a1c goal - novomedlink · 7.875 8.25 4.125 7.875 xultophy® 100/3.6 patient brochure finished size:...

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7.875 8.25 4.125 7.875 Xultophy ® 100/3.6 Patient Brochure Finished size: 4.125 x 7.875 in Flat size: 8.25 x 7.875 16 pages = 12 pages plus cover w/ back pocket Lowers blood sugar along with diet and exercise in adults with type 2 diabetes. Please see Important Safety Information throughout and enclosed Medication Guide and Prescribing Information, including Boxed Warning. A proven step to reach your A1C goal Indications and Usage What is Xultophy ® 100/3.6 (insulin degludec and liraglutide injection) 100 units/mL and 3.6 mg/mL? Xultophy ® 100/3.6 is an injectable prescription medicine that contains 2 diabetes medicines, insulin degludec, 100 units/mL, and liraglutide, 3.6 mg/mL. Xultophy ® 100/3.6 should be used along with diet and exercise to lower blood sugar (glucose) in adults with type 2 diabetes mellitus. · Xultophy ® 100/3.6 is not recommended as the first choice of medicine for treating diabetes. · Xultophy ® 100/3.6 is not recommended for use in combination with any other product containing liraglutide or another glucagon-like peptide-1 receptor agonist (GLP-1 RA). · Xultophy ® 100/3.6 is not for use in people with type 1 diabetes or people with diabetic ketoacidosis (increased ketones in the blood or urine). · It is not known if Xultophy ® 100/3.6 can be used with mealtime insulin. · It is not known if Xultophy ® 100/3.6 is safe and effective for use in children. Important Safety Information What is the most important information I should know about Xultophy ® 100/3.6? Xultophy ® 100/3.6 may cause serious side effects, including: · Possible thyroid tumors, including cancer. Tell your health care provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats and mice, liraglutide, one of the components of Xultophy ® 100/3.6, and medicines that work like liraglutide caused thyroid tumors, including thyroid cancer. It is not known if Xultophy ® 100/3.6 will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. 3 Xultophy ® 100/3.6...a step toward better blood sugar control When you’re living with type 2 diabetes, you know how challenging it can be to manage your blood sugar. Even if you’re eating right, staying active, and taking your diabetes medicine every day, you may still be struggling to reach your A1C goal. It may be time to talk with your health care provider about Xultophy ® 100/3.6. Xultophy ® 100/3.6 can be the next step you need to help control your blood sugar and reach your A1C goal. What is Xultophy ® 100/3.6? Xultophy ® 100/3.6 is a once-daily combination medicine used with diet and exercise to help lower blood sugar in adults with type 2 diabetes. Xultophy ® 100/3.6 combines 2 proven diabetes medicinesTresiba ® (insulin degludec) and Victoza ® (liraglutide)into 1 pen Xultophy ® 100/3.6 works for a full 24 hours to lower blood sugar, including after you eat Xultophy ® 100/3.6 is proven to lower A1C Xultophy ® 100/3.6 is taken once daily, at the same time each day, with or without food Important Safety Information (cont’d) Who should not use Xultophy ® 100/3.6? Do not use Xultophy ® 100/3.6 if: · you or any of your family have ever had MTC or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). · you are having an episode of low blood sugar or if you are allergic to insulin degludec, liraglutide, or any of the ingredients in Xultophy ® 100/3.6. What should I tell my health care provider before using Xultophy ® 100/3.6? Tell your health care provider about all your medical conditions, including if you: · have or have had problems with your pancreas, kidneys, or liver. Please see additional Important Safety Information throughout and enclosed Medication Guide and Prescribing Information, including Boxed Warning. 2 Actor portrayal.

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Page 1: A1C goal - NovoMedLink · 7.875 8.25 4.125 7.875 Xultophy® 100/3.6 Patient Brochure Finished size: 4.125 x 7.875 in Flat size: 8.25 x 7.875 16 pages = 12 pages plus cover w/ back

7.875

8.25

4.125

7.875

Xultophy® 100/3.6 Patient BrochureFinished size: 4.125 x 7.875 inFlat size: 8.25 x 7.87516 pages = 12 pages plus cover w/ back pocket

Lowers blood sugar along with diet and exercise in adults with type 2 diabetes.

