## 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
CLICK
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 FULL DOSE 1
INJECTION STARTS WHEN AUDIBLE
CLICK IS HEARD1

VIEW INJECTION SITES

CLICK
DONE - IT'S THAT SIMPLE!2*

EXPLORE DEVICE

SCAN QR CODE

## 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).

1

## 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 WELL-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

Please see full Prescribing Information, including Boxed WARNINGS, for BYDUREON, and BYDUREON BCise.
You may report side effects related to AstraZeneca products by clicking here.
©2020 AstraZeneca. All rights reserved.
BYDUREON and BCise are registered trademarks of the AstraZeneca group of companies.
US-43356 Last Updated 8/20

# INJECTION SITES

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

# 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

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

CLOSE

STEP 1

MIX

STEP 2

UNLOCK

STEP 3

UNSCREW

STEP 4

INJECT

ISI

EXPLORE

QR CODE