Please see Important Safety Information throughout …...Lose weight on average 3%† ‡ Lower systolic blood pressure XIGDUO XR is not a weight-loss or blood pressure drug. †Secondary

Please see Important Safety Information throughout and on pages 8-9. Please visit www.XIGDUOXRMedGuide.com for Medication Guide, and www.XIGDUOXRPI.com for US Full Prescribing Information, including Boxed WARNING about lactic acidosis, for XIGDUO XR.

1

http://www.XIGDUOXRMedGuide.com

https://www.azpicentral.com/xigduo/pi_xigduoxr.pdf

“ I’ve been working to lower my A1C, but metformin alone isn’t getting me to my goal.”

All images in this brochure are actor portrayals.

You know your A1C goal—and you’re working hard to reach it. But lately you may be frustrated with your progress. Despite exercising more and eating better, your blood sugar is still high.

There may be other options to help you reach your goals. So the next step is to speak with your doctor about your treatment plan.

Some questions to ask:

What is my A1C goal?

What websites do you recommend for healthy recipes?

Should I make changes to my exercise plan?

What are my options to help me reach my A1C goal?

A lower A1C. A plan to help get there.

2

Please see Important Safety Information on pages 8-9. Please visit www.XIGDUOXRMedGuide.com for Medication Guide, and www.XIGDUOXRPI.com for US Full Prescribing Information, including Boxed WARNING about lactic acidosis, for XIGDUO XR.

https://www.azpicentral.com/xigduo/medguide_xigduoxr.pdf


For adults with type 2 diabetes in addition to diet and exercise leArn About

onCe-dAily XiGduo® Xr (dapagliflozin and metformin HCl

extended-release)

what is the most important information i should know about XiGduo Xr?

XIGDUO XR can cause serious side effects, including lactic acidosis. Metformin, one of the medicines in XIGDUO XR, can cause a rare, but serious, side effect called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital. Stop taking XIGDUO XR and call your healthcare provider right away if you have any of the following symptoms which could be signs of lactic acidosis: feel cold in your hands or feet, feel very weak or tired, unusual (not normal) muscle pain, trouble breathing, unusual sleepiness or sleep longer than usual, stomach pains, nausea or vomiting, feel dizzy or lightheaded, or have a slow or irregular heartbeat.

You have a higher chance of getting lactic acidosis with XIGDUO XR if you have severe kidney problems, your kidneys are affected by certain x-ray tests that use injectable dye, have liver problems, drink alcohol (very often or a lot of alcohol in short-term “binge” drinking), get dehydrated (lose a large amount of body fluids), have surgery, have a heart attack, severe infection, or stroke.

importAnt SAfety informAtion for XiGduo® Xr (dapagliflozin and metformin HCl extended-release)


How to take XIGDUO XR 4

How XIGDUO XR works 5

XIGDUO XR Savings 6

XIGDUO XR Support 7

Important Safety Information 8

Approved uses for XiGduo® Xr (dapagliflozin and metformin HCl extended-release)what is XiGduo Xr?

XIGDUO XR contains 2 prescription medicines called dapagliflozin and metformin. XIGDUO XR is used along with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes when treatment with either dapagliflozin or metformin has not controlled your blood sugar.

XIGDUO XR is not for people with type 1 diabetes or diabetic ketoacidosis (increased ketones in your blood or urine).

3



For adults with type 2 diabetes in addition to diet and exercise

important Safety informationwhat are the possible side effects of XiGduo Xr?Serious side effects can happen in people who take XIGDUO XR, including:

• Dehydration (the loss of body water and salt) which may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). You may be at a higher risk of dehydration if you have low blood pressure, take medicines to lower your blood pressure, including water pills (diuretics), are 65 years of age or older, are on a low-salt diet, or have kidney problems. Talk to your doctor about what you can do to prevent dehydration

• Ketoacidosis occurred in people with type 1 and type 2 diabetes during treatment with dapagliflozin, one of the medicines in XIGDUO XR. Ketoacidosis is a serious condition which may require hospitalization and may lead to death. Symptoms may include nausea, tiredness, vomiting, trouble breathing, and abdominal pain. If you get any of these symptoms, stop taking XIGDUO XR and call your healthcare provider right away. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL

XiGduo Xr—A CombinAtion of two tHerApieS

may help significantly lower blood sugar.

Convenient onCe-dAily doSinG

XiGduo Xr is a pill you take: Once a day

In the morning with your meal

in a clinical trial, XiGduo Xr lowered

A1C approximately 50% more than metformin alone.*

* In a clinical study assessing dapagliflozin 5 mg + metformin XR.

important Safety informationwho should not take XiGduo Xr?Do not take XIGDUO XR if you:• have moderate to severe kidney problems or are on dialysis.

