Padcev

Enfortumab vedotin

Locally advanced or metastatic urothelial cancer in adults who have previously received programmed death receptor-1 or programmed death-ligand 1 inhibitor & platinum-containing chemotherapy.

IV infusion Infuse over 30 min. Recommended dose: 1.25 mg/kg on days 1, 8 & 15 of 28-day cycle until disease progression or unacceptable toxicity. Patient weighing ≥100 kg Max: 125 mg. 1st dose reduction: 1 mg/kg up to 100 mg. 2nd dose reduction: 0.75 mg/kg up to 75 mg. 3rd reduction: 0.5 mg/kg up to 50 mg.

Hypersensitivity.

Not to be administered as IV push or bolus inj. Permanently discontinue if confirmed SJS or TEN, grade 4 or recurrent severe skin reactions; grade ≥3 pneumonitis/ILD & peripheral neuropathy occurs. Withhold treatment for suspected SJS, TEN or bullous lesions; grade 2 worsening w/ fever or grade 3 skin reactions; Grade 2 pneumonitis/ILD; if blood glucose is elevated (>13.9 mmol/L, >250 mg/dL). Stop infusion & monitor for adverse reactions if extravasation occurs. Mild to moderate skin reactions predominantly maculopapular rash. Hyperglycemia & diabetic ketoacidosis, including fatal events, in patients w/ & w/o pre-existing DM. Severe, life-threatening or fatal pneumonitis/ILD. Peripheral neuropathy, predominantly peripheral sensory neuropathy. Ocular disorders, predominantly dry eye. Skin & soft tissue injury. Patients w/ pre-existing hyperglycemia or high BMI (≥30 kg/m²). Observe patients for fever or flu-like symptoms as 1st sign of severe skin reaction. Monitor patients starting w/ 1st cycle & throughout treatment for skin reactions; for signs & symptoms indicative of pneumonitis/ILD eg, hypoxia, cough, dyspnea or interstitial infiltrates on radiologic exams; symptoms of new or worsening peripheral neuropathy; possible infusion site extravasation during administration. Monitor blood glucose levels prior to dosing & periodically throughout treatment in patients w/ or at risk for DM or hyperglycemia. Consider artificial tears for prophylaxis of dry eye & referral for ophth evaluation if ocular symptoms do not resolve or worsen. ESRD. Severe hepatic impairment. Females of reproductive potential should have pregnancy test w/in 7 days prior to starting treatment & to use effective contraception during, & for at least 12 mth after stopping treatment. Men are advised not to father a child during treatment & up to 9 mth following last dose & to have sperm samples frozen & stored before treatment. Not recommended during pregnancy. Discontinue lactation during treatment & for at least 6 mth after last dose. Ped patients.

Anemia; diarrhea, vomiting, nausea; fatigue; hyperglycemia, decreased appetite; peripheral sensory neuropathy, dysgeusia; dry eye; alopecia, pruritus, rash, maculo-papular rash, dry skin; increased ALT & AST, decreased wt. Infusion site extravasation; peripheral, peripheral motor & peripheral sensorimotor neuropathy, paresthesia, hypoesthesia, gait disturbance, muscular weakness; drug eruption, skin exfoliation, conjunctivitis, bullous dermatitis, blister, stomatitis, palmar-plantar erythrodysesthesia syndrome, eczema, erythema, erythematous, macular, papular, pruritic & vesicular rash.

Increased unconjugated MMAE C_max & AUC exposure w/ ketoconazole. Concomitant use w/ strong CYP3A4 inhibitors eg, boceprevir, clarithromycin, cobicistat, indinavir, itraconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole. Decreased exposure of unconjugated MMAE w/ moderate effect w/ strong CYP3A4 inducers eg, rifampicin, carbamazepine, phenobarb, phenytoin, St. John's wort (Hypericum perforatum).

Targeted Cancer Therapy

L01FX13 - enfortumab vedotin ; Belongs to the class of other monoclonal antibodies and antibody drug conjugates. Used in the treatment of cancer.

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