What Tresiba is and what it is used for
Tresiba contains long-acting basal insulin called insulin degludec. It is used to treat diabetes mellitus in adults, adolescents, and children from 1 year of age. Tresiba helps your body lower blood sugar levels. It is dosed once daily. At times when you cannot follow your usual dosing schedule, you can change the timing of dosing because Tresiba lowers blood sugar for a long time (see section 3 “Flexibility in dosing timing”). Tresiba can be used with rapid-acting insulin taken with meals. In diabetes mellitus type 2, Tresiba can be used together with diabetes medicines in the form of tablets or with injectable diabetes medicines of a different type than insulin.
What you need to know before you use Tresiba
Do not use Tresiba
- if you are allergic to insulin degludec or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you start using Tresiba. Pay particular attention to the following:
- Low blood sugar (hypoglycemia) – if your blood sugar is too low, follow the advice for low blood sugar in section 4.
- High blood sugar (hyperglycemia) – if your blood sugar is too high, follow the advice for high blood sugar in section 4.
- Switching from other insulin preparations – the insulin dose may need to be changed if you switch from another type, brand, or manufacturer of insulin. Talk to a doctor.
- Concomitant use of pioglitazone, see “Pioglitazone” below.
- Eye disease – rapid improvement in blood sugar control may lead to a temporary worsening of diabetic eye disease. If you get eye problems, talk to a doctor.
- Make sure you are using the right type of insulin – always check the label of the insulin before each injection to avoid confusing Tresiba with other insulin preparations.
If you have poor vision, see section 3.
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. Insulin may not work as well if you inject it into an area with nodules or a thickened or shriveled area (see “How to use Tresiba”). Contact the doctor if you notice skin changes at the injection site and before changing the injection site if you are currently injecting into 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
Other medicines and Tresiba
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 and this may mean that your insulin dose needs to be changed.
Below is a list of the most common medicines that can affect your insulin treatment.
Your blood sugar level may drop (hypoglycemia) if you take:
- other medicines, against diabetes (tablets or as an injection )
- sulfonamides, against infection er
- 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)
- acetylsalicylic acid (and other salicylates), for pain and mild fever
- MAO inhibitors, against depression
- ACE inhibitors, against certain heart problems or high blood pressure
Your blood sugar level may increase (hyperglycemia) if you take:
- danazol, for endometriosis (endometrial tissue that grows outside the uterus)
- contraceptives ( birth control pills ), for birth control
- thyroid hormones, against thyroid diseases
- growth hormone, against growth hormone deficiency
- glucocorticoids, e.g. cortisone, against inflammation
- sympathomimetics, eg adrenaline, salbutamol, or terbutaline, against asthma
- thiazides, for high blood pressure or if your body retains too much fluid (fluid retention).
Octreotide and lanreotide: used to treat a rare disorder of overproduction of growth hormone ( acromegaly ). These can either raise or lower your blood sugar level.
Pioglitazone: diabetes medicine (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).
If any of the above apply to you (or if you are unsure), talk to your doctor, pharmacist, or nurse.
Tresiba and alcohol
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. The insulin dose may need to be changed during pregnancy and after delivery. It is necessary to have close control of your diabetes during pregnancy. Avoiding low blood sugar (hypoglycemia) is particularly important for your child’s health.
Driving ability and use of machinery
Too low or too high blood sugar can affect your ability to drive or use tools or machines. Too low or too 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 or use machines:
- if you often get low blood sugar
- if you find it difficult to recognize signs of low blood sugar.
Important information about some ingredients in Tresiba
This medicine contains less than 1 mmol sodium (23 mg) per dose. This means that Tresiba is almost “sodium-free”.
How to use Tresiba
Always use this medicine as directed by your doctor. Consult a doctor, pharmacist, or nurse if you are unsure.
If you are blind or have severe vision problems and cannot read the dose counter on the pen, you should not use this insulin preparation without help. Get the help of someone who has good eyesight and knows how to use the injection pen.
Doctors will decide together with you:
- how much Tresiba do you need each day.
- when to check your blood sugar level and if you need a higher or lower dose.
Flexibility in dosing time
- Always follow your doctor’s dosage recommendations.
- Use Tresiba once a day, preferably at the same time each day.
- When you cannot take Tresiba at the same time of day, you can change the time you take Tresiba. Make sure there are at least 8 hours between doses. There is no experience with flexible dosing timing for Tresiba in children and adolescents.
- If you want to change your dietary habits, you should first consult with your doctor, pharmacist, or nurse, as changing your dietary habits may change your need for insulin.
The doctor may change your dose depending on your blood sugar level.
When using other medicines, ask the doctor if your treatment needs to be adjusted.
Use in the elderly (≥65 years)
Tresiba can be used by the elderly, but you may need to check your blood sugar level more often if you are elderly. Talk to your doctor about dose changes.
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 Tresiba dose.
To inject the drug
Before you use Tresiba for the first time, your doctor or nurse will show you how to use it.