Please see Important Safety Information throughout and enclosed Medication Guide and Prescribing Information, including Boxed Warning.

A proven step to reach your

A1C goal

Indications and UsageWhat is Xultophy® 100/3.6 (insulin degludec and liraglutide injection) 100 units/mL and 3.6 mg/mL?Xultophy® 100/3.6 is an injectable prescription medicine that contains 2 diabetes medicines, insulin degludec, 100 units/mL, and liraglutide, 3.6 mg/mL. Xultophy® 100/3.6 should be used along with diet and exercise to lower blood sugar (glucose) in adults with type 2 diabetes mellitus.· Xultophy® 100/3.6 is not recommended as the first choice of medicine for treating diabetes.

· Xultophy® 100/3.6 is not recommended for use in combination with any other product containing liraglutide or another glucagon-like peptide-1 receptor agonist (GLP-1 RA).

· Xultophy® 100/3.6 is not for use in people with type 1 diabetes or people with diabetic ketoacidosis (increased ketones in the blood or urine).

· It is not known if Xultophy® 100/3.6 can be used with mealtime insulin.· It is not known if Xultophy® 100/3.6 is safe and effective for use in children.

Important Safety InformationWhat is the most important information I should know about Xultophy® 100/3.6?Xultophy® 100/3.6 may cause serious side effects, including:· Possible thyroid tumors, including cancer. Tell your health care provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats and mice, liraglutide, one of the components of Xultophy® 100/3.6, and medicines that work like liraglutide caused thyroid tumors, including thyroid cancer. It is not known if Xultophy® 100/3.6 will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.

3

Xultophy® 100/3.6...a step toward better blood sugar controlWhen you’re living with type 2 diabetes, you know how challenging it can be to manage your blood sugar. Even if you’re eating right, staying active, and taking your diabetes medicine every day, you may still be struggling to reach your A1C goal.

It may be time to talk with your health care provider about Xultophy® 100/3.6. Xultophy® 100/3.6 can be the next step you need to help control your blood sugar and reach your A1C goal.

What is Xultophy® 100/3.6?Xultophy® 100/3.6 is a once-daily combination medicine used with diet and exercise to help lower blood sugar in adults with type 2 diabetes.

Xultophy® 100/3.6 combines 2 proven diabetes medicines—Tresiba® (insulin degludec) and Victoza® (liraglutide)—into 1 pen

Xultophy® 100/3.6 works for a full 24 hours to lower blood sugar, including after you eat

Xultophy® 100/3.6 is proven to lower A1C

Xultophy® 100/3.6 is taken once daily, at the same time each day, with or without food

Important Safety Information (cont’d)Who should not use Xultophy® 100/3.6? Do not use Xultophy® 100/3.6 if:· you or any of your family have ever had MTC or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

· you are having an episode of low blood sugar or if you are allergic to insulin degludec, liraglutide, or any of the ingredients in Xultophy® 100/3.6.

What should I tell my health care provider before using Xultophy® 100/3.6?Tell your health care provider about all your medical conditions, including if you:· have or have had problems with your pancreas, kidneys, or liver.

Please see additional Important Safety Information throughout and enclosed Medication Guide and Prescribing Information, including Boxed Warning.2

Actor portrayal.

Page 2: A1C goal - NovoMedLink · 7.875 8.25 4.125 7.875 Xultophy® 100/3.6 Patient Brochure Finished size: 4.125 x 7.875 in Flat size: 8.25 x 7.875 16 pages = 12 pages plus cover w/ back

Lowers blood sugar along with diet and exercise in adults with type 2 diabetes.

Please see Important Safety Information throughout and enclosed Medication Guide and Prescribing Information, including Boxed Warning.

A proven step to reach your

A1C goal

Indications and UsageWhat is Xultophy® 100/3.6 (insulin degludec and liraglutide injection) 100 units/mL and 3.6 mg/mL?Xultophy® 100/3.6 is an injectable prescription medicine that contains 2 diabetes medicines, insulin degludec, 100 units/mL, and liraglutide, 3.6 mg/mL. Xultophy® 100/3.6 should be used along with diet and exercise to lower blood sugar (glucose) in adults with type 2 diabetes mellitus.· Xultophy® 100/3.6 is not recommended as the first choice of medicine for treating diabetes.

