7/29/2016
`
`ONGLYZA® (saxagliptin) | Adult Type 2 Diabetes Medication
`
`| Prescribing Information | Approved Uses | Med Guide Important Safety Information | Approved Uses
`
`| Prescribing Information
`
` | Medication Guide
`
`For US Consumers
`
`Visit HCP Site >
`
`Go to Healthcare Professional Site
`
`MENU
`
`Register
`
`»
`
`A MEDICATION FOR ADULTS WITH TYPE 2 DIABETES,
`IN COMBINATION WITH DIET AND EXERCISE
`
`A type 2 diabetes medication
`that can help you get to your A1C
`goal
`
`LEARN ABOUT ONGLYZA »
`LEARN HOW ONGLYZA MAY HELP
`
`Save with a $0 co-pay offer
`You may be eligible to get ONGLYZA for as little as $0
`a month for as long as your doctor prescribes.*
`Important Safety Information
`
`*Subject to eligibility. Restrictions apply. Not available for
`government-insured patients. Savings subject to monthly limit.
`
`Do not take ONGLYZA if you:
`Download the Doctor Discussion Guide
`are allergic to any of its ingredients. Serious allergic reactions can occur with ONGLYZA and may
`Talk to your doctor and find out if ONGLYZA is the right
`include swelling of the face, lips or throat, difficulty swallowing or breathing, swelling of the skin,
`type 2 diabetes medication for you.
`hives, rash, itching, flaking, or peeling. If you have these symptoms, stop taking ONGLYZA and
`contact your doctor right away
`Register for support
`Serious side effects can happen in people who take ONGLYZA:
`Get ongoing prescription coverage support, savings,
`Inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Before taking
`Important Safety Information
`and tips for managing type 2 diabetes.
`ONGLYZA, tell your doctor if you ever had pancreatitis, gallstones, history of alcoholism, or high
`Do not take ONGLYZA if you:
`triglyceride levels. Stop taking ONGLYZA and contact your doctor right away if you have pain in your
`are allergic to any of its ingredients. Serious allergic reactions can occur with ONGLYZA and may
`stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your
`include swelling of the face, lips or throat, difficulty swallowing or breathing, swelling of the skin,
`abdomen through to your back. The pain may happen with or without vomiting. These may be
`hives, rash, itching, flaking, or peeling. If you have these symptoms, stop taking ONGLYZA and
`symptoms of pancreatitis
`contact your doctor right away
`Heart failure. Before taking ONGLYZA tell your doctor if you have ever had heart failure or problems
`Serious side effects can happen in people who take ONGLYZA:
`
`https://www.onglyza.com/
`
`1/3
`
`AstraZeneca Exhibit 2127
`Mylan v. AstraZeneca
`IPR2015-01340
`
`Page 1 of 20
`
`

