Xultophy 

What is Xultophy?

• 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 receptor agonist).
• 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.

What is the most important information I should know about Xultophy?

Xultophy 100/3.6 may cause serious side effects, including:

• Possible thyroid tumors, including cancer. Tell your healthcare 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.
• Do not use Xultophy 100/3.6 if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Who should not use Xultophy?

Do not use Xultophy 100/3.6 if:

• you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (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 (hypoglycemia)
• you are allergic to insulin degludec, liraglutide or any of the ingredients in Xultophy 100/3.6. See below for a complete list of ingredients in Xultophy 100/3.6.

What should I tell my healthcare provider before using Xultophy?

Before using Xultophy 100/3.6, tell your healthcare 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 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 receptor agonists.
• have had an allergic reaction to a GLP-1 receptor agonist medicine.
• are pregnant or plan to become pregnant. It is not known if Xultophy 100/3.6 will harm your unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant while using Xultophy 100/3.6.
• are breastfeeding or plan to breastfeed. It is not known if Xultophy 100/3.6 passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using Xultophy 100/3.6.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Xultophy 100/3.6 may affect the way some medicines work, and some medicines may affect the way Xultophy 100/3.6 works.

Before using Xultophy 100/3.6, talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking other medicines to treat diabetes.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use Xultophy?

• Read the Instructions for Use that comes with Xultophy 100/3.6.
• Use Xultophy 100/3.6 exactly as your healthcare provider tells you to.
• Do not change your dosing schedule without first talking to your healthcare provider. The dose counter on your Xultophy 100/3.6 pen shows the number of units of Xultophy 100/3.6 to be injected.
• Your healthcare provider should show you how to use Xultophy 100/3.6 before you use it for the first time.
• Xultophy 100/3.6 is injected under the skin (subcutaneously) of your thigh, upper arm or stomach (abdomen).
• Do not inject Xultophy 100/3.6 into a muscle (intramuscularly) or vein (intravenously) or use in an insulin infusion pump.
• Use Xultophy 100/3.6 at the same time each day with or without food.
• If you miss a dose of Xultophy 100/3.6, resume your 1 time daily dosing schedule at the next scheduled dose. Do not take 2 doses at the same time or increase your dose to make up for the missed dose. If you miss more than 3 days of Xultophy 100/3.6, call your healthcare provider for further instructions about taking Xultophy 100/3.6 at the right dose and to help lower your chance of having an upset stomach.
• Do not dilute Xultophy 100/3.6 with any other liquids.
• Do not mix Xultophy 100/3.6 with any other insulin products or GLP-1 receptor agonists in the same injection.
• Do not split your dose of Xultophy 100/3.6. Give your full dose of Xultophy 100/3.6 in 1 injection.
• Check the Pen label each time you give your injection to make sure you are using the correct medicine.
• Do not take more than 50 units of Xultophy 100/3.6 each day. Xultophy 100/3.6 contains two medicines: insulin degludec and liraglutide. If you take too much Xultophy 100/3.6, it can cause severe nausea and vomiting. Do not take Xultophy 100/3.6 with other GLP-1 receptor agonists. If you take too much Xultophy 100/3.6, call your healthcare provider or go to the nearest hospital emergency room right away.
• Change (rotate) your injection sites within the area you choose with each injection to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
  • Do not use the exact same spot for each injection.
  • Do not inject where the skin has pits, is thickened, or has lumps.
  • Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
• 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 healthcare provider what your blood sugars should be and when you should check your blood sugar levels.

Your dose of Xultophy 100/3.6 and other diabetes medicines 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 because of other medicines you take.

What should I avoid while using Xultophy?

While taking Xultophy 100/3.6 do not:

• drive or operate heavy machinery, until you know how Xultophy 100/3.6 affects you.
• drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

What are the possible side effects of Xultophy?

