teprotumumab
Tepezza · ATC code L04AG13
- Key facts
- Active substance
- teprotumumab
- Drug class
- Immunosuppressive drug
- ATC code
- L04AG13
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- TEPEZZA 500 mg powder for concentrate for solution for infusion
- Marketing authorisation holder
- Amgen Europe B.V.
- Information as of
- 2026-10-29
Key facts
Teprotumumab is a monoclonal antibody against the insulin-like growth factor-1 receptor (IGF-1R) used to treat moderate to severe thyroid eye disease in adults (Tepezza).
What it is used for
- Treatment of moderate to severe thyroid eye disease (TED) in adults.
Dosing
- Tepezza: initial dose 10 mg/kg actual body weight, followed by 20 mg/kg for 7 additional doses once every three weeks as an intravenous infusion.
- First 2 infusions over at least 90 minutes; if well tolerated, infusions 3 to 8 over 60 minutes. Not as a push or bolus.
- Clinical response is expected with 8 doses; no additional doses if response is not achieved.
- For infusion reactions during the first two infusions, premedication with antihistamine, antipyretic and/or corticosteroid or a slower infusion rate is recommended.
- No dose adjustment in the elderly or in renal or hepatic impairment; not for children and adolescents before growth is complete.
Contraindications
- Hypersensitivity to the active substance or any excipient.
- Pregnancy.
Important warnings
- Infusion reactions (approximately 4%) during or within 90 minutes after infusion; monitor closely.
- Severe, sometimes permanent hearing impairment including hearing loss (13.8% in trials): audiometry before, during and after treatment; caution with ototoxic medicines.
- Hyperglycaemia, including diabetic ketoacidosis: check blood glucose before and during treatment and for 6 months afterwards.
- Exacerbation of pre-existing inflammatory bowel disease may occur.
Side effects
- Most common: muscle spasms (27.6%), diarrhoea (14.5%), alopecia (13.2%), hyperglycaemia (13.2%), fatigue (12.5%), nausea (10.5%) and headache (10.5%).
- Serious, including: diabetic ketoacidosis (0.7%), deafness (1.3%), diabetes mellitus (2.6%), inflammatory bowel disease (0.7%), infusion-related reaction (0.7%).
Interactions
- No interaction studies; no metabolic interactions are expected.
- Caution with ototoxic medicines (e.g. aminoglycosides, vancomycin, platinum chemotherapy, loop diuretics).
Pregnancy and breastfeeding
- Contraindicated in pregnancy; women of childbearing potential should use effective contraception before, during and for 6 months after the last dose.
- As a precaution, should not be used during breast-feeding.
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.
Common questions – ask Medelix
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)
- TepezzaAmgen Europe B.V. · EMEA/H/C/006396
Source: European Medicines Agency (EMA), product information
Brand names in 2 more European countries
- Iceland
- Tepezza
- Norway
- Tepezza
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.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Tepezza – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/tepezza-epar-product-information_en.pdf
- Wikidata (CC0): ATC L04AG.
Editorial: Medelix editorial team · last updated 2026-10-29 · 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.