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
Side 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%)
Mode 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