Tepezza (teprotumumab-trbw)
Insulin-like Growth Factor-1 Receptor Inhibitor (IGF-1R) mAb Intravenous Vial (Ea)
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)
Drug class: Insulin-like Growth Factor-1 Receptor Inhibitor (IGF-1R) mAb
Therapeutic class: Endocrine
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.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Tepezza 500 Mg Vial | Maintenance | Infuse 20 mg/kg over 60-90 minute(s) by intravenous route every 3 weeks. |
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.
Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
Igg Antibodies And Derivatives/Efgartigimod-Alfa
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Efgartigimod-alfa binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)
CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The manufacturer of efgartigimod-alfa states that efgartigimod-alfa should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, efgartigimod-alfa should be discontinued.(3)
DISCUSSION: Clinical drug interaction studies with efgartigimod-alfa have not been performed. Efgartigimod-alfa may decrease concentrations of compounds that bind to the human FcRn.(3)
Igg Antibodies And Derivatives/Nipocalimab-Aahu
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Nipocalimab-aahu binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)
CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The manufacturer of nipocalimab-aahu states that nipocalimab-aahu should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, nipocalimab-aahu should be discontinued.(3)
DISCUSSION: Clinical drug interaction studies with nipocalimab-aahu have not been performed. Nipocalimab-aahu may decrease concentrations of compounds that bind to the human FcRn.(3)
Moderate Interaction: Assess the risk to the patient and take action as needed.
Igg Antibodies And Derivatives/Rozanolixizumab-Noli
SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Rozanolixizumab-noli binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)
CLINICAL EFFECTS: The effectiveness of medications that bind to FcRn may be decreased.(3)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The manufacturer of rozanolixizumab-noli states that concurrent use with medications that bind to the human neonatal Fc receptor (FcRn) should be closely monitored for reduced effectiveness of these medications. If long-term use of such medications is essential for the patient, consider discontinuing rozanolixizumab-noli and use alternative therapies.(3)
DISCUSSION: Clinical drug interaction studies with rozanolixizumab-noli have not been performed. Rozanolixizumab-noli may decrease concentrations of compounds that bind to the human FcRn.(3)
Contraindications
*None.
There are no contraindication contraindications for this drug.
- Inflammatory bowel disease
- Pregnancy
- Diabetes mellitus
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.
Less Frequent
- Hypertension
Rare or Very Rare
- Diabetic ketoacidosis
- Encephalopathy
- Hyperosmolar hyperglycemic state
- Intestinal perforation
More Frequent
- Alopecia
- Diarrhea
- Dry skin
- Dysgeusia
- Fatigue
- Headache disorder
- Hearing loss
- Hyperglycemia
- Muscle spasm
- Nausea
Less Frequent
- Abnormal vaginal bleeding
- Amenorrhea
- Dysmenorrhea
- Dyspnea
- Earache
- Myalgia
- Nail disorders
- Sensation of warmth
- Weight loss
Rare or Very Rare
- Inflammatory bowel disease
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
| Code | Type | Description |
|---|---|---|
| Thyroid eye disease | ||
| E05.00 | ICD10CM | Thyrotoxicosis with diffuse goiter without thyrotoxic crisis or storm |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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