Teprotumumab: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 15, 2026🚩 Report this page

Teprotumumab

Monoclonal Antibodies

Sold as Tepezza

GB MHRAEU EMACA Health Canada

Drug class: Monoclonal Antibodies
Availability: See label
Routes: Intravenous
Markets covered: 3
Products on record: 3

L04AGMonoclonal Antibodies

Overview

Teprotumumab is an active pharmaceutical ingredient in the Monoclonal Antibodies group (L04AG). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	1	May 15, 2026
EU European Union	EMA	1	March 25, 2026
CA Canada	Health Canada	1	February 13, 2026

GBUnited Kingdom· MHRA

1 product

Uses

GBOfficial regulatory label· revised May 15, 2026[1]

1).

How to take

GBOfficial regulatory label· revised May 15, 2026

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised March 25, 2026[2]

TEPEZZA is indicated in adults for the treatment of moderate to severe thyroid eye disease (TED).

How to take

EU

CACanada· Health Canada

1 product

1 product on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].

Brands in Canada (1)

TEPEZZAAMGEN CANADA INC

Drug interactions

Known interactions involving Teprotumumab. Select one for details. This list is informational and not a complete interaction checker.

Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.

Sources & citations

[1]MHRA (UK) · PLGB138320098 · revised May 15, 2026
[2]European Medicines Agency · EMEA/H/C/006396 · revised March 25, 2026
[3]Health Canada (DPD) · 02557061 · revised February 13, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

TEPEZZA must be administered as an intravenous infusion via an infusion pump. TEPEZZA must be administered by a healthcare professional and under the supervision of a physician experienced in the diagnosis and treatment of TED with access to appropriate medical support to manage potential severe reactions such as serious infusion-related reactions.
Posology TEPEZZA dosing is based on the patient’s actual body weight. The recommended dose of TEPEZZA is 10 mg/kg of body weight for the initial dose followed by 20 mg/kg of body weight for 7 additional doses given once every three weeks as an intravenous infusion.
For the first 2 infusions, the diluted solution is administered as an intravenous infusion over at least 90 minutes. If well tolerated, infusions 3 to 8 can be administered over 60 minutes every three weeks. Available data suggest that clinical response is usually achieved within 8 doses of treatment.
4). 2). There is no data in those over 80 years of age. 2). No dose adjustment is considered necessary in patients with mild to moderate renal impairment. Hepatic impairment The effect of hepatic impairment on the pharmacokinetics of TEPEZZA is unknown.
2). Paediatric population The safety and efficacy of TEPEZZA in children < 18 years of age has not been established. 1). Method of administration • TEPEZZA must be administered as an intravenous infusion via an infusion pump. 9%) solution for infusion, prior to infusion • TEPEZZA must not be co-administered with other medicinal products through the same infusion line.
• TEPEZZA must not be administered as an intravenous push or bolus. • For the first 2 infusions, administer the diluted solution intravenously over at least 90 minutes. If well tolerated, the minimum time for subsequent infusions can be reduced to 60 minutes.
• If not well tolerated, the minimum time for subsequent infusions should remain at 90 minutes, the rate of infusion should be reduced and pre-medication is recommended for subsequent infusions. 6.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised May 15, 2026[1]