`
`ONGLYZA® (saxagliptin) | Adult Type 2 Diabetes Medication
`7/29/2016
`with your kidneys. Contact your doctor right away if you have any of the following symptoms of heart
`failure: increasing shortness of breath or trouble breathing, especially when you lie down; an
`unusually fast increase in weight; swelling in the feet, ankles or legs
`
`When ONGLYZA is used with certain other diabetes medicines to treat high blood sugar, such as a
`sulfonylurea or insulin, the risk of low blood sugar (hypoglycemia) is higher. Symptoms of low blood
`sugar include shaking, hunger, sweating, headache, rapid heartbeat, change in mood, and change in
`vision. Follow your doctor’s instructions for treating low blood sugar
`
`Some people who take medicines called DPP-4 inhibitors like ONGLYZA, may develop joint pain that
`can be severe. Call your doctor if you have severe joint pain
`
`When ONGLYZA is used with a thiazolidinedione (TZD), such as pioglitazone or rosiglitazone, to treat
`high blood sugar, peripheral edema (fluid retention) may become worse. If you have symptoms of
`peripheral edema, such as swelling of hands, feet, or ankles, call your doctor
`
`The most common side effects with ONGLYZA include upper respiratory tract infection, urinary tract
`infection, and headache.
`
`Before you take ONGLYZA:
`
`Your doctor should test your blood to measure how well your kidneys are working before and during
`treatment with ONGLYZA. You may need a lower dose if your kidneys are not working well
`
`Tell your doctor if you start or stop taking other medications, including antibiotics, antifungals or
`HIV/AIDS medications, as your doctor may need to change your dose of ONGLYZA
`
`Tell your doctor if you are pregnant, breast-feeding, or plan to become pregnant or breast-feed
`
`Approved Uses
`
`ONGLYZA is a prescription medicine used along with diet and exercise to lower blood sugar in adults
`with type 2 diabetes.
`
`ONGLYZA should not be used to treat people with type 1 diabetes or diabetic ketoacidosis (increased
`ketones in the blood or urine).
`
`Please read full Prescribing Information
`
` and Medication Guide
`
` for ONGLYZA.
`
`You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
`www.FDA.gov/medwatch, or call 1-800-FDA-1088.
`
`Important Safety Information
`For US Consumers
`Do not take ONGLYZA if you:
`ONGLYZA is a registered trademark and AZ&Me is a trademark of the AstraZeneca group of companies.
`are allergic to any of its ingredients. Serious allergic reactions can occur with ONGLYZA and may
`©2016 AstraZeneca. All rights reserved.
`include swelling of the face, lips or throat, difficulty swallowing or breathing, swelling of the skin,
`1882503-3216502 Last Updated 4/16
`hives, rash, itching, flaking, or peeling. If you have these symptoms, stop taking ONGLYZA and
`contact your doctor right away
`Prescribing Information
`Serious side effects can happen in people who take ONGLYZA:
`
`https://www.onglyza.com/
`
`2/3
`
`Page 2 of 20
`
`

`
`ONGLYZA® (saxagliptin) | Adult Type 2 Diabetes Medication
`
`7/29/2016
`Medication Guide
`
`Contact Us
`
`Site Map
`
`Privacy Notice | Legal Statement
`
`   
`
`Important Safety Information
`Do not take ONGLYZA if you:
`
`are allergic to any of its ingredients. Serious allergic reactions can occur with ONGLYZA and may
`include swelling of the face, lips or throat, difficulty swallowing or breathing, swelling of the skin,
`hives, rash, itching, flaking, or peeling. If you have these symptoms, stop taking ONGLYZA and
`contact your doctor right away
`
`Serious side effects can happen in people who take ONGLYZA:
`
`https://www.onglyza.com/
`
`3/3
`
`Page 3 of 20
`
`

`
`2/12/2016
`
`Type 2 Diabetes Management | Lower Blood Sugar Levels
`
`| Prescribing Information | Approved Uses | Med Guide Important Safety Information | Approved Uses
`
`| Prescribing Information
`
` | Medication Guide
`
`For US Consumers
`
`Visit HCP Site >
`
`Go to Healthcare Professional Site
`
`MENU
`
`»
`Register
`
`How ONGLYZA works with your body to lower blood sugar
`levels in type 2 diabetes management
`
`Not all medicines for type 2 diabetes management work the same way. Find out below how
`ONGLYZA enhances the body’s natural ability to control blood sugar, which may help you with
`your type 2 diabetes management.
`
`Important Safety Information
`Do not take ONGLYZA if you are allergic to any of its ingredients. Serious allergic reactions can occur
`with ONGLYZA and may include swelling of the face, lips or throat, difficulty swallowing or breathing,
`swelling of the skin, hives, rash, itching, flaking, or peeling. If you have these symptoms, stop taking
`ONGLYZA and contact your doctor right away.
`
`Serious side effects can happen to people taking ONGLYZA, including inflammation of the
`pancreas (pancreatitis) which may be severe and lead to death. Before taking ONGLYZA, tell your doctor
`if you ever had pancreatitis, gallstones, history of alcoholism, or high triglyceride levels. Stop taking
`ONGLYZA and contact your doctor right away if you have pain in your stomach area (abdomen) that is
`severe and will not go away. The pain may be felt going from your abdomen through to your back. The
`
`https://www.onglyza.com/treatment­for­type­2­diabetes/management.html
`
`1/5
`
`Page 4 of 20
`
`

