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Drug overview for EMRELIS (telisotuzumab vedotin-tllv):
Generic name: TELISOTUZUMAB VEDOTIN-TLLV (tel-EYE-soe-TOOZ-ue-mab ve-DOE-tin)
Drug class: Antineoplastic Monoclonal Antibodies
Therapeutic class: Antineoplastics
Telisotuzumab vedotin-tllv, a c-Met-directed antibody conjugated with the microtubule inhibitor monomethyl auristatin E (MMAE), is an antineoplastic agent.
No enhanced Uses information available for this drug.
Generic name: TELISOTUZUMAB VEDOTIN-TLLV (tel-EYE-soe-TOOZ-ue-mab ve-DOE-tin)
Drug class: Antineoplastic Monoclonal Antibodies
Therapeutic class: Antineoplastics
Telisotuzumab vedotin-tllv, a c-Met-directed antibody conjugated with the microtubule inhibitor monomethyl auristatin E (MMAE), is an antineoplastic agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
EMRELIS 20 MG VIAL
EMRELIS 100 MG VIAL
The following indications for EMRELIS (telisotuzumab vedotin-tllv) have been approved by the FDA:
Indications:
Non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression
Professional Synonyms:
None.
Indications:
Non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression
Professional Synonyms:
None.
The following dosing information is available for EMRELIS (telisotuzumab vedotin-tllv):
It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:
*For IV infusion only.
*The recommended dosage of telisotuzumab vedotin-tllv is 1.9 mg/kg (up to a maximum of 190 mg for patients greater than or equal to 100 kg) administered as an IV infusion over 30 minutes every 2 weeks until disease progression or unacceptable toxicity.
*Reconstitute and further dilute telisotuzumab vedotin-tllv prior to IV infusion.
*See Full Prescribing Information for additional instructions on preparation and administration, and dosage modification recommendations for adverse reactions.
*For IV infusion only.
*The recommended dosage of telisotuzumab vedotin-tllv is 1.9 mg/kg (up to a maximum of 190 mg for patients greater than or equal to 100 kg) administered as an IV infusion over 30 minutes every 2 weeks until disease progression or unacceptable toxicity.
*Reconstitute and further dilute telisotuzumab vedotin-tllv prior to IV infusion.
*See Full Prescribing Information for additional instructions on preparation and administration, and dosage modification recommendations for adverse reactions.
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| EMRELIS 20 MG VIAL | Maintenance | Adults infuse 1.9 mg/kg (up to a maximum of 190 mg) over 30 minute(s) by intravenous route every 2 weeks |
| EMRELIS 100 MG VIAL | Maintenance | Adults infuse 1.9 mg/kg (up to a maximum of 190 mg) over 30 minute(s) by intravenous route every 2 weeks |
No generic dosing information available.
The following drug interaction information is available for EMRELIS (telisotuzumab vedotin-tllv):
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 EMRELIS (telisotuzumab vedotin-tllv):
Drug contraindication overview.
None.
None.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Lactation |
There are 1 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| 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 |
|---|
| Peripheral neuropathy |
The following adverse reaction information is available for EMRELIS (telisotuzumab vedotin-tllv):
Adverse reaction overview.
The most common adverse reactions (>=20%) were peripheral neuropathy, fatigue, decreased appetite, and peripheral edema. The most common Grade 3 or 4 laboratory abnormalities (>=2%) were decreased lymphocytes, increased glucose, increased alanine aminotransferase, increased gamma glutamyl transferase, decreased phosphorus, decreased sodium, decreased hemoglobin, and decreased calcium.
The most common adverse reactions (>=20%) were peripheral neuropathy, fatigue, decreased appetite, and peripheral edema. The most common Grade 3 or 4 laboratory abnormalities (>=2%) were decreased lymphocytes, increased glucose, increased alanine aminotransferase, increased gamma glutamyl transferase, decreased phosphorus, decreased sodium, decreased hemoglobin, and decreased calcium.
