Screening report
EMRELIS (TELISOTUZUMAB VEDOTIN)
“…in 29 responders. 15 REFERENCES 1. "OSHA Hazardous Drugs." OSHA . http://www.osha.gov/SLTC/hazardousdrugs/index.html 16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied EMRELIS…”
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“…vedotin-tllv) For Injection 20 mg per vial Hazardous Drug For Intravenous Infusion after reconstitution and dilution Single-Dose Vial Discard Unused Portion Dispense the enclose…”
“…a hazardous component. Follow applicable special handling and disposal procedures in accordance with local requirements. 1 Reconstitute and further dilute EMRELIS prior to intravenous infusi…”
“…2 months after the last dose. Males Based on genotoxicity findings, advise male patients with female partners of reproductive potential to use effective contraception durin…”
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Animal study“…vedotin-tllv or the small molecule MMAE. Mutagenesis MMAE was positive for genotoxicity in the in vivo rat bone marrow micronucleus study through an aneugenic mechanism…”
Animal study“…MMAE. Mutagenesis MMAE was positive for genotoxicity in the in vivo rat bone marrow micronucleus study through an aneugenic mechanism. MMAE was not mutagenic in the ba…”
“…prior to subsequent infusions. ( 5.4 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise patients about the potential risk to a fetus and to use effective contraception…”
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“…prior to subsequent infusions. 5. 5 Embryo-Fetal Toxicity Based on the mechanism of action and findings in animals, EMRELIS can cause fetal harm when administered to a…”
“…pregnant rats during organogenesis resulted in embryo-fetal mortality and structural abnormalities at exposures similar to the clinical exposure at the recommended dose [see Data…”
“…not to breastfeed. ( 8.2 ) Infertility : May impair fertility. ( 8.3 ) 8.1 Pregnancy Risk Summary Based on the mechanism of action and findings in animals, EMRELIS can cause fetal h…”
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“…of reproductive potential that EMRELIS may impair fertility [see ( 13 ) ]. EMRELIS™ [telisotuzumab vedotin-tllv] Manufactured by: AbbVie Inc. North Chicago, IL 60064, U.S.A. U.S…”
“…) Lactation : Advise not to breastfeed. ( 8.2 ) Infertility : May impair fertility. ( 8.3 ) 8.1 Pregnancy Risk Summary Based on the mechanism of action and findings in animals, EM…”
“…level. Grade 4 Permanently discontinue EMRELIS. Interstitial Lung Disease (ILD)/Pneumonitis [see Warnings and Precautions ( 5.2 )] Grade 1 Withhold EMRELIS and consider corticosteroids as soon…”
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“…[see Dosage and Administration ( 2.3 )]. 5.2 Interstitial Lung Disease /Pneumonitis EMRELIS can cause severe, life-threatening, or fatal interstitial lung disease (ILD)/pneumonitis. In the s…”
“…can cause severe, life-threatening, or fatal interstitial lung disease (ILD)/pneumonitis. In the safety population [see Adverse Reactions ( 6.1 )], ILD/pneumonitis occurred in 10% of patient…”
“…Telisotuzumab vedotin-tllv is a c-Met directed antibody-drug conjugate (ADC) comprised of a humanized immunoglobulin G1 kappa (IgG1κ) monoclonal antibody conjugated to the small molecule mic…”
Set aside: found but not counted (4)
For information only. This is a count of how many of the six NIOSH hazard-criteria appear in this label after negated and supporting-only statements are set aside. Findings from animal studies count, as NIOSH’s definition counts them, and are tagged “Animal data”. It is not a hazard determination, and the drug-class hint is not counted.