Active Ingredient: Teprotumumab
Teprotumumab is indicated in adults for the treatment of moderate to severe thyroid eye disease (TED).
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 10 milligrams teprotumumab per kilogram of body weight, one dose, over the duration of 3 weeks. Afterwards, intravenous, 20 milligrams teprotumumab per kilogram of body weight, once every 3 weeks, 7 doses in total.
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. Clinical response is expected with 8 doses of treatment. Additional doses should not be administered if response is not achieved with this regimen.
For patients experiencing immediate hypersensitivity reactions or infusion-related reactions during the first two infusions of teprotumumab, pre-medication with an antihistamine, antipyretic, corticosteroid products and/or administering all subsequent infusions at a slower infusion rate is recommended.
Teprotumumab must be administered as an intravenous infusion.
Teprotumumab must not be co-administered with other medicinal products through the same infusion line.
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