"Boehringer Ingelheim and Eli Lilly have filed a supplemental new drug application (sNDA) with the US Food and Drug Administration (FDA) based on cardiovascular risk reduction data from the landmark EMPA-REG OUTCOME trial for their SGLT2 inhibitor"...
BYDUREON is an extended-release formulation of exenatide, administered as an injection once every 7 days (weekly).
Type 2 Diabetes Mellitus
Important Limitations Of Use
BYDUREON is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of the rat thyroid C-cell tumor findings to humans. Prescribe BYDUREON only to patients for whom the potential benefits are considered to outweigh the potential risk [see WARNINGS AND PRECAUTIONS].
The concurrent use of BYDUREON with insulin has not been studied and cannot be recommended.
BYDUREON and BYETTA® (exenatide) injection both contain the same active ingredient, exenatide, and therefore should not be used together.
Based on postmarketing data, exenatide has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. BYDUREON 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 BYDUREON. Other antidiabetic therapies should be considered in patients with a history of pancreatitis [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].
DOSAGE AND ADMINISTRATION
BYDUREON (2 mg per dose) should be administered once every 7 days (weekly). The dose can be administered at any time of day, with or without meals.
If a dose is missed, it should be administered as soon as noticed, provided the next regularly scheduled dose is due at least 3 days later. Thereafter, patients can resume their usual dosing schedule of once every 7 days (weekly).
If a dose is missed and the next regularly scheduled dose is due 1 or 2 days later, the patient should not administer the missed dose and instead resume BYDUREON with the next regularly scheduled dose.
Changing Weekly Dosing Schedule
The day of weekly administration can be changed if necessary as long as the last dose was administered 3 or more days before.
BYDUREON must be injected immediately after the dose is prepared. BYDUREON is administered as a subcutaneous (SC) injection in the abdomen, thigh, or upper arm region. Advise patients to use a different injection site each week when injecting in the same region. BYDUREON must not be administered intravenously or intramuscularly. BYDUREON is intended for patient self-administration.
Prior to initiation of BYDUREON, patients should be trained by their healthcare professional. For the BYDUREON Pen, study data demonstrated that training reduced the risk of administration errors such as inadequate mixing or incomplete dosing. Patients using the BYDUREON Pen should be trained on proper mixing and injection technique to ensure the product is adequately mixed and a full dose is delivered. Refer to the accompanying Instructions for Use for complete administration instructions with illustrations. The instructions can also be found at www.bydureon.com.
Changing From BYETTA To BYDUREON
Prior treatment with BYETTA is not required when initiating BYDUREON therapy. If the decision is made to start BYDUREON in an appropriate patient already taking BYETTA, BYETTA should be discontinued. Patients changing from BYETTA to BYDUREON may experience transient (approximately 2 weeks) elevations in blood glucose concentrations.
Dosage Forms And Strengths
BYDUREON exenatide extended-release for injectable suspension is available as:
- BYDUREON single-dose tray which contains one vial of 2 mg exenatide, one vial connector, one prefilled diluent syringe, and two needles (one provided as a spare).
- BYDUREON Pen. Each single-dose pen contains 2 mg of exenatide and diluent, and includes one needle. Each carton contains one spare needle.
Do not substitute needles or any other components provided with BYDUREON. See HOW SUPPLIED/Storage and Handling for additional information.
BYDUREON (exenatide extended-release for injectable suspension) for once every 7 days (weekly) subcutaneous administration is supplied as:
BYDUREON single-dose tray, supplied in cartons that contain four single-dose trays (NDC 0310-6520-04). Each single-dose tray contains:
- One vial containing 2 mg exenatide (as a white to off-white powder)
- One prefilled syringe delivering 0.65 mL diluent
- One vial connector
- Two custom needles (23G, 5/16”) specific to this delivery system (one is a spare needle)
BYDUREON Pen, supplied in cartons that contain four single-dose pens and one spare needle (NDC 0310-6530-04). Each single-dose pen contains:
- One pen containing 2 mg of exenatide (as a white to off-white powder) and delivering 0.65 mL diluent.
- One custom needle (23G, 9/32”) specific to this delivery system.
Do not substitute needles or any other components provided with BYDUREON.
Storage And Handling
- BYDUREON should be stored in the refrigerator at 36°F to 46°F (2°C to 8°C), up to the expiration date or until preparing for use. BYDUREON should not be used past the expiration date. The expiration date can be found on the carton, on the cover of the single-dose tray, or on the pen label.
- Do not freeze BYDUREON. Do not use BYDUREON if it has been frozen. Protect from light.
- BYDUREON can be kept at room temperature not to exceed 77°F (25°C) [see USP Controlled Room Temperature] for no more than a total of 4 weeks, if needed.
- Use the diluent only if it is clear and free of particulate matter.
- After suspension, the mixture should be white to off-white and cloudy.
- BYDUREON must be administered immediately after the exenatide powder is suspended in the diluent.
- Use a puncture-resistant container to discard BYDUREON with the needle still attached. Do not reuse or share needles or syringes.
- Keep out of the reach of children.
Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. By: Amylin Ohio LLC, West Chester, OH 45071. Revised: Sep 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/26/2015
Additional Bydureon Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.