Who gets it
About 1 in 3 people with Graves' disease develop eye problems, and smoking increases the risk.
NEIMedical Eye Care · Prescription
TEPEZZA Teprotumumab-trbw for thyroid eye disease.
TEPEZZA is an intravenous infusion indicated for the treatment of thyroid eye disease regardless of disease activity or duration. Optometrists recognize the disease, co-manage surface and diplopia care, and refer for infusion therapy.
8infusions, given every 3 weeks
10 then 20 mg/kgfirst dose, then the remaining seven
71% and 83%proptosis responders at week 24 in Studies 1 and 2
1 in 3people with Graves' disease who develop eye problems
The disease and the drug
Treating the orbit, not only the thyroid
Thyroid eye disease causes swelling of the tissues around the eye, leading to bulging, lid retraction, dryness and double vision. Teprotumumab blocks the insulin-like growth factor-1 receptor.
Symptoms
Bulging eyes, dryness, puffy lids, double vision, light sensitivity and eye pain or pressure.
NEIIndication
Treatment of thyroid eye disease regardless of activity or duration.
LabelResults
Proptosis responder rates at week 24 were 71% versus 20% on placebo in Study 1, and 83% versus 10% in Study 2.
LabelThe infusion course
Infusions are given in an infusion setting under the prescriber's supervision.
- Eight infusions every three weeks
- Hearing assessment before, during and after
- Glucose monitoring
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Dosing
10 mg/kg for the first infusion, then 20 mg/kg every three weeks for seven more infusions.
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Infusion time
At least 90 minutes for the first two infusions; later infusions may be shortened to 60 minutes if tolerated.
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Supply
500 mg single-dose vial of lyophilized powder for reconstitution.
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Company
Marketed by Amgen; manufactured by Horizon Therapeutics Ireland DAC.
Co-management
The optometrist's role
Patients need surface care and monitoring long before and after any infusion.
Recognize
Look for proptosis, lid retraction, exposure keratopathy and new diplopia, especially in patients with thyroid disease.
Support
Treat dryness with lubricants and gels, advise on smoking cessation, and use prisms for diplopia when appropriate.
Refer
Refer moderate to severe or progressive cases for evaluation of medical therapy, and watch for signs of optic nerve compression.
Safety information
Indication
TEPEZZA is indicated for the treatment of Thyroid Eye Disease regardless of Thyroid Eye Disease activity or duration.
Warnings and precautions
- Infusion reactions during or within 1.5 hours of an infusion
- Exacerbation or new onset of inflammatory bowel disease
- Hyperglycemia; monitor glucose and control diabetes before and during treatment
- Hearing impairment, which can be severe and sometimes permanent; assess hearing before, during and after treatment
- Encephalopathy reported after approval
Most common adverse reactions (5% or more)
- Muscle spasms 25%
- Nausea 17%
- Alopecia 13%
- Diarrhea and fatigue 12% each
- Hyperglycemia and hearing impairment 10% each
- Dysgeusia, headache and dry skin 8% each
Product details
| Generic name | Teprotumumab-trbw |
|---|---|
| Route | Intravenous infusion |
| Vial | 500 mg single-dose |
| Initial US approval | 2020 |
Questions about TEPEZZA
Who is a candidate?
Patients with thyroid eye disease; the label covers the disease regardless of activity or duration. The treating physician decides on therapy.
How many infusions are given?
Eight, every three weeks: 10 mg/kg first, then 20 mg/kg for the remaining seven.
What should patients be told about hearing?
Hearing impairment, sometimes permanent, has been reported, so hearing is assessed before, during and after treatment.
Does it affect blood sugar?
Hyperglycemia occurred in 10% of patients, so glucose is checked before and during treatment.
What can optometrists do?
Recognize the disease, manage the ocular surface and diplopia, monitor for optic nerve compression and coordinate referral.
Does smoking matter?
Yes. NEI notes smoking increases the risk of eye problems in Graves' disease, and quitting is the most important lifestyle change.
References
Recognize thyroid eye disease early
Protect the surface, manage diplopia, and refer patients who may benefit from infusion therapy.
TEPEZZA is a trademark of Horizon Therapeutics, an Amgen company. Written for licensed eye care professionals. Review the full Prescribing Information. Individual results vary.