Insulin degludec

What it is used for

XULTOPHY 100/3.6 is a combination of insulin degludec and liraglutide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: XULTOPHY 100/3.6 contains liraglutide. Coadministration with any other product containing liraglutide or another glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended.

XULTOPHY 100/3.6 is not recommended for the treatment of diabetic ketoacidosis. XULTOPHY 100/3.6 has not been studied in combination with prandial insulin. XULTOPHY 100/3.6 is a combination of insulin degludec, a long-acting human insulin analog, and liraglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use: Coadministration with any other product containing liraglutide or another GLP-1 receptor agonist is not recommended. Not recommended for the treatment of diabetic ketoacidosis. Has not been studied in combination with prandial insulin.

Storing it

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.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured by:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, New Jersey 08536

U.S. License Number 1261

For more information call Novo Nordisk at 1-800-727-6500

Revised: 06/2022

© 2016 – 2022 Novo Nordisk

More about this medicine

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: 11/2024

Instructions for Use

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.

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).

• o 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.
• o 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).

• o If you select the wrong dose, you can turn the dose selector forwards or backwards to the correct dose.
• o The even numbers are printed on the dial.
• o 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 Figure L).

• To see how much XULTOPHY 100/3.6 is left in your pen:

• o 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.
• o 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).

• o 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).

• 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).

• o When the dose counter returns to “0”, you will not get your full dose until 6 seconds later.
• o 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.
• o 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).

• o 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).

• o 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:

• o 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.
• o 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:

• o made of a heavy-duty plastic
• o can be closed with a tight-fitting, puncture resistant lid, without sharps being able to come out
• o upright and stable during use
• o leak-resistant
• o 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.