PRESCRIBING INFORMATION

INSTRUCTIONS FOR USE

INSTRUCTIONS OVERVIEW

STORAGE & HANDLING

DISPOSAL TIPS

REFERENCES

STEP 1

MIX

ORANGE CAP UP

SHAKE HARD UP AND
DOWN FOR AT LEAST 15
SECONDS TO DISPERSE
MEDICINE EVENLY¹

COMPLETE

STEP 2

UNLOCK

ORANGE CAP UP
TWIST KNOB FROM LOCK TO UNLOCK¹

COMPLETE

STEP 3

UNSCREW

ORANGE CAP UP
TWIST ORANGE CAP COUNTERCLOCKWISE¹
DO NOT PULL

COMPLETE

STEP 4

INJECT

IMMEDIATELY INJECT BY PUSHING
AGAINST THE SKIN AND HOLDING FOR
15 SECONDS TO ENSURE A FULDOSE ¹

INJECTION STARTS WHEN AUDIBLE
CLICK IS HEARD¹

VIEW INJECTION SITES

CLICK

DONE - IT'S THAT SIMPLE!^3*

EXPLORE DEVICE

SCAN QR CODE

^*In a human factor validation study, most participants, 89 of 104 (85.5%),
rated the complete overall injection task as either "easy" or "very easy."²

WELCOME TO THE BYDUREON BCISE

3D DEVICE SIMULATOR

Learn to use once-weekly BYDUREON BCise. BYDUREON BCise is for adults with T2D along with
diet and exercise uncontrolled on their current treatment, who need a GLP-1 RA.¹

For complete instructions, please see Instructions for Use.

START

WARNING: RISK OF THYROID C-CELL TUMORS

Exenatide extended-release causes an increased incidence in thyroid C-cell tumors at clinically relevant exposures in rats compared to controls. It is unknown whether BYDUREON BCise causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC) in humans, as the human relevance of exenatide extended-release-induced rodent thyroid C-cell tumors has not been determined. See additional Important Safety Information (ISI).

EXPLORE

BYDUREON BCISE IN 3D

Swipe the screen to rotate the device. Pinch and expand to zoom in and out.

SINGLE DOSE AUTOINJECTOR

FOR APPROPRIATE PATIENTS,

CHOOSE BYDUREON BCISE

SWIPE UP OR DOWN
ON THE DEVICE TO MIX

SUCCESS = MEDICINE IS MIXED EVENLY, AND
CLOUDY IN COLOR. YOU DO NOT SEE ANY MEDICINE
ALONG THE SIDES, BOTTOM OR TOP.¹

DO NOT PROCEED TO THE NEXT STEP UNTIL
MEDICINE IS ALL MIXED.¹

CONTINUE
TO STEP 2

SWIPE LEFT ACROSS
THE DEVICE TO UNLOCK

SUCCESS = AUDIBLE CLICK SOUND¹

CONTINUE
TO STEP 3

SWIPE RIGHT ACROSS THE
DEVICE TO UNSCREW CAP

SUCCESS = ORANGE CAP LIFTS OFF WITHOUT
EFFORT AND GREEN SHIELD POPS UP¹

CONTINUE
TO STEP 4

SWIPE DOWN ON THE
DEVICE TO INJECT

SUCCESS = ORANGE ROD APPEARS IN
WINDOW, PLUNGER STOPS MOVING AND
DEVICE HAS BEEN HELD FIRMLY AGAINST
SKIN FOR FULL 15 SECONDS¹

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF THYROID C-CELL TUMORS

Exenatide extended-release causes an increased incidence in thyroid C-cell tumors at clinically relevant exposures in rats compared to controls. It is unknown whether BYDUREON BCise® [(exenatide extended-release) injectable suspension] causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC) in humans, as the human relevance of exenatide extended-release-induced rodent thyroid C-cell tumors has not been determined

BYDUREON BCise is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with the use of BYDUREON BCise and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for detection of MTC in patients treated with BYDUREON BCise

CONTRAINDICATIONS

Personal or family history of MTC, patients with MEN 2
Prior serious hypersensitivity reactions to exenatide or product components
History of drug-induced, immune-mediated thrombocytopenia from exenatide products

