Bydureon (Exenatide) - Indications and Dosage

INDICATIONS AND USAGE

BYDUREON is an extended-release formulation of exenatide, administered as an injection once every seven days (weekly).

Type 2 Diabetes Mellitus

BYDUREON is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies ].

Important Limitations of Use

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.

BYDUREON is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise.

BYDUREON is not a substitute for insulin. BYDUREON should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.

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.

DOSAGE AND ADMINISTRATION

Recommended Dosing

BYDUREON (2 mg per dose) should be administered once every seven days (weekly). The dose can be administered at any time of day, with or without meals.

Missed Dose

If a dose is missed, it should be administered as soon as noticed, provided the next regularly scheduled dose is due at least three days later. Thereafter, patients can resume their usual dosing schedule of once every seven days (weekly).

If a dose is missed and the next regularly scheduled dose is due one or two 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.

Administration

BYDUREON is intended for patient self-administration. BYDUREON is provided in a single-dose tray containing: one vial of 2 mg exenatide, one vial connector, one prefilled diluent syringe and two needles (one provided as a spare) [see How Supplied/Storage and Handling ]. Do not substitute needles or any other components in the tray.

BYDUREON must be injected immediately after the powder is suspended in the diluent and transferred to the syringe. 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.

See the BYDUREON 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 two weeks) elevations in blood glucose concentrations.

DOSAGE FORMS AND STRENGTHS

BYDUREON is 2 mg exenatide extended-release for injectable suspension for subcutaneous administration once every seven days (weekly).

HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

BYDUREON (exenatide extended-release for injectable suspension) for once every seven days (weekly) subcutaneous administration is supplied in cartons of 4 single-dose trays for use (NDC 66780-219-04).

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)

Do not substitute needles or any other components in the tray.

Storage and Handling

• BYDUREON should be stored in the refrigerator at 36ËšFto 46ËšF (2ËšC to 8ËšC), 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 and the cover of the single-dose tray.
• Do not freeze the BYDUREON tray. Do not use BYDUREON if it has been frozen. Protect from light.
• Each single-dose tray can be kept at room temperature not to exceed 77°F (25ËšC) [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 and transferred to the syringe.
• Use a puncture-resistant container to discard the syringe with the needle still attached. Do not reuse or share needles or syringes.
• Keep out of the reach of children.