Tepezza
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Omid Afkhami-Ardakani
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Overview
Tepezza is an Insulin-like Growth Factor-1 Receptor (IGF-1R) Inhibitor that is FDA approved for the treatment of Thyroid Eye Disease (TED).. Common adverse reactions include Muscle spasms, Nausea, diarrhea, Alopecia, dry skin, Hyperglycemia, Dysgeusia, headache, and Hearing impairment..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Administer Tepezza intravenously with an initial dose of 10 mg/kg, followed by 20 mg/kg every three weeks for a total of eight infusions.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Tepezza in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Tepezza in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Safety and effectiveness have not been established in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Tepezza in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Tepezza in pediatric patients.
Contraindications
There is limited information regarding Tepezza Contraindications in the drug label.
Warnings
Infusion Reactions: Infusion reactions have been observed. Consider premedication and monitor patients during infusion.
Exacerbation of Preexisting Inflammatory Bowel Disease (IBD): Tepezza may exacerbate IBD. Monitor patients with IBD for disease activity.
Hyperglycemia: Increased blood glucose levels have been reported. Monitor blood glucose levels in patients with diabetes or prediabetes.
Hearing Impairment Including Hearing Loss: Hearing impairment has been reported. Assess hearing before, during, and after treatment.
Embryo-Fetal Toxicity: Tepezza can cause fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for 6 months after the last dose.
Adverse Reactions
Clinical Trials Experience
Musculoskeletal: Muscle spasms.
Gastrointestinal: Nausea, diarrhea.
Dermatologic: Alopecia, dry skin.
Metabolic: Hyperglycemia.
Neurologic: Dysgeusia, headache.
Ophthalmic: Hearing impairment.
Postmarketing Experience
There is limited information regarding Tepezza Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Tepezza Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Tepezza in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Tepezza in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Tepezza during labor and delivery.
Nursing Mothers
It is unknown whether Tepezza is excreted in human milk; breastfeeding is not recommended during treatment and for 3 weeks after the final dose.
Pediatric Use
There is no FDA guidance on the use of Tepezza in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Tepezza in geriatric settings.
Gender
There is no FDA guidance on the use of Tepezza with respect to specific gender populations.
Race
There is no FDA guidance on the use of Tepezza with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Tepezza in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Tepezza in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Tepezza in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Tepezza in patients who are immunocompromised.
Administration and Monitoring
Administration
Administer Tepezza intravenously with an initial dose of 10 mg/kg, followed by 20 mg/kg every three weeks for a total of eight infusions.
Infuse over approximately 90 minutes for the first two infusions; subsequent infusions may be administered over 60 minutes if well tolerated.
Monitoring
Monitor patients for infusion reactions during and after administration.
Monitor blood glucose levels in patients with diabetes or prediabetes.
Assess hearing before, during, and after treatment.
Monitor patients with preexisting IBD for disease activity.
IV Compatibility
Not applicable
Overdosage
There is limited information regarding Tepezza overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Tepezza Pharmacology in the drug label.
Mechanism of Action
Teprotumumab-trbw is a fully human monoclonal antibody that binds to the insulin-like growth factor-1 receptor (IGF-1R), inhibiting its activation and signaling. This inhibition reduces the inflammatory response and orbital tissue expansion associated with Thyroid Eye Disease.
Structure
There is limited information regarding Tepezza Structure in the drug label.
Pharmacodynamics
There is limited information regarding Tepezza Pharmacodynamics in the drug label.
Pharmacokinetics
Absorption: Administered intravenously; bioavailability is 100%.
Distribution: Volume of distribution is approximately 7.58 L.
Metabolism: Expected to undergo catabolism to peptides and amino acids.
Elimination: Clearance is approximately 0.27 L/day; half-life is approximately 20 days.
Nonclinical Toxicology
Carcinogenicity: Long-term animal studies for carcinogenic potential have not been conducted.
Genotoxicity: No genotoxicity assessments reported.
Reproductive toxicity: Fetal harm observed in animal models at clinically relevant doses.
Clinical Studies
There is limited information regarding Tepezza Clinical Studies in the drug label.
How Supplied
Form: Lyophilized powder for reconstitution.
Strength: 500 mg per vial.
Packaging: Single-use vial.
Storage
Store vials refrigerated at 2°C to 8°C (36°F to 46°F); do not freeze.
Keep in the original carton to protect from light.
Reconstituted solution should be used immediately or stored for up to 4 hours at 2°C to 8°C.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
Advise patients:
On the schedule and duration of treatment (eight infusions over ~24 weeks).
About possible infusion reactions and the need to report symptoms such as shortness of breath, hives, or swelling.
About potential worsening of inflammatory bowel disease if present.
That hyperglycemia can occur, especially in those with diabetes or impaired glucose tolerance; glucose monitoring may be necessary.
That hearing problems, including hearing loss, have been reported — report any changes in hearing.
To avoid pregnancy during treatment and for at least 6 months after the last dose due to fetal risk.
Precautions with Alcohol
Alcohol-Tepezza interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
Tepezza®
Manufactured by Horizon Therapeutics USA, Inc.
Look-Alike Drug Names
There is limited information regarding Tepezza Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.