100 units/ml + 3.6 mg/ml solution
for injection
insulin degludec + liraglutide
What Xultophy is and what it is used for
What Xultophy is used for
Xultophy is used to improve blood glucose (sugar) levels in adult patients with type 2 diabetes mellitus. You have diabetes because your body:
• not producing enough insulin to control blood sugar or
• cannot use insulin properly.
How Xultophy works
Xultophy contains two active substances that help your body control blood sugar:
• Insulin degludec – a long-acting basal insulin that lowers blood sugar levels.
• Liraglutide – a “GLP-1 analog” that helps the body produce more insulin with meals and that lowers the amount of sugar produced in the body.
Xultophy and diabetes medicines in tablet form
Xultophy is used with medicines against diabetes in tablet form (eg metformin, pioglitazone, and sulphonamides). It is prescribed when treatment with these drugs (used alone or in combination with GLP-1 therapy or basal insulin) is not sufficient to control blood sugar levels.
If you are treated with GLP-1
You should stop your GLP-1 treatment before starting Xultophy.
If you use insulin
You must stop your insulin treatment before starting Xultophy.
What you need to know before using Xultophy
Do not use Xultophy
• if you are allergic to insulin degludec, liraglutide, or any of the other ingredients of this medicine (listed in section 6).
Warningsanalogutions
Talk to your doctor, pharmacist, or nurse before using Xultophy.
• If you also take a sulphonylurea (eg glimepiride or glibenclamide), your doctor may reduce your dose of the sulphonylurea depending on your blood sugar level.
• o not use Xult,ophy if you have type 1 diabetes or if you have so-called ketoacidosis (a condition where acid builds up in the blood).
• Use of Xultophy is not recommended in patients with inflammatory bowel disease or slow gastric emptying (diabetes-related gastroparesis).
Pay particular attention to the following when using Xultophy:
• Low blood sugar (hypoglycemia) – if your blood sugar is low, follow the advice in section 4 “Low blood sugar (hypoglycemia)”.
• High blood sugar ( hyper gel, ycaemia ) – if your blood sugar is high, follow the advice in section 4 “High blood sugar (hyperglycemia)”.
• Make sure you are, e using the right medicine – Always check the pen label before each injection to avoid mixing up Xultophy with other preparations.
Important information before using this medicine:
Tell your doctor if you:
• have problems with the eyes. A rapid improvement in blood sugar control may cause diabetes-related eye problems to temporarily worsen. In the long term, the improvement in blood sugar control can alleviate eye problems.
• have or have had thyroid disease.
Important information while you are using this medicine:
• If you have severe pain inhypoglycemiathe pain does not go away, you should tell your doctor – this may be a sign of hypoglycemia pancreas ( acute pancreatitis ).
• Dehydration (loss of fluid from the body) can occur if you feel sick, vomit, or havhyperglycemiathen important to drink a lot to restore the body’s fluid balance.
Skin changes at the injection site
To help prevent changes in the fatty tissue under the skin, e.g. skin thickening, skin shrinkage, or nodules under the skin, you should constantly change the injection site. The insulin it may not work as well if you inject into an area with nodules or a thickened or shriveled area (see “How to use Xultophy”). Contact the doctor iu notice skin changes at the injection site and before changing the injection site if you are currently injecting in an affected area. The doctor may advise you to check your blood sugar more often and to adjust your insulin dose or the dose of other diabetes medicines.
Children and young people
Do not give this medicine to children or adolescents. There is no, experiendiarrheaatment with Xultophy in children and adolescents under 18 years of age.
Other medicines and Xultophy
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other media, cines. Some medicines affect your blood sugar level and this may mean that your dose of Xititittophy needs to be changed.
Below is a list of the most common medicines that can affect your treatment with Xultophy.
Your blood sugar level may drop if you take:
• other medicines against diabetes (tablets or as an injection )
• sulfonamides – against infection
• anabolic steroids — eg testosterone
• beta-blockers – against high blood pressure. They can make it harder to recognize the warning signs of low blood sugar (see section 4, Warning signs of low blood sugar – these can come suddenly)
• acetylsalicylic acid (and medicines called salicylates) – for pain and mild fever
• MAO inhibitors – against depression
• ACE inhibitors – against certain h,h, heart problems or high blood pressure.