· Xultophy® 100/3.6 is not recommended for use in combination with any other product containing liraglutide or another glucagon-like peptide-1 receptor agonist (GLP-1 RA).

· Xultophy® 100/3.6 is not for use in people with type 1 diabetes or people with diabetic ketoacidosis (increased ketones in the blood or urine).

· It is not known if Xultophy® 100/3.6 can be used with mealtime insulin.· It is not known if Xultophy® 100/3.6 is safe and effective for use in children.

Page 3: A1C goal - NovoMedLink · 7.875 8.25 4.125 7.875 Xultophy® 100/3.6 Patient Brochure Finished size: 4.125 x 7.875 in Flat size: 8.25 x 7.875 16 pages = 12 pages plus cover w/ back

Important Safety InformationWhat is the most important information I should know about Xultophy® 100/3.6?Xultophy® 100/3.6 may cause serious side effects, including:· Possible thyroid tumors, including cancer. Tell your health care provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats and mice, liraglutide, one of the components of Xultophy® 100/3.6, and medicines that work like liraglutide caused thyroid tumors, including thyroid cancer. It is not known if Xultophy® 100/3.6 will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.

3

Xultophy® 100/3.6...a step toward better blood sugar controlWhen you’re living with type 2 diabetes, you know how challenging it can be to manage your blood sugar. Even if you’re eating right, staying active, and taking your diabetes medicine every day, you may still be struggling to reach your A1C goal.

It may be time to talk with your health care provider about Xultophy® 100/3.6. Xultophy® 100/3.6 can be the next step you need to help control your blood sugar and reach your A1C goal.

What is Xultophy® 100/3.6?Xultophy® 100/3.6 is a once-daily combination medicine used with diet and exercise to help lower blood sugar in adults with type 2 diabetes.

Xultophy® 100/3.6 combines 2 proven diabetes medicines—Tresiba® (insulin degludec) and Victoza® (liraglutide)—into 1 pen

Xultophy® 100/3.6 works for a full 24 hours to lower blood sugar, including after you eat

Xultophy® 100/3.6 is proven to lower A1C

Xultophy® 100/3.6 is taken once daily, at the same time each day, with or without food

Important Safety Information (cont’d)Who should not use Xultophy® 100/3.6? Do not use Xultophy® 100/3.6 if:· you or any of your family have ever had MTC or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

· you are having an episode of low blood sugar or if you are allergic to insulin degludec, liraglutide, or any of the ingredients in Xultophy® 100/3.6.

What should I tell my health care provider before using Xultophy® 100/3.6?Tell your health care provider about all your medical conditions, including if you:· have or have had problems with your pancreas, kidneys, or liver.

Please see additional Important Safety Information throughout and enclosed Medication Guide and Prescribing Information, including Boxed Warning.2

Actor portrayal.

Page 4: A1C goal - NovoMedLink · 7.875 8.25 4.125 7.875 Xultophy® 100/3.6 Patient Brochure Finished size: 4.125 x 7.875 in Flat size: 8.25 x 7.875 16 pages = 12 pages plus cover w/ back

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Why Xultophy® 100/3.6?You are already taking at least 1 diabetes medicine to treat your diabetes. Xultophy® 100/3.6 is different because it combines 2 proven diabetes medicines—Tresiba® (a long-acting insulin) and Victoza® (a non-insulin injectable)—into 1 pen with a once-daily dose.

If your blood sugar is not in your target range with your current treatment, you may benefit from Xultophy® 100/3.6.

How Xultophy® 100/3.6 works Xultophy® 100/3.6 works in 2 ways to control blood sugar:

1. It adds insulin when your body isn’t making enough to lower blood sugar throughout the day

2. It helps your pancreas work better to produce more insulin when your blood sugar levels are high

Xultophy® 100/3.6—a proven step to improve blood sugar controlXultophy® 100/3.6 lowers blood sugar for a full 24 hours so you can stay in control all day long, even after meals (when blood sugar tends to rise higher than normal in response to the food you’ve eaten). Keeping your daily blood sugar controlled is an important part of lowering your A1C.

