7/29/2016
`
`Adult Type 2 Diabetes Medication | KOMBIGLYZE® XR (saxagliptin and metformin HCl extended‐release) tablets
`
`Important Safety Information | Approved Uses | Prescribing Information, including Boxed WARNING
`
`  
`
`| Medication Guide
`
`   | Prescribing Information, including Boxed WARNING | Approved Uses | Med Guide
`
`For US Consumers
`
`Visit HCP Site
`
`Go to Healthcare Professional Site
`
`MENU
`
`Register
`
`FOR ADULTS WITH TYPE 2 DIABETES, IN
`COMBINATION WITH DIET AND EXERCISE
`
`your treatment plan
`
`When you need powerful A1C reductions right from the start
`
`LEARN HOW KOMBIGLYZE XR MAY HELP   »
`
`FOR ADULTS WITH TYPE 2 DIABETES, IN
`COMBINATION WITH DIET AND EXERCISE
`
`Important Safety Information
`
`your treatment plan
`
`KOMBIGLYZE XR can cause serious side effects, including:
`Lactic Acidosis: Metformin hydrochloride, one of the medicines in KOMBIGLYZE XR, ...Read Morecan cause a rare, but serious,
`side effect called lactic acidosis (a build-up of lactic acid in the blood) that can ...Read More cause death. Lactic acidosis is a
`LEARN HOW KOMBIGLYZE XR MAY HELP   »
`medical emergency and must be treated in a ...Read Morehospital. Stop taking KOMBIGLYZE XR and call your doctor right away
`if you get any of the following symptoms of lactic acidosis: feel very weak and tired, unusual (not normal) muscle pain, trouble
`breathing, unusual sleepiness or sleep longer than usual, unexplained stomach or intestinal problems with nausea and
`vomiting or diarrhea, feel cold (especially in your arms and legs), dizzy or lightheaded, or have a slow or irregular heartbeat.
`
`When you need powerful A1C reductions right from the start
`
`You have a higher chance of getting lactic acidosis if you have kidney or liver problems, have congestive heart failure that
`requires treatment with medicines, drink a lot of alcohol (very often or short-term “binge” drinking), get dehydrated (lose a
`large amount of body fluids), have certain x-ray tests with injectable dyes or contrast agents, have surgery, have a heart attack,
`https://www.kombiglyzexr.com/
`
`1/2
`
`AstraZeneca Exhibit 2133
`Mylan v. AstraZeneca
`IPR2015-01340
`
`Page 1 of 18
`
`

`
`Adult Type 2 Diabetes Medication | KOMBIGLYZE® XR (saxagliptin and metformin HCl extended‐release) tablets
`7/29/2016
`LEARN HOW KXR MAY HELP »
`
`Save with a $0 co-pay offer
`
`You may be able to get KOMBIGLYZE XR for as low as $0 a month for as long as
`your doctor prescribes it.*
`
`*Subject to eligibility. Restrictions apply. Not available for government-insured patients. Savings subject to monthly limit.
`
`Download the Doctor Discussion Guide
`
`Talk to your healthcare provider to see if KOMBIGLYZE XR is right for you.
`
`Join our patient support program
`
`Get ongoing prescription coverage support, savings, and tips for managing
`type 2 diabetes.
`
`For US Consumers
`KOMBIGLYZE XR is a registered trademark and AZ&Me is a trademark of the AstraZeneca group of companies.
`©2016 AstraZeneca. All rights reserved.
`1803103-3217001 Last Updated 5/16
`
`Prescribing Information, including
`Boxed WARNING
`
`Medication Guide
`Contact Us
`
`Site Map
`
`Important Safety Information
`Privacy Notice | Legal Statement
`KOMBIGLYZE XR can cause serious side effects, including:
`Lactic Acidosis: Metformin hydrochloride, one of the medicines in KOMBIGLYZE XR, ...Read Morecan cause a rare, but serious,
`side effect called lactic acidosis (a build-up of lactic acid in the blood) that can ...Read More cause death. Lactic acidosis is a
`medical emergency and must be treated in a ...Read Morehospital. Stop taking KOMBIGLYZE XR and call your doctor right away
`if you get any of the following symptoms of lactic acidosis: feel very weak and tired, unusual (not normal) muscle pain, trouble
`breathing, unusual sleepiness or sleep longer than usual, unexplained stomach or intestinal problems with nausea and
`vomiting or diarrhea, feel cold (especially in your arms and legs), dizzy or lightheaded, or have a slow or irregular heartbeat.
`
`You have a higher chance of getting lactic acidosis if you have kidney or liver problems, have congestive heart failure that
`requires treatment with medicines, drink a lot of alcohol (very often or short-term “binge” drinking), get dehydrated (lose a
`large amount of body fluids), have certain x-ray tests with injectable dyes or contrast agents, have surgery, have a heart attack,
`https://www.kombiglyzexr.com/
`
`2/2
`
`Page 2 of 18
`
`