`
`2/12/2016
`
`Type 2 Diabetes Management | Lower Blood Sugar Levels
`
`When you have type 2 diabetes, your
`pancreas doesn’t release enough insulin
`or your body’s cells may not use insulin
`properly. This can cause your blood
`sugar level to spike too high after
`meals.
`
`ONGLYZA works by enhancing your
`natural ability to control blood sugar by
`helping the body increase the level of
`insulin after meals. This may result in
`lower after-meal blood sugar spikes.
`
`When you have type 2 diabetes, your
`https://www.onglyza.com/treatment­for­type­2­diabetes/management.html
`
`ONGLYZA works by reducing the
`
`2/5
`
`Page 5 of 20
`
`

`
`2/12/2016
`
`Type 2 Diabetes Management | Lower Blood Sugar Levels
`When you have type 2 diabetes, your
`ONGLYZA works by reducing the
`pancreas releases too much glucagon.
`amount of sugar released by your liver
`This makes your liver release too much
`overnight and between meals. This may
`sugar, and your blood sugar level can
`result in lower blood sugar in the
`rise, even when you are sleeping.
`morning and between meals.
`
`What’s your type 2 diabetes management plan?
`
`Now that you have seen how ONGLYZA enhances the body’s natural ability to control blood
`sugar, ask your doctor if ONGLYZA is the right medicine to help you with your type 2 diabetes
`management. Download the Doctor Discussion Guide.
`
`Get a $0 co-pay offer
`You may be eligible to get ONGLYZA for as little as $0 a month for as long as
`your doctor prescribes.*
`
`*Subject to eligibility. Restrictions apply. Not available for government-insured patients.
`Out-of-pocket savings up to $150.
`
`START SAVING
`
`Make the most of your next appointment
`Start the conversation about ONGLYZA with the Doctor Discussion Guide.
`
`DOWNLOAD NOW
`
`Register for a free information kit
`Get support and resources to help manage your type 2 diabetes and learn
`more about ONGLYZA.
`
`SIGN UP TODAY
`
`Important Safety Information
`
`Do not take ONGLYZA if you are allergic to any of its ingredients. Serious allergic reactions can
`occur with ONGLYZA and may include swelling of the face, lips or throat, difficulty swallowing or
`breathing, swelling of the skin, hives, rash, itching, flaking, or peeling. If you have these
`https://www.onglyza.com/treatment­for­type­2­diabetes/management.html
`
`3/5
`
`Page 6 of 20
`
`

`
`Type 2 Diabetes Management | Lower Blood Sugar Levels
`2/12/2016
`breathing, swelling of the skin, hives, rash, itching, flaking, or peeling. If you have these
`symptoms, stop taking ONGLYZA and contact your doctor right away.
`
`Serious side effects can happen to people taking ONGLYZA, including inflammation of the
`pancreas (pancreatitis) which may be severe and lead to death. Before taking ONGLYZA, tell your
`doctor if you ever had pancreatitis, gallstones, history of alcoholism, or high triglyceride levels.
`Stop taking ONGLYZA and contact your doctor right away if you have pain in your stomach area
`(abdomen) that is severe and will not go away. The pain may be felt going from your abdomen
`through to your back. The pain may happen with or without vomiting. These may be symptoms of
`pancreatitis.
`
`When ONGLYZA is used with certain other diabetes medicines to treat high blood sugar, such as
`a sulfonylurea or insulin, the risk of low blood sugar (hypoglycemia) is higher. Symptoms of low
`blood sugar include shaking, hunger, sweating, headache, rapid heartbeat, change in mood, and
`change in vision. Follow your doctor’s instructions for treating low blood sugar.
`
`Some people who take medicines called DPP-4 inhibitors like ONGLYZA, may develop joint pain
`that can be severe. Call your doctor if you have severe joint pain.
`
`When ONGLYZA is used with a thiazolidinedione (TZD), such as pioglitazone or rosiglitazone, to
`treat high blood sugar, peripheral edema (fluid retention) may become worse. If you have
`symptoms of peripheral edema, such as swelling of hands, feet, or ankles, call your doctor.
`
`The most common side effects with ONGLYZA include upper respiratory tract infection, urinary
`tract infection, and headache.
`
`Your doctor should test your blood to measure how well your kidneys are working before and
`during treatment with ONGLYZA. You may need a lower dose if your kidneys are not working
`well.
`
`Tell your doctor if you start or stop taking other medications, including antibiotics, antifungals or
`HIV/AIDS medications, as your doctor may need to change your dose of ONGLYZA.
`
`Tell your doctor if you are pregnant, breast-feeding, or plan to become pregnant or breast-feed.
`
`Approved Uses
`
`ONGLYZA is a prescription medicine used along with diet and exercise to lower blood sugar in
`adults with type 2 diabetes.
`
`ONGLYZA should not be used to treat people with type 1 diabetes or diabetic ketoacidosis
`(increased ketones in the blood or urine).
`
`If you have had inflammation of the pancreas (pancreatitis), it is not known if you have a higher
`chance of getting pancreatitis while taking ONGLYZA.
`
`Please read full Prescribing Information
`
` and Medication Guide
`
` for ONGLYZA.
`
`You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
`www.FDA.gov/medwatch, or call 1-800-FDA-1088.
`
`For US Consumers
`©2015 AstraZeneca. All rights reserved.
`https://www.onglyza.com/treatment­for­type­2­diabetes/management.html
`
`4/5
`
`Page 7 of 20
`
`