Xultophy 100/3.6 may cause serious side effects that can lead to death, including:

• See “What is the most important information I should know about Xultophy 100/3.6?”
• inflammation of your pancreas (pancreatitis). Stop using Xultophy 100/3.6 and call your healthcare 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.
• low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Xultophy 100/3.6 with another medicine that can cause low blood sugar.
  
  Signs and symptoms of low blood sugar may include:
  • dizziness or light-headedness
  • sweating
  • confusion or drowsiness
  • headache
  • blurred vision
  • slurred speech
  • shakiness
  • fast heartbeat
  • anxiety, irritability, or mood changes
  • hunger
  • weakness
  • 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 healthcare 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:
  • hives
  • rash
  • itching
  • fast heartbeat
  • fainting or feeling dizzy
  • swelling of your face, lips, tongue, or throat
  • problems breathing or swallowing
  • sudden coughing
  • chest pain or tightness
• gallbladder problems. Gallbladder problems have happened in some people who take liraglutide, an ingredient in Xultophy 100/3.6. Tell your healthcare provider right away if you get symptoms of gallbladder problems which may include:
  • pain in your upper stomach (abdomen)
  • fever
  • yellowing of skin or eyes (jaundice)
  • clay-colored stools
• low potassium in your blood (hypokalemia).
• heart failure. Taking certain diabetes pills called thiazolidinediones or 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 before. If you already have heart failure, it may get worse while you take TZDs with Xultophy 100/3.6. Your healthcare provider should monitor you closely while you are taking TZDs with Xultophy 100/3.6. Tell your healthcare 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. Treatment with TZDs and Xultophy 100/3.6 may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.

The most common side effects of Xultophy 100/3.6 include stuffy or runny nose, sore throat, headache, nausea, diarrhea, increased blood levels of lipase, and upper respiratory tract infection. Talk to your healthcare provider about any side effect that bothers you or does not go away.

These are not all the possible side effects of Xultophy 100/3.6.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Keep Xultophy 100/3.6 and all medicines out of the reach of children.

General information about the safe and effective use of Xultophy

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Xultophy 100/3.6 for a condition for which it was not prescribed. Do not give Xultophy 100/3.6 to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about Xultophy 100/3.6 that is written for health professionals.

How should I store Xultophy?

Before use:

• Store unused Xultophy 100/3.6 pens in the refrigerator at 36°F to 46°F (2°C to 8°C).
• Do not freeze Xultophy 100/3.6. Do not use Xultophy 100/3.6 if it has been frozen.
• Unused pens may be used until the expiration date printed on the label, if kept in the refrigerator.
• If Xultophy 100/3.6 is stored outside of refrigeration prior to first use, it should be used or thrown away within 21 days.
• Store the pens in the carton they come in to keep them clean and protected from light.

Pen in use:

• Store the pen you are currently using at room temperature at 59°F to 86°F (15°C to 30°C) or in a refrigerator at 36°F to 46°F (2°C to 8°C).
• Do not freeze Xultophy 100/3.6. Do not use Xultophy 100/3.6 if it has been frozen.
• Keep Xultophy 100/3.6 away from heat and light.
• The Xultophy 100/3.6 pen you are using should be thrown away after 21 days, even if it still has Xultophy 100/3.6 left in it and the expiration date has not passed.

What are the ingredients in Xultophy?

Active Ingredients: insulin degludec and liraglutide

Inactive Ingredients: glycerol, phenol, zinc, and water for injection. Hydrochloric acid or sodium hydroxide may be added to adjust pH.

For more information, go to www.novonordisk-us.com or call 1-800-727-6500.

