Teprotumumab

Indications

Teprotumumab is used for: Thyroid Eye Disease

Adult Dose

Thyroid Eye Disease Indicated for thyroid eye disease 10 mg/kg IV initially, followed by 20 mg/kg IV q3 weeks for 7 additional infusions Hepatic impairment Effect of hepatic impairment on the pharmacokinetics of teprotumumab-trbw is unknown

Child Dose

Renal Dose

Renal impairment Mild-to-moderate (CrCl 30-89 mL/min): No significant difference in pharmacokinetics observed

Administration

Contra Indications

Precautions

Infusion reactions may occur; if an infusion reaction occurs, interrupt or slow infusion rate and use appropriate medical management May cause exacerbation of preexisting inflammatory bowel disease (IBD); monitor patients with preexisting IBD for flare of disease; discontinue treatment if IBD worsens Hyperglycemia reported; monitor glucose levels in all patients; treat hyperglycemia with glycemic control medications

Pregnancy-Lactation

Pregnancy Based on findings in animals and its mechanism of action, fetal harm may occur when administered to a pregnant woman Adequate and well-controlled studies have not been conducted in pregnant women Data are insufficient with use in pregnant women to inform any drug-associated risks for adverse developmental outcomes Animal data In utero teprotumumab exposure in cynomolgus monkeys dosed once weekly with teprotumumab throughout pregnancy resulted in external and skeletal abnormalities Teprotumumab exposure may lead to an increase in fetal loss; therefore, do not use during pregnancy If patient becomes pregnant during treatment, discontinue treatment and advise patient of the potential risk to the fetus Contraception Advise females of reproductive potential to use effective contraception before initiation, during treatment, and for 6 months following the last dose Lactation There is no information regarding the presence of teprotumumab in human milk, the effects on the breastfed infant, or the effects on milk production

Interactions

Adverse Effects

Side effects of Teprotumumab : >10% Muscle spasms (25%) Nausea (17%) Alopecia (13%) Diarrhea (12%) Fatigue (12%) 1-10% Hyperglycemia (10%) Hearing impairment (10%) Dysgeusia (8%) Headache (8%) Dry skin (8%)

Mechanism of Action

Monoclonal antibody that binds insulin-like growth factor-1 receptor (IGF-1R) Mechanism of action for thyroid eye disease has not been fully characterized Teprotumumab-trbw binds to IGF-1R and blocks its activation and signaling