Patient Information Leaflet

Xultophy 100 units/mL + 3.6 mg/mL solution for injection

insulin degludec + liraglutide
Please read this leaflet carefully before using this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Xultophy is and what it is used for
What you need to know before using Xultophy
How to use Xultophy
Possible side effects
How to store Xultophy
Contents of the pack and other information

1. 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:

does not produce enough insulin to control blood sugar levels, or
is unable to 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 analogue that helps your body produce more insulin after meals and reduces the amount of sugar produced by your body.

Xultophy and oral diabetes medicines
Xultophy is used in combination with oral diabetes medicines (such as metformin, pioglitazone, and sulfonylureas). It is prescribed when these medicines (used alone or together with a GLP-1 or basal insulin) are not sufficient to control blood sugar levels.
If you are using a GLP-1 medicine
You must stop treatment with GLP-1 before starting Xultophy.
If you are using insulin
You must stop treatment with insulin before starting Xultophy.

2. What you need to know before using Xultophy

Do not use Xultophy

if you are allergic to insulin degludec or liraglutide or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Xultophy.

If you are also taking a sulfonylurea (such as glimepiride or glibenclamide), your doctor may advise you to reduce the dose of the sulfonylurea depending on your blood sugar levels.
Do not use Xultophy if you have type 1 diabetes or ‘ketoacidosis’ (a condition characterized by a build-up of acid in the blood).
The use of Xultophy is not recommended in patients with inflammatory bowel disease or delayed stomach emptying (diabetic gastroparesis).
Make sure you are using the correct medicine – Always check the label before each injection to avoid accidental confusion between Xultophy and other medicines.
If you are scheduled for surgery under anesthesia, inform your doctor that you are taking Xultophy.

Pay special attention to the following conditions when using Xultophy:

low blood sugar level (hypoglycemia). If your blood sugar level is low, follow the instructions in section 4, ‘Low blood sugar level (hypoglycemia)’.
high blood sugar level (hyperglycemia). If your blood sugar level is high, follow the instructions in section 4, ‘High blood sugar level (hyperglycemia)’.

Important information to know before using this medicine:
Inform your doctor if:

you have eye problems. Rapid improvement in blood glucose control may temporarily worsen eye problems in people with diabetes. Long-term improvement in blood glucose control may help reduce eye complications.
you have or have had a thyroid disease.

Important information to know during the use of this medicine:

if you have severe stomach pain that does not go away, inform your doctor. It could be a sign of inflammation of the pancreas (acute pancreatitis).
dehydration (loss of fluids from the body) may occur with nausea, vomiting, or diarrhea. It is important to drink plenty of fluids to prevent dehydration.

Skin changes at the injection site
Rotate the injection site to help prevent changes in the fatty tissue under the skin, such as thickening of the skin, thinning of the skin, or the appearance of lumps under the skin.
Insulin may not work as well if you inject into an area with lumps, into a thinned area, or into a thickened area (see section 3, ‘How to use Xultophy’). Inform your doctor if you notice skin changes at the injection site. If you are currently injecting into one of these affected areas, talk to your doctor before starting to inject in another area. Your doctor may ask you to monitor your blood glucose more closely and adjust your insulin dose or other antidiabetic medicines.

Children and adolescents
Do not give this medicine to children or adolescents. There is no experience 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 medicines. Some medicines affect blood sugar levels, which may mean that your dose of Xultophy needs to be changed.
Below are listed the most common medicines that could affect treatment with Xultophy.

Your blood sugar level may decrease if you take:

other diabetes medicines (tablets or injections)
sulfonamides, for infections
anabolic steroids, such as testosterone
beta-blockers, for high blood pressure. These can make it difficult to recognize early warning signs of low blood sugar (see section 4 for ‘Early warning signs of low blood sugar, which can occur suddenly’).
acetylsalicylic acid (and medicines called ‘salicylates’), for pain and mild fever
monoamine oxidase inhibitors (MAOIs), for depression
angiotensin-converting enzyme (ACE) inhibitors, for certain heart conditions or high blood pressure.

