TEPEZZA

/ Amgen

The recommended dose of Teprotumumab is an intravenous infusion of 10 mg/kg for the initial dose followed by an intravenous infusion of 20 mg/kg every three weeks for 7 additional infusions.
See prescribing information for full details.

Teprotumumab is indicated for the treatment of moderate to severe Thyroid Eye Disease regardless of activity and duration.

Hypersensitivity to the active substance or to any of the excipients.

Infusion Reactions: Infusion reactions have been reported in approximately 4% of patients treated with TEPEZZA. Signs and symptoms of infusion-related reactions include transient increases in blood pressure, feeling hot, tachycardia, dyspnea, headache and muscular pain. Infusion reactions may occur during any of the infusions or within 1.5 hours after an infusion. 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.
Exacerbation of Preexisting Inflammatory Bowel Disease: Monitor patients with IBD for flare of disease. If IBD exacerbation is suspected, consider discontinuation of Teprotumumab.
Hyperglycemia: Hyperglycemia or increased blood glucose may occur in patients treated with Teprotumumab. In clinical trials, 10% of patients (two thirds of whom had pre-existing diabetes or impaired glucose tolerance) experienced hyperglycemia.
Hearing Impairment Including Hearing Loss: Teprotumumab may cause severe hearing impairment including hearing loss, which in some cases may be permanent
Side Effects (most common): Muscle spasms, Nausea, Alopecia, Diarrhea, Fatigue, Hyperglycemia, Hearing impairment, Dysgeusia, Headache, Dry skin, Weight decreased, Nail disorder.
See prescribing information for full details.

most common adverse reactions (≥5%): Muscle spasms, Nausea, Alopecia, Diarrhea, Fatigue, Hyperglycemia, Hearing impairment, Dysgeusia, Headache, Dry skin, Weight decreased, Nail disorder.
See prescribing information for full details.

No studies evaluating the drug interaction potential

Pregnancy: Adequate and well-controlled studies with teprotumumab have not been conducted in pregnant women. There are insufficient data with teprotumumab use in pregnant women to inform any drug associated risks for adverse developmental outcomes. Appropriate forms of contraception should be implemented prior to initiation, during treatment and for 6 months following the last dose of teprotumumab. If the patient becomes pregnant during treatment, this medical product should be discontinued and the patient advised of the potential risk to the fetus.
Lactation: There is no information regarding the presence of teprotumumab in human milk, the effects on the breast-fed infant or the effects on milk production.

No information is available for patients who have received an overdosage