`
`Type 2 Diabetes Management | Lower Blood Sugar Levels
`2/12/2016
`©2015 AstraZeneca. All rights reserved.
`ONGLYZA is a registered trademark of the AstraZeneca group of companies.
`1882503-3193200 Last Updated 12/15
`
`Prescribing Information
`
`Medication Guide
`
`Contact Us
`
`Site Map
`
`Privacy Notice | Legal Statement
`
`   
`
`https://www.onglyza.com/treatment­for­type­2­diabetes/management.html
`
`5/5
`
`Page 8 of 20
`
`

`
`7/29/2016
`
`Savings and Support | ONGLYZA® (saxagliptin)
`
`| Prescribing Information | Approved Uses | Med Guide Important Safety Information | Approved Uses
`
`| Prescribing Information
`
` | Medication Guide
`
`For US Consumers
`
`Visit HCP Site >
`
`Go to Healthcare Professional Site
`
`MENU
`
`»
`Register
`
`Savings and Support
`
`We understand many of the day-to-day challenges you face living with type 2 diabetes. So whether
`you’re making changes to your treatment or wondering about what might come next, we’re here to listen
`—and help—with a variety of services, including:
`
`Savings Card Support
`
`Eligible patients may request a savings card to get ONGLYZA for as little as $0 a month.*
`
`Learn more »
`
`*Subject to eligibility. Restrictions apply. Not available for government-insured patients. Savings subject to monthly limit.
`
` 
`
`Important Safety Information
`Do not take ONGLYZA if you:
`
`are allergic to any of its ingredients. Serious allergic reactions can occur with ONGLYZA and may
`include swelling of the face, lips or throat, difficulty swallowing or breathing, swelling of the skin,
`hives, rash, itching, flaking, or peeling. If you have these symptoms, stop taking ONGLYZA and
`contact your doctor right away
`
`Serious side effects can happen in people who take ONGLYZA:
`
`https://www.onglyza.com/savings­support.html
`
`1/5
`
`Page 9 of 20
`
`

`
`7/29/2016
`
`Savings and Support | ONGLYZA® (saxagliptin)
`
`AZhelps Savings Card
`
`   
`
`The ONGLYZA savings card is now part of AZhelps. Eligible patients can still get ONGLYZA for as little as
`$0 a month.* And now, you can access the savings card with your mobile phone.
`
`Learn more »
`
`*Subject to eligibility. Restrictions apply. Not available for government-insured patients. Savings subject to monthly limit.
`
` 
`
`ONGLYZA Prescription Coverage Counselors
`
`Questions about your prescription coverage?
`
`†
`Call our trained ONGLYZA Prescription Coverage Counselors for answers. They’ll help you determine
`your co‐pay amount, answer questions, and provide information to help you process your benefit
`verification.
`
`Learn more »
`
`†
`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.
`
` 
`
`ONGLYZA Care Partners
`
`When you talk to one of our ONGLYZA Care Partners, you’ll connect to a broader network of patient
`support.
`
`Learn more »
`Important Safety Information
` 
`Do not take ONGLYZA if you:
`
`are allergic to any of its ingredients. Serious allergic reactions can occur with ONGLYZA and may
`Fit2Me™ Program
`include swelling of the face, lips or throat, difficulty swallowing or breathing, swelling of the skin,
`Fit2Me™ is a free, online diet and lifestyle support program designed to help you and your doctor make
`hives, rash, itching, flaking, or peeling. If you have these symptoms, stop taking ONGLYZA and
`diet and lifestyle choices that fit into your type 2 diabetes treatment plan.
`contact your doctor right away
`
`Serious side effects can happen in people who take ONGLYZA:
`Learn more »
`
`https://www.onglyza.com/savings­support.html
`
`2/5
`
`Page 10 of 20
`
`

