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.
Assess patients for elevated blood glucose and symptoms of hyperglycemia prior to infusion and continue to monitor while on treatment.
Assess patients’ hearing before, during, and after treatment
Monitor patients for signs and symptoms of inflammatory bowel disease (IBD). If IBD exacerbation is suspected, discontinue use.
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 this medical product. 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.
Inflammatory Bowel Disease: May cause an exacerbation of inflammatory bowel disease (IBD). IBD has been reported in some patients without a prior diagnosis of IBD. If IBD exacerbation is suspected, consider discontinue use.
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

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 have not been conducted in pregnant women. There are insufficient data in pregnant women to inform any drug associated risks for adverse developmental outcomes. Based on mechanism of action inhibiting IGF-1R, postnatal exposure to teprotumumab may cause harm. Advise females of reproductive potential to use effective contraception prior to initiation, during treatment and for 6 months after the last dose.
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