Please wait while the formulary information is being retrieved.
Drug overview for TEPEZZA (teprotumumab-trbw):
Generic name: teprotumumab-trbw (TEP-roe-TOOM-ue-mab)
Drug class: Insulin-like Growth Factor-1 Receptor Inhibitor (IGF-1R) mAb
Therapeutic class: Endocrine
Teprotumumab-trbw, a humanimmunoglobulin G1 (IgG1) monoclonal antibody, is an insulin-like growth factor-1 receptor (IGF-1R) inhibitor.
No enhanced Uses information available for this drug.
Generic name: teprotumumab-trbw (TEP-roe-TOOM-ue-mab)
Drug class: Insulin-like Growth Factor-1 Receptor Inhibitor (IGF-1R) mAb
Therapeutic class: Endocrine
Teprotumumab-trbw, a humanimmunoglobulin G1 (IgG1) monoclonal antibody, is an insulin-like growth factor-1 receptor (IGF-1R) inhibitor.
No enhanced Uses information available for this drug.
DRUG IMAGES
TEPEZZA 500 MG VIAL
The following indications for TEPEZZA (teprotumumab-trbw) have been approved by the FDA:
Indications:
Thyroid eye disease
Professional Synonyms:
Ophthalmic Graves' disease
Thyroid ophthalmopathy
Indications:
Thyroid eye disease
Professional Synonyms:
Ophthalmic Graves' disease
Thyroid ophthalmopathy
The following dosing information is available for TEPEZZA (teprotumumab-trbw):
No enhanced Dosing information available for this drug.
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| TEPEZZA 500 MG VIAL | Maintenance | Adults infuse 20 mg/kg over 60-90 minute(s) by intravenous route every 3 weeks |
No generic dosing information available.
The following drug interaction information is available for TEPEZZA (teprotumumab-trbw):
There are 0 contraindications.
There are 2 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| 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) |
VYVGART, VYVGART HYTRULO |
| 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) |
IMAAVY |
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| 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) |
RYSTIGGO |
The following contraindication information is available for TEPEZZA (teprotumumab-trbw):
Drug contraindication overview.
*None.
*None.
There are 0 contraindications.
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Inflammatory bowel disease |
| Pregnancy |
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Diabetes mellitus |
The following adverse reaction information is available for TEPEZZA (teprotumumab-trbw):
Adverse reaction overview.
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.
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 3 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Hypertension |
| Rare/Very Rare |
|---|
|
Diabetic ketoacidosis Hyperosmolar hyperglycemic state |
There are 16 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Alopecia Diarrhea Dry skin Dysgeusia Fatigue Headache disorder Hearing loss Hyperglycemia Muscle spasm Nausea |
Abnormal vaginal bleeding Amenorrhea Dysmenorrhea Dyspnea Myalgia Sensation of warmth |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for TEPEZZA (teprotumumab-trbw):
Safety and efficacy of teprotumumab have not been established in pediatric patients.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
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.
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.
The following prioritized warning is available for TEPEZZA (teprotumumab-trbw):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for TEPEZZA (teprotumumab-trbw)'s list of indications:
| Thyroid eye disease | |
| E05.00 | Thyrotoxicosis with diffuse goiter without thyrotoxic crisis or storm |
Formulary Reference Tool