`
`7/29/2016
`
` 
`
`AZ Co-pay Calculator
`
`Savings and Support | ONGLYZA® (saxagliptin)
`
`Check cost information for your AstraZeneca diabetes medicine with a helpful online resource.
`
`Learn more »
`
`Fit2Me is a diet and lifestyle support program YOU design—YOUR WAY.
`Find out about a program that fits you because it’s based on diet and lifestyle
`choices you make with your doctor’s help.
`
`GET FITTED NOW
`
`Register for support
`Don’t miss out on savings, resources, prescription coverage support, and more.
`
`Make the most of your next appointment
`Start the conversation about ONGLYZA with the Doctor Discussion Guide.
`
`SIGN UP TODAY
`
`DOWNLOAD NOW
`
`Important Safety Information
`
`Do not take ONGLYZA if you:
`
`are allergic to any of its ingredients. Serious allergic reactions can occur with ONGLYZA and may
`include swelling of the face, lips or throat, difficulty swallowing or breathing, swelling of the skin,
`hives, rash, itching, flaking, or peeling. If you have these symptoms, stop taking ONGLYZA and contact
`your doctor right away
`Important Safety Information
`Do not take ONGLYZA if you:
`Serious side effects can happen in people who take ONGLYZA:
`are allergic to any of its ingredients. Serious allergic reactions can occur with ONGLYZA and may
`Inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Before taking
`include swelling of the face, lips or throat, difficulty swallowing or breathing, swelling of the skin,
`ONGLYZA, tell your doctor if you ever had pancreatitis, gallstones, history of alcoholism, or high
`hives, rash, itching, flaking, or peeling. If you have these symptoms, stop taking ONGLYZA and
`triglyceride levels. Stop taking ONGLYZA and contact your doctor right away if you have pain in your
`contact your doctor right away
`stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your
`abdomen through to your back. The pain may happen with or without vomiting. These may be
`Serious side effects can happen in people who take ONGLYZA:
`symptoms of pancreatitis
`
`Heart failure. Before taking ONGLYZA tell your doctor if you have ever had heart failure or problems
`https://www.onglyza.com/savings­support.html
`
`3/5
`
`Page 11 of 20
`
`

`
`Savings and Support | ONGLYZA® (saxagliptin)
`7/29/2016
`Heart failure. Before taking ONGLYZA tell your doctor if you have ever had heart failure or problems
`with your kidneys. Contact your doctor right away if you have any of the following symptoms of heart
`failure: increasing shortness of breath or trouble breathing, especially when you lie down; an
`unusually fast increase in weight; swelling in the feet, ankles or legs
`
`When ONGLYZA is used with certain other diabetes medicines to treat high blood sugar, such as a
`sulfonylurea or insulin, the risk of low blood sugar (hypoglycemia) is higher. Symptoms of low blood
`sugar include shaking, hunger, sweating, headache, rapid heartbeat, change in mood, and change in
`vision. Follow your doctor’s instructions for treating low blood sugar
`
`Some people who take medicines called DPP-4 inhibitors like ONGLYZA, may develop joint pain that
`can be severe. Call your doctor if you have severe joint pain
`
`When ONGLYZA is used with a thiazolidinedione (TZD), such as pioglitazone or rosiglitazone, to treat
`high blood sugar, peripheral edema (fluid retention) may become worse. If you have symptoms of
`peripheral edema, such as swelling of hands, feet, or ankles, call your doctor
`
`The most common side effects with ONGLYZA include upper respiratory tract infection, urinary tract
`infection, and headache.
`
`Before you take ONGLYZA:
`
`Your doctor should test your blood to measure how well your kidneys are working before and during
`treatment with ONGLYZA. You may need a lower dose if your kidneys are not working well
`
`Tell your doctor if you start or stop taking other medications, including antibiotics, antifungals or
`HIV/AIDS medications, as your doctor may need to change your dose of ONGLYZA
`
`Tell your doctor if you are pregnant, breast-feeding, or plan to become pregnant or breast-feed
`
`Approved Uses
`
`ONGLYZA is a prescription medicine used along with diet and exercise to lower blood sugar in adults
`with type 2 diabetes.
`
`ONGLYZA should not be used to treat people with type 1 diabetes or diabetic ketoacidosis (increased
`ketones in the blood or urine).
`
`Please read full Prescribing Information
`
` and Medication Guide
`
` for ONGLYZA.
`
`You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
`www.FDA.gov/medwatch, or call 1-800-FDA-1088.
`
`For US Consumers
`ONGLYZA is a registered trademark and Fit2Me is a trademark of the AstraZeneca group of companies.
`Important Safety Information
`©2016 AstraZeneca. All rights reserved.
`Do not take ONGLYZA if you:
`1882503-3216502 Last Updated 4/16
`
`are allergic to any of its ingredients. Serious allergic reactions can occur with ONGLYZA and may
`include swelling of the face, lips or throat, difficulty swallowing or breathing, swelling of the skin,
`Prescribing Information
`hives, rash, itching, flaking, or peeling. If you have these symptoms, stop taking ONGLYZA and
`Medication Guide
`contact your doctor right away
`
`Serious side effects can happen in people who take ONGLYZA:
`Contact Us
`
`Site Map
`https://www.onglyza.com/savings­support.html
`
`4/5
`
`Page 12 of 20
`
`