`
`7/29/2016
`
`How to Manage Type 2 Diabetes | Lower Blood Sugar Levels
`
`Important Safety Information | Approved Uses | Prescribing Information, including Boxed WARNING
`
`  
`
`| Medication Guide
`
`   | Prescribing Information, including Boxed WARNING | Approved Uses | Med Guide
`
`For US Consumers
`
`Visit HCP Site
`
`Go to Healthcare Professional Site
`
`MENU
`
`Register
`
`Important Safety Information
`
`KOMBIGLYZE XR can cause serious side effects, including:
`Lactic Acidosis: Metformin hydrochloride, one of the medicines in KOMBIGLYZE XR, ...Read Morecan cause a rare, but serious,
`side effect called lactic acidosis (a build-up of lactic acid in the blood) that can ...Read More cause death. Lactic acidosis is a
`medical emergency and must be treated in a ...Read Morehospital. Stop taking KOMBIGLYZE XR and call your doctor right away
`if you get any of the following symptoms of lactic acidosis: feel very weak and tired, unusual (not normal) muscle pain, trouble
`breathing, unusual sleepiness or sleep longer than usual, unexplained stomach or intestinal problems with nausea and
`vomiting or diarrhea, feel cold (especially in your arms and legs), dizzy or lightheaded, or have a slow or irregular heartbeat.
`
`You have a higher chance of getting lactic acidosis if you have kidney or liver problems, have congestive heart failure that
`requires treatment with medicines, drink a lot of alcohol (very often or short-term “binge” drinking), get dehydrated (lose a
`large amount of body fluids), have certain x-ray tests with injectable dyes or contrast agents, have surgery, have a heart attack,
`https://www.kombiglyzexr.com/type­2­diabetes­medication/blood­sugar.html
`
`1/6
`
`Page 3 of 18
`
`

`
`7/29/2016
`
`How to Manage Type 2 Diabetes | Lower Blood Sugar Levels
`
`How KOMBIGLYZE XR works to kickstart your A1C control
`
`KOMBIGLYZE XR is believed to work in four different ways to help control blood sugar.
`
`Not all medicines for type 2 diabetes work the same way. The graphic below demonstrates how KOMBIGLYZE
`XR is believed to work in four different ways to help control blood sugar.
`
`Works to decrease the amount of sugar
`absorbed by the gut
`
`Important Safety Information
`
`KOMBIGLYZE XR can cause serious side effects, including:
`Lactic Acidosis: Metformin hydrochloride, one of the medicines in KOMBIGLYZE XR, ...Read Morecan cause a rare, but serious,
`side effect called lactic acidosis (a build-up of lactic acid in the blood) that can ...Read More cause death. Lactic acidosis is a
`medical emergency and must be treated in a ...Read Morehospital. Stop taking KOMBIGLYZE XR and call your doctor right away
`if you get any of the following symptoms of lactic acidosis: feel very weak and tired, unusual (not normal) muscle pain, trouble
`breathing, unusual sleepiness or sleep longer than usual, unexplained stomach or intestinal problems with nausea and
`vomiting or diarrhea, feel cold (especially in your arms and legs), dizzy or lightheaded, or have a slow or irregular heartbeat.
`
`You have a higher chance of getting lactic acidosis if you have kidney or liver problems, have congestive heart failure that
`requires treatment with medicines, drink a lot of alcohol (very often or short-term “binge” drinking), get dehydrated (lose a
`large amount of body fluids), have certain x-ray tests with injectable dyes or contrast agents, have surgery, have a heart attack,
`https://www.kombiglyzexr.com/type­2­diabetes­medication/blood­sugar.html
`
`2/6
`
`Page 4 of 18
`
`

