The most common adverse reactions in registration trials associated with BYETTA vs placebo (PBO) were nausea (44% vs 18%), vomiting (13% vs 4%), and diarrhea (13% vs 6%).
Other adverse reactions ≥5% and more than PBO were feeling jittery, dizziness, headache, and dyspepsia. With a thiazolidinedione (TZD), adverse reactions were similar; as monotherapy, most common was nausea (8% vs 0%).
Nausea usually decreases over time.
For complete safety profile, see the Prescribing Information.
The effect of BYETTA to slow gastric emptying can reduce the extent and rate of absorption of orally administered drugs. BYETTA should be used with caution in patients receiving oral medications that have a narrow therapeutic index or require rapid gastrointestinal absorption.
Oral medications that are dependent on threshold concentrations for efficacy, such as oral contraceptives and antibiotics, should be taken at least 1 hour before BYETTA injection. If such drugs are to be administered with food, they should be taken with a meal or snack when BYETTA is not administered.
There have been postmarketing reports of increased international normalized ratio (INR) sometimes associated with bleeding with concomitant use of warfarin and BYETTA. Monitor INR frequently until stable upon initiation or alteration of BYETTA therapy.
The incidence of withdrawal in the registration trials of BYETTA plus certain oral antidiabetic medications was 7% for BYETTA-treated patients vs 3% for placebo-treated patients. The incidence of withdrawal in the monotherapy clinical trial was 1% for BYETTA-treated patients vs 0% for placebo-treated patients.
BYETTA is contraindicated in patients with prior severe hypersensitivity reactions to exenatide or to any of the product components.
In the 30-week registration trials, 44% of patients taking BYETTA plus oral antidiabetic agents reported nausea. In the monotherapy trial, 8% of patients taking BYETTA reported nausea. Nausea was mostly mild to moderate and it occurred most commonly upon initiation of therapy. With continued therapy, the frequency and severity decreased over time in most of the patients who initially experienced nausea. Of BYETTA-treated patients, 3% withdrew due to nausea over the course of the entire 30-week clinical trials; in the monotherapy trial, 1% of BYETTA-treated patients withdrew due to nausea.
Initiation of BYETTA at 5 mcg BID for at least a month followed by dose escalation to 10 mcg BID has been found to minimize the occurrence of nausea.
In a 24-week study of BYETTA as monotherapy, patients receiving BYETTA had an increased risk of hypoglycemia (5% at 5 mcg and 4% at 10 mcg vs 1% placebo). In three 30-week placebo-controlled clinical trials, patients receiving BYETTA in combination with a sulfonylurea had an increased risk of hypoglycemia (14% at 5 mcg and 36% at 10 mcg vs 3% placebo). Patients receiving BYETTA in combination with metformin plus a sulfonylurea had an increased risk of hypoglycemia (19% at 5 mcg and 28% at 10 mcg vs 13% placebo). To reduce the risk of hypoglycemia, clinicians may consider reducing the sulfonylurea dose. In a 16-week study of patients receiving BYETTA with a thiazolidinedione, the incidence of mild-to-moderate hypoglycemia compared to placebo was 11% vs 7%.
In animal toxicology studies, BYETTA produced no impairment of fertility. The effects on human fertility are unknown.
There are no adequate and well-controlled studies of BYETTA use in pregnant women. Based on animal data, BYETTA may cause fetal harm. BYETTA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Yes, Amylin Pharmaceuticals, Inc. maintains a registry to monitor the pregnancy outcomes of women exposed to BYETTA (exenatide) during their pregnancy. Please consider enrolling and/or referring your patients who are currently pregnant and have been exposed to BYETTA during the pregnancy by calling 1-800-633-9081 or visiting ExenatidePregnancyRegistry.com.
It is not known whether BYETTA is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when BYETTA is administered to a nursing woman.
No. The FDA has approved the use of BYETTA in patients 17 years of age or older. Safety and effectiveness have not been established in pediatric patients.
Yes. BYETTA was studied in 282 patients 65 years of age or older and in 16 patients 75 years or older. No differences in safety or effectiveness were observed between these patients and younger patients. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in the elderly based on renal function.
BYETTA should not be used in patients with end-stage renal disease or severe renal impairment (creatinine clearance <30 mL/min) and should be used with caution in patients with renal transplanation. In patients with end-stage renal disease receiving dialysis, single doses of BYETTA 5 mcg were not well tolerated due to gastrointestinal side effects. Caution should be applied when initiating BYETTA or escalating the dose of BYETTA in patients with moderate renal failure.