`
`7/29/2016
`Site Map
`
`Savings and Support | ONGLYZA® (saxagliptin)
`
`Privacy Notice | Legal Statement
`
`   
`
`Important Safety Information
`Do not take ONGLYZA if you:
`
`are allergic to any of its ingredients. Serious allergic reactions can occur with ONGLYZA and may
`include swelling of the face, lips or throat, difficulty swallowing or breathing, swelling of the skin,
`hives, rash, itching, flaking, or peeling. If you have these symptoms, stop taking ONGLYZA and
`contact your doctor right away
`
`Serious side effects can happen in people who take ONGLYZA:
`
`https://www.onglyza.com/savings­support.html
`
`5/5
`
`Page 13 of 20
`
`

`
`7/29/2016
`
`Type 2 Diabetes Medication for Adults | ONGLYZA® (saxagliptin)
`
`| Prescribing Information | Approved Uses | Med Guide Important Safety Information | Approved Uses
`
`| Prescribing Information
`
` | Medication Guide
`
`For US Consumers
`
`Visit HCP Site >
`
`Go to Healthcare Professional Site
`
`MENU
`
`»
`Register
`
`Struggling to reach your A1C goals? Consider adding ONGLYZA,
`a treatment for type 2 diabetes
`
`When you’re living with type 2 diabetes, it’s a daily challenge to keep your blood sugar in check. As a
`treatment for type 2 diabetes, ONGLYZA, in combination with diet and exercise, can help lower blood
`sugar. ONGLYZA may give you the boost you need to get your type 2 diabetes under control.
`
`As with all decisions concerning treatment of type 2 diabetes, it is important to work with your
`healthcare provider on developing a plan. Be sure to ask if once-daily ONGLYZA is right for you.
`
`4 Key Facts About ONGLYZA
`
`Taken once daily
`
`Proven to lower A1C
`
` 
`
` 
`
`ONGLYZA has been tested in multiple
`
`ONGLYZA is a prescription medicine for
`https://www.onglyza.com/type­2­diabetes­medication.html
`
`clinical studies including thousands of
`
`1/4
`
`Page 14 of 20
`
`

