugar may occur if this drug is prescribed with other diabetes medications. Talk with your doctor or pharmacist about whether the dose(s) of your other diabetes medication(s) needs to be lowered. Drinking large quantities of alcohol, not getting enough calories from food, or doing unusually heavy exercise may also lead to low blood sugar. Symptoms may include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, headache, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, candy, or drinking a glass of fruit juice or non-diet soda. Check with your doctor or pharmacist to find out what you should do if you miss a meal.Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor right away.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: See also Warning section.Before using exenatide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: a disease of the pancreas (pancreatitis), kidney disease, stomach/intestinal disorders (such as gastroparesis, digestion problems), gallbladder disease, a certain blood disorder from exenatide (drug-induced thrombocytopenia).You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.Limit alcohol while using this medication because it can increase your risk of developing low blood sugar.It may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Consult your doctor because this may require a change in your treatment plan, medications, or blood sugar testing.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your blood sugar while pregnant. Your doctor may change your diabetes treatment during your pregnancy. Discuss the risks and benefits of different treatments (such as diet, exercise, and medications including insulin).It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.A product that may interact with this drug is: warfarin.Beta-blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar, such as dizziness, hunger, or sweating, are unaffected by these drugs.Many drugs can affect your blood sugar, making it harder to control. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your diabetes medication, exercise program, or diet.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe nausea/vomiting.
NOTES: Do not share this medication with others.Attend a diabetes education program to learn more about how to manage your diabetes with medications, diet, exercise, and regular medical exams.Learn the symptoms of high and low blood sugar and how to treat low blood sugar. Check your blood sugar regularly as directed and share the results with your doctor.Lab and/or medical tests (such as kidney function, fasting blood glucose, hemoglobin A1c) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is within 2 days of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store in the refrigerator. Do not freeze. The medication may also be stored at room temperature but must be used within 4 weeks. Protect the medication from light. Once mixed, the medication should be used right away. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised July 2022. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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