- Also, read the manual that comes with your insulin injection device.
- Check the name and strength on the label to make sure it is Tresiba 100 units/ml.
Do not use Tresiba
- in insulin infusion pumps.
- if the cartridge or the injection aid you are using is damaged. In that case, return it to the pharmacy/point of purchase. Further instructions can be found in the manual for the injection device.
- if the cartridge has been damaged or has not been stored correctly (see section 5 “How to store Tresiba”).
- if insulin it is not clear and colorless.
How to inject
- Tresiba is given as an injection under the skin ( subcutaneous injection ). 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).
- Alternate injection sites within the same area where you inject each day reduce the risk of developing nodules or pits 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.
If you have used too much Tresiba
If you use too much insulin, your blood sugar can become too low (hypoglycemia). See the advice in section 4 “Too low blood sugar”.
If you forget to use Tresiba
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 inject a double dose but resume your once-a-day dosing.
If you stop using Tresiba
Do not stop using insulin without first talking to your doctor. If you stop using insulin, it can lead to very high blood sugar and ketoacidosis (a condition with too much acid in the blood). See the advice in section 4 “Too high blood sugar”.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Low blood sugar (hypoglycemia) is very common with insulin treatment (may affect more than 1 in 10 users). It can be very serious. If your blood sugar level drops too much, you may pass out. Severe hypoglycemia can cause brain damage and be life-threatening. If you have symptoms of low blood sugar (insulin sensitivity), get your blood sugar level raised immediately. See the advice below under “Too low blood sugar”.
If you have a serious allergic reaction (which occurs in rare cases) to insulin et or any of the ingredients in Tresiba, stop using Tresiba and see a doctor immediately. The signs of a serious allergic reaction are that:
- the local reactions spread to other parts of the body
- you suddenly feel sick and sweat
- you start vomiting
- you have difficulty breathing
- you get 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) (which 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)
Local reactions: There may be local reactions at the injection site. It can include the following symptoms: pain, redness, hives, swelling, and itching. The reactions usually disappear after a few days. See your doctor if they don’t go away after a few weeks. Stop using Tresiba and see a doctor immediately if the reactions become severe. More information can be found above under the section on severe allergic reactions.
Uncommon (may affect up to 1 in 100 users
Swelling around the joints: 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.
Rare (may affect up to 1 in 1,000 users
This medicine can cause allergic reactions such as hives, swelling of the tongue and lips, diarrhea, nausea, fatigue, and itching.
General complications of diabetes treatment
- Too low blood sugar (hypoglycemia)
You can get too low blood sugar:
if you drink alcohol, use too much insulin, exercise more than usual, eat too little, or skip a meal.
Warning signs of low blood sugar – these can come on suddenly:
Headache, slurred speech, palpitations, cold sweats, cool and pale skin, nausea, strong hunger, tremors or nervousness/anxiety, feeling unusually tired, weakness and drowsiness, confusion and difficulty concentrating, and short-term vision changes.
This is what you do if you get low blood sugar
- Eat dextrose tablets or any other high-sugar snack, 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 with all basal insulins the recovery from the period of low blood sugar may be delayed.
- When the symptoms of low blood sugar have disappeared or when your blood sugar level has stabilized, continue your insulin treatment as usual
So should others if you lose consciousness
Tell everyone you associate with that you have diabetes. Tell them what can happen if your blood sugar gets too low, for example, you may lose consciousness.
Tell them that if you lose consciousness, they must do the following:
- turn on your side
- get medical attention right away
- 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 severely 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 used an injection of glucagon
- you have had low blood sugar several times recently.
The dose or timing of your insulin injections, your meals, or your exercise habits may need to be changed.
- Too high blood sugar ( hyperglycemia )
You can get too high blood sugar:
if you eat more or exercise less than usual, drink alcohol, get an infection or fever, have not used enough insulin, regularly use less insulin than you need, forget to use your insulin, or stop using insulin without talking to your doctor first.
Warning signs of 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.
This is what you do if you get high blood sugar
- Test your blood sugar level.
- Do a urine or blood ketone test.
- Seek medical attention immediately.
If you get side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects that are not mentioned in this information.
How to store Tresiba
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the Penfill 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 freeze. Do not store near the cooling element.
After first use or if included as a spare
Do not store it in a refrigerator. You can take the Tresiba cartridge ( Penfill ) with you and store it at room temperature (maximum 30°C) for up to 8 weeks.
To protect Tresiba Penfill from light, always store it in the outer carton 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
- The active substance is insulin degludec. Each ml of solution contains 100 units of insulin degludec. Each cartridge contains 300 units of insulin degludec in 3 ml of solution.
- Other ingredients are glycerol, metacresol, phenol, zinc acetate, hydrochloric acid and sodium hydroxide (for pH adjustment), and water for injections (see section 2).
Appearance and package sizes of the medicine
Tresiba is a clear and colorless solution for injection in a cartridge (300 units per 3 ml).
Novo Nordisk A/S
DK-2880 Bagsværd, Denmark