TEPEZZA (teprotumumab-trbw)

There are 0 contraindications.

There are 2 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Inflammatory bowel disease
Pregnancy

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Diabetes mellitus

There are 3 severe adverse reactions.

More Frequent	Less Frequent
None.	Hypertension

Rare/Very Rare
Diabetic ketoacidosis Hyperosmolar hyperglycemic state

There are 16 less severe adverse reactions.

More Frequent	Less Frequent
Alopecia Diarrhea Dry skin Dysgeusia Fatigue Headache disorder Hearing loss Hyperglycemia Muscle spasm Nausea	Abnormal vaginal bleeding Amenorrhea Dysmenorrhea Dyspnea Myalgia Sensation of warmth

Rare/Very Rare
None.

Teprotumumab inhibits insulin-like growth factor 1 receptor (IGF-1R); based on its mechanism of action and findings in animal studies, teprotumumab may cause fetal harm when used during pregnancy. No adequate and well-controlled studies of teprotumumab have been conducted in pregnant women. However, studies in pregnant cynomolgus monkeys found that teprotumumab use was associated with increased fetal loss, decreased placental size and weight, decreased fetal size and weight, decreased amniotic fluid volumes, and multiple external and skeletal abnormalities in exposed fetuses.

Advise females of reproductive potential to use effective contraceptive methods prior to teprotumumab initiation, during teprotumumab treatment, and for 6 months after the last dose of teprotumumab. If the patient becomes pregnant while receiving teprotumumab, discontinue teprotumumab and apprise the patient of the potential hazard to the fetus.

It is not known whether teprotumumab or its metabolites are distributed into human milk. The effects of the drug on breast-fed infants or on the production of milk are unknown.

The manufacturer makes no specific dosage recommendations for geriatric patients. Of the 171 patients enrolled in clinical trials of teprotumumab, 15% were >=65 years of age; no differences in efficacy or safety were observed between patients >=65 years of age and younger patients.