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MedsAcross

Molecule

Teprotumumab

Insulin-like Growth Factor-1 Receptor Inhibitor
Available on requestBiologicOrphanCold chainImmunology and transplantMultiple sclerosis
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Teprotumumab is an insulin-like growth factor-1 receptor inhibitor indicated for the treatment of Thyroid Eye Disease regardless of Thyroid Eye Disease activity or duration. It is available as powder for injection for intravenous use. MedsAcross supplies Teprotumumab for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Insulin-like Growth Factor-1 Receptor Inhibitor, Insulin-like Growth Factor-1 Receptor Inhibitors
ATC classification
L04AG13 Teprotumumab · Immunosuppressive drug, subgroup L04AG
US FDA first approval
21 January 2020
EU status
Authorised
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Intravenous
Dosage forms
Powder for injection
Biologic
Yes
Identifiers
UNII Y64GQ0KC0AQ7701391

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

TEPEZZA is indicated for the treatment of Thyroid Eye Disease regardless of Thyroid Eye Disease activity or duration. TEPEZZA is an insulin-like growth factor-1 receptor inhibitor indicated for the treatment of Thyroid Eye Disease regardless of Thyroid Eye Disease activity or duration

Source: US FDA prescribing information

How it works

Teprotumumab-trbw's mechanism of action in patients with Thyroid Eye Disease has not been fully characterized. Teprotumumab-trbw binds to IGF-1R and blocks its activation and signaling.

Source: US FDA prescribing information

Dosing overview

Initiate dosing with 10 mg/kg for first infusion, followed by 20 mg/kg every 3 weeks for 7 additional infusions. Administer TEPEZZA by intravenous infusion over 60 to 90 minutes

Source: US FDA prescribing information

Warnings and precautions

Infusion Reactions: If an infusion reaction occurs, interrupt or slow the rate of infusion and use appropriate medical management. Inflammatory Bowel Disease (IBD): Monitor patients, for signs and symptoms of disease, including patients without a history of IBD, discontinue TEPEZZA if IBD exacerbation is suspected. Hyperglycemia: Assess patients for elevated blood glucose and symptoms of hyperglycemia prior to infusion and continue to monitor while on treatment with TEPEZZA. Ensure patients with hyperglycemia or preexisting diabetes are under appropriate glycemic control before and while receiving TEPEZZA. Hearing Impairment Including Hearing Loss: TEPEZZA may cause severe hearing impairment including hearing loss, which in some cases may be permanent. Assess patients' hearing before, during, and after treatment with TEPEZZA and consider the benefit-risk of treatment with patients.

Source: US FDA prescribing information

Side effects

The following clinically significant adverse reactions are described elsewhere in the labeling: Infusion Reactions Inflammatory Bowel Disease Hyperglycemia Hearing Impairment Including Hearing Loss Most common adverse reactions (incidence greater than 5%) are muscle spasm, nausea, alopecia, diarrhea, fatigue, hyperglycemia, hearing impairment, dry skin, dysgeusia, headache, weight decreased, and nail disorder

Source: US FDA prescribing information

Storage

Refrigerate at 2°C to 8°C (36°F to 46°F) in original carton until time of use to protect from light. Do not freeze.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Teprotumumab, sorted by availability.

MedicineManufacturerRegisterAvailability
Tepezza 500 mg powder for injectionIntravenous Cold chainHorizon TherapeuticsUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 21 January 2020Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Teprotumumab available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Teprotumumab and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Teprotumumab have?

The catalogue lists 1 brand names for Teprotumumab, including Tepezza.

Is Teprotumumab approved by the US FDA?

Yes. The US FDA first approved Teprotumumab on 21 January 2020, according to Drugs@FDA.

Is Teprotumumab authorised in the European Union?

Yes. Teprotumumab has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Teprotumumab need cold chain shipping?

At least one listed presentation of Teprotumumab must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

Which ATC class is Teprotumumab in?

Teprotumumab is classified under ATC code L04AG13 (Teprotumumab).

References

  1. TEPEZZA prescribing information (Horizon Therapeutics). U.S. National Library of Medicine, DailyMed. Retrieved 28 September 2026
  2. Tepezza: European public assessment report (EPAR). European Medicines Agency. Retrieved 25 March 2026

Request Teprotumumab for export supply

Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.