exenatide injectable suspension (Rx)

Brand and Other Names:Bydureon BCise
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Dosing & Uses

AdultPediatricGeriatric

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

Next:

Interactions

Interaction Checker

and exenatide injectable suspension

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                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.

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                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

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                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

                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
                • 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
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                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.

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                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

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                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
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                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.

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                Patient Handout

                Patient Education
                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), yellowing of the eyes/skin, easy bruising/bleeding.Exenatide has rarely caused a very serious (possibly fatal) disease of the pancreas (pancreatitis). Get medical help right away if you develop symptoms of pancreatitis, including: 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), stones in your gallbladder (gallstones), 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 March 2022. Copyright(c) 2022 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.

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                Formulary

                FormularyPatient Discounts

                Adding plans allows you to compare formulary status to other drugs in the same class.

                To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                Adding plans allows you to:

                • View the formulary and any restrictions for each plan.
                • Manage and view all your plans together – even plans in different states.
                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.