`
`7/29/2016
`
`How to Manage Type 2 Diabetes | Lower Blood Sugar Levels
`Helps the body respond better to its
`own insulin
`
`Works to reduce the amount of sugar
`made by the liver
`
`Works to decrease the amount of sugar
`absorbed by the gut
`
`Important Safety Information
`
`KOMBIGLYZE XR can cause serious side effects, including:
`Lactic Acidosis: Metformin hydrochloride, one of the medicines in KOMBIGLYZE XR, ...Read Morecan cause a rare, but serious,
`side effect called lactic acidosis (a build-up of lactic acid in the blood) that can ...Read More cause death. Lactic acidosis is a
`medical emergency and must be treated in a ...Read Morehospital. Stop taking KOMBIGLYZE XR and call your doctor right away
`Helps the body respond better to its
`if you get any of the following symptoms of lactic acidosis: feel very weak and tired, unusual (not normal) muscle pain, trouble
`own insulin
`breathing, unusual sleepiness or sleep longer than usual, unexplained stomach or intestinal problems with nausea and
`vomiting or diarrhea, feel cold (especially in your arms and legs), dizzy or lightheaded, or have a slow or irregular heartbeat.
`
`You have a higher chance of getting lactic acidosis if you have kidney or liver problems, have congestive heart failure that
`requires treatment with medicines, drink a lot of alcohol (very often or short-term “binge” drinking), get dehydrated (lose a
`large amount of body fluids), have certain x-ray tests with injectable dyes or contrast agents, have surgery, have a heart attack,
`https://www.kombiglyzexr.com/type­2­diabetes­medication/blood­sugar.html
`
`3/6
`
`Page 5 of 18
`
`

`
`7/29/2016
`
`How to Manage Type 2 Diabetes | Lower Blood Sugar Levels
`
`Works to reduce the amount of sugar
`made by the liver
`
`Helps the body respond better to its
`own insulin
`
`Important Safety Information
`
`KOMBIGLYZE XR can cause serious side effects, including:
`Helps your body make more insulin
`Lactic Acidosis: Metformin hydrochloride, one of the medicines in KOMBIGLYZE XR, ...Read Morecan cause a rare, but serious,
`when you eat
`side effect called lactic acidosis (a build-up of lactic acid in the blood) that can ...Read More cause death. Lactic acidosis is a
`medical emergency and must be treated in a ...Read Morehospital. Stop taking KOMBIGLYZE XR and call your doctor right away
`if you get any of the following symptoms of lactic acidosis: feel very weak and tired, unusual (not normal) muscle pain, trouble
`breathing, unusual sleepiness or sleep longer than usual, unexplained stomach or intestinal problems with nausea and
`vomiting or diarrhea, feel cold (especially in your arms and legs), dizzy or lightheaded, or have a slow or irregular heartbeat.
`
`You have a higher chance of getting lactic acidosis if you have kidney or liver problems, have congestive heart failure that
`requires treatment with medicines, drink a lot of alcohol (very often or short-term “binge” drinking), get dehydrated (lose a
`large amount of body fluids), have certain x-ray tests with injectable dyes or contrast agents, have surgery, have a heart attack,
`https://www.kombiglyzexr.com/type­2­diabetes­medication/blood­sugar.html
`
`4/6
`
`Page 6 of 18
`
`

