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The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 04668/0414.
Xultophy 100 units/mL + 3.6 mg/mL solution for injection
Xultophy® 100 units/mL + 3.6 mg/mL
solution for injection
insulin degludec + liraglutide
1. What Xultophy® is and what it is used for
2. What you need to know before you use Xultophy®
3. How to use Xultophy®
4. Possible side effects
5. How to store Xultophy®
6. Contents of the pack and other information
Xultophy® is used to improve blood glucose (sugar) levels in adult patients with type 2 diabetes mellitus. You have diabetes because your body:
Xultophy® contains two active substances that help your body control your blood sugar:
Xultophy® is used with oral medicines for diabetes (such as metformin, pioglitazone and sulfonylurea medicines). It is prescribed when these medicines (used alone or with GLP-1 treatment or with basal insulin) are not enough to control your blood sugar levels.
You should stop your GLP-1 treatment prior to starting on Xultophy®.
You should stop your insulin treatment prior to starting on Xultophy®.
Talk to your doctor, pharmacist or nurse before using Xultophy®.
If you know that you are due to have surgery where you will be under anaesthesia (sleeping), please tell your doctor that you are taking Xultophy®.
Be especially aware of the following when using Xultophy®:
Tell your doctor if you:
The injection site should be rotated to help prevent changes to the fatty tissue under the skin, such as skin thickening, skin shrinking or lumps under the skin. The insulin may not work very well if you inject into a lumpy, shrunken or thickened area (see section 3 ‘How to use Xultophy®’). Tell your doctor if you notice any skin changes at the injection site. Tell your doctor if you are currently injecting into these affected areas before you start injecting in a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.
Do not give this medicine to children or adolescents. There is no experience with Xultophy® in children and adolescents under 18 years old.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. Some medicines affect your blood sugar level – this may mean your Xultophy® dose has to change.
Listed below are the most common medicines, which may affect your Xultophy® treatment.
Your blood sugar level may fall if you take:
Your blood sugar level may rise if you take:
Octreotide and lanreotide – used for treatment of acromegaly (a rare illness with too much growth hormone). They may increase or decrease your blood sugar level.
Pioglitazone – tablets used for the treatment of type 2 diabetes mellitus. Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke, who were treated with pioglitazone and insulin, experienced the development of heart failure. Inform your doctor straight away if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).
Warfarin or other blood thinners – medicines used to prevent clotting of the blood. Tell your doctor if you are taking warfarin or other blood thinners as you might need to have blood tests more often to measure how thick your blood is (called ‘International Normalised Ratio’ or INR test).
If you drink alcohol, your need for Xultophy® may change. Your blood sugar level may either rise or fall. You should therefore monitor your blood sugar level more often than usual.
Do not use Xultophy® if you are pregnant or plan to become pregnant. Tell your doctor if you are pregnant, think you might be pregnant or are planning to have a baby. It is not known if Xultophy® affects the baby.
Do not use Xultophy® if you are breast-feeding. It is not known if Xultophy® passes into breast milk.
Having low or high blood sugar can affect your ability to drive or use any tools or machines. If your blood sugar is low or high, your ability to concentrate or react might be affected. This could be dangerous to yourself or others. Ask your doctor whether you can drive if:
Xultophy® contains less than 1 mmol sodium (23 mg) per dose. This means that the medicine is essentially ‘sodium-free’.
Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.
If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help. Get help from a person with good eyesight who is trained to use the Xultophy® pre-filled pen.
Your dose of Xultophy® is administered as ‘dose steps’. The dose counter on the pen shows the number of dose steps.
Xultophy® is a pre-filled dial-a-dose pen.
Carefully read the ‘Instructions on how to use’ on the other side of this leaflet and use the pen as described.
Always check the pen label before you inject your medicine to ensure that you use the correct pen.
Before you use Xultophy® for the first time, your doctor or nurse will show you how to inject.
Detailed instructions for use are on the other side of this leaflet.
Xultophy® can be used in elderly patients but if you are elderly you may need to check your blood sugar level more often. Talk to your doctor about changes in your dose.
If you have kidney or liver problems, you may need to check your blood sugar level more often. Talk to your doctor about changes in your dose.
If you use more Xultophy® than you should, your blood sugar may get low (hypoglycaemia) or you may feel or be sick (nausea or vomiting). If your blood sugar gets low, see the advice in section 4 ‘Low blood sugar (hypoglycaemia)’.
If you forget a dose, inject the missed dose when discovering the mistake, ensuring a minimum of 8 hours between doses. If you discover that you missed your previous dose when it is time to take your next regular scheduled dose, do not take a double dose.
Do not stop using Xultophy® without talking to your doctor. If you stop using Xultophy® this could lead to a very high blood sugar level, see the advice in section 4 ‘High blood sugar (hyperglycaemia)’.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following serious side effects may happen with this medicine:
If you inject insulin at the same place, the fatty tissue may shrink (lipoatrophy) or thicken (lipohypertrophy) (may affect up to 1 in 100 people). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis; how often this occurs is not known). The insulin may not work very well if you inject into a lumpy, shrunken or thickened area. Change the injection site with each injection to help prevent these skin changes.