Low blood sugar is a common side effect of insulin and insulin-containing products like Xultophy® 100/3.6. In studies, less than 1% of people taking Xultophy® 100/3.6 reported episodes of very low blood sugar.

Important Safety Information (cont’d)Tell your health care provider about all your medical conditions, including if you: (cont’d)· have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs (thiazolidinediones) with Xultophy® 100/3.6.

· have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.

· are taking certain medicines called GLP-1 RAs, or have had an allergic reaction to a GLP-1 RA.

· are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if Xultophy® 100/3.6 passes into your breast milk.

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Before using Xultophy® 100/3.6, talk to your health care provider about low blood sugar and how to manage it.

Important Safety Information (cont’d)How should I use Xultophy® 100/3.6?· Read the Instructions for Use and take Xultophy® 100/3.6 exactly as your health care provider tells you.

· Do not change your dosing schedule without first talking to your health care provider.

· Do not inject Xultophy® 100/3.6 into a muscle or vein or use in an insulin infusion pump.

insulin degludec injection 100 Units/mL

Please see additional Important Safety Information throughout and enclosed Medication Guide and Prescribing Information, including Boxed Warning.

Page 5: A1C goal - NovoMedLink · 7.875 8.25 4.125 7.875 Xultophy® 100/3.6 Patient Brochure Finished size: 4.125 x 7.875 in Flat size: 8.25 x 7.875 16 pages = 12 pages plus cover w/ back

Aver

age

A1C

(%)

8.0

9.0

7.8%

8.7%

8.4%

One study where people switched to Xultophy® 100/3.6

from liraglutidef

Two studies where people switched to Xultophy® 100/3.6

from a long-acting insulinc,d,e

The percentage of people who reached the ADA A1C goal across3 clinical studies for Xultophy® 100/3.6 ranged from 57.3% to 74.6%.

A1C (%) results at end of study6.4%6.9% 6.6%

6.0

7.0 7%ADA A1C goal

Less than

a Individual results may vary from results in clinical studies. b Three 26-week, head-to-head studies were done involving more than 1300 people with type 2 diabetes.

c Study B compared Xultophy® 100/3.6 with a long-acting insulin. Those taking long-acting insulin lowered their A1C an average 1.05% (from 8.8% to 7.7%), while those switching to Xultophy® 100/3.6 dropped 1.94%. End-of-study doses of both medicines was 46 units.

d Study C compared Xultophy® 100/3.6 with the leading long-acting insulin, Lantus®. Those taking Lantus® lowered their A1C an average 1.16% (from 8.2% to 7.1%), while those switching to Xultophy® 100/3.6 dropped 1.67%.

e Average doses at the end of the study were 41 units of Xultophy® 100/3.6 and 66 units of Lantus®. The clinical importance of this difference is uncertain. Doses could not be increased by more than 4 units per week and there was no maximum dose of Lantus®. A1C results may not reflect those seen outside a clinical study, where different doses of Lantus® can be used.

f Study A compared Xultophy® 100/3.6 with a medicine called liraglutide. Those taking unchanged liraglutide lowered their A1C an average 0.36% (from 7.8% to 7.4%), while those switching to Xultophy® 100/3.6 dropped 1.31%. The end-of-study dose of Xultophy® 100/3.6 was 44 units.

Important Safety Information (cont’d)How should I use Xultophy® 100/3.6? (cont’d)· Use Xultophy® 100/3.6 at the same time each day with or without food. Do not take more than 50 units of Xultophy® 100/3.6 each day.· Check the Pen label each time you give your injection to make sure you are using the correct medicine.

· Do not share your Xultophy® 100/3.6 pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

· Check your blood sugar levels. Ask your health care provider what your blood sugar levels should be and when you should check them.

Your dose of Xultophy® 100/3.6 may need to change because of change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or other medicines you take.

What should I avoid while taking Xultophy® 100/3.6?· Do not drive or operate heavy machinery, until you know how Xultophy® 100/3.6 affects you. Do not drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

What are the possible side effects of Xultophy® 100/3.6?Xultophy® 100/3.6 may cause serious side effects that can be life-threatening, including:· inflammation of your pancreas (pancreatitis). Stop using Xultophy® 100/3.6 and call your health care provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.

