FAQs: Dosing
What is the dosing for BYETTA?
At what point should the dose of BYETTA be increased?
Can BYETTA be used with the thiazolidinedione + metformin combination pills?
What happens if a dose is missed?
What is the risk of hypoglycemia when BYETTA is used in combination with a sulfonylurea?
How should the BYETTA Pen be stored?
What is the dosing for BYETTA?
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
For additional details on dosing and administration of BYETTA, see the Prescribing Information.
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At what point should the dose of BYETTA be increased?
Based on clinical response, the dose of BYETTA can be increased to 10 mcg twice daily after 1 month of therapy.
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Why should I increase the dose at 1 month? I usually wait until I measure A1C before deciding whether or not to increase the dose.
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
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Does a patient have to be on a maximally effective dose of metformin, a sulfonylurea, or a thiazolidinedione before beginning treatment with BYETTA?
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.
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Can BYETTA be used with the thiazolidinedione + metformin combination pills?
Yes. BYETTA was studied in 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.
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What happens if a dose is missed?
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.
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What is the risk of hypoglycemia when BYETTA is used in combination with a sulfonylurea?
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 only when BYETTA is used in combination with a sulfonylurea. To reduce the risk of hypoglycemia when used with a sulfonylurea, a reduction in the dose of the sulfonylurea may be considered.
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How should the BYETTA Pen be stored?
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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Reference
- Data on file, Amylin Pharmaceuticals, Inc. and Lilly USA, LLC.
BYETTA is indicated as adjunctive therapy to improve glycemic control in patients with type 2 diabetes mellitus 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.
Important Safety Information
Precautions:
- BYETTA is not a substitute for insulin in insulin-requiring patients. BYETTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
- Patients should be observed for signs and symptoms of acute pancreatitis (persistent severe abdominal pain which may be accompanied by vomiting). If pancreatitis is suspected, BYETTA and other potentially suspect drugs should be discontinued. Resuming treatment with BYETTA is not recommended if pancreatitis is confirmed and an alternative etiology for the pancreatitis has not been identified.
- Patients should be observed for signs and symptoms of hypersensitivity reactions.
- BYETTA is not recommended for use in patients with end-stage renal disease, severe renal impairment, or severe gastrointestinal disease.
- Patients should be observed for signs of altered renal function, including those who are taking concomitant agents known to affect renal function/hydration status, such as diuretics, ACE inhibitors and NSAIDs, or those experiencing significant vomiting and/or diarrhea, which may lead to dehydration.
- Patients receiving BYETTA with a sulfonylurea have an increased risk of hypoglycemia. To reduce the risk of hypoglycemia, clinicians may consider reducing the sulfonylurea dose.
Drug Interactions:
- The effect of BYETTA to slow gastric emptying may reduce the extent and rate of absorption of orally administered drugs, so it should be used with caution in patients receiving oral medications that require rapid gastrointestinal absorption.
- Medications that are dependent on threshold concentrations for efficacy, such as 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.
Adverse Reactions:
- The most common adverse events associated with BYETTA were nausea, vomiting, diarrhea, feeling jittery, dizziness, headache, and dyspepsia.
For complete safety profile and other important prescribing considerations, see the Prescribing Information.
02-07-5499-B ©2009 Amylin Pharmaceuticals, Inc. and Lilly USA, LLC.
The BYETTA mark and BYETTA design mark are registered trademarks of Amylin Pharmaceuticals, Inc.
The BYETTA By Your Side mark and design mark are service marks of Amylin Pharmaceuticals, Inc.
All other trademarks are property of their respective owners.
Patent Nos. 5,424,286, 6,858,576, 6,872,700, 6,902,744, 6,956,026, 7,297,761, 7,521,423.
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