Other side effects include:
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Not known (frequency cannot be estimated from the available data)
Low blood sugar may happen if you:
Warning signs of low blood sugar – these may come on suddenly
Headache, slurred speech, fast heartbeat, cold sweat, cool pale skin, feeling sick (nausea), feeling very hungry, shaking, feeling nervous or worried, unusually tired, weak and sleepy or confused, difficulty concentrating, short-lasting changes in your sight.
What to do if you get low blood sugar:
What others need to do if you pass out:
Tell everyone you spend time with that you have diabetes. Tell them what could happen if your blood sugar gets low, including the risk of passing out.
Let them know that if you pass out, they must:
You may recover more quickly from passing out if you receive glucagon. This can only be given by someone who knows how to use it.
Talk to your doctor if:
This is because the dosing of your Xultophy® injections, food or exercise may need to be changed.
High blood sugar may happen if you:
Warning signs of high blood sugar – these normally appear gradually
Flushed, dry skin, feeling sleepy or tired, dry mouth, fruity (acetone) breath, urinating more often, feeling thirsty, losing your appetite, feeling or being sick (nausea or vomiting).
These may be signs of a very serious condition called ‘ketoacidosis’. This is a build-up of acid in the blood because the body is breaking down fat instead of sugar. If not treated, this could lead to diabetic coma and eventually death.
What to do if you get high blood sugar:
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:
Great Britain
or search for MHRA Yellow Card in the Google Play or Apple App Store
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pen label and carton after ‘EXP’. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C - 8 °C). Keep away from the freezing element. Do not freeze.
Do not freeze. You can carry Xultophy® with you and keep it at room temperature (no more than 30 °C) or in a refrigerator (2 °C - 8 °C) for up to 21 days. The product should be thrown away 21 days after first opening.
Always keep the cap on the pre-filled pen when you are not using it in order to protect it from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Xultophy® is a clear and colourless solution.
Pack sizes of 1, 3, 5 and a multipack containing 10 (2 packs of 5) pens of 3 mL. Not all pack sizes may be marketed.
Now turn over for information on how to use your pre-filled pen.
This leaflet was last revised in 09/2024
Xultophy®, NovoTwist® and NovoFine® are trademarks owned by Novo Nordisk A/S, Denmark.
© 2024
Novo Nordisk A/S
Please read these instructions carefully before using your Xultophy® pre-filled pen.
Do not use the pen without proper training from your doctor or nurse.
Start by checking your pen to make sure that it contains Xultophy® 100 units/mL + 3.6 mg/mL.
Different parts of your pen include:
Pen cap
Pen window
Pen label
pen scale
Dose counter
Dose pointer
Dose Selector
Dose Button
Dose Button with smooth surface
Different parts of your needle include:
Outer needle cap
Inner needle cap
Needle
Paper tab
If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help. Get help from a person with good eyesight who is trained to use the Xultophy® pre-filled pen.
Xultophy® is a medicine that contains insulin degludec and liraglutide. Xultophy® is administered as ‘dose steps’. One dose step contains 1 unit insulin degludec + 0.036 mg liraglutide.
Your pen is a pre-filled dial-a-dose pen. It contains 3 mL of Xultophy® solution. It delivers doses from:
Your pen delivers doses in increments of 1 dose step.
Do not do any conversion of your dose. The dose steps dialled equal the number shown in the dose counter.
Your pen is designed to be used with NovoTwist® or NovoFine® disposable needles up to a length of 8 mm and as thin as 32G. Needles are not included in the pack.
Important information
Pay special attention to these notes as they are important for safe use of the pen.
Always use a new needle for each injection.
This may prevent blocked needles, contamination, infection and inaccurate dosing.
Never use a bent or damaged needle.
Always make sure that a drop appears at the needle tip before you inject. This makes sure that the solution flows.
If no drop appears, you will not inject any medicine, even though the dose counter may move. This may indicate a blocked or damaged needle.
It is important always to check the flow before you inject. If you do not check the flow, you may get too little medicine, or no medicine at all. This may lead to high blood sugar level.
Always use the dose counter and the dose pointer to see how many dose steps you have selected before injecting the medicine.
Do not count the pen clicks. If you select and inject the wrong dose, your blood sugar level may get high or low.
Do not use the pen scale, it only shows approximately how much solution is left in your pen.
How much solution is left?
Be very careful to calculate correctly if splitting your dose.
If in doubt, take the full dose with a new pen. If you split the dose wrongly, you will inject too little or too much medicine. This may make your blood sugar level high or low.
Always watch the dose counter to know how many dose steps you inject. Hold the dose button down until the dose counter shows 0. If the dose counter does not return to 0, the full dose has not been delivered, which may lead to high blood sugar level.
How to identify a blocked or damaged needle?
How to handle a blocked needle?
Change the needle as described in section 5 and repeat all steps starting with section 1: Prepare your pen with a new needle. Make sure you select the full dose you need.
Never touch the dose counter when you inject. This can interrupt the injection.
Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.
Always remove the needle from your pen after each injection.
This may prevent blocked needles, contamination, infection, leakage of solution and inaccurate dosing.
Further important information
Caring for your pen