`
`7/29/2016
`
`How to Manage Type 2 Diabetes | Lower Blood Sugar Levels
`
`Works to reduce the amount of sugar
`made by the liver
`
`Helps your body make more insulin
`when you eat
`
`You and your doctor will manage your diabetes with regular blood tests, including your blood sugar levels and
`†
`your A1C.
`
`Continue to check your blood sugar as your doctor tells you to.
`
`†
`
`A1C is a laboratory test that shows your average blood sugar level over the past 2 to 3 months.
`
`Save with a $0 co-pay offer
`
`You may be able to get KOMBIGLYZE XR for as low as $0 a month for as long as
`Important Safety Information
`your doctor prescribes it.*
`SEE HOW »
`KOMBIGLYZE XR can cause serious side effects, including:
`*Subject to eligibility. Restrictions apply. Not available for government-insured patients. Savings subject to monthly limit.
`Lactic Acidosis: Metformin hydrochloride, one of the medicines in KOMBIGLYZE XR, ...Read Morecan cause a rare, but serious,
`side effect called lactic acidosis (a build-up of lactic acid in the blood) that can ...Read More cause death. Lactic acidosis is a
`medical emergency and must be treated in a ...Read Morehospital. Stop taking KOMBIGLYZE XR and call your doctor right away
`if you get any of the following symptoms of lactic acidosis: feel very weak and tired, unusual (not normal) muscle pain, trouble
`breathing, unusual sleepiness or sleep longer than usual, unexplained stomach or intestinal problems with nausea and
`vomiting or diarrhea, feel cold (especially in your arms and legs), dizzy or lightheaded, or have a slow or irregular heartbeat.
`Talk to your healthcare provider to see if KOMBIGLYZE XR is right for you.
`You have a higher chance of getting lactic acidosis if you have kidney or liver problems, have congestive heart failure that
`START NOW »
`requires treatment with medicines, drink a lot of alcohol (very often or short-term “binge” drinking), get dehydrated (lose a
`large amount of body fluids), have certain x-ray tests with injectable dyes or contrast agents, have surgery, have a heart attack,
`https://www.kombiglyzexr.com/type­2­diabetes­medication/blood­sugar.html
`
`Download the Doctor Discussion Guide
`
`5/6
`
`Page 7 of 18
`
`

`
`7/29/2016
`
`How to Manage Type 2 Diabetes | Lower Blood Sugar Levels
`
`Join our patient support program
`
`Get ongoing prescription coverage support, savings, and tips for managing
`type 2 diabetes.
`REGISTER HERE »
`
`For US Consumers
`KOMBIGLYZE XR is a registered trademark of the AstraZeneca group of companies.
`©2016 AstraZeneca. All rights reserved.
`1803103-3217001 Last Updated 5/16
`
`Prescribing Information, including
`Boxed WARNING
`
`Medication Guide
`Contact Us
`
`Site Map
`
`Privacy Notice | Legal Statement
`
`Important Safety Information
`
`KOMBIGLYZE XR can cause serious side effects, including:
`Lactic Acidosis: Metformin hydrochloride, one of the medicines in KOMBIGLYZE XR, ...Read Morecan cause a rare, but serious,
`side effect called lactic acidosis (a build-up of lactic acid in the blood) that can ...Read More cause death. Lactic acidosis is a
`medical emergency and must be treated in a ...Read Morehospital. Stop taking KOMBIGLYZE XR and call your doctor right away
`if you get any of the following symptoms of lactic acidosis: feel very weak and tired, unusual (not normal) muscle pain, trouble
`breathing, unusual sleepiness or sleep longer than usual, unexplained stomach or intestinal problems with nausea and
`vomiting or diarrhea, feel cold (especially in your arms and legs), dizzy or lightheaded, or have a slow or irregular heartbeat.
`
`You have a higher chance of getting lactic acidosis if you have kidney or liver problems, have congestive heart failure that
`requires treatment with medicines, drink a lot of alcohol (very often or short-term “binge” drinking), get dehydrated (lose a
`large amount of body fluids), have certain x-ray tests with injectable dyes or contrast agents, have surgery, have a heart attack,
`https://www.kombiglyzexr.com/type­2­diabetes­medication/blood­sugar.html
`
`6/6
`
`Page 8 of 18
`
`

`
`2/17/2016
`
`Reduce A1C | Adult Type 2 Diabetes | KombiglyzeXR.com
`
`Important Safety Information | Indication | Prescribing Information, including Boxed WARNING
`
`  
`
`| Medication Guide
`
`   | Prescribing Information, including Boxed WARNING | Indication
`
`| Med Guide
`
`For US Consumers
`
`Visit HCP Site
`
`Go to Health Care Professional Site
`
`MENU
`
`Register »
`
`Important Safety Information
`
`Lactic Acidosis: Metformin hydrochloride, one of the medicines in KOMBIGLYZE XR, can cause a rare, but serious, side
`effect called lactic acidosis (a build-up of lactic acid in the blood)...Read More that can cause death. Lactic acidosis is a
`medical emergency and must be...Read More treated in a hospital. Stop taking KOMBIGLYZE XR and call your doctor
`right away if you get any of the following symptoms of lactic acidosis: feel very weak and tired, unusual (not normal)
`muscle pain, trouble breathing, unusual sleepiness or sleep longer than usual, unexplained stomach or intestinal
`problems with nausea and vomiting...Read More or diarrhea, feel cold (especially in your arms and legs), dizzy or
`lightheaded, or have a slow or irregular heartbeat.
`
`https://www.kombiglyzexr.com/lowering­a1c/reduce­a1c.html
`
`1/7
`
`Page 9 of 18
`
`