Your healthcare provider should do blood tests to check how well your kidneys are working before and during your treatment with XIGDUO XR

• are allergic to dapagliflozin, metformin, or any of the ingredients in XIGDUO XR. Symptoms of a serious allergic reaction may include: skin rash, raised red patches on your skin (hives), swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing. If you have any of these symptoms, stop taking XIGDUO XR and contact your healthcare provider or go to the nearest hospital emergency room right away

Additionally, XiGduo Xr may help you: Lose weight on average 3%†§

Lower systolic blood pressure‡§

XIGDUO XR is not a weight-loss or blood pressure drug.†Secondary end point. ‡Other end point. §Individual results may vary.


4

Are you thinking about your next A1C test? Your doctor may be, too. Since your A1C measures blood sugar control over time, it is a good indicator of how your treatment has been working for you over the past 3 months. If your numbers aren't where you both want them to be, please ask your doctor if XIGDUO XR could help.




XIGDUO XR helps significantly lower blood sugar by combining the experience of metformin with a different kind of medicine called an SGLT2 inhibitor.Metformin reduces the amount of sugar absorbed by the digestive system and made by the liver, and helps your body to better respond to its own insulin. Dapagliflozin, a SGLT2 inhibitor, helps remove some sugar through the urine.

important Safety informationwho should not take XiGduo Xr?Do not take XIGDUO XR if you:• have moderate to severe kidney problems or are on

dialysis. Your healthcare provider should do blood tests to check how well your kidneys are working before and during your treatment with XIGDUO XR

How XiGduo Xr workS

XIGDUO XR works by

reduCinG And removinG sugar in your body

muSCleSXIGDUO XR helps your muscles use sugar for energy. This allows your body to better respond to its own insulin and reduces the amount of sugar in the body.

kidneyS

XIGDUO XR helps remove some sugar when your body has more than it needs.

liverXIGDUO XR helps reduce the amount of sugar made by your liver.

diGeStive SyStem

XIGDUO XR helps reduce the amount of sugar absorbed from the food you eat.

XIGDUO XR works with multiple areas of your body to

reduce and remove some sugar.


5



®

* As low as $0 for as long as your doctor prescribes any

available dose of XIGDUO XR.

† Data on File, US-8797. AstraZeneca Pharmaceuticals LP.

Program managed by PSKW, LLC, on behalf of AstraZeneca.

Fingertip Formulary is a registered trademark of Fingertip

Formulary, LLC.

Please see accompanying US Full

Prescribing Information, including

Boxed WARNING and Medication

Guide for XIGDUO XR.

Subject to eligibility. Restrictions apply.

Not available for government-insured patients.

See back of card for details.

Eligible commercially insured patients

BIN# 004682

PCN# CN

GRP# EC00000000

ID# XXXXXXXXXXX

Co-pAy EVERY MONTH

$0*

for most patients†

5/1000 mgtablets

®

* As low as $0 for as long as your doctor prescribes XIGDUO XR. Subject to eligibility and monthly savings limit. Restrictions apply. Not available for government-insured patients.

†Data on File, US-8797. AstraZeneca Pharmaceuticals LP.


6

reGiSter And SAve todAy!

reGiSter todAy! Register for savings and support for XiGduo Xr. It’s simple. Give us a call at 1-844-631-3978 or visit us at www.xigduosavings.com

ELIGIBILITY: You may be eligible for this offer if you are insured by commercial insurance and your insurance does not cover the full cost of your prescription, or you are not insured and are responsible for the cost of your prescriptions. Patients who are enrolled in a state or federally funded prescription insurance program are not eligible for this offer. This includes patients enrolled in Medicare Part D, Medicaid, Medigap, Veterans Affairs (VA), Department of Defense (DOD) programs or TriCare, and patients who are Medicare eligible and enrolled in an employer-sponsored group waiver health plan or government-subsidized prescription drug benefit program for retirees. If you are enrolled in a state or federally funded prescription insurance program, you may not use this savings card even if you elect to be processed as an uninsured (cash-paying) patient. This offer is not insurance, is restricted to residents of the United States and Puerto Rico, and to patients over 18 years of age.

TERMS OF USE: Eligible commercially insured patients with a valid prescription for XIGDUO® XR (dapagliflozin/metformin HCI extended-release) who present this savings card at participating pharmacies will pay as low as $0 per 30-day supply maximum savings limit applies; patient out-of-pocket expense may vary. If you pay cash for your prescription, AstraZeneca will pay up to the first $150, and you will be responsible for any remaining balance, for each monthly prescription. Other restrictions may apply. Patient is responsible for applicable taxes, if any. Non-transferable, limited to one per person, cannot be combined with any other offer. Void where prohibited by law, taxed or restricted. Patients, pharmacists, and prescribers cannot seek reimbursement from health insurance or any third party for any part of the benefit received by the patient through this offer. AstraZeneca reserves the right to rescind, revoke, or amend this offer, eligibility and terms of use at any time without notice. This offer is not conditioned on any past, present or future purchase, including refills. Offer must be presented along with a valid prescription at the time of purchase. For additional details about this offer, please visit www.XIGDUOsavings.com. If you have any questions regarding this offer, please call 1-844-631-3978.