Your blood sugar level may increase if you take:

danazol, a medicine that affects ovulation
oral contraceptives, birth control pills
thyroid hormones, for thyroid diseases
growth hormone, for low levels of growth hormone
medicines called ‘glucocorticoids’, such as cortisone, for inflammation
medicines called ‘sympathomimetics’, such as epinephrine (adrenaline), salbutamol, or terbutaline, for asthma
diuretics called ‘thiazides’, for high blood pressure or excessive fluid retention.

Octreotide and lanreotide, used to treat acromegaly (a rare disease characterized by excessive production of growth hormone). Both may increase or decrease blood sugar levels.
Pioglitazone, tablets used to treat type 2 diabetes mellitus. Some patients with long-standing type 2 diabetes and heart problems or a history of stroke, who were treated with pioglitazone and insulin, have developed heart failure. Inform your doctor immediately if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling (edema).
Warfarin or other blood thinners, medicines used to prevent blood clotting. Inform your doctor if you are taking warfarin or other blood thinners, as you may need to have blood tests more frequently to measure blood thickness (‘International Normalized Ratio’ or INR test).

Xultophy and alcohol
If you drink alcohol, your need for Xultophy may change. Your blood sugar level may increase or decrease. Therefore, you should check your blood sugar level more frequently than usual.

Pregnancy and breastfeeding
Do not use Xultophy if you are pregnant or planning to become pregnant. Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy. It is not known whether Xultophy has effects on the unborn child.
Do not use Xultophy if you are breastfeeding. It is not known whether Xultophy passes into breast milk.

Driving and using machines
Low or high blood sugar levels may affect your ability to drive or use tools or machines. If your blood sugar level is low or high, your concentration or reaction ability may be impaired. This could endanger yourself or others. Ask your doctor if you can drive when:

your blood sugar level often becomes low
you have difficulty recognizing the signs of low blood sugar.

Important information about some ingredients of Xultophy
Xultophy contains less than 1 mmol of sodium (23 mg) per dose, i.e., it is practically ‘sodium-free’.

3. How to use Xultophy

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor, pharmacist, or nurse.
If you are blind or have visual problems and cannot read the dose counter on the pen, do not use this pen without assistance. Ask someone with good eyesight, who has been trained to use the Xultophy pre-filled pen, to help you.
Your doctor will tell you:

how much Xultophy you will need each day
when to check your blood sugar level
how to adjust your dose.

The dose of Xultophy is administered in 'single doses'. The pen's dose counter shows the number of single doses.
Time of administration

Use Xultophy once daily, preferably at the same time each day. Choose a time of day that best suits you.
If it is not possible to use Xultophy at the same time every day, you may use it at a different time. Ensure that at least 8 hours have passed between doses.
It is not necessary to use Xultophy with a meal.
Always follow your doctor’s advice regarding dose and dose adjustments.
If you wish to change your usual diet, consult your doctor, pharmacist, or nurse first, as a change in diet may alter your need for Xultophy.

How to handle Xultophy
Xultophy is a pre-filled pen with dose selection.

Xultophy is administered in 'single doses'. The pen's dose counter displays the number of single doses.
One single dose contains 1 unit of insulin degludec and 0.036 mg of liraglutide.
The maximum daily dose of Xultophy is 50 single doses (50 units of insulin degludec and 1.8 mg of liraglutide). Read carefully the 'Instructions for use' on the back of this leaflet and use the pen as described. Always check the pen label before injecting the medicine to ensure you are using the correct pen.

How to inject
Before using Xultophy for the first time, your doctor or nurse must show you how to perform the injection.

Xultophy is administered by subcutaneous injection (under the skin). Do not inject it into a vein or into a muscle.
The best injection sites are the front of the thighs, the upper arms, or the front of the waist (abdomen).
Change the injection site daily within the chosen area to reduce the risk of developing lumps or skin depressions (see section 4).
Always use a new needle for each injection. Reusing needles increases the risk of needle blockage, which may lead to inaccurate dosing. Dispose of the needle carefully after each use.
Do not use a syringe to withdraw solution from the pen, to avoid dosing errors and potential overdoses.