In a study vs Lantus®,a,d people who took Xultophy® 100/3.6, on average:· Lowered their A1C from 8.4% to 6.6%d

Additional results:

· Needed 38% less insulin to reach A1C goale

· Experienced a 3-pound weight reduction, while those taking Lantus® gained about 4 poundsg

Xultophy® 100/3.6 is proven to lower A1C

Across all clinical studies, Xultophy® 100/3.6 helped the majority of people reach an average A1C of less than 7%, the American Diabetes Association (ADA) goal.a,b

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gWeight gain can occur with insulin-containing products like Xultophy® 100/3.6.

Please see additional Important Safety Information throughout and enclosed Medication Guide and Prescribing Information, including Boxed Warning.

Page 6: A1C goal - NovoMedLink · 7.875 8.25 4.125 7.875 Xultophy® 100/3.6 Patient Brochure Finished size: 4.125 x 7.875 in Flat size: 8.25 x 7.875 16 pages = 12 pages plus cover w/ back

The Xultophy® 100/3.6 penXultophy® 100/3.6 comes in a prefilled pen that:∙ Can deliver from 10 to 50 units in a single injection∙ Is adjustable in 1-unit increments ∙ Has no push-button extension∙ Is recommended to be used with NovoFine® and NovoTwist®—

thin needles that are designed for less pain

Lasts 21 days once in useYou can take your Xultophy® 100/3.6 pen with you for up to 3 weeks without needing to put it in a cooler or refrigerator. Once in use, the Xultophy® 100/3.6 pen can be stored at room temperature between 59ºF and 86ºF or in a refrigerator at 36ºF to 46ºF.

How to take Xultophy® 100/3.6Your health care provider will tell you your starting dose and show you how to adjust your dose based on your pre-breakfast blood sugar readings.· Take Xultophy® 100/3.6 exactly as your health care provider tells you to

· Take Xultophy® 100/3.6 once daily at the same time each day· Xultophy® 100/3.6 can be taken with or without food. So you don’t have to plan your dose around your meals

Needles are sold separately and may require a prescription in some states.

Questions about Xultophy® 100/3.6? Talk to a Diabetes Health Coach. Coaches are Certified Diabetes Educators (CDEs) who can help. Call 1-866-696-4086 Monday through Friday, 9:00 am to 6:00 pm ET.

Important Safety Information (cont’d)What are the possible side effects of Xultophy® 100/3.6? (cont’d)· low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Xultophy® 100/3.6 with another medication that can cause low blood sugar. Signs and symptoms of low blood sugar may include: shakiness, irritability, fast heartbeat, dizziness, weakness, sweating, confusion, drowsiness, hunger, headache, and feeling jittery.

· kidney problems (kidney failure). Worsening of kidney failure and sudden kidney failure have happened in people with kidney problems and in people without kidney problems who have taken liraglutide, one of the ingredients in Xultophy® 100/3.6. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse. Tell your health care provider if you have diarrhea, nausea, or vomiting. Drink plenty of fluids to help reduce your risk of dehydration during treatment with Xultophy® 100/3.6.

· serious allergic reactions. Stop using Xultophy® 100/3.6 and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or a fast heartbeat.

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Please see additional Important Safety Information throughout and enclosed Medication Guide and Prescribing Information, including Boxed Warning.

Page 7: A1C goal - NovoMedLink · 7.875 8.25 4.125 7.875 Xultophy® 100/3.6 Patient Brochure Finished size: 4.125 x 7.875 in Flat size: 8.25 x 7.875 16 pages = 12 pages plus cover w/ back

You are not eligible for this savings offer if you are enrolled in or participate in Medicaid, Medicare, Medigap, VA, DOD, TRICARE, or any similar federal or state health care program.

Xultophy® 100/3.6 Instant Savings Card You can get your Xultophy®100/3.6 Instant Savings Card from your health care provider, or get one online at SaveOnXultophy10036.com.