9%). The most common serious adverse reactions are; diarrhoea, inflammatory bowel disease, infusion -related reaction. Tabulated list of adverse reactions The adverse reaction frequencies from clinical trials are based on all-cause adverse event frequencies, where a proportion of the events for an adverse reaction may have other causes than the medicinal product, such as the disease, other medicines or unrelated causes.
Adverse reactions reported in clinical trials and derived from spontaneous reporting are listed below in table 1. The adverse reactions are listed by MedDRA System Organ Class and by frequency. The frequencies of adverse reactions is based on 4 placebo-controlled studies with 285 patients.
Patients were exposed to teprotumumab for a median of 148 days. Frequencies are defined according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000); not known (cannot be estimated from the available data).
Table 1. Adverse reactions MedDRA system organ class Very common (> 1/10) Common (> 1/100 to < 1/10) Uncommon (> 1/1 000 to < 1/100) Rare (> 1/1 0 000 to < 1/1 0 00) Not known/cannot be estimated from available data Infections and infestations COVID-19 Metabolism and nutrition disorders Hyperglycaemia1 Diabetic ketoacidosis Hyperosmolar hyperglycaemic state2 Nervous system disorders Headache Dysgeusia Ear and labyrinth disorders Ear discomfort, Autophony, Deafness, Eustachian tube dysfunction, Eustachian tube patulous, Hypoacusis, Neurosensory hypoacusis, Tinnitus Conductive deafness, Deafness unilateral, Hyperacusis, Tympanic membrane disorder Gastrointestinal disorders Diarrhoea Nausea Inflammatory bowel disease1 Skin and subcutaneous tissue disorders Alopecia Dry skin Nail bed disorder, Nail discoloration, Onychoclasis Ingrowing nail Musculoskeletal and connective tissue disorders Muscle spasms Reproductive system and breast disorders Amenorrhea, Hypomenorrhea, Dysmenorrhea, Irregular menstruation, Heavy menstrual bleeding General disorders and administration site conditions Fatigue Investigations Weight decreased Injury, poisoning and procedural complications Infusion -related reaction 1 1 See below description of selected adverse reactions 2 Observed in the post-marketing setting – frequency cannot be estimated from the available data.
Description of selected adverse reactions Infusion-related reactions Infusion-related reactions were usually mild or moderate in intensity and can be successfully managed with antihistamines and/or corticosteroids, if needed. No infusion-related reactions in TED trials were reported as anaphylactic reactions.
4 for action to be taken in case of infusion -related reactions. Inflammatory bowel disease (IBD) In study TED01RV, a teprotumumab-treated participant, who had a pre-existing IBD, experienced severe diarrhoea. 4. Hyperglycaemia In clinical trials, all hyperglycaemia events reported in teprotumumab-treated patients were mild or moderate in severity.
In the completed clinical trials, all events resolved. 8 days (range: 1 to 169 days) from first infusion of TEPEZZA. One serious event of Diabetic ketoacidosis was reported in a patient from the placebo group who received a single dose of TEPEZZA.
This event was severe and resolved. The time to onset for this event was 20 days. 4. Hearing impairment In clinical trials, the majority of hearing impairment events reported in teprotumumab-treated patients were mild or moderate in severity.
9 days (range: 3 to 153 days). One serious event of conductive deafness was reported for a teprotumumab-treated patient. This event was severe, led to discontinuation of Teprotumumab and did not resolve. The time to onset for this event was 152 days.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

GBOfficial regulatory label· Warnings and precautions· revised May 15, 2026[1]

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Infusion-related reactions TEPEZZA may cause infusion reactions.
8). Patients should be advised to contact their healthcare professionals if they experience signs and symptoms of infusion-related reactions including but not limited to transient increases in blood pressure, feeling hot, tachycardia, dyspnoea, headache and muscular pain.
Patients should be monitored closely throughout the infusion and for 90 minutes after completion of the infusion. Based on the severity of the infusion- related reaction, TEPEZZA infusion should be interrupted or discontinued, and appropriate medical management should be instituted.
In patients who experience an infusion reaction, consideration should be given to pre-medicating with an antihistamine, antipyretic, corticosteroid and/or administering all subsequent infusions at a slower infusion rate. For patients who experience an anaphylactic reaction, discontinue TEPEZZA immediately and permanently.
Hyperglycaemia Hyperglycaemia or increased blood glucose may occur in patients treated with TEPEZZA. 2% of patients (80% of whom had pre-existing diabetes or impaired glucose tolerance) experienced hyperglycaemia. Adverse events associated with hyperglycaemia may include diabetes mellitus, diabetic ketoacidosis, glucose tolerance impaired, glycosylated haemoglobin increased and a hyperosmolar hyperglycaemic state.
Hyperglycaemic events should be managed with medications for glycaemic control, if necessary. Assess patients for elevated blood glucose and symptoms of hyperglycaemia prior to infusion and continue to monitor while on treatment with TEPEZZA.
8). Blood glucose monitoring is recommended for 6 months after completion of treatment with teprotumumab. Hearing impairment TEPEZZA may cause severe hearing impairment including hearing loss, which in some cases may be permanent. 8).
Assess patients’ hearing before, during and after treatment with TEPEZZA. For patients with pre-existing hearing impairment, the benefit-risk of treatment should be considered. The benefit-risk of continuing treatment with TEPEZZA should be reconsidered in patients who experience severe hearing impairment during the treatment.

This is not medical advice. Consult a qualified healthcare professional.

Treatment with this medicinal product must be initiated and supervised by a physician experienced in the diagnosis and treatment of thyroid eye disease. It should be administered by a healthcare professional and under the supervision of a physician with access to appropriate medical support to manage infusion-related reactions.
Posology Dosing is based on the patient’s actual body weight. The recommended dose is 10 mg/kg of body weight for the initial dose followed by 20 mg/kg of body weight for 7 additional doses given once every three weeks as an intravenous infusion.
For the first 2 infusions, the diluted solution is administered as an intravenous infusion over at least 90 minutes. If well tolerated, infusions 3 to 8 can be administered over 60 minutes every three weeks (see Method of administration).
Clinical response is expected with 8 doses of treatment. Additional doses should not be administered if response is not achieved with this regimen. 4). 2). Renal impairment Renal impairment is generally not expected to have any significant impact on the pharmacokinetics of monoclonal antibodies.
2). Hepatic impairment Hepatic impairment is generally not expected to have any significant impact on the pharmacokinetics of monoclonal antibodies. 2). 3). The safety and efficacy of teprotumumab in adolescents whose growth is complete to less than 18 years has not been established.
No data are available. Method of administration • This medicinal product must be administered as an intravenous infusion. It must not be administered as an intravenous push or bolus. • Prior to infusion: - the powder must be reconstituted with water for injection.
9%) solution for infusion. • TEPEZZA must not be co-administered with other medicinal products through the same infusion line. • For the first 2 infusions, the diluted solution must be administered intravenously over at least 90 minutes.
If well tolerated, the minimum time for subsequent infusions can be reduced to 60 minutes. • If the 60-minute infusion is not well tolerated, the minimum time for subsequent infusions should remain at 90 minutes, the rate of infusion should be reduced and pre-medication is recommended for subsequent infusions.
6.