Detailed instructions for use are provided on the back of this leaflet.
Do not use Xultophy:

If the pen is damaged or has not been stored correctly (see section 5).
If the liquid visible through the pen window is not clear and colourless.

Use in elderly patients (65 years of age or older)
Xultophy can be used in elderly patients, but if you are elderly, you may need to monitor your blood sugar level more frequently. Discuss dose adjustments with your doctor.
If you have kidney or liver problems
If you have kidney or liver problems, you may need to monitor your blood sugar level more frequently. Discuss dose adjustments with your doctor.
If you use more Xultophy than you should
If you use more Xultophy than prescribed, your blood sugar level may become low (hypoglycaemia), or you may experience nausea or vomiting. If your blood sugar level becomes low, follow the instructions in section 4 'Low blood sugar level (hypoglycaemia)'.
If you forget to use Xultophy
If you miss a dose, inject the missed dose as soon as you remember, ensuring at least 8 hours between doses. If you realize you missed the previous dose, do not take a double dose at the next scheduled time.
If you stop using Xultophy
Do not stop using Xultophy without first discussing it with your doctor. If you stop using Xultophy, you may develop very high blood sugar levels; follow the instructions in section 4 'High blood sugar level (hyperglycaemia)'.
If you have any questions about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. 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 level (very common: may affect more than 1 in 10 people). If your blood sugar level becomes too low, you may faint (lose consciousness). Severe hypoglycaemia can cause brain damage and may be life-threatening. If you experience signs of low blood sugar, act immediately to raise your blood sugar level. Follow the instructions under 'Low blood sugar level (hypoglycaemia)' later in this section.
Severe allergic reactions (anaphylactic reaction) (not known: frequency cannot be estimated from the available data). If you experience a severe allergic reaction to any of the ingredients in Xultophy, stop using Xultophy and contact your doctor immediately. Signs of a severe allergic reaction include:
- Localised reactions spreading to other parts of the body
- Suddenly feeling unwell and beginning to sweat
- Difficulty breathing
- Rapid heartbeat or dizziness.

Skin changes at the injection site:
If you inject insulin into the same spot repeatedly, fatty tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy) (may affect up to 1 in 100 people). Lumps under the skin may also be caused by the build-up of a protein called amyloid (cutaneous amyloidosis; frequency not known). Insulin may not work as effectively if you inject into an area with lumps, thinning skin, or thickened skin. Change your injection site with each injection to help prevent these skin changes.
Other side effects include:
Common (may affect up to 1 in 10 people)

Dizziness.
Decreased appetite, nausea or vomiting, diarrhoea, constipation, indigestion (dyspepsia), inflammation of the stomach lining (gastritis), stomach ache, heartburn or abdominal bloating; these effects usually disappear after a few days or weeks.
Reactions at the injection site. Signs may include bruising, bleeding, pain, redness, hives, swelling, or itching; these effects usually disappear after a few days. If they do not disappear within a few weeks, contact your doctor. If they become severe, stop using Xultophy and contact your doctor immediately.
Increased levels of pancreatic enzymes such as lipase and amylase.

Uncommon (may affect up to 1 in 100 people)

Hives (red, sometimes itchy, bumps on the skin).
Allergic reactions (hypersensitivity) such as rash, itching, and facial swelling.
Dehydration (loss of fluids from the body); it is important to drink plenty of fluids to prevent dehydration.
Belching and gas (flatulence).
Skin rash.
Itching.
Increased heart rate.
Gallstones.
Inflamed gallbladder.
Altered taste perception.

Not known frequency (frequency cannot be estimated from the available data)

Inflammation of the pancreas (pancreatitis).
Delayed gastric emptying.
Swelling of arms or legs (peripheral oedema); when you first start using this medicine, your body may retain more fluid than normal. This causes swelling around the ankles and other joints. This effect usually lasts only a short time.