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Save on Xultophy® 100/3.6 With the Xultophy® 100/3.6 Instant Savings Card, eligible patients pay as little as $30 per 30-day supply for up to 24 monthsa

· Receive a FREE box of Novo Nordisk needlesb

· Eligibility and other restrictions apply. Visit SaveOnXultophy.com for program details and full terms and conditions

Eligibility and Restrictions: Patient is not eligible if he/she participates in or seeks reimbursement or submits a claim for reimbursement to any federal or state healthcare program with prescription drug coverage, such as Medicaid, Medicare, Medigap, VA, DOD, TRICARE, or any similar federal or state health care program (each a Government Program), or where prohibited by law. Patient must be enrolled in, and must seek reimbursement from or submit a claim for reimbursement to, a commercial insurance plan. Offer excludes full cash-paying patients. By using this offer, you are certifying that you meet the eligibility criteria and will comply with the terms and conditions described herein and will not seek reimbursement for any benefi t received through this card. Novo Nordisk’s Eligibility and Restrictions, and Offer Details may change from time to time, and for the complete and most recent version, please visit SavingsCardEligibility.com. Patients with questions about the Savings Card offer may call 1-877-304-6855. This offer is valid in the United States and may be redeemed at participating retail pharmacies. Absent a change in Massachusetts law, effective July 1, 2019, the Savings Card will no longer be valid for residents of Massachusetts. Patient is responsible for complying with any insurance carrier co-payment disclosure requirements, including disclosing any savings received from this program. This program is managed by ConnectiveRx on behalf of Novo Nordisk. The parties reserve the right to rescind, revoke or amend this offer without notice at any time.Offer Details: Pay as little as $30 per 30-day, $60 per 60-day, or $90 per 90-day supply for up to 24 months from the date of Savings Card activation, subject to a maximum savings of $400 per 30-day supply, $800 per 60-day, or $1,200 per 90-day supply. Get one (1) free box of Novo Nordisk needles when you activate your Savings Card and enroll in the program. Limit 1 box of needles per person and maximum savings of $60. Needles are sold separately, will need a prescription and need to be processed by a pharmacist. Needles must not be shared.Pharmacist: When you apply this offer, you are certifying that you have not submitted a claim for reimbursement under any Government Program for this prescription, or where prohibited by law. Participation in this program must comply with all applicable laws and regulations as a pharmacy provider. By participating in this program, you are certifying that you will comply with the eligibility criteria, and terms and conditions described herein. You also certify that you will not seek reimbursement for any benefi t received through this card.Pharmacist instructions for a patient with an Eligible Third Party: Submit the claim to the primary Third Party Payer fi rst, then submit the balance due to CHANGE HEALTHCARE as a Secondary Payer COB [coordination of benefi ts] with patient responsibility amount and a valid Other Coverage Code, (e.g. 8). The patient is responsible initially for the Pay As Little As amount and the card pays up to the Savings Benefi t. Offer excludes full cash-paying patients. Reimbursement will be received from CHANGE HEALTHCARE. For any questions regarding CHANGE HEALTHCARE online processing, please call the Help Desk at 1-800-433-4893.

Xultophy® 100/3.6 is a registered trademark of Novo Nordisk A/S. Novo Nordisk is a registered trademark of Novo Nordisk A/S. © 2019 Novo Nordisk Printed in the U.S.A. US19XUM00112 March 2019

Peel

To activate your card, call

1-877-304-6852or visit SaveOnXultophy10036.com

PA

Y AS LITTLE AS

FOR UP TO 2 YEARS

1per day

$

Please see enclosed Medication Guide and Prescribing Information,

including Boxed Warning.

BIN: 600426GRP:

PCN: 54ID:

Pay as little as $30 per 30-day supply, plus receive a FREE box of Novo Nordisk needles.

Maximum monthly savings of $400. Up to 24 months. Eligibility and restrictions apply. See back for details.

Xultophy® 100/3.6 Instant Savings Card

ECXXXXXXXX 00000000000Pe

el

To activate your card, call

1-877-304-6852or visit SaveOnXultophy10036.com

Please see additional Important Safety Information throughout and enclosed Medication Guide and Prescribing Information, including Boxed Warning.

Important Safety Information (cont’d)What are the possible side effects of Xultophy® 100/3.6? (cont’d)· gallbladder problems. Gallbladder problems have happened in some people who take Xultophy® 100/3.6. Tell your health care provider right away if you get symptoms of gallbladder problems including pain in the right or middle upper stomach area, fever, nausea and vomiting, or your skin or the white part of your eyes turn yellow.