There are 3 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Interstitial pneumonitis Pleural effusions Pneumonia |
| Rare/Very Rare |
|---|
| None. |
There are 22 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Abnormal hepatic function tests Anemia Anorexia Blurred vision Constipation Fatigue Hyperglycemia Hypoalbuminemia Hypocalcemia Hypokalemia Hypomagnesemia Hyponatremia Hypophosphatemia Keratitis Leukopenia Lymphopenia Nausea Neutropenic disorder Peripheral edema Peripheral neuropathy Thrombocytopenic disorder Vomiting |
None. |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for EMRELIS (telisotuzumab vedotin-tllv):
Safety and effectiveness of telisotuzumab vedotin-tllv have not been established in pediatric patients.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Based on the mechanism of action and findings in animals, telisotuzumab vedotin-tllv can cause fetal harm when administered to a pregnant woman. There are no available human data on telisotuzumab vedotin-tllv use in pregnant women to inform a drug-associated risk. In an animal reproduction study, administration of the small molecule component of telisotuzumab vedotin-tllv, MMAE, to pregnant rats during organogenesis resulted in embryo-fetal mortality and structural abnormalities at exposures similar to the clinical exposure at the recommended dose.
Advise patients of the potential risks to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Advise patients of the potential risks to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
There are no data on the presence of telisotuzumab vedotin-tllv or MMAE in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise lactating women not to breastfeed during treatment with telisotuzumab vedotin-tllv and for 1 month after the last dose.
Of the 168 patients with previously treated EGFR wild-type non-squamous NSCLC with c-Met protein overexpression treated with telisotuzumab vedotin-tllv in the LUMINOSITY study, 50% were >=65 years of age and 12% were >=75 years of age. No overall differences in safety or effectiveness were observed between older and younger patients.
The following prioritized warning is available for EMRELIS (telisotuzumab vedotin-tllv):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for EMRELIS (telisotuzumab vedotin-tllv)'s list of indications:
| Non-squamous NSCLC with high c-met protein | |
| C34 | Malignant neoplasm of bronchus and lung |
| C34.0 | Malignant neoplasm of main bronchus |
| C34.00 | Malignant neoplasm of unspecified main bronchus |
| C34.01 | Malignant neoplasm of right main bronchus |
| C34.02 | Malignant neoplasm of left main bronchus |
| C34.1 | Malignant neoplasm of upper lobe, bronchus or lung |
| C34.10 | Malignant neoplasm of upper lobe, unspecified bronchus or lung |
| C34.11 | Malignant neoplasm of upper lobe, right bronchus or lung |
| C34.12 | Malignant neoplasm of upper lobe, left bronchus or lung |
| C34.2 | Malignant neoplasm of middle lobe, bronchus or lung |
| C34.3 | Malignant neoplasm of lower lobe, bronchus or lung |
| C34.30 | Malignant neoplasm of lower lobe, unspecified bronchus or lung |
| C34.31 | Malignant neoplasm of lower lobe, right bronchus or lung |
| C34.32 | Malignant neoplasm of lower lobe, left bronchus or lung |
| C34.8 | Malignant neoplasm of overlapping sites of bronchus and lung |
| C34.80 | Malignant neoplasm of overlapping sites of unspecified bronchus and lung |
| C34.81 | Malignant neoplasm of overlapping sites of right bronchus and lung |
| C34.82 | Malignant neoplasm of overlapping sites of left bronchus and lung |
| C34.9 | Malignant neoplasm of unspecified part of bronchus or lung |
| C34.90 | Malignant neoplasm of unspecified part of unspecified bronchus or lung |
| C34.91 | Malignant neoplasm of unspecified part of right bronchus or lung |
| C34.92 | Malignant neoplasm of unspecified part of left bronchus or lung |
| C39.9 | Malignant neoplasm of lower respiratory tract, part unspecified |
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