`
`2/17/2016
`
`Reduce A1C | Adult Type 2 Diabetes | KombiglyzeXR.com
`
`How KOMBIGLYZE XR may help to reduce A1C
`
`The combination of saxagliptin and metformin hydrochloride, the two medicines that make
`up KOMBIGLYZE XR tablets, has been tested in multiple clinical studies including thousands
`of adult patients with type 2 diabetes. This combination, in addition to diet and exercise, has
`been shown to lower A1C.
`
`Two studies are featured below. The metformin tablets used in these studies, in combination
`with saxagliptin, were in the immediate-release (IR) form. However, they have been shown to
`be similar to the extended-release (XR) form used in KOMBIGLYZE XR.
`
` This information is not meant to show which type 2 diabetes medicine is right for you. Ask
`your doctor about clinical study results involving the combination of saxagliptin and
`metformin and what the results mean. Then, together, you can decide what action to take.
`
`A 24-week clinical study of saxagliptin plus metformin IR in patients
`whose blood sugar was not controlled enough by metformin IR alone
`
`This clinical study involved 743 adult type 2 diabetes patients whose blood sugar was not
`controlled enough by taking metformin IR by itself.
`
`Of these patients, 564 were given a 2.5-, 5-, or 10-mg dose of saxagliptin plus metformin IR
`and 179 were given a placebo plus metformin IR. The patients started the study with an A1C
`of 8.1%, on average.
`
`Note: The 10-mg dose is not an approved dose. Be sure to speak to your doctor about which
`dose is right for you.
`
`After 24 weeks, results showed significant A1C reduction
`
`•
`https://www.kombiglyzexr.com/lowering­a1c/reduce­a1c.html
`
`2/7
`
`Page 10 of 18
`
`

`
`Reduce A1C | Adult Type 2 Diabetes | KombiglyzeXR.com
`Patients taking a 2.5-mg dose of saxagliptin plus metformin IR lowered their A1C by 0.6%,
`on average
`
`Patients taking a 5-mg dose of saxagliptin plus metformin IR lowered their A1C by 0.7%, on
`average
`
`Patients taking placebo plus metformin IR did not lower their A1C 
`
`2/17/2016
`
`• • •
`
`A number of patients achieved an A1C of less than 7%, including:
`
`37% of those taking a 2.5-mg dose of saxagliptin plus metformin IR
`
`44% of those taking a 5-mg dose of saxagliptin plus metformin IR
`
`17% of those on placebo plus metformin
`
`• • •
`
`A number of patients reported having low blood sugar (hypoglycemia) during the study:
`
`7.8% of those taking a 2.5-mg dose of saxagliptin plus metformin IR
`
`5.8% of those taking a 5-mg dose of saxagliptin plus metformin IR
`
`5% of those on placebo plus metformin IR
`
`• • •
`
`A number of patients were taken out of the study because their doctors didn’t see the trial
`treatments as effective enough for controlling their A1C (15% taking a 2.5-mg dose of
`saxagliptin plus metformin IR, 13% taking a 5-mg dose of saxagliptin plus metformin IR, and
`27% on placebo plus metformin IR).
`
`These results are the average responses from the total population in the trial. Your personal
`results on a medicine may vary from those of the patients in this clinical trial.
`
`Who should not take KOMBIGLYZE XR?
`
`Do not take KOMBIGLYZE XR if you have kidney problems, have a condition called metabolic
`acidosis or diabetic ketoacidosis (increased ketones in the blood or urine), or are allergic to
`
`https://www.kombiglyzexr.com/lowering­a1c/reduce­a1c.html
`
`3/7
`
`Page 11 of 18
`
`