Your blog, d sugar level may increase if you take the:
• danazol – a drug that affects ovulation
• oral contraceptives ( birth control pills ) – for birth control
• thyroid hormones – against thyroid disease
• growth hormone – against low levels of growth hormone
• medicines called glucocorticoids, eg cortisone – against inflammation
• medicines called sympathomimetics, eg adrenaline, salbutamol, or terbutaline – for asthma
• diuretics called thiazides – for high blood pressure or if your body retains too much fluid (fluid retention).
Octreotide and lanreotide – are used to treat acromegaly (a rare disease with overproduction of growth hormone ). These can raise or lower your blood sugar level.
Pioglitazone – tablets for the treatment of diabetes mellitus type 2. Some patients who had type 2 diabetes and heart disease for many years or had a previous stroke developed heart failure when treated with pioglitazone and insulin. Inform your doctor immediately if you develop signs of heart failure such as unexpected shortness of breath, rapid weight gain, or local swelling (edema).
Warfarin and other blood thinners – medicines used to prevent the blood from clotting. Tell your doctor you are taking warfarin o, r other blood thinners as you may need more frequent blood tests to measure how thick your blood is (called an INR test).
Xultophy and alcohol
Your need for Xultophy may are change if you drink alcohol. The blood sugar level can either be raised or lowered. You should therefore check your blood sugar level more often than usual.
Pregnancy and breastfeeding
You should not use Xultophy if you are pregnant or planning to become pregnant. Tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby. It is not known whether Xultophy affects the baby.
You should not use Xultophy if you are breastfeeding. It is not known whether X, trophy passes into deedema.
Driving ability and use of machinery
Low or high blood sugar can affect your ability to drive or use tools or machines. Low or high blood sugar can affect your ability to concentrate and react. This can be dangerous to yourself and others. Ask your doctor if you should drive:
• if you often get low blood sugar
• if you find it difficult to recognize signs of low blood sugar.
Important information about some content topics in Xultophy
Xultophy contains less than 1 mmol sodium (23 mg) per dose. This means that Xultophy is almost ‘sodium-free’.
How to use Xultophy
Always use this medicine as directed by your doctor. C,c, consult a doctor, pharmacist, or nurse if you are unsure.
If you are blind or visually impaired and cannot read the dose of counbreastfeeding you should not use the injection pen without assistance. Get the help of someone who has good vision and knows how to use the Xultophy pre-filled pen.
Your doctor will tell you:
• how much Xultophy you need each day
• when you need to check your blood sugar level
• how to adjust dose one.
Does one of Xultophy is administered in “dose increments”. The dose counter on the injection pen shows the number of dose steps.
Dosing time
• Use Xultophy once a day, preferably at the same time each day. Choose the time of day that suits you best.
• If you can use Xultophy at the same time every day, you can change the time you use Xultophy. Make sure there are at least 8 hours between doses.
• Xultophy must not be,,, taken with a meal.
• Always follow the doctor’s instructions regarding dose and dose adjustment.
• If you want to change your dietary habits, you should first consult a doctor, pharmacist, or nurse, as changing dietary habits may change your need for Xultophy.
How Xultophy should be handled
Xultophy is a pre-filled pen with a dose selector.
• Xultophy is administered in “dose steps”. The dose counteDoess the injection pen show the number of dose steps?
• One dose step contains 1 unit of insulin degludec and 0.036 mg of liraglutide.
• Maximum daily dose of Xultophy is 50 dose steps (50 units of insulin degludec and 1.8 mg liraglutide).
Carefully read the instructions for use for Xultophy on the other side of this leaflet and use the injection pen as directed.
Always check the label on the pen before injecting the medicine to make sure you are using the correct pen.
How to inject
Before you use Xultophy for the first time, your doctor or nurse will show you how to inject.
• Xultophy is given as an injection under the skin ( subcutaneously ). It must not be injected into a vein or muscle.
• The best places to inject are the front of the thighs, the upper arms, or the front of the waist (abdomen).