Instructions for use for Xultophy

Xultophy 100/3.6 (ZUL-to-fye)
(insulin degludec and liraglutide) injection

• Do not share your Xultophy 100/3.6 pen with another person. You may give an infection to them or get an infection from them.
• Xultophy 100/3.6 pen (“pen”) is a prefilled disposable, single-patient-use pen containing 300 units of insulin degludec and 10.8 mg of liraglutide (insulin degludec and liraglutide) injection. You can inject doses from 10 to 50 units in a single injection (with each unit of insulin degludec, the pen also delivers 0.036 mg of liraglutide). The dose can be increased by 1 unit at a time. The dose equals the number of units shown in the dose counter.
• People who are blind or have vision problems should not use the pen without help from a person trained to use the pen.

Supplies you will need to give your Xultophy 100/3.6 injection:

• Xultophy 100/3.6 pen
• a new NovoFine or NovoTwist needle
• alcohol swab
• a sharps container for throwing away used pens and needles. See “After your injection” at the end of these instructions.

Preparing your Xultophy 100/3.6 pen:

• Wash your hands with soap and water.
• Before you start to prepare your injection, check the Xultophy 100/3.6 pen label before each use to make sure it is your Xultophy 100/3.6 pen.
• Xultophy 100/3.6 should look clear and colorless. Do not use Xultophy 100/3.6 if it is cloudy or colored.
• Do not use Xultophy 100/3.6 past the expiration date printed on the label or 21 days after you start using the pen.
• Always use a new needle for each injection to help ensure sterility and prevent blocked needles. Do not reuse or share needles with another person. You may give other people a serious infection or get a serious infection from them.

NovoFine

NovoTwist

Step 1:

• Pull pen cap straight off (See Figure B).

Step 2:

• Check the liquid in the pen (See Figure C). Xultophy 100/3.6 should look clear and colorless. Do not use it if it looks cloudy or colored.

Step 3:

• Select a new needle.
• Pull off the paper tab from the outer needle cap (See Figure D).

Step 4:

• Push the capped needle straight onto the pen and twist the needle on until it is tight (See Figure E).

Step 5:

• Pull off the outer needle cap. Do not throw it away (See Figure F).

Step 6:

• Pull off the inner needle cap and throw it away (See Figure G).

Priming your Xultophy 100/3.6 pen:

Step 7:

• Turn the dose selector to select the priming symbol ( ). (See Figure H).

Step 8:

• Hold the pen with the needle pointing up. Tap the top of the pen gently a few times to let any air bubbles rise to the top (See Figure I).

Step 9:

• Hold the pen with the needle pointing up. Press and hold in the dose button until the dose counter shows “0”. The “0” must line up with the dose pointer.
• A drop of Xultophy 100/3.6 should be seen at the needle tip (See Figure J).
  • If you do not see a drop of Xultophy 100/3.6, repeat steps 7 to 9, no more than 6 times, until a drop of Xultophy 100/3.6 appears at the needle tip.
  • If you still do not see a drop of Xultophy 100/3.6, change the needle and repeat steps 7 to 9.

Selecting your dose: Make sure you prime your pen before setting your dose.

Step 10:

Xultophy 100/3.6 pen is made to deliver the number of units that your healthcare provider prescribed.

Take your dose exactly as your healthcare provider tells you to. Do not change your dosing schedule without first talking to your healthcare provider.

• Turn the dose selector to select the dose you need to inject. The dose pointer should line up with your dose (See Figure K).
  • If you select the wrong dose, you can turn the dose selector forwards or backwards to the correct dose.
  • The even numbers are printed on the dial.
  • The odd numbers are shown as lines.

• The Xultophy 100/3.6 pen scale will show you how much Xultophy 100/3.6 is left in your pen (See

• To see how much Xultophy 100/3.6 is left in your pen:
  • Turn the dose selector until it stops. The dose counter will line up with the dose that is left in your pen. If the dose counter shows 50, there is a dose of at least 50 units left in your pen.
  • If the dose counter shows between 10 and 50, the number shown in the dose counter is the total units left in your pen.
  • If there is not enough Xultophy 100/3.6 left in your pen for a full dose, do not use it. Use a new Xultophy 100/3.6 pen.