`
`Reduce A1C | Adult Type 2 Diabetes | KombiglyzeXR.com
`2/17/2016
`metformin hydrochloride, saxagliptin, or any of the ingredients in KOMBIGLYZE XR.
`
`Serious allergic reactions can occur with KOMBIGLYZE XR 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 KOMBIGLYZE XR and contact your doctor right away.
`
`A 24-week clinical study of saxagliptin plus metformin IR in patients
`new to type 2 diabetes medicine
`
`This clinical study involved 1,306 adult type 2 diabetes patients whose blood sugar was not
`controlled enough by diet and exercise.
`
`Of these patients, 643 were given a 5- or 10-mg dose of saxagliptin plus metformin IR, 335
`were given a 10-mg dose of saxagliptin plus placebo, and 328 were given a placebo plus
`metformin IR. The patients started the study with an A1C of 9.4% to 9.6%, on average.
`
`Note: The 10-mg dose is not an approved dose. Be sure to speak to your doctor about which
`dose is right for you.
`
`After 24 weeks, results showed significant A1C reduction
`
`Patients taking a 5-mg dose of saxagliptin plus metformin IR lowered their A1C by 2.5%, on
`average
`
`Patients taking placebo plus metformin IR lowered their A1C by 2.0%, on average
`
`• •
`
`A number of patients achieved an A1C of less than 7%, including 60% of those taking a 5-mg
`dose of saxagliptin plus metformin IR and 41% of those on placebo plus metformin IR.
`
`A number of patients reported having low blood sugar (hypoglycemia) during the study (3.4%
`of those taking a 5-mg dose of saxagliptin plus metformin IR and 4% of those on placebo plus
`metformin IR).
`
`https://www.kombiglyzexr.com/lowering­a1c/reduce­a1c.html
`
`4/7
`
`Page 12 of 18
`
`

`
`Reduce A1C | Adult Type 2 Diabetes | KombiglyzeXR.com
`2/17/2016
`These results are the average responses from the total population in the trial. Your personal
`results on a medicine may vary from those of the patients in this clinical trial.
`
`What is the most important information you should know about
`KOMBIGLYZE XR?
`
`Serious side effects can happen to people taking KOMBIGLYZE XR, including inflammation of
`the pancreas (pancreatitis), which may be severe and lead to death.
`
`Before taking KOMBIGLYZE XR, tell your doctor if you ever had pancreatitis, gallstones,
`history of alcoholism, or high triglyceride levels.
`
`Stop taking KOMBIGLYZE XR 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.
`Co-pays as little as $0
`*
`
`You may be eligible to save on KOMBIGLYZE XR.
`
`*Subject to eligibility. Restrictions apply.
`SEE HOW »
`
`Discuss A1C and other factors
`
`The KOMBIGLYZE XR Doctor Discussion Guide can
`help.
`START NOW »
`
`Register now
`
`Get helpful information about KOMBIGLYZE XR.
`REGISTER HERE »
`
`IMPORTANT SAFETY INFORMATION for KOMBIGLYZE XR
`
`Lactic Acidosis: Metformin hydrochloride, one of the medicines in KOMBIGLYZE 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
`
`https://www.kombiglyzexr.com/lowering­a1c/reduce­a1c.html
`
`5/7
`
`Page 13 of 18
`
`

