Levemir FlexPen 100 units/mL – long-acting insulin detemir for diabetes

Levemir contains insulin detemir – a modern long-acting insulin analogue. It is used to lower high blood sugar in people with diabetes and provides an even, basal effect for up to 24 hours.

It comes as a 100 units/mL solution for injection in a pre-filled FlexPen (3 mL = 300 units); the pack contains 5 pens without needles. It is prescription-only.

What is Levemir used for and how is it used correctly?

Key facts about the medicine

What is Levemir used for?

• Lowering high blood sugar in adults, adolescents and children aged 1 year and above with diabetes mellitus.
• It can be used together with rapid-acting insulins given at mealtimes.
• In type 2 diabetes it may also be combined with diabetes tablets and/or injectable non-insulin diabetes medicines.

How is Levemir used and dosed?

• The dose is set individually by the doctor; do not change insulin without their advice. Adjustment may be needed when switching from another insulin or when a new diabetes medicine is added.
• Frequency: combined with tablets and/or non-insulin injectables – once a day; in a basal-bolus regimen – once or twice a day as needed. The injection can be given at any time of day but at the same time every day; with two doses the evening dose is given in the evening or at bedtime.
• Method: subcutaneous injection into the front of the thigh, front of the abdomen or upper arm; rotate the injection site within the same area every time.
• Before injecting, check that it is the right insulin; use the pen according to the enclosed FlexPen instructions.
• Measure your blood sugar regularly.

Special patient groups

• Children and adolescents: can be used from 1 year of age; there is no experience in children under 1 year.
• Kidney or liver impairment and people over 65: check blood sugar more often and discuss the dose with your doctor.
• Very low albumin: careful blood sugar monitoring is needed.

Contraindications – when the medicine must not be used

• allergy to insulin detemir or any of the excipients;
• a beginning hypoglycaemia (do not inject when you feel signs of low sugar);
• use in insulin infusion pumps;
• a FlexPen that has been dropped, damaged or crushed; insulin not stored correctly, frozen or not clear and colourless.

Warnings and precautions

• kidney, liver, pituitary, adrenal or thyroid problems;
• more exercise than usual or a change in diet, illness, travel across time zones – these may change insulin needs;
• skin changes at the injection site (thickening, wrinkling, lumps, cutaneous amyloidosis) – insulin injected there may work less well; tell your doctor before changing the site, as the dose may need adjusting;
• diabetic retinopathy – a rapid improvement in blood sugar may temporarily worsen it.

Interactions with other medicines, food and drink

• May lower blood sugar: other diabetes medicines, MAO inhibitors, beta-blockers, ACE inhibitors, salicylates, anabolic steroids, sulphonamides.
• May raise blood sugar: oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics (epinephrine, salbutamol, terbutaline), growth hormone, danazol.
• Octreotide and lanreotide may both lower and raise blood sugar; beta-blockers may mask the warning signs of hypoglycaemia.
• Pioglitazone: some patients with long-standing type 2 diabetes and heart disease developed heart failure – see your doctor if you notice breathlessness, rapid weight gain or swelling.
• Alcohol may both raise and lower blood sugar – close glucose control is recommended.

Pregnancy and breast-feeding

• Insulin needs may change during pregnancy and after delivery; tight diabetes control and preventing hypoglycaemia are also important for the baby’s health – consult your doctor.
• During breast-feeding the insulin dose may need adjusting.

Driving and using machines

• Low or high blood sugar can reduce concentration and reaction time. Discuss driving with your doctor if you have frequent hypoglycaemia or find its warning signs hard to recognise.

Possible side effects

• Very common: hypoglycaemia (low blood sugar) – signs: cold sweat, pale skin, headache, palpitations, nausea, extreme hunger, temporary vision changes, drowsiness, tiredness and weakness, nervousness, tremor, anxiety, confusion, difficulty concentrating.
• Uncommon: local reactions at the injection site (pain, redness, rash, swelling, itching), lipoatrophy or lipohypertrophy, temporary vision problems at the start of treatment, swollen joints due to water retention, worsening of diabetic retinopathy.
• Rare: acute painful neuropathy (temporary pain when blood sugar improves rapidly).
• Very rare: serious (systemic) allergic reaction.
• Not known: cutaneous amyloidosis (lumps under the skin).

Overdose, missed dose and stopping treatment

• Too much insulin: blood sugar becomes too low – take glucose or a sugary snack, measure your blood sugar and rest. Loss of consciousness requires a glucagon injection or emergency help; others must not give food or drink to an unconscious person.
• Missed dose: blood sugar may become too high (hyperglycaemia) – measure it and act as agreed with your doctor.
• Stopping treatment: do not stop insulin without your doctor – severe hyperglycaemia and ketoacidosis may occur.

Related information

For additional care and support with diabetes (regular blood sugar self-monitoring), see also the category Blood glucose meters – products in this category do not replace the medicine you have been prescribed.

Composition, pack and manufacturer

• Active substance: insulin detemir 100 units/mL; one pen contains 300 units in 3 mL.
• Excipients: glycerol; phenol; metacresol; zinc acetate; disodium phosphate dihydrate; sodium chloride; hydrochloric acid; sodium hydroxide; water for injections.
• Appearance: clear, colourless aqueous solution in a multi-dose disposable pen.
• Pack: 5 pre-filled pens of 3 mL, without needles.
• Marketing authorisation holder: Novo Nordisk Pharma d.o.o., Milutina Milankovića 9b, Belgrade; manufacturers: Novo Nordisk A/S, Bagsværd, Denmark and Novo Nordisk Production SAS, Chartres, France.
• Authorisation: 515-01-03794-20-001 of 16.07.2021.

Storage

• Before opening: in a refrigerator (2–8 °C), away from the cooling element; do not freeze.
• In use or carried as a spare: up to 6 weeks below 30 °C or in a refrigerator; do not freeze.
• Keep the cap on the pen to protect from light; protect from heat and sunlight.
• Keep out of the sight and reach of children.

Frequently asked questions

How many times a day is Levemir given?

With tablets or non-insulin diabetes medicines – once a day; in a basal-bolus regimen – once or twice a day, always at the same time. The doctor sets the dose and schedule.

Where is Levemir injected?

Under the skin of the front of the thigh, abdomen or upper arm, rotating the site with every injection. Never into a vein or muscle.

What should I do if my blood sugar drops?

Take glucose tablets or a sugary snack, measure your blood sugar and rest. If hypoglycaemia is frequent or severe, talk to your doctor about the dose.

Can the pen in use be kept out of the fridge?

Yes, for up to 6 weeks below 30 °C, protected from heat and light. Keep unopened pens in the fridge and never freeze them.

Sources

• ALIMS – Package leaflet Levemir FlexPen (PIL, Serbian)
• ALIMS – Summary of product characteristics Levemir FlexPen (SmPC, Serbian)

Date sources were checked: 25.10.2026.