BY USING THIS CARD, YOU AND YOUR PHARMACIST UNDERSTAND AND AGREE TO COMPLY WITH THESE ELIGIBILITY REQUIREMENTS AND TERMS OF USE.

https://www.xigduoxr.com/savings-and-support/rx-savings.html



®

* As low as $0 for as long as your doctor prescribes any available dose of XIGDUO XR.

† Data on File, US-8797. AstraZeneca Pharmaceuticals, LP.

Please see accompanying US Full Prescribing Information, including Boxed WARNING and Medication Guide for XIGDUO XR.Subject to eligibility. Restrictions apply. Not available for government-insured patients. See back of card for details.

Program managed by PSKW, LLC, on behalf of AstraZeneca. Fingertip Formulary is a registered trademark of Fingertip Formulary, LLC.

Eligible commercially insured patients

BIN# 004682PCN# CNGRP# EC00000000ID# XXXXXXXXXXX

CO-PAY EVERY MONTH

$0*

for most patients†

5/1000 mgtablets

®

Visit XiGduoXr.com or call 1-855-XiGduo2 (1-855-944-3862)

to learn more about XIGDUO XR Support Services.


7

SurroundinG you with Support

* As low as $0 for as long as your doctor prescribes XIGDUO XR. Subject to eligibility. Restrictions apply. Not available for government-insured patients.

† Data on File, US-8797. AstraZeneca Pharmaceuticals LP (See page 9 for details.)

$0* co-pay every month for most patients† Eligible commercially insured patients.

register and save on XiGduo® Xr (dapagliflozin and metformin HCi extended-release) today!

XiGduo Xr Care partners*

Get connected to a variety of support services, tips, and information with the help of XIGDUO XR Care Partners.

XiGduo Xr prescription Coverage Counselors†

We have Prescription Coverage Counselors that you can talk to on the phone about your

XIGDUO XR coverage and benefit verification. They can help you determine your co-pay amount and what information you’ll need to process your benefit verification.

* Care Partners cannot provide medical advice and can only provide information about AstraZeneca medications. Decisions regarding your health and treatment of your condition should be made with your own healthcare provider.

† Prescription Coverage Counselors do not file claims or appeals on behalf of patients or healthcare professionals. Coverage or co-pay amounts may change prior to the time of actual prescription fill.


https://www.xigduoxr.com


important Safety information for XiGduo® Xr (dapagliflozin and metformin HCl extended-release)what is the most important information i should know about XiGduo Xr?

XIGDUO XR can cause serious side effects, including lactic acidosis. Metformin, one of the medicines in XIGDUO XR, can cause a rare, but serious, side effect called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital. Stop taking XIGDUO XR and call your healthcare provider right away if you have any of the following symptoms which could be signs of lactic acidosis: feel cold in your hands or feet, feel very weak or tired, unusual (not normal) muscle pain, trouble breathing, unusual sleepiness or sleep longer than usual, stomach pains, nausea or vomiting, feel dizzy or lightheaded, or have a slow or irregular heartbeat.

You have a higher chance of getting lactic acidosis with XIGDUO XR if you have severe kidney problems, your kidneys are affected by certain x-ray tests that use injectable dye, have liver problems, drink alcohol (very often or a lot of alcohol in short-term “binge” drinking), get dehydrated (lose a large amount of body fluids), have surgery, have a heart attack, severe infection, or stroke.

who should not take XiGduo Xr?

Do not take XIGDUO XR if you:• have moderate to severe kidney problems or are on

dialysis. Your healthcare provider should do blood tests to check how well your kidneys are working before and during your treatment with XIGDUO XR

• are allergic to dapagliflozin, metformin, or any of the ingredients in XIGDUO XR. Symptoms of a serious allergic reaction may include: skin rash, raised red patches on your skin (hives), swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing. If you have any of these symptoms, stop taking XIGDUO XR and contact your healthcare provider or go to the nearest hospital emergency room right away

what are the possible side effects of XiGduo Xr?