• Change the injection site within the area where you inject each day to reduce the risk of nodules or pits forming in the skin (see section 4).
• Always use a new injection needle for each injection. Reusing needles can increase the risk of clogged needles and lead to incorrect dosing. Dispose of the needle safely after each use.
• To avoid incorrect dosages and possible overdose, do not use a syringe to withdraw the solution from the pen.
Detailed instructions for use can be found on the other side of this leaflet.
Do not use Xultophy:
• If the injection pen has been damaged or has not been stored correctly (see section 5).
• If the liquid you can see through the pen window is not clear and colorless.
Use in elderly patients (65 years or older)
Xultophy can be used in elderly patients, but you may need to check your blood sugar level more often if you are elderly. Talk to your doctor about changes to your dose.
If you have problems with your kidneys or liver
If you have problems with your kidneys or liver, you may need to check your blood sugar level more often. Talk to your doctor about changes to your dose.
If you use too much Xultophy
If you have used too much Xultophy, your blood sugar may become low (hypoglycemia) or you may feel sick and vomit. If your blood sugar becomes low, you must follow the advice in section 4 “Low blood sugar (hypoglycemia)”.
If you forget to use Xultophy
If you forget a dose, inject the missed dose once you realize the mistake, but make sure there are at least 8 hours between doses. If you find that you have missed the previous dose, when it is time to take the next scheduled dose, do not take a double dose.
If you stop using Xultophy
Do not stop using Xultophy without first talking to your doctor. If you stop using Xultophy, it can lead to very high blood sugar. Follow the advice in section 4 “High blood sugar (hyperglycemia)”.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following serious side effects may occur with this medicine:
• Low blood sugar (very common: may affect more than 1 in 10 people).
If your blood sugar level becomes low, you may pass out. Severe hypoglycemia can cause brain damage and be life-threatening. If you have signs of low blood sugar (insulin sensitivity), you should immediately ensure that the blood sugar level is raised. Follow the advice in “Low blood sugar ( hypoglycemia )” further down in this section.
• Severe allergic reaction ( anaphylactic reaction ) (frequency not known: frequency cannot be estimated from available data).
If you have a serious allergic reaction to any of the ingredients in Xultophy, you should stop using Xultophy and see a doctor immediately. The signs of a serious allergic reaction are that:
• local reactions spread to other parts of the body
• you suddenly feel sick and sweat
• you have difficulty breathing
• you have palpitations or feel dizzy.
Skin changes at the injection site
If you inject insulin in the same place, the fat tissue may either shrink (lipoatrophy) or thicken (lipohypertrophy) (may affect up to 1 in 100 people). Nodules under the skin can also be caused by the accumulation of a protein called amyloid ( cutaneous amyloidosis. How often this occurs is not known). Insulin it may not work as well if you inject it into an area with nodules or a thickened or shriveled area. Change the injection site for each injection to prevent these skin changes.
Other side effects include:
Common (may affect up to 1 in 10 users)
• Decreased appetite, nausea and vomiting, diarrhea, constipation, indigestion ( dyspepsia ), gastritis ( gastritis ), stomach pain, heartburn, and bloating. These are usually transient and disappear after a few days or weeks.
• Injection site reactions. The signs can include bruising, bleeding, pain, redness, hives, swelling, or itching. These usually go away after a few days. See your doctor if they don’t go away after a few weeks. Stop using Xultophy and see a doctor immediately if the reactions become severe.
• Increase in pancreatic enzymes, such as lipase and amylase.
Uncommon (may affect up to 1 in 100 users)
• Hives (red bumps on the skin that sometimes itch).
• Allergic reactions (hypersensitivity), e.g. rash, itching, and swelling of the face.
• Dehydration (fluid loss from the body) – it is important to drink a lot to restore the body’s fluid balance.
• Belching and gas in the stomach ( flatulence ).
• Rash.
• Itching.
• Increased heart rate.
• Gallstones.
• Inflamed gallbladder.
Frequency not known (frequency cannot be calculated from available data)
• Inflammation of the pancreas ( pancreatitis ).
