Miscellaneous ocular agents:
Indications for: TEPEZZA
Thyroid eye disease regardless of disease activity or duration.
Clinical Trials:
The approval of Tepezza was supported by data from 2 studies evaluating the safety and efficacy of teprotumumab in a total of 171 patients with active thyroid eye disease. Across both trials, 84 patients were randomly assigned to Tepezza and 87 were randomly assigned to placebo.
The primary endpoint was proptosis responder rate at week 24, defined as the percentage of patients with ≥2mm reduction in proptosis in the study eye from baseline, without deterioration in the nonstudy eye (≥2mm increase) in proptosis.
Results showed a proptosis responder rate of 71% and 83% in Tepezza-treated patients compared with 20% and 10% with placebo in Study 1 and Study 2, respectively; Tepezza was also associated with improvement in the less severely impacted nonstudy eye.
In addition, a subgroup of patients were evaluated for diplopia, a secondary endpoint, using a 4-point scale where scores ranged from 0 for no diplopia to 3 for constant diplopia. A diplopia responder was defined as a patient with baseline diplopia >0 and a score of 0 at week 24. Among these patients, 53% of Tepezza-treated patients (n=35/66) and 25% of placebo-treated patients (n=15/59) were diplopia responders.
Adult Dosage:
Give 1st two infusions by IV infusion over 90mins; if tolerated, may reduce subsequent infusions to 60mins. Initially 10mg/kg followed by 20mg/kg every 3 weeks for 7 additional infusions.
Children Dosage:
Not established.
TEPEZZA Warnings/Precautions:
Exacerbation of preexisting inflammatory bowel disease; if suspected, consider discontinuation. Hyperglycemia may occur; assess for elevated blood glucose, symptoms of hyperglycemia prior to infusion, monitor during treatment. Patients with hyperglycemia or pre-existing diabetes: ensure appropriate glycemic control before and while receiving treatment. Assess for hearing impairment. Advise females of reproductive potential to use effective contraception prior to initiation, during and for 6 months after the last dose. Pregnancy: not recommended. Nursing mothers.
TEPEZZA Classification:
Human insulin-like growth factor-1 receptor inhibitor (IGF-1R).
Adverse Reactions:
Muscle spasm, nausea, alopecia, diarrhea, fatigue, hyperglycemia, hearing impairment, dry skin, dysgeusia, headache; infusion-related reactions.
Drug Elimination:
Half-life: 20 (±5) days.
Clearance: 0.27 (±0.08) L/day.
Generic Drug Availability:
NO
How Supplied:
Single-dose vial—1
