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Emrelis (telisotuzumab vedotin-tllv)
telisotuzumab vedotin
Adult Dosing .
Dosage forms: INJ
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing incl. toxicity-related dose adjustments
- [dosing clarification]
- for patients >100 kg, cap wt at 100 kg for dose calculations
nonsquamous non-small cell lung CA, locally advanced or metastatic
- [1.9 mg/kg/dose IV q2wk]
- Max: 190 mg/dose; Info: for patients w/ high c-Met protein overexpression
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin 1.1-1.5x ULN or AST >ULN: no adjustment; bilirubin >1.5x ULN: not defined
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- avoid: breastfeeding during tx and x1mo after D/C
- caution: patients of childbearing potential
- caution: male patients of reproductive potential
Drug Interactions .
Overview
telisotuzumab vedotin
microtubule inhibitor; c-Met-directed antibody
- CYP3A4 substrate
- immunomodulatory effects
- peripheral neuropathy
Avoid/Use Alternative
- adenovirus vaccine, live
- chikungunya vaccine, live
- cholera vaccine, live
- dengue vaccine, live
- influenza nasal vaccine, live
- measles/mumps/rubella vaccine, live
- rabies vaccine
- rotavirus vaccine, live
- smallpox vaccine, live
- typhoid vaccine, live
- varicella vaccine, live
- yellow fever vaccine, live
Monitor/Modify Tx
- anthrax vaccine
- chikungunya vaccine
- COVID-19 vaccine
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- ebola vaccine, live
- Haemophilus b vaccine
- hepatitis A vaccine
- hepatitis B vaccine
- human papillomavirus vaccine
- influenza H5N1 vaccine
- influenza vaccine
- Japanese encephalitis vaccine
- meningococcal vaccine
- pneumococcal vaccine
- poliovirus vaccine
- respiratory syncytial virus vaccine
- smallpox/mpox vaccine, live
- tick-borne encephalitis vaccine
- typhoid vaccine
Caution Advised
- adagrasib
- ado-trastuzumab emtansine
- amiodarone
- apalutamide
- atazanavir
- benznidazole
- bortezomib
- bosentan
- brentuximab vedotin
- butalbital
- cabazitaxel
- carbamazepine
- carboplatin
- cenobamate
- ceritinib
- chloramphenicol
- ciltacabtagene autoleucel
- ciprofloxacin
- cisplatin
- clarithromycin
- cobicistat
- dabrafenib
- daptomycin
- delafloxacin
- dinutuximab
- disulfiram
- docetaxel
- efavirenz
- elranatamab
- encorafenib
- enfortumab vedotin
- enzalutamide
- eribulin
- ethanol
- ethanol (in some formulations)
- etravirine
- fexinidazole
- fosphenytoin
- glofitamab
- hydroxychloroquine
- idelalisib
- itraconazole
- ivosidenib
- ixabepilone
- ixazomib
- ketoconazole
- leflunomide
- levofloxacin
- levoketoconazole
- linezolid
- lonafarnib
- lopinavir/ritonavir
- lorlatinib
- lumacaftor/ivacaftor
- mavacamten
- metronidazole
- mifepristone
- miglustat
- mirvetuximab soravtansine
- mitapivat
- mitotane
- modafinil
- mosunetuzumab
- moxifloxacin
- nafcillin
- naxitamab
- nefazodone
- nelarabine
- nelfinavir
- ofloxacin
- oxaliplatin
- paclitaxel
- pacritinib
- pentobarbital
- pexidartinib
- phenobarbital
- phenytoin
- polatuzumab vedotin
- pomalidomide
- ponatinib
- posaconazole
- primidone
- repotrectinib
- ribociclib
- rifabutin
- rifampin
- rifapentine
- ritonavir
- sotorasib
- St. John's wort
- talquetamab
- teclistamab
- teriflunomide
- thalidomide
- tinidazole
- tipranavir
- tisagenlecleucel
- tisotumab vedotin
- tucatinib
- vigabatrin
- vinblastine
- vincristine
- vinorelbine
- voriconazole
Adverse Reactions .
Serious Reactions
- peripheral neuropathy
- interstitial lung dz
- pneumonitis
- pleural effusion
- pneumonia
- ocular surface disorder
- infusion rxn
Common Reactions
- peripheral neuropathy
- fatigue
- peripheral edema
- appetite decr.
- nausea
- blurred vision
- constipation
- pneumonia
- keratitis
- vomiting
- interstitial lung dz
- pneumonitis
- arthralgia
- dizziness
- dry eyes
- infusion rxn
- photophobia
- albumin decr.
- glucose incr.
- calcium decr.
- ALT or AST incr.
- lymphocytes decr.
- GGT incr.
- Hgb decr.
- phosphate decr.
- sodium decr.
- alk phos incr.
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; signs/symptoms of infusion rxn during infusion; signs/symptoms of peripheral neuropathy, interstitial lung dz; ophthalmic exam if ocular signs/symptoms
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; risk of teratogenicity and embryo-fetal death based on animal data at 2x systemic exposure and drug's mechanism of action
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective contraception during tx and x2mo after D/C in patients of childbearing potential and during tx and x4mo after D/C in male patients
Lactation
Clinical Summary
avoid breastfeeding during tx and x1mo after D/C; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for telisotuzumab vedotin: catabolism; CYP450: unknown; Info: antibody-drug conjugate releases active drug monomethyl auristatin E (MMAE); for MMAE: unknown; CYP450: 3A4 substrate
Excretion: unknown; Half-life: 3 days (antibody-conjugated MMAE), 4 days (unconjugated MMAE)
Subclass: Immunotherapy, Antibody-Drug Conjugates ; Immunotherapy, MET Inhibitors ; Mitosis Inhibitors, Antimicrotubule Agents
Mechanism of Action
binds to c-MET-expressing cells, forming internalized complex which releases monomethyl auristatin E (MMAE) intracellularly; MMAE binds to microtubules, inhibiting mitosis and inducing apoptosis (antibody-drug conjugate)
Formulary .
No Formulary Selected
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