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised March 25, 2026[2]

5%). 4). Tabulated list of adverse reactions Adverse reactions reported in clinical trials and derived from spontaneous reporting are listed below in table 1. The frequencies of adverse reactions are based on 4 placebo-controlled studies with 285 patients (teprotumumab = 152 patients; placebo = 133 patients).
Patients were exposed to teprotumumab for a median of 148 days. The adverse reaction frequencies from clinical trials are based on all-cause adverse event frequencies, where a proportion of the events for an adverse reaction may have other causes than the medicinal product, such as the disease, other treatments or unrelated causes.
The adverse reactions are listed by MedDRA System Organ Class and by frequency. Frequencies are defined according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000); not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. Table 1. 9% patients treated with teprotumumab and all were mild or moderate in intensity and transient and were successfully managed with antihistamines and/or corticosteroids, if needed.
4 for action to be taken in case of infusion-related reactions. 7%)]. 7%) with pre-existing hearing impairment reported an event of neurosensory hypoacusis, which led to the discontinuation of teprotumumab. 7%) with pre-existing hearing impairment reported a serious event of conductive deafness, also resulting in the discontinuation of teprotumumab.
4. 0%) were mild or moderate in severity and managed as needed with treatments used for glycaemic control. 7%) was reported in clinical studies for a patient who received a single-dose of teprotumumab. Post-marketing cases of hyperosmolar hyperglycaemic state have been reported.
The events of diabetes mellitus, diabetic ketoacidosis, and hyperosmolar hyperglycaemic state all occurred in patients with pre-existing 9 diabetes or pre-existing pre-diabetes, and other co-morbidities. Patients with diabetes or pre-diabetes at baseline may experience increased hyperglycaemic excursion, as insulin and IGF-1 receptors are homologous and share downstream signalling pathways.
4. Inflammatory bowel disease (IBD) In study TED01RV, a teprotumumab-treated participant, who had a pre-existing IBD, experienced severe diarrhoea. 4. 0% experienced madarosis. Most cases were mild. Patients may experience unresolved hair loss after completing teprotumumab treatment.
Muscle spasms In clinical studies, muscle spasms were the most commonly reported adverse […]

EUOfficial regulatory label· Warnings and precautions· revised March 25, 2026[2]

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Infusion-related reactions Teprotumumab may cause infusion reactions.
8). Infusion reactions may occur during any of the infusions or within 90 minutes after an infusion. Patients should be monitored closely throughout the infusion and for 90 minutes after completion of infusion. Following the monitoring period, patients should be advised to contact their healthcare professionals if symptoms of infusion-related reactions, including transient hypertension, feeling hot, tachycardia, dyspnoea, headache, abdominal pain, muscular pain, palpitations, rash, haptic hallucinations, sleep paralysis, nasal congestion, urticaria, or diarrhoea occur.
Based on the severity of the infusion-related reaction, infusion should be interrupted or discontinued, and appropriate medical management should be instituted. In patients who experience an infusion reaction, consideration should be given to pre-medicating with an antihistamine, antipyretic, corticosteroid and/or administering all subsequent infusions at a slower infusion rate.
Hearing impairment Teprotumumab may cause severe hearing impairment including hearing loss, which in some cases may be permanent. 8). Patients should be advised to report symptoms of altered hearing promptly to their healthcare professional.
For patients with pre-existing hearing impairment, worsening of hearing impairment symptoms during or after the completion of the treatment with teprotumumab can occur. The benefit-risk of treatment should be considered in these patients.
Patient’s hearing should be assessed using audiometry before starting treatment (first infusion), during treatment (around the third or fourth infusion) and after completing treatment with teprotumumab. If a patient experiences subjective hearing changes during treatment, additional audiometric assessments are recommended, as necessary.
It is advised to monitor for hearing changes in all patients for 6 months after completion of treatment. Prolonged follow-up may be needed for patients who develop hearing changes, at the discretion of the treating physician. It should be strongly considered to discontinue teprotumumab in patients experiencing hearing loss that requires intervention, limits their ability to self-care, or is considered profound.

This is not medical advice. Consult a qualified healthcare professional.