`
`7/29/2016
`
`Type 2 Diabetes Medication for Adults | ONGLYZA® (saxagliptin)
`ONGLYZA is a prescription medicine for
`clinical studies including thousands of
`the treatment of type 2 diabetes taken
`adult patients with type 2 diabetes. In all
`by mouth one time each day.
`of these studies, ONGLYZA in addition to
`diet and exercise has been shown to
`lower A1C. Your results may vary.
`
`Taken any time of day
`
` 
`
` 
`
`ONGLYZA can be taken with or without
`food any time of day.
`
`Enhances the body’s natural
`ability to control blood sugar
`
`ONGLYZA works by helping the body
`increase the level of insulin after meals
`and reducing the amount of sugar
`released by the liver overnight and
`between meals.
`
`As a type 2 diabetes medication, ONGLYZA should not be used to treat people with type 1 diabetes or to
`treat diabetic ketoacidosis (increased ketones in the blood or urine).
`
`Ask your doctor if ONGLYZA could be right for you.
`
`ONGLYZA may help you achieve your treatment goals. Learn more at the links below.
`
`Discover how ONGLYZA may help »
`
`Important Safety Information
`Find out how ONGLYZA works »
`Do not take ONGLYZA if you:
`
`are allergic to any of its ingredients. Serious allergic reactions can occur with ONGLYZA and may
`Get help talking to your doctor about ONGLYZA »
`include swelling of the face, lips or throat, difficulty swallowing or breathing, swelling of the skin,
`hives, rash, itching, flaking, or peeling. If you have these symptoms, stop taking ONGLYZA and
`contact your doctor right away
`
`Serious side effects can happen in people who take ONGLYZA:
`Start saving with the $0 co-pay offer
`Inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Before taking
`You may be eligible to get ONGLYZA for as little as $0 a month for as long as your
`doctor prescribes.*
`
`https://www.onglyza.com/type­2­diabetes­medication.html
`
`GET A SAVINGS CARD
`
`2/4
`
`Page 15 of 20
`
`

`
`7/29/2016
`
`GET A SAVINGS CARD
`*Subject to eligibility. Restrictions apply. Not available for government-insured patients. Savings subject
`to monthly limit.
`
`Type 2 Diabetes Medication for Adults | ONGLYZA® (saxagliptin)
`
`Talk with your doctor
`Considering ONGLYZA for the treatment of type 2 diabetes? Start the conversation
`with the Doctor Discussion Guide.
`
`DOWNLOAD NOW
`
`Register for a free information kit
`Get support and resources to help manage your type 2 diabetes and learn more
`about ONGLYZA.
`
`SIGN UP TODAY
`
`Important Safety Information
`
`Do not take ONGLYZA if you:
`
`are allergic to any of its ingredients. Serious allergic reactions can occur with ONGLYZA and may
`include swelling of the face, lips or throat, difficulty swallowing or breathing, swelling of the skin,
`hives, rash, itching, flaking, or peeling. If you have these symptoms, stop taking ONGLYZA and contact
`your doctor right away
`
`Serious side effects can happen in people who take ONGLYZA:
`
`Inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Before taking
`ONGLYZA, tell your doctor if you ever had pancreatitis, gallstones, history of alcoholism, or high
`triglyceride levels. Stop taking ONGLYZA and contact your doctor right away if you have pain in your
`stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your
`Important Safety Information
`abdomen through to your back. The pain may happen with or without vomiting. These may be
`Do not take ONGLYZA if you:
`symptoms of pancreatitis
`are allergic to any of its ingredients. Serious allergic reactions can occur with ONGLYZA and may
`Heart failure. Before taking ONGLYZA tell your doctor if you have ever had heart failure or problems
`include swelling of the face, lips or throat, difficulty swallowing or breathing, swelling of the skin,
`with your kidneys. Contact your doctor right away if you have any of the following symptoms of heart
`hives, rash, itching, flaking, or peeling. If you have these symptoms, stop taking ONGLYZA and
`failure: increasing shortness of breath or trouble breathing, especially when you lie down; an
`contact your doctor right away
`unusually fast increase in weight; swelling in the feet, ankles or legs
`Serious side effects can happen in people who take ONGLYZA:
`When ONGLYZA is used with certain other diabetes medicines to treat high blood sugar, such as a
`Inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Before taking
`sulfonylurea or insulin, the risk of low blood sugar (hypoglycemia) is higher. Symptoms of low blood
`sugar include shaking, hunger, sweating, headache, rapid heartbeat, change in mood, and change in
`vision. Follow your doctor’s instructions for treating low blood sugar
`
`Some people who take medicines called DPP-4 inhibitors like ONGLYZA, may develop joint pain that
`can be severe. Call your doctor if you have severe joint pain
`
`When ONGLYZA is used with a thiazolidinedione (TZD), such as pioglitazone or rosiglitazone, to treat
`https://www.onglyza.com/type­2­diabetes­medication.html
`
`3/4
`
`Page 16 of 20
`
`

