Tepezza (teprotumumab-trbw)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Teprotumumab-trbw, a humanimmunoglobulin G1 (IgG1) monoclonal antibody, is an insulin-like growth factor-1 receptor (IGF-1R) inhibitor.
Teprotumumab-trbw is a fully human immunoglobulin G1(IgG1) monoclonal antibody specific for insulin-like growth factor-1 receptor (IGF-1R). It is produced in Chinese hamster ovary (CHO-DG44) cells. Teprotumumab-trbw binds to IGF-1R and inhibits its activation and signaling; the specific mechanism of action in patients with thyroid eye disease is uncertain.
The elimination half-life for teprotumumab-trbw is 20 days. Metabolism of teprotumumab-trbw is expected to occur via proteolysis, but the metabolic pathway for teprotumumab-trbw has not been fully characterized. The pharmacokinetics of teprotumumab-trbw are not significantly impacted by age (18-80 years), gender, race/ethnicity, or weight (46-169 kg).
USES: This medication is used to treat thyroid eye disease, also known as Graves' eye disease. Teprotumumab belongs to a class of drugs known as monoclonal antibodies. It is not known exactly how it works, but it may help improve symptoms such as a feeling of irritation or grittiness in the eyes, redness or swelling of the white part of the eyeball (conjunctiva), excessive tearing or dry eyes, swelling of the eyelids, sensitivity to light, bulging of the eyes, or double vision.
Generic name: teprotumumab-trbw
Pronunciation: (TEP-roe-TOOM-ue-mab)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Tepezza
Indications
The following indications are listed for Tepezza:
- Thyroid Eye Disease
Also known as: Ophthalmic Graves' Disease, Thyroid Ophthalmopathy.
Dosing
No dosing information is available for this tab.
No dosing information is available for this tab.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
No studies evaluating the drug interaction potential of teprotumumab have been conducted.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*None.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
The most common adverse reactions (incidence >5%) are muscle spasm, nausea, alopecia,diarrhea, fatigue, hyperglycemia, hearing impairment, dry skin, dysgeusia, headache, decreased weight,and nail disorder.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
Safety and efficacy of teprotumumab have not been established in pediatric patients.
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.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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