• Swelling of the arms or legs (peripheral edema) – When you start treatment, more fluid than normal may accumulate in the body. This causes swelling around the ankles and other joints. Most of the time it is short-lived.
General complications of diabetes treatment
Low blood sugar ( hypoglycemia )
You may have low blood sugar if you:
• drinks alcohol
• exercise more than usual
• eats too little or skips meals
• using too much Xultophy.
Low blood sugar warning signs – these can come on suddenly
Headache, slurred speech, palpitations, cold sweats, cool and pale skin, nausea, strong hunger, tremors, nervousness or anxiety, unusual tiredness, weakness and drowsiness or confusion, difficulty concentrating, and short-term vision changes.
Here’s what to do if you get low blood sugar:
• Eat dextrose tablets or any other snack that contains a lot of sugar – such as candy, cookies, or fruit juice. (Always carry dextrose tablets or high-sugar snacks with you just in case.)
• If possible, check your blood sugar and rest. You may need to check your blood sugar more than once, as the improvement in your blood sugar level does not always happen all at once.
• When the symptoms of low blood sugar have disappeared or when your blood sugar level has stabilized, you should continue with the treatment as usual.
What others should do if you lose consciousness:
Tell everyone you associate with that you have diabetes. Tell them what can happen if your blood sugar gets low, for example, you may lose consciousness.
Tell them that if they lose consciousness, they must do the following:
• turn on your side
• get medical attention immediately
• do not give yourself anything to eat or drink as you may suffocate.
You may regain consciousness more quickly if you receive an injection of glucagon. Such an injection should only be given by a person who knows how to use it.
• If you are given glucagon, you will need sugar or a snack containing sugar as soon as you regain consciousness.
• If you do not respond to the glucagon injection, you must be treated in the hospital.
• If severe low blood sugar is not treated, it can eventually cause brain damage. These can be short or long-term. Low blood sugar can even cause death.
Talk to your doctor about:
• you have had blood sugar so low that you have lost consciousness
• you have received an injection of glucagon
• you have had low blood sugar several times recently.
Dose on your Xultophy injection, your meals or exercise habits may need to be changed.
High blood sugar ( hyperglycemia )
You can get high blood sugar if you:
• drinks alcohol
• exercise less than usual
• eats more than usual
• get an infection or fever
• have not used enough Xultophy, regularly use fewer Xultophy than you need, forget to use Xultophy, or stop using Xultophy without first talking to your doctor.
Warning signals for high blood sugar – these usually occur gradually
Reddened dry skin; drowsiness or tiredness; dry mouth, fruity (acetone-like) breath; frequent urination, thirst; loss of appetite, nausea, or vomiting.
These signs may indicate a very serious condition called ketoacidosis. It means an accumulation of acid in the blood because the body breaks down fat instead of sugar. If left untreated, it can lead to diabetic coma and eventually death.
Here’s what to do if you get high blood sugar:
• Test your blood sugar level.
• Do a blood or urine ketone test.
• Seek medical attention immediately.
How to store Xultophy
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the pen label and carton after “EXP”. The expiration date is the last day of the specified month.
Before first use
Store in a refrigerator (2°C to 8°C). Do not place it near the cooling element. Do not freeze.
During use
Do not freeze. You can take Xultophy with you and store it at room temperature (up to 30°C) or in a refrigerator (2°C to 8°C) for up to 21 days. Discarded 21 days after opening.
To protect the pre-filled pen from light, always put the pen cap on when not in use.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substances are insulin degludec and liraglutide. Each ml of solution contains 100 units of insulin degludec and 3.6 mg of liraglutide. Each unused pre-filled pen (3 ml) contains 300 units of insulin degludec and 10.8 mg of liraglutide.
- Other ingredients are glycerol, phenol, zinc acetate, hydrochloric acid and sodium hydroxide (for pH adjustment), and water for injections. See also section 2 “Important information about some of the ingredients of Xultophy” for information on sodium.
Appearance and package sizes of the medicine
Xultophy is a clear and colorless solution.
Pack sizes: 1, 3, and 5 as well as multipacks of 10 (2 packs x 5) pre-filled pens of 3 ml. Not all pack sizes may be marketed.
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd, Denmark