Screening report
PADCEV EJFV (ENFORTUMAB VEDOTIN)
“…7 Figure 8 Figure 9 15 REFERENCES 1. "OSHA Hazardous Drugs." OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html 16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied PADCEV (e…”
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“…• PADCEV is a hazardous drug. Follow applicable special handling and disposal procedures. 1 Prior to administration, the PADCEV vial is reconstituted with Sterile Water for Injection (SWFI). The re…”
“…PADCEV is a hazardous drug. Follow applicable special handling and disposal procedures. 1 17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient I…”
“…agent (MMAE) have not been conducted. MMAE was genotoxic in the rat bone marrow micronucleus study through an aneugenic mechanism. This effect is consistent with the pharmaco…”
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“…rat bone marrow micronucleus study through an aneugenic mechanism. This effect is consistent with the pharmacological effect of MMAE as a microtubule-disrupting agent. MMAE…”
“…MMAE was genotoxic in the rat bone marrow micronucleus study through an aneugenic mechanism. This effect is consistent with the pharmacological effect of MMAE as a microtubul…”
“…for suspected extravasation. ( 5.6 ) • Embryo-Fetal Toxicity: PADCEV can cause fetal harm. Advise of the potential risk to a fetus and to use effective contraception. ( 5.…”
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“…infusion and monitor for adverse reactions. 5.7 Embryo-Fetal Toxicity Based on the mechanism of action and findings in animals, PADCEV can cause fetal harm when administered to a p…”
“…of organogenesis caused maternal toxicity, embryo-fetal lethality, structural malformations and skeletal anomalies at maternal exposures similar to the clinical exposures at t…”
“…males of reproductive potential that PADCEV may impair fertility [see ( 8.3 )]. Manufactured and Marketed by: Astellas Pharma US, Inc. Northbrook, Illinois 60062 Distributed and Mark…”
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“…3 weeks after the last dose [see ( 8.2 )] . Infertility Advise females and males of reproductive potential that PADCEV may impair fertility [see ( 8.3 )]. Manufactured and M…”
Animal study“…PADCEV and for 4 months after the last dose. Infertility Females Based on findings in animal studies with MMAE-containing antibody-drug conjugates (ADCs), PADCEV may impair fem…”
“…treatment at the same dose level. Pneumonitis/Interstitial Lung Disease (ILD) [see Warnings and Precautions ( 5.3 )] Grade 2 Withhold until Grade ≤1, then resume treatment at the same dose le…”
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“…is >250 mg/dL. ( 2.2 , 5.2 ) • Pneumonitis/Interstitial Lung Disease (ILD): Severe, life-threatening or fatal pneumonitis/ILD may occur. Withhold PADCEV for Grade 2 pneumonitis/ILD and con…”
“…and Administration ( 2.2 )] . 5.3 Pneumonitis/Interstitial Lung Disease (ILD) Severe, life-threatening or fatal pneumonitis/ILD occurred in patients treated with PADCEV. When PADCEV was given…”
“…Enfortumab vedotin-ejfv is a Nectin-4 directed antibody-drug conjugate (ADC) comprised of a fully human anti-Nectin-4 IgG1 kappa monoclonal antibody (AGS-22C3) conjugated to the small molecu…”
Set aside: found but not counted (3)
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.