Giving your injection:

• Inject your Xultophy 100/3.6 exactly as your healthcare provider has shown you. Your healthcare provider should tell you if you need to pinch the skin before injecting.
• Xultophy 100/3.6 can be injected under the skin (subcutaneously) of your stomach area (abdomen), upper legs (thighs) or upper arms.
• Change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. Do not use the same injection site for each injection. Do not inject where the skin has pits, is thickened, or has lumps. Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.

Step 11:

• Choose your injection site (stomach, upper legs or upper arms) and wipe the skin with an alcohol swab (See Figure M). Let the injection site dry before you inject your dose.

Step 12:

• Insert the needle into your skin (See Figure N).
  • Make sure you can see the dose counter. Do not cover it with your fingers, this can stop your injection.

Step 13:

• Press and hold down the dose button until the dose counter shows “0” (See Figure O).
  • The “0” must line up with the dose pointer. You may hear or feel a click.

Step 14:

• Keep the needle in your skin after the dose counter has returned to “0” and slowly count to 6 (See Figure P).
  • When the dose counter returns to “0”, you will not get your full dose until 6 seconds later.
  • If the needle is removed before you count to 6, you may see a stream of Xultophy 100/3.6 coming from the needle tip.
  • If you see a stream of Xultophy 100/3.6 coming from the needle tip you will not get your full dose. If this happens you should check your blood sugar levels more often because you may need more Xultophy 100/3.6.

Step 15:

• Pull the needle out of your skin (See Figure Q).
  • If you see blood after you take the needle out of your skin, press the injection site lightly with a piece of gauze or an alcohol swab. Do not rub the area.

Step 16:

• Carefully remove the needle from the pen after each use and throw it away (See Figure R).
  • Do not recap the needle. Recapping the needle can lead to needle stick injury.

Note: If you do not have a sharps container, follow the steps below:

• Carefully slip the needle into the outer needle cap (See Figure S). Safely remove the needle and throw it away as soon as you can.
• Do not store the pen with the needle attached. Storing without the needle attached helps prevent leaking, blocking of the needle, and air from entering the pen.

Step 17:

• Replace the pen cap by pushing it straight on (See Figure T).

After your injection:

• The used Xultophy pen may be thrown away in your household trash after you have removed the needle.
• Put your used needles in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles in your household trash.
• If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
  • made of a heavy-duty plastic
  • can be closed with a tight-fitting, puncture resistant lid, without sharps being able to come out
  • upright and stable during use
  • leak-resistant
  • properly labeled to warn of hazardous waste inside the container
• When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about the safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal.
• Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

How should I store my Xultophy 100/3.6 pen?

Before use:

• Store unused Xultophy 100/3.6 pens in the refrigerator at 36°F to 46°F (2°C to 8°C).
• Do not freeze Xultophy 100/3.6. Do not use Xultophy 100/3.6 if it has been frozen.
• Unused pens may be used until the expiration date printed on the label, if kept in the refrigerator.
• If Xultophy 100/3.6 is stored outside of refrigeration prior to first use, it should be used or thrown away within 21 days.
• Store the pens in the carton they come in to keep them clean and protected from light.

Pen in use:

• Store the pen you are currently using at room temperature at 59°F to 86°F (15°C to 30°C) or in a refrigerator at 36°F to 46°F (2°C to 8°C).
• Do not freeze Xultophy 100/3.6. Do not use Xultophy 100/3.6 if it has been frozen.
• Keep Xultophy 100/3.6 away from heat and light.
• The Xultophy 100/3.6 pen you are using should be thrown away after 21 days, even if it still has Xultophy 100/3.6 left in it and the expiration date has not passed.

General Information about the safe and effective use of Xultophy 100/3.6.

• Keep Xultophy 100/3.6 pens and needles out of the reach of children.
• Always use a new needle for each injection.

Instructions for use revised 06/2022.