`
`Reduce A1C | Adult Type 2 Diabetes | KombiglyzeXR.com
`2/17/2016
`taking KOMBIGLYZE XR and call your doctor right away if you get any of the following
`symptoms of lactic acidosis: feel very weak and tired, unusual (not normal) muscle pain, trouble
`breathing, unusual sleepiness or sleep longer than usual, unexplained stomach or intestinal
`problems with nausea and vomiting or diarrhea, feel cold (especially in your arms and legs),
`dizzy or lightheaded, or have a slow or irregular heartbeat.
`
`You have a higher chance of getting lactic acidosis if you have kidney or liver problems, have
`congestive heart failure that requires treatment with medicines, drink a lot of alcohol (very often
`or short-term “binge” drinking), get dehydrated (lose a large amount of body fluids), have
`certain x-ray tests with injectable dyes or contrast agents, have surgery, have a heart attack,
`severe infection, or stroke, or are 80 years of age or older and have not had your kidney function
`tested.
`
`Do not take KOMBIGLYZE XR if you have kidney problems, have a condition called metabolic
`acidosis or diabetic ketoacidosis (increased ketones in the blood or urine), or are allergic to
`metformin hydrochloride, saxagliptin, or any of the ingredients in KOMBIGLYZE XR. Serious
`allergic reactions can occur with KOMBIGLYZE XR 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 KOMBIGLYZE XR and contact your doctor right
`away.
`
`Serious side effects can happen to people taking KOMBIGLYZE XR, including inflammation of
`the pancreas (pancreatitis) which may be severe and lead to death. Before taking KOMBIGLYZE
`XR, tell your doctor if you ever had pancreatitis, gallstones, history of alcoholism, or high
`triglyceride levels. Stop taking KOMBIGLYZE XR 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.
`
`Your doctor should do blood tests to check how well your kidneys are working before and
`during your treatment with KOMBIGLYZE XR.
`
`If you take KOMBIGLYZE XR with another medicine that can cause low blood sugar
`(hypoglycemia), such as sulfonylureas or insulin, you have a higher risk of having low blood
`sugar. Symptoms of low blood sugar include, shaking, sweating, rapid heartbeat, change in
`vision, hunger, headache and change in mood. Follow your doctor’s instructions for treating low
`blood sugar.
`
`Some people who take medicines called DPP-4 inhibitors, one of the medicines in
`KOMBIGLYZE XR, may develop joint pain that can be severe. Call your doctor if you have severe
`joint pain.
`
`The most common side effects of KOMBIGLYZE XR include upper respiratory tract infection,
`stuffy or runny nose and sore throat, urinary tract infection, headache, diarrhea, and nausea and
`vomiting.
`
`Tell your doctor if you will be starting or stopping certain other types of medicines, such as
`antibiotics, or medicines that treat fungus or HIV/AIDS, as your doctor may need to change your
`dose of KOMBIGLYZE XR.
`
`Tell your doctor if you are pregnant, breast-feeding, or plan to become pregnant or breast-feed.
`
`https://www.kombiglyzexr.com/lowering­a1c/reduce­a1c.html
`
`6/7
`
`Page 14 of 18
`
`

`
`Reduce A1C | Adult Type 2 Diabetes | KombiglyzeXR.com
`2/17/2016
`Swallow KOMBIGLYZE XR whole; do not crush, cut, or chew.
`WHAT IS KOMBIGLYZE XR?
`
`KOMBIGLYZE XR is a prescription medicine that contains saxagliptin and metformin
`hydrochloride. KOMBIGLYZE XR is used with diet and exercise to help control high blood sugar
`(hyperglycemia) in adults with type 2 diabetes. Your doctor will decide if treatment with both
`saxagliptin and metformin is right for you.
`
`KOMBIGLYZE XR 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 KOMBIGLYZE XR.
`
`Please read full Prescribing Information, including Boxed WARNING
`Guide
` for KOMBIGLYZE XR.
`
` and Medication
`
`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.
`KOMBIGLYZE XR is a registered trademark of the AstraZeneca group of companies.
`1803103-3193203 Last Updated 12/15
`
`Prescribing Information,
`including Boxed WARNING
`
`Medication Guide
`
`Savings Program
`Contact Us
`
`Site Map
`
`Privacy Notice | Legal Statement
`
`https://www.kombiglyzexr.com/lowering­a1c/reduce­a1c.html
`
`7/7
`
`Page 15 of 18
`
`

`
`7/29/2016
`
`Type 2 Diabetes Medication | KOMBIGLYZE® XR (saxagliptin and metformin HCl extended‐release) tablets
`
`Important Safety Information | Approved Uses | Prescribing Information, including Boxed WARNING
`
`  
`
`| Medication Guide
`
`   | Prescribing Information, including Boxed WARNING | Approved Uses | Med Guide
`
`For US Consumers
`
`Visit HCP Site
`
`Go to Healthcare Professional Site
`
`MENU
`
`Register
`
`Important Safety Information
`
`KOMBIGLYZE XR can cause serious side effects, including:
`Lactic Acidosis: Metformin hydrochloride, one of the medicines in KOMBIGLYZE XR, ...Read Morecan cause a rare, but serious,
`side effect called lactic acidosis (a build-up of lactic acid in the blood) that can ...Read More cause death. Lactic acidosis is a
`medical emergency and must be treated in a ...Read Morehospital. Stop taking KOMBIGLYZE XR and call your doctor right away
`if you get any of the following symptoms of lactic acidosis: feel very weak and tired, unusual (not normal) muscle pain, trouble
`breathing, unusual sleepiness or sleep longer than usual, unexplained stomach or intestinal problems with nausea and
`vomiting or diarrhea, feel cold (especially in your arms and legs), dizzy or lightheaded, or have a slow or irregular heartbeat.
`
`You have a higher chance of getting lactic acidosis if you have kidney or liver problems, have congestive heart failure that
`requires treatment with medicines, drink a lot of alcohol (very often or short-term “binge” drinking), get dehydrated (lose a
`large amount of body fluids), have certain x-ray tests with injectable dyes or contrast agents, have surgery, have a heart attack,
`https://www.kombiglyzexr.com/type­2­diabetes­medication.html
`
`1/3
`
`Page 16 of 18
`
`

