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insulin degludec

Tresiba · ATC code A10AE06

Also known as: İnsülin degludek

Key facts
Active substance
insulin degludec
Drug class
Lente insulin
ATC code
A10AE06
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Tresiba 100 units/mL FlexTouch solution for injection in pre-filled pen / Tresiba 200 units/mL FlexTouch solution for injection in pre-filled pen / Tresiba 100 units/mL FlexPen solution for injection in pre-filled pen
Marketing authorisation holder
Novo Nordisk A/S
Information as of
2026-10-28

Key facts

Insulin degludec is a long-acting basal insulin for once-daily subcutaneous use in diabetes mellitus from the age of 1 year (Tresiba).

What it is used for

  • Treatment of diabetes mellitus in adults, adolescents and children from the age of 1 year.

Dosing

  • Once daily subcutaneously at any time of day, preferably at the same time every day; adjust the dose individually based on fasting plasma glucose. Must not be given intravenously.
  • Type 2 diabetes: recommended starting dose 10 units daily; can be combined with oral antidiabetics, GLP-1 receptor agonists and bolus insulin. Type 1 diabetes: must be combined with short-/rapid-acting mealtime insulin.
  • Transfer from other basal insulins is usually unit-to-unit; consider a 20% dose reduction when transferring from twice-daily basal insulin or insulin glargine 300 units/mL, and in type 1 diabetes.
  • Tresiba 100 units/mL FlexTouch: 1–80 units per injection in steps of 1 unit; 200 units/mL FlexTouch: 2–160 units in steps of 2 units; 100 units/mL FlexPen: 1–60 units. No dose conversion when changing strength.
  • Dosing time can be flexible, with at least 8 hours between injections; a forgotten dose should be taken upon discovery.
  • Elderly and renal or hepatic impairment: intensify glucose monitoring and adjust the dose individually.

Contraindications

  • Hypersensitivity to the active substance or any excipient.

Important warnings

  • Hypoglycaemia, e.g. with a missed meal, unplanned strenuous exercise or too high a dose; the prolonged effect may delay recovery.
  • Inadequate dosing or stopping treatment may lead to hyperglycaemia and diabetic ketoacidosis.
  • Concomitant illness, especially infections and fever, usually increases insulin requirement.
  • Rotate injection sites to reduce the risk of lipodystrophy and cutaneous amyloidosis.
  • Avoid mix-ups: check the insulin label and the dialled units before each injection.

Side effects

  • Very common: hypoglycaemia.
  • Common: injection site reactions.
  • Uncommon: lipodystrophy, peripheral oedema; rare: hypersensitivity, urticaria; not known: cutaneous amyloidosis.

Interactions

  • May reduce insulin requirement: oral antidiabetics, GLP-1 receptor agonists, MAOIs, beta-blockers, ACE inhibitors, salicylates, anabolic steroids and sulfonamides.
  • May increase insulin requirement: oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone and danazol.
  • Beta-blockers may mask hypoglycaemia symptoms; alcohol may intensify or reduce the effect.
  • Cases of cardiac failure have been reported with pioglitazone plus insulin.

Pregnancy and breastfeeding

  • Treatment may be considered during pregnancy if clinically needed.
  • No clinical experience during breast-feeding; no metabolic effects are anticipated in the breast-fed infant.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • TresibaNovo Nordisk A/S · EMEA/H/C/002498

Source: European Medicines Agency (EMA), product information

Turkey

  • Tresiba FlextouchNOVO NORDİSK SAĞLIK ÜRÜNLERİ TİC LTD. ŞTİ. · 7 register entries
  • Tresiba PenfillNOVO NORDİSK SAĞLIK ÜRÜNLERİ TİC LTD. ŞTİ. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 2 more European countries
Iceland
Tresiba Flexpen, Tresiba Flextouch, Tresiba Penfill
Norway
Tresiba

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Tresiba – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/tresiba-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  3. Wikidata (CC0): ATC A10AE.

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.