`
`Type 2 Diabetes Medication for Adults | ONGLYZA® (saxagliptin)
`7/29/2016
`When ONGLYZA is used with a thiazolidinedione (TZD), such as pioglitazone or rosiglitazone, to treat
`high blood sugar, peripheral edema (fluid retention) may become worse. If you have symptoms of
`peripheral edema, such as swelling of hands, feet, or ankles, call your doctor
`
`The most common side effects with ONGLYZA include upper respiratory tract infection, urinary tract
`infection, and headache.
`
`Before you take ONGLYZA:
`
`Your doctor should test your blood to measure how well your kidneys are working before and during
`treatment with ONGLYZA. You may need a lower dose if your kidneys are not working well
`
`Tell your doctor if you start or stop taking other medications, including antibiotics, antifungals or
`HIV/AIDS medications, as your doctor may need to change your dose of ONGLYZA
`
`Tell your doctor if you are pregnant, breast-feeding, or plan to become pregnant or breast-feed
`
`Approved Uses
`
`ONGLYZA is a prescription medicine used along with diet and exercise to lower blood sugar in adults
`with type 2 diabetes.
`
`ONGLYZA should not be used to treat people with type 1 diabetes or diabetic ketoacidosis (increased
`ketones in the blood or urine).
`
`Please read full Prescribing Information
`
` and Medication Guide
`
` for ONGLYZA.
`
`You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
`www.FDA.gov/medwatch, or call 1-800-FDA-1088.
`
`For US Consumers
`ONGLYZA is a registered trademark of the AstraZeneca group of companies.
`©2016 AstraZeneca. All rights reserved.
`1882503-3216502 Last Updated 4/16
`
`Prescribing Information
`
`Medication Guide
`Important Safety Information
`Contact Us
`Do not take ONGLYZA if you:
`Site Map
`are allergic to any of its ingredients. Serious allergic reactions can occur with ONGLYZA and may
`include swelling of the face, lips or throat, difficulty swallowing or breathing, swelling of the skin,
`hives, rash, itching, flaking, or peeling. If you have these symptoms, stop taking ONGLYZA and
`contact your doctor right away
`
`Serious side effects can happen in people who take ONGLYZA:
`Privacy Notice | Legal Statement
`Inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Before taking
`
`   
`
`https://www.onglyza.com/type­2­diabetes­medication.html
`
`4/4
`
`Page 17 of 20
`
`

`
`7/29/2016
`
`What Is Type 2 Diabetes?
`
`| Prescribing Information | Approved Uses | Med Guide Important Safety Information | Approved Uses
`
`| Prescribing Information
`
` | Medication Guide
`
`For US Consumers
`
`Visit HCP Site >
`
`Go to Healthcare Professional Site
`
`MENU
`
`»
`Register
`
`What Is Type 2 Diabetes?
`
`Type 2 diabetes—previously known as adult‐onset or non‐insulin‐dependent diabetes—is a chronic
`condition that affects the way your body controls the amount of sugar (glucose) in the blood.
`
`Causes of Type 2 Diabetes
`
`Type 2 diabetes can be caused by changes in multiple organs and hormones in the body. Over time,
`these changes lead to high sugar (glucose) levels. Insulin is a hormone that transfers glucose from the
`blood into cells to produce the energy needed for daily activities. In people who have type 2 diabetes,
`insulin can’t do its job. That’s because too little insulin is produced to keep glucose levels normal, or the
`body fails to respond to it.
`
`As part of this condition, other hormones—which help control the amount of glucose appearing in or
`being transferred from the blood—also don’t work the right way. This causes blood glucose levels to go
`up. These high glucose levels can get worse because the body increases the amount of glucose that is
`produced, filtered and reabsorbed.
`
`When you have been diagnosed with type 2 diabetes, setting personal goals is the first step toward
`Important Safety Information
`managing some of the many changes associated with this disease.
`Do not take ONGLYZA if you:
`Learn how to set personal goals for managing type 2 diabetes »
`are allergic to any of its ingredients. Serious allergic reactions can occur with ONGLYZA and may
`include swelling of the face, lips or throat, difficulty swallowing or breathing, swel