BYDUREON PACKAGE INSERT PDF

Learn about BYDUREON, a non-insulin treatment option for adults with type 2 diabetes available in the BYDUREON Pen. Find dosing and administration information for BYDUREON, including instructions for use. Learn about BYDUREON® BCise® including efficacy, safety, PK profile, and dosing, and available resources, including Important Safety Information.

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Send the page ” ” to a friend, relative, colleague or yourself. We do not record any personal information entered above. Initially, 5 mcg subcutaneously twice daily psckage within the minute period before the morning and evening meal.

Alternatively, administer before the 2 main meals of the day, with the doses approximately 6 hours or more apart. Exenatide should not be administered after a meal. Based on glucose monitoring and clinical response, may increase after 1 month to exenatide 10 mcg subcutaneously twice daily.

Bydureon (exenatide) dose, indications, adverse effects, interactions from

Initiation with 5 mcg reduces the incidence and severity of gastrointestinal side effects. May be used as monotherapy or with other antidiabetic medications. Dose adjustment pcakage metformin or a thiazolidinedione is not usually required when exenatide is added. A reduction in the dose of a sulfonylurea may be needed to reduce the risk of hypoglycemia. Combined use with prandial insulin has not been studied and cannot be recommended.

Exenatide is approved for use inserh basal insulin.

An insulin glargine dose titration algorithm is in the exenatide package insert. When added to insulin detemir, a reduction in the dose of insulin detemir may be needed to reduce hypoglycemia; the insulin detemir package label recommends a dose of insulin detemir 10 units subcutaneously once daily when combining with a GLP-1 receptor agonist. Administer at any time of day, with or without meals.

Packkage a dose is missed, administer it as soon as noticed, as long as the next regularly scheduled dose is due at least 3 days later.

After that, 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 1 or 2 days isnert, the patient should not administer the missed dose, instead they should wait until the next regularly scheduled dose. The day of weekly administration can be changed if needed, as long as the last dose was administered 3 or more days before. Extended-release exenatide is not a first-line therapy for inserr inadequately controlled on diet and exercise.

Concurrent treatment with prandial insulin has not been studied and cannot be recommended. Exenatide may be used with basal insulin. Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Exenatide is cleared primarily by inseet kidney. No dosage adjustment needed. Use is not recommended. Hemodialysis Exenatide is not recommended for use in patients with end-stage renal disease ESRD on continuous or intermittent hemodialysis. Administer by subcutaneous injection only. Do not administer by intravenous or intramuscular injection. Visually inspect for particulate matter and discoloration prior to administration whenever solution and container permit.

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Do NOT mix exenatide with insulin. When using exenatide with basal insulin, administer as separate injections. It is acceptable for the injections to be in the same body region but the injections should NOT be adjacent to each other. Diabetes medication pens should never be shared among patients. Even if the disposable needle is changed, sharing may result in transmission of hepatitis viruses, HIV, or other blood-borne pathogens.

Do not share pens among multiple patients in an inpatient setting; use multidose vials instead if available, or, reserve use of any pen to 1 patient only.

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Regular-release injection solution Byetta multi-dose pen-injector: Administer twice daily, within the minute time period prior to the morning and evening meals. Alternatively, administer before the 2 main meals of the day, bydureob 6 hours or more apart. Do not administer after meals. For patients who are to self-administering exenatide, adequate oral as well as written instructions on the use of the injector pen bydureoh be supplied before they self-administer a dose.

Regular-release exenatide is available as a pre-filled pen; do not transfer exenatide from the pen to a syringe or a vial. Pen needles for the Byetta Pen are not included and must be purchased separately.

The following pen needles have been tested and are considered to be compatible with the Byetta pre-filled pen: Artsana InsuPen 29G and 31G bydurwon needles. The exenatide Byetta pen-injector must be primed prior to the first use. See the pen user manual for directions. Inject subcutaneously into the thigh, abdomen, or upper arm. Double-check dosage prior to administration. Lightly pinch a fold of skin; insert the needle; release the skin; inject at a 90 degree angle.

Thin or smaller individuals can use a 45 degree angle to avoid intramuscular injection. Aspiration is not necessary. Inject over 2 to 4 seconds. Rotate administration sites with each injection to prevent lipodystrophy. After use, properly dispose of used pen needles. Replace the blue cap after injection. Do not store the pen with the needle on, as the medication may leak out bydureno air bubbles may form in the cartridge.

After first use, the Byetta Pen injector can be kept at a temperature not to exceed 77 degrees F 25 degrees C. When carrying the pen away from home, store the pen at a temperature between 36 to 77 degrees F 2 to 25 degrees C and keep dry.

A Byetta Pen can be used for up to 30 days after first use. After 30 days, throw away the pen, even if some medicine remains in it. Extended-release injection suspension Bydureon single-dose Pen: Administer once every 7 days weekly ; the dose can be administered at any time of day, with or without meals. Do not substitute needles or any other components in the tray. Visually inspect for particulate matter.

Exenatide must be well-suspended mixed prior to use from a pen or syringe kit. Ensure the medicine is mixed evenly; rotate and shake or tap as directed until there is no white medicine visible on sides of the pen or syringe. Medicine is mixed well when it appears as an even mix that is cloudy. Extended-release exenatide must be injected immediately after suspended in the diluent within the Pen device or the syringe.

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Pull the bjdureon cover straight off the pen for use. For the pen, insert the needle into your skin.

See the manufacturer’s instructions for use for complete administration directions and illustrations. These are available at www. After injection, properly dispose of the pen and needles. Extended-release injection suspension Bydureon BCise single-use Autoinjector: Let the autoinjector come to room temperature for approximately 15 minutes before administration.

Shake the autoinjector well, in an bydurron motion, for at least 15 seconds to ensure the medicine is bydureonn evenly; shake until there is no white medicine on sides, bottom, or top. Medicine is mixed well when it appears as an even mix that is cloudy; it is okay to see air bubbles.

Once the medicine is fully mixed, the autoinjector must be used immediately. Hold the autoinjector upright with the orange cap toward the ceiling. Unlock the autoinjector by turning the knob from bydurdon to unlock until a click is heard.

While still holding the autoinjector upright, unscrew the orange cap. A green shield will pop up after the cap is removed; the green shield hides the needle.

It is normal to see a few drops of liquid inside the cap; do not recap the autoinjector. Subcutaneous Administration using the Autoinjector: Push the autoinjector against the skin at the chosen injection site.

Once the needle is inserted, press the injection button until you hear a “click” and then hold the button for 15 additional seconds to deliver the full dose. After injection, an orange rod will appear in the window. When the autoinjector is removed from the skin, the green shield will move back up to lock over the needle. After injection, properly dispose of the autoinjector. Exenatide is contraindicated in any patient who has exhibited exenatide hypersensitivity or bydueon to any of its inactive ingredients.

The effect of exenatide to slow gastric emptying may reduce the extent and rate of absorption of orally administered drugs. Exenatide should be used with caution in patients receiving oral medications that require rapid gastrointestinal absorption.

Prolonged exposure to stomach acid may pckage the film coating on certain medications and may result in decreased efficacy. When possible it may be prudent to take any oral medication at least 1 hour prior to administration of injectable exenatide, although specific research addressing this issue is not available.

Exenatide is not a substitute for insulin in patients who packxge insulin. Exenatide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. The concurrent use of exenatide with prandial insulin has not been studied and cannot be recommended. Diabetic patients must follow a regular, prescribed diet and exercise schedule to avoid either hypo- or hyperglycemia.