· low potassium in your blood (hypokalemia).· heart failure. Taking certain diabetes medicines called TZDs with Xultophy® 100/3.6 may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems.If you already have heart failure, it may get worse while you take TZDs with Xultophy® 100/3.6. Tell your health care provider if you have any new or worse symptoms of heart failure, including shortness of breath, tiredness, swelling of your ankles or feet, and sudden weight gain.

Important Safety Information (cont’d)The most common side effects of Xultophy® 100/3.6 may include stuffy or runny nose, sore throat, headache, nausea, diarrhea, increased blood levels of lipase, and upper respiratory tract infection.

aMaximum savings of $400 per month, up to 24 months.bNeedles may require a prescription in some states.

Page 8: A1C goal - NovoMedLink · 7.875 8.25 4.125 7.875 Xultophy® 100/3.6 Patient Brochure Finished size: 4.125 x 7.875 in Flat size: 8.25 x 7.875 16 pages = 12 pages plus cover w/ back

We are here to helpWhen you start Xultophy® 100/3.6, you will get the support you need through Cornerstones4Care®. This free support program helps you build skills to better manage your diabetes.

1. Get phone calls from a Diabetes Health Coach. Coaches are Certified Diabetes Educators (CDEs) who can help you with Xultophy® 100/3.6

2. Access an online coaching program

– A digital learning plan that offers support during your first 90 days

3. You will also get access to:

– Emails and newsletters that cover topics that matter to you

– Meal planning tools

– A library of free, downloadable booklets to help you learn more about important topics

– Interactive trackers

How do I get started?Signing up for support from Cornerstones4Care® is easy. 1. Sign up online at StartingXultophy10036.comOR2. Call to register at 1-866-696-4085

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Please see additional Important Safety Information throughout and enclosed Medication Guide and Prescribing Information, including Boxed Warning.

Important Safety InformationWhat is the most important information I should know about Xultophy® 100/3.6?Xultophy® 100/3.6 may cause serious side effects, including:· Possible thyroid tumors, including cancer. Tell your health care provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats and mice, liraglutide, one of the components of Xultophy® 100/3.6, and medicines that work like liraglutide caused thyroid tumors, including thyroid cancer. It is not known if Xultophy® 100/3.6 will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.

Who should not use Xultophy® 100/3.6? Do not use Xultophy® 100/3.6 if:· you or any of your family have ever had MTC or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

· you are having an episode of low blood sugar or if you are allergic to insulin degludec, liraglutide, or any of the ingredients in Xultophy® 100/3.6.

Indications and UsageWhat is Xultophy® 100/3.6 (insulin degludec and liraglutide injection) 100 units/mL and 3.6 mg/mL?Xultophy® 100/3.6 is an injectable prescription medicine that contains 2 diabetes medicines, insulin degludec, 100 units/mL, and liraglutide, 3.6 mg/mL. Xultophy® 100/3.6 should be used along with diet and exercise to lower blood sugar (glucose) in adults with type 2 diabetes mellitus.· Xultophy® 100/3.6 is not recommended as the first choice of medicine for treating diabetes.

· Xultophy® 100/3.6 is not recommended for use in combination with any other product containing liraglutide or another glucagon-like peptide-1 receptor agonist (GLP-1 RA).

· Xultophy® 100/3.6 is not for use in people with type 1 diabetes or people with diabetic ketoacidosis (increased ketones in the blood or urine).

· It is not known if Xultophy® 100/3.6 can be used with mealtime insulin.· It is not known if Xultophy® 100/3.6 is safe and effective for use in children.

Important Safety Information (cont’d)What should I tell my health care provider before using Xultophy® 100/3.6?Tell your health care provider about all your medical conditions, including if you:· have or have had problems with your pancreas, kidneys, or liver.· have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs (thiazolidinediones) with Xultophy® 100/3.6.

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Please see additional Important Safety Information throughout and enclosed Medication Guide and Prescribing Information, including Boxed Warning.14

Important Safety Information (cont’d)Tell your health care provider about all your medical conditions, including if you: (cont’d)· have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.

· are taking certain medicines called GLP-1 RAs, or have had an allergic reaction to a GLP-1 RA.

· are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if Xultophy® 100/3.6 passes into your breast milk.

