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FAQs: Dosing
BYETTA therapy should be initiated at 5 mcg administered twice daily at any time within the 60-minute period before the morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart). BYETTA should not be administered after a meal. Based on clinical response, the dose of BYETTA can be increased to 10 mcg twice daily after 1 month of therapy. Each dose of BYETTA should be administered as a subcutaneous injection in the thigh, abdomen, or upper arm.
For additional details on dosing and administration of BYETTA, see the Prescribing Information.
Based on clinical response, the dose of BYETTA can be increased to 10 mcg twice daily after 1 month of therapy.
Effects of BYETTA have been shown to be dose-dependent. Patients should start at 5 mcg BID. The dose can be increased to 10 mcg BID based on glycemic response and tolerability. Greater A1C and weight reductions were achieved with 10 mcg BID vs 5 mcg BID in patients taking BYETTA plus certain oral antidiabetic medications (-0.8% vs -0.5% and -4.2 lb vs -3.1 lb, respectively).1 BYETTA is not indicated for the management of obesity, and weight change was a secondary endpoint in clinical trials.
No. BYETTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It can also be used in patients who are taking metformin, a sulfonylurea, a thiazolidinedione, a combination of metformin and a sulfonylurea, or a combination of metformin and a thiazolidinedione, but have not achieved adequate glycemic control, regardless of the doses of those agents.
Yes. BYETTA was studied and is indicated in patients with type 2 diabetes treated with both a TZD and metformin. Patients who were already using a combination pill containing both a TZD and metformin were eligible to be in the BYETTA and TZD clinical study.
If a dose is missed, take the next dose at the regularly scheduled time. Extra doses should not be taken to make up for the missed one.
Clinical trials have shown that BYETTA does not carry an intrinsic risk of hypoglycemia, which is consistent with its glucose-dependent action. The risk of hypoglycemia increases when BYETTA is used in combination with glucose-independent insulin secretagogues (eg, sulfonylureas). To reduce the risk of hypoglycemia when used with a sulfonylurea, a reduction in the dose of the sulfonylurea may be considered.
Prior to first use, the BYETTA Pen should be stored in the original carton in a refrigerator at 36°F to 46°F (2°C to 8°C) protected from light. After the BYETTA Pen is first used, it can be stored at a room temperature not to exceed 77°F (25°C). Do not freeze.
For additional details on dosing and administration of BYETTA, see the Prescribing Information.
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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
Contraindications
- 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.
Adverse Reactions
- 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).
Drug Interactions
- 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.
For complete safety profile and other important prescribing considerations, see the Prescribing Information and Medication Guide.
Reference
- Data on file, Amylin Pharmaceuticals, Inc.
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