WARNINGS AND PRECAUTIONS

Acute Pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been reported. After initiation, observe patients carefully for symptoms of pancreatitis. If suspected, discontinue promptly and do not restart if confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis
Hypoglycemia Risk of hypoglycemia is increased when exenatide is coadministered with insulin or insulin secretagogues. Consider lowering the dose of these agents when coadministered with BYDUREON BCise
Acute Kidney Injury May induce nausea and vomiting with transient hypovolemia and may worsen renal function. Increased serum creatinine, renal impairment, worsened chronic renal failure, and acute renal failure, sometimes requiring hemodialysis and kidney transplantation have been reported. Not recommended in patients with eGFR <45 mL/min/1.73 m2
Gastrointestinal Disease Because exenatide is commonly associated with gastrointestinal adverse reactions, not recommended in patients with severe gastrointestinal disease (eg, gastroparesis)
Immunogenicity Patients may develop antibodies to exenatide. Patients with higher titer antibodies may have an attenuated HbA1c response. In clinical trials, attenuated glycemic response was associated with BYDUREON BCise-treated patients. If worsening of or failure to achieve adequate glycemic control occurs, consider alternative antidiabetic therapy
Hypersensitivity Reports of serious hypersensitivity reactions (eg, anaphylaxis and angioedema). If this occurs, patients should discontinue BYDUREON BCise and promptly seek medical advice
Drug-induced, immune-mediated thrombocytopenia and associated bleeding has been reported with exenatide. Serious bleeding, which may be fatal, has been reported. Discontinue promptly if suspected and avoid re-exposure to exenatide
Injection-Site Reactions Serious reactions (eg, abscess, cellulitis, and necrosis), with or without subcutaneous nodules, have been reported
Acute Gallbladder Disease has been reported in GLP-1 receptor agonist trials, including exenatide. If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated

ADVERSE REACTIONS

Most common (≥5%) in clinical trials: injection-site nodule (10.5%), nausea (8.2%).

DRUG INTERACTIONS

Oral Medications BYDUREON BCise slows gastric emptying and may reduce the rate of absorption of orally administered drugs
Warfarin Increased international normalized ratio (INR) sometimes associated with bleeding has been reported with concomitant use of exenatide with warfarin. Monitor INR frequently until stable upon initiation of BYDUREON BCise

PREGNANCY

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

INDICATION AND LIMITATIONS OF USE

BYDUREON BCise is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Not recommended as first-line therapy for patients inadequately controlled on diet and exercise
Not a substitute for insulin. Should not be used to treat type 1 diabetes or diabetic ketoacidosis
Use with prandial insulin has not been studied
Do not coadminister with other exenatide-containing products
Not studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis

You may report side effects related to AstraZeneca products by clicking here.

Please see full Prescribing Information, including Boxed WARNINGS, for BYDUREON, and BYDUREON BCise.

©2020 AstraZeneca. All rights reserved.
BYDUREON and BCise are trademarks of the AstraZeneca group of companies.
All other trademarks are property of their respective owners.
US-43356 Last Updated 8/20

INJECTION SITES

Weekly injection may use same body part, with new injection site¹

Waiting for Approval

INSTRUCTIONS OVERVIEW

For complete instructions, please see Instructions for Use.

MAX

Shake up and down
for at least 15 seconds
until well mixed¹

UNLOCK

Turn clockwise
to unlock¹

UNSCREW

Unscrew orange cap
counterclockwise¹

INJECT

Inject immediately and
hold for 15 seconds to
get full dose¹

HOW SUPPLIED, STORAGE & HANDLING¹

BYDUREON Bcise comes in a box with a 4-week supply and full instructions for use.

BYDUREON Bcise should be stored flat in the refrigerator between 36°F and 46°F
(2°C and 8°C). Protect from light.

BYDUREON Bcise may be kept at room temperature, not to exceed 86°F (30°C),
for up to 4 weeks.

DISPOSAL TIPS

Do NOT dispose in household trash¹
Use an FDA-cleared sharps container¹
If not available, use heavy-duty plastic container
with a tight-fitting, puncture-resistant lid¹
Properly label as hazardous waste¹
Follow all state and local disposal laws¹

Visit www.safeneedledisposal.org for more information.

REFERENCES

BYDUREON BCise® ([exenatide extended-release] injectable suspension)
[prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020.
Data on file, REF-14053, AstraZeneca Pharmaceuticals LP.

STEP 1

MIX

STEP 2

UNLOCK

STEP 3

UNSCREW

STEP 4

INJECT

ISI

EXPLORE

QR CODE

STEP 1

STEP 2

STEP 3

STEP 4

WELCOME TO THE BYDUREON BCISE

3D DEVICE SIMULATOR

EXPLORE

BYDUREON BCISE IN 3D

SINGLE DOSE AUTOINJECTOR

FOR APPROPRIATE PATIENTS,

CHOOSE BYDUREON BCISE

INJECTION SITES

Waiting for Approval

Waiting for Approval

INSTRUCTIONS OVERVIEW

HOW SUPPLIED, STORAGE & HANDLING1

DISPOSAL TIPS

REFERENCES

HOW SUPPLIED, STORAGE & HANDLING¹