General effects of diabetes treatment
► Low blood sugar level (hypoglycaemia)
Your blood sugar level may drop if you:

Drink alcohol
Exercise more than usual
Eat too little or skip a meal
Use too much Xultophy.

Warning signs of low blood sugar, which may occur suddenly:
Headache, speech and language disturbances, rapid heartbeat, cold sweating, cold and pale skin, nausea, intense hunger, trembling, nervousness or anxiety, unusual tiredness, weakness, drowsiness, confusion, difficulty concentrating, temporary visual disturbances.
What to do if your blood sugar level is low:

Eat sugar cubes or a sugary snack such as sweets, biscuits, or fruit juice (always carry sugar cubes or a sugary snack with you, to use if needed).
Check your blood sugar level if possible, then rest. You may need to check your blood sugar level more than once, as improvement may not be immediate.
Wait until the symptoms of low blood sugar have disappeared or your blood sugar level has stabilised, then continue your treatment with the medicine as usual.

What others should do if you faint:
Tell everyone you spend time with that you have diabetes and what the possible consequences are, including the risk of fainting due to low blood sugar. Explain to them that if you faint, they must:

Turn you onto your side
Seek immediate medical help
Do not give you food or drink, as this could cause choking.

You may regain consciousness more quickly if you receive glucagon, which should only be administered by someone trained in its use.

If you are given glucagon, you will need sugar or a sweet snack as soon as you regain consciousness.
If you do not respond to glucagon treatment, you will need to be taken to hospital.
If severe hypoglycaemia is not treated promptly, it can cause temporary or permanent brain damage and may even lead to death.

Contact your doctor if:

Your blood sugar level has become so low that you fainted
You have used glucagon
You have recently had several episodes of low blood sugar. Your doctor may need to adjust your Xultophy injection dose, your diet, or your exercise routine.

► High blood sugar level (hyperglycaemia)
Your blood sugar level may rise if you:

Drink alcohol
Exercise less than usual
Eat more than usual
Have an infection or fever
Do not use enough Xultophy, continue to use less Xultophy than you need, forget to use Xultophy, or stop using Xultophy without talking to your doctor.

Warning signs of high blood sugar, which usually develop gradually:
Dry, flushed skin, drowsiness or tiredness, dry mouth, fruity breath (acetone), increased urination, thirst, loss of appetite, 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 metabolising fat instead of sugar. If left untreated, it may lead to diabetic coma and possibly death.
What to do if your blood sugar level is high:

Check your blood sugar level.
Test for the presence of ketones in your blood or urine.
Contact your doctor immediately.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Xultophy

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pen label and on the box after 'EXP'. The expiry date refers to the last day of that month.
Before opening
Store in a refrigerator (2 °C – 8 °C). Keep away from refrigerating elements. Do not freeze.
During use
Do not freeze. You may carry Xultophy and store it at room temperature (not above 30 °C) or in the refrigerator (2 °C – 8 °C) for up to 21 days. The product must be discarded 21 days after first opening.
When not in use, store the pre-filled pen with the cap on to protect the medicine from light.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Xultophy contains

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.
The other components are glycerol, phenol, zinc acetate, hydrochloric acid, 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.

Description of the appearance of Xultophy and contents of the pack
Xultophy is a clear, colourless solution.
Packs containing 1, 3 and 5 pens, and a multipack containing 10 pens (2 packs of 5) of 3 mL.
Not all pack sizes may be marketed.
Now turn the leaflet over for information on how to use the pre-filled pen.
Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu .

Instructions for the use of Xultophy 100 units/mL + 3.6 mg/mL injection solution

Read these instructions carefully before using the Xultophy pre-filled pen. Do not use the pen without having received proper instruction from your doctor or nurse. Start by checking the pen to ensure it contains Xultophy 100 units/mL + 3.6 mg/mL, then review the illustrations below to learn about the different parts of the pen and the needle. If you are blind or have severe vision problems, do not use this pen without assistance. Ask for help from someone with good eyesight who has been trained in using the Xultophy pre-filled pen. Xultophy is a medicine containing insulin degludec and liraglutide. Xultophy is administered in 'unit doses'. One unit dose contains 1 unit of insulin degludec + 0.036 mg of liraglutide. The pen is a pre-filled pen with adjustable dosing. It contains 3 mL of Xultophy solution. It delivers doses from: – 1 unit dose – up to a maximum of 50 unit doses (50 units of insulin degludec + 1.8 mg of liraglutide). The pen delivers doses in increments of 1 unit dose. Do not perform any dose conversion. The selected unit doses correspond directly to the number shown in the dose counter. The pen is designed to be used with NovoTwist or NovoFine disposable needles up to 8 mm in length and as thin as 32G. Needles are not included. Important information Pay close attention to these notes as they are essential for the safe use of the pen.
Xultophy pre-filled pen and needle (example) Pen cap Outer needle cap Inner needle cap Needle Protective seal Graduated scale Pen window Pen label Dose counter Dose indicator Dose button with smooth surface Dose selector Injection button
1 Preparing the pen with a new needle• Check the name and colored label on the pen to confirm it contains Xultophy. This is especially important if you use more than one type of injectable medicine. Using the wrong medicine may harm your health. • Remove the pen cap.	A
Check that the solution in the pen is clear and colourless. Look through the pen window. If the solution appears cloudy, do not use the pen.	B
Take a new needle and remove the protective seal.	C
Push the needle onto the pen and twist it until it is secure.	D
Remove the outer needle cap and keep it for later use. You will need it after injection to safely remove the needle from the pen.	E
Remove the inner needle cap and discard it. Do not attempt to reattach it, as you may accidentally prick yourself with the needle. A drop of solution may appear at the needle tip. This is normal, but you must still check the flow. Do not attach a new needle to the pen until you are ready to administer the injection. Always use a new needle for each injection. This prevents needle blockage, contamination, infection, and incorrect dosing. Never use a bent or damaged needle.	F
2 Checking the flow • Rotate the dose selector and select 2 unit doses. Ensure the dose counter shows 2. • The dose counter and dose indicator show how many unit doses of Xultophy have been selected.	A 2 unit doses selected
Hold the pen with the needle pointing upwards. Gently tap the top of the pen several times with your finger so that air bubbles collect at the top.	B
Press and hold the injection button until the dose counter resets to zero. The 0 must align with the dose indicator. A drop of solution should appear at the needle tip. A small drop may remain at the tip, but it will not be injected. If no drop appears, repeat steps 2A to 2C up to six times. If still no drop appears, replace the needle and repeat steps 2A to 2C once more. If no drop appears even after this, discard the pen and use a new one. Always ensure a drop appears at the needle tip before injection. The presence of a drop confirms proper solution flow. If no drop appears, no medicine will be injected, even if the dose counter moves. This may indicate a blocked or damaged needle. Always check the flow before injection. Failure to do so may result in injecting an insufficient dose or no dose at all, which could lead to high blood sugar levels.	C
3 Selecting the dose• Rotate the dose selector to select the required dose. The dose counter displays the dose in unit doses. If you select the wrong dose, you can correct it by rotating the dose selector forward or backward. A maximum of 50 unit doses can be selected on the pen. The dose selector changes the number of unit doses. Only the dose counter and dose indicator show how many unit doses have been selected for each injection. You may select up to 50 unit doses per injection. When the pen contains fewer than 50 unit doses, the dose counter displays the number of remaining unit doses. The dose selector makes a distinct click when rotated forward, backward, or beyond the number of remaining unit doses. Do not count the clicks of the pen. Before injecting the medicine, always use the dose counter and dose indicator to verify how many unit doses have been selected. Do not count the clicks of the pen. If you select and inject the wrong dose, your blood sugar level may increase or decrease. Do not use the pen scale, which only approximately shows	A Examples 5 dose levels selected 24 dose levels selected