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Before using Xultophy® 100/3.6, talk to your health care provider about low blood sugar and how to manage it.How should I use Xultophy® 100/3.6?· Read the Instructions for Use and take Xultophy® 100/3.6 exactly as

your health care provider tells you.· Do not change your dosing schedule without first talking to your health

care provider.· Do not inject Xultophy® 100/3.6 into a muscle or vein or use in an insulin

infusion pump.· Use Xultophy® 100/3.6 at the same time each day with or without

food. Do not take more than 50 units of Xultophy® 100/3.6 each day.· Check the Pen label each time you give your injection to make sure you

are using the correct medicine.· Do not share your Xultophy® 100/3.6 pen with other people, even

if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

· Check your blood sugar levels. Ask your health care provider what your blood sugar levels should be and when you should check them.

Your dose of Xultophy® 100/3.6 may need to change because of change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or other medicines you take.

What should I avoid while taking Xultophy® 100/3.6? · Do not drive or operate heavy machinery, until you know how

Xultophy® 100/3.6 affects you. Do not drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

What are the possible side effects of Xultophy® 100/3.6?Xultophy® 100/3.6 may cause serious side effects that can be life-threatening, including:· inflammation of your pancreas (pancreatitis). Stop using

Xultophy® 100/3.6 and call your health care provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.

Call 1-866-696-4085 or visit Xultophy10036.com for more information.

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· low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Xultophy® 100/3.6 with another medication that can cause low blood sugar. Signs and symptoms of low blood sugar may include: shakiness, irritability, fast heartbeat, dizziness, weakness, sweating, confusion, drowsiness, hunger, headache, and feeling jittery.

· kidney problems (kidney failure). Worsening of kidney failure and sudden kidney failure have happened in people with kidney problems and in people without kidney problems who have taken liraglutide, one of the ingredients in Xultophy® 100/3.6. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse. Tell your health care provider if you have diarrhea, nausea, or vomiting. Drink plenty of fluids to help reduce your risk of dehydration during treatment with Xultophy® 100/3.6.

· serious allergic reactions. Stop using Xultophy® 100/3.6 and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or a fast heartbeat.

· gallbladder problems. Gallbladder problems have happened in some people who take Xultophy® 100/3.6. Tell your health care provider right away if you get symptoms of gallbladder problems including pain in the right or middle upper stomach area, fever, nausea and vomiting, or your skin or the white part of your eyes turn yellow.

· low potassium in your blood (hypokalemia).· heart failure. Taking certain diabetes medicines called TZDs with

Xultophy® 100/3.6 may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems. This can happen even if you have never had heart failure or heart problems. If you already have heart failure, it may get worse while you take TZDs with Xultophy® 100/3.6. Tell your health care provider if you have any new or worse symptoms of heart failure, including shortness of breath, tiredness, swelling of your ankles or feet, and sudden weight gain.

The most common side effects of Xultophy® 100/3.6 may include stuffy or runny nose, sore throat, headache, nausea, diarrhea, increased blood levels of lipase, and upper respiratory tract infection.

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Consider these questions before talking with your health care provider

Q. Is my A1C greater than the American Diabetes Association (ADA) recommended goal of less than 7%?

Q. Is my current diabetes medicine doing enough to get me to my goals?

Q. Am I currently taking more than 1 diabetes medicine?

Q. Has my health care provider talked with me about adding another diabetes medicine?

Q. Do I have health insurance (not Medicare or Medicaid)?

Notes:

Cornerstones4Care®, NovoFine®, NovoTwist®, Tresiba®, Victoza®, and Xultophy® 100/3.6 are registered trademarks of Novo Nordisk A/S. Novo Nordisk is a registered trademark of Novo Nordisk A/S. All other trademarks, registered or unregistered, are the property of their respective owners.© 2019 Novo Nordisk Printed in the U.S.A. US19XUM00058 April 2019

If you need assistance with prescription costs, help may be available. Visit pparx.org or call 1-888-4PPA-NOW.

Xultophy® 100/3.6 is available by prescription only. Talk to your health care provider about your diabetes management plan, including diet and exercise. 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.

Look up your cost and a savings offer at MyXultophy10036Cost.com.

Please see Important Safety Information throughout and enclosed Medication Guide and Prescribing Information, including Boxed Warning.