For complete safety profile and other important prescribing considerations, see the Prescribing Information.
Indication and Usage
BYETTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
- Not a substitute for insulin and should not be used in patients with type 1 diabetes or diabetic ketoacidosis.
- Concurrent use with prandial insulin cannot be recommended.
- Has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using BYETTA; consider other antidiabetic therapies for these patients.
Important Safety Information for BYETTA® (exenatide) injection
- BYETTA is contraindicated in patients with prior severe hypersensitivity reactions to exenatide or to any of the product components.
Warnings and Precautions
- Based on postmarketing data BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. After initiation and dose increases of BYETTA, observe patients carefully for pancreatitis (persistent severe abdominal pain, sometimes radiating to the back, with or without vomiting). If pancreatitis is suspected, BYETTA should be discontinued promptly. BYETTA should not be restarted if pancreatitis is confirmed.
- Increased risk of hypoglycemia when used in combination with glucose-independent insulin secretagogues (eg, sulfonylureas); reduction of the sulfonylurea dose may be needed. When used with insulin, evaluate and consider reducing the insulin dose in patients at increased risk of hypoglycemia.
- Postmarketing reports of altered renal function, including increased serum creatinine, renal impairment, worsened chronic renal failure, and acute renal failure, sometimes requiring hemodialysis and kidney transplantation. BYETTA should not be used in patients with severe renal impairment or end-stage renal disease. Use with caution in patients with renal transplantation or when initiating or escalating the dose in patients with moderate renal failure.
- Not recommended in patients with severe gastrointestinal disease (eg, gastroparesis).
- Patients may develop antibodies to exenatide. In 3 registration trials, antibody levels were measured in 90% of patients, with up to 4% of patients having high-titer antibodies and attenuated glycemic response. If worsening of or failure to achieve adequate glycemic control occurs, consider alternative antidiabetic therapy.
- Postmarketing reports of serious hypersensitivity reactions (eg, anaphylaxis and angioedema). If this occurs, patients should discontinue BYETTA and other suspect medications and promptly seek medical advice.
- No clinical studies establishing conclusive evidence of macrovascular risk reduction with BYETTA or any other antidiabetic drug.
- Most common adverse reactions in registration trials associated with BYETTA vs placebo (PBO): nausea (44% vs 18%), vomiting (13% vs 4%), and diarrhea (13% vs 6%). Other adverse reactions ≥5% and more than PBO: feeling jittery, dizziness, headache, and dyspepsia. With a thiazolidinedione (TZD), adverse reactions were similar; as monotherapy, most common was nausea (8% vs 0%). With insulin glargine: nausea (41% vs 8%), vomiting (18% vs 4%), diarrhea (18% vs 8%), headache (14% vs 4%), constipation (10% vs 2%), dyspepsia (7% vs 2%), asthenia (5% vs 1%).
- Hypoglycemia incidence, BYETTA vs PBO, with metformin (MET): 5.3% (10 mcg) and 4.5% (5 mcg) vs 5.3%; with SFU, 35.7% (10 mcg) and 14.4% (5 mcg) vs 3.3%; with MET + SFU, 27.8% (10 mcg) and 19.2% (5 mcg) vs 12.6%; with TZD, 10.7% (10 mcg) vs 7.1%; as monotherapy, 3.8% (10 mcg) and 5.2% (5 mcg) vs 1.3%; with insulin glargine, 24.8% (10 mcg) vs 29.5%.
- Withdrawals: as monotherapy, 2 of 155 BYETTA patients withdrew due to headache and nausea vs 0 PBO; with MET and/or SFU vs PBO, nausea (3% vs <1%) and vomiting (1% vs 0); with TZD ± MET, nausea (9%) and vomiting (5%), with <1% of PBO patients withdrawing due to nausea; with insulin glargine vs PBO, nausea (5.1% vs 0), vomiting (2.9% vs 0).
- BYETTA slows gastric emptying and can reduce the extent and rate of absorption of orally administered drugs. Use with caution with medications that have a narrow therapeutic index or require rapid gastrointestinal absorption. Medications dependent on threshold concentrations for efficacy should be taken at least 1 hour before BYETTA.
- Postmarketing reports of increased international normalized ratio (INR) sometimes associated with bleeding with concomitant use of warfarin. Monitor INR frequently until stable upon initiation or alteration of BYETTA.
Use in Specific Populations
- Based on animal data, BYETTA may cause fetal harm and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
- Caution should be exercised when administered to a nursing woman.
- Safety and effectiveness have not been established in pediatric patients.
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