`
`7/29/2016
`
`Type 2 Diabetes Medication | KOMBIGLYZE® XR (saxagliptin and metformin HCl extended‐release) tablets
`
`Taking metformin but still not reaching your A1C goal? Consider KOMBIGLYZE
`XR.
`
`Managing type 2 diabetes can be challenging, especially if you’re taking metformin and finding that it isn’t
`doing enough to get your A1C numbers to goal. For some, combining metformin with another kind of type 2
`diabetes medicine may work better. This combination pill could be the kickstart you need.
`
`The first once-daily prescription medicine combining saxagliptin and metformin in one tablet.
`KOMBIGLYZE XR may lower your A1C.
`
`KOMBIGLYZE XR is a prescription medicine that contains saxagliptin and metformin hydrochloride.
`KOMBIGLYZE XR is used with diet and exercise to help control high blood sugar (hyperglycemia) in adults with
`type 2 diabetes. Your doctor will decide if treatment with both saxagliptin and metformin is right for you.
`
`KOMBIGLYZE XR should not be used to treat people with type 1 diabetes or diabetic ketoacidosis (increased
`ketones in the blood or urine). 
`
` 
`
`Click the links below to learn more about KOMBIGLYZE XR.
`
`Discover how KOMBIGLYZE XR may help »
`
`Discover how KOMBIGLYZE XR may help »
`
`Learn how KOMBIGLYZE XR works »
`
`Learn how KOMBIGLYZE XR works »
`Important Safety Information
`Get help talking to your doctor about
`Get help talking to your doctor about KOMBIGLYZE
`KOMBIGLYZE XR can cause serious side effects, including:
`KOMBIGLYZE XR »
`XR »
`Lactic Acidosis: Metformin hydrochloride, one of the medicines in KOMBIGLYZE XR, ...Read Morecan cause a rare, but serious,
`side effect called lactic acidosis (a build-up of lactic acid in the blood) that can ...Read More cause death. Lactic acidosis is a
`medical emergency and must be treated in a ...Read Morehospital. Stop taking KOMBIGLYZE XR and call your doctor right away
`if you get any of the following symptoms of lactic acidosis: feel very weak and tired, unusual (not normal) muscle pain, trouble
`breathing, unusual sleepiness or sleep longer than usual, unexplained stomach or intestinal problems with nausea and
`You may be able to get KOMBIGLYZE XR for as low as $0 a month for as long as
`vomiting or diarrhea, feel cold (especially in your arms and legs), dizzy or lightheaded, or have a slow or irregular heartbeat.
`your doctor prescribes it.*
`You have a higher chance of getting lactic acidosis if you have kidney or liver problems, have congestive heart failure that
`SEE HOW »
`requires treatment with medicines, drink a lot of alcohol (very often or short-term “binge” drinking), get dehydrated (lose a
`large amount of body fluids), have certain x-ray tests with injectable dyes or contrast agents, have surgery, have a heart attack,
`https://www.kombiglyzexr.com/type­2­diabetes­medication.html
`
`Save with a $0 co-pay offer
`
`2/3
`
`Page 17 of 18
`
`

`
`7/29/2016
`
`Type 2 Diabetes Medication | KOMBIGLYZE® XR (saxagliptin and metformin HCl extended‐release) tablets
`*Subject to eligibility. Restrictions apply. Not available for government-insured patients. Savings subject to monthly limit.
`
`Download the Doctor Discussion Guide
`
`Talk to your healthcare provider to see if KOMBIGLYZE XR is right for you.
`START NOW »
`
`Join our patient support program
`
`Get ongoing prescription coverage support, savings, and tips for managing
`type 2 diabetes