how much solution remains in the pen.
How much solution is left?• The pen scale approximately indicates how much solution remains in the pen.	A Approximate amount of solution remaining
To precisely determine how much solution remains, use the dose counter: Rotate the dose selector until the dose counter stops. If it shows 50, at least 50 unit doses remain in the pen. If it shows less than 50, the number displayed is the number of unit doses remaining. • If you need more medicine than remains in the pen, you may split the dose between two pens. If splitting the dose, be very careful to calculate the correct number. If unsure, inject the full dose using a new pen. Incorrectly splitting the dose may result in injecting too little or too much medicine, which could increase or decrease your blood sugar level.	B Example Dose counter stopped: 42 remaining unit doses
4 Injecting the dose • Insert the needle into the skin as shown by your doctor or nurse. • Make sure you can see the dose counter. Do not cover it with your fingers, as this may interrupt the injection.	A
Press and hold the injection button until the dose counter shows 0. The 0 must align with the dose indicator. You may hear or feel a click.	B
Keep the needle in the skin after the dose counter resets to 0 and count slowly to 6. • If the needle is removed too early, you may notice solution leaking from the needle tip. In this case, the full dose will not have been delivered, and you should increase the frequency of blood sugar monitoring.	C Count slowly: 1-2-3-4-5-6
Remove the needle from the skin. If bleeding occurs at the injection site, apply gentle pressure without rubbing the area. After injection, you may see a drop of solution at the needle tip. This is normal and does not affect the dose. Always check the dose counter to know how many unit doses you are injecting. Hold the injection button down until the dose counter shows 0. If the dose counter does not reset to 0, the full dose has not been delivered, which may result in high blood sugar levels. How to identify a blocked or damaged needle. • If the dose counter does not show 0 after continuously pressing the injection button, a blocked or damaged needle may have been used. • In this case, no medicine will have been administered, even if the dose counter moved from the originally set dose. How to handle a blocked needle. Replace the needle as described in section 5 and repeat all steps starting from step 1: Preparing the pen with a new needle. Ensure you select the full required dose. Never touch the dose counter during injection, as this may interrupt the injection.	D
5 After injection• Place the needle tip into the outer needle cap resting on a flat surface, without touching the needle or outer cap.	A
Once the needle is covered, press the outer cap fully on, taking care. • Unscrew the needle and dispose of it carefully according to your doctor’s or nurse’s instructions.	B
Replace the pen cap on the pen after each use to protect the solution from light. Always discard the needle after each injection to ensure a sharp needle is used next time and to prevent needle blockage. If the needle is blocked, no medicine will be injected. When the pen is empty, discard it without the needle attached, as instructed by your doctor, nurse, pharmacist, or local authorities. Never attempt to reattach the inner needle cap, as you may prick yourself with the needle. Always remove the needle from the pen after each injection.	C
This can prevent needle blockage, contamination, infection, solution leakage, and incorrect dosing.
Additional important information• Always keep an extra pen and new needles available in case you lose or damage your pen or needles. • Always keep the pen and needles out of sight and reach of others, especially children. • Never share the pen with other people. The medicine may be harmful to their health. • Never share needles with other people to avoid cross-infection. • Exercise extreme caution when handling used needles to prevent needle-stick injuries and cross-infection.
Pen maintenance • Do not leave the pen in a car or other places where it could overheat or become too cold. • Do not store the pen at temperatures above 30°C. • Do not expose the pen to dust, dirt, or liquids. • Do not wash, immerse, or lubricate the pen. If necessary, clean it with a neutral detergent on a damp cloth. • Do not drop the pen or hit it against hard surfaces. If dropped or if you suspect damage, attach a new needle and check the solution flow before injection. • Do not attempt to refill the pen. When empty, it must be discarded. • Do not attempt to repair or disassemble the pen.