Serious side effects can happen in people who take XIGDUO XR, including:• Dehydration (the loss of body water and salt) which may

cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). You may be at a higher risk of dehydration if you have low blood pressure, take medicines to lower your blood

pressure, including water pills (diuretics), are 65 years of age or older, are on a low-salt diet, or have kidney problems. Talk to your doctor about what you can do to prevent dehydration

• Ketoacidosis occurred in people with type 1 and type 2 diabetes during treatment with dapagliflozin, one of the medicines in XIGDUO XR. Ketoacidosis is a serious condition which may require hospitalization and may lead to death. Symptoms may include nausea, tiredness, vomiting, trouble breathing, and abdominal pain. If you get any of these symptoms, stop taking XIGDUO XR and call your healthcare provider right away. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL

• Kidney problems. Sudden kidney injury occurred in people taking XIGDUO XR. Talk to your doctor right away if you reduce the amount you eat or drink, or if you lose liquids; for example, from vomiting, diarrhea or excessive heat exposure

• Serious urinary tract infections (UTI), some that lead to hospitalization, occurred in people taking dapagliflozin, one of the medicines in XIGDUO XR. Tell your doctor if you have any signs or symptoms of UTI including a burning feeling when passing urine, a need to urinate often, the need to urinate right away, pain in the lower part of your stomach (pelvis), or blood in the urine with or without fever, back pain, nausea, or vomiting

• Low blood sugar (hypoglycemia) can occur if you take with another medicine that can cause low blood sugar, such as sulfonylureas or insulin. Symptoms of low blood sugar include shaking, sweating, fast heartbeat, dizziness, hunger, headache and irritability. Follow your healthcare provider's instructions for treating low blood sugar

• Bacterial infections under the skin of the genitals and areas around them. Rare but serious infections that cause severe tissue damage under the skin of the genitals and areas around them have happened with dapagliflozin, one of the medications in XIGDUO XR. This infection has happened in women and men and may lead to hospitalization, surgeries and death. Seek medical attention immediately if you have fever or you are feeling very weak, tired or uncomfortable and you also develop any pain or tenderness, swelling, or redness of the skin in the genitals and areas around them

• Vaginal yeast infections in women who take XIGDUO XR. Talk to your healthcare provider if you experience vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), or vaginal itching

• Yeast infection of skin around the penis (balanitis) in men who take XIGDUO XR. Talk to your healthcare provider if you experience redness, itching, or swelling of the penis; rash of the penis; foul smelling discharge from the penis; or pain in the skin around penis. Certain uncircumcised men may have swelling of the penis that makes it difficult to pull back the skin around the tip of the penisPlease visit www.XIGDUOXRMedGuide.com for Medication

Guide, and www.XIGDUOXRPI.com for US Full Prescribing Information, including Boxed WARNING about lactic acidosis, for XIGDUO XR. (continued)

8




• Increase in bad cholesterol (LDL-C). Your healthcare provider should check your LDL-C during treatment with XIGDUO XR

• Bladder cancer. In studies of dapagliflozin in people with diabetes, bladder cancer occurred in a few more people who were taking dapagliflozin than in people who were taking other diabetes medications. There were too few cases of bladder cancer to know if bladder cancer was related to dapagliflozin. Tell your healthcare provider right away if you have blood or a red color in your urine or pain while you urinate

what should i tell my doctor before taking XiGduo Xr? Tell your healthcare provider: • all of your medical conditions, including problems

with your kidneys, liver, bladder, heart, or pancreas • if you have had, or have risk factors for, ketoacidosis

(including type 1 diabetes, are eating less due to illness, surgery, or change in your diet, are going to have surgery, or binge drink)

• if you are going to get an injection of dye or contrast agents for an x-ray procedure

• if you are pregnant, or plan to become pregnant. XIGDUO XR may harm your unborn baby

• if you are breastfeeding, or plan to breastfeed. It is unknown if XIGDUO XR passes into your breast milk • about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements

The most common side effects of XIGDUO XR include yeast infections of the vagina or penis, stuffy or runny nose and sore throat, diarrhea, headache, nausea, and vomiting.

You are encouraged to report negative side effects of AstraZeneca prescription drugs by calling 1-800-236-9933. If you prefer to report these to the FDA, either visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

important Safety information for XiGduo Xr (cont'd)

NOTES

Please visit www.XIGDUOXRMedGuide.com for Medication Guide, and www.XIGDUOXRPI.com for US Full Prescribing Information, including Boxed WARNING about lactic acidosis, for XIGDUO XR. 9


https://www.fda.gov/Safety/MedWatch/default.htm


NOTES

10

XIGDUO XR is a registered trademark of the AstraZeneca group of companies.©2018 AstraZeneca. All rights reserved.US-24935 11/18

11

Please visit www.XIGDUOXRMedGuide.com for Medication Guide, and www.XIGDUOXRPI.com for US Full Prescribing Information, including Boxed WARNING about lactic acidosis, for XIGDUO XR.

http://www.XIGDUOXRMedGuide.com

http://www.XIGDUOXRPI.com

Documents

Please see Important Safety Information throughout …...Lose weight on average 3%† ‡ Lower systolic blood pressure XIGDUO XR is not a weight-loss or blood pressure drug. †Secondary