Bladder, kidney, and other urologic cancers:

Indications for PADCEV:

Treatment of locally advanced or metastatic urothelial cancer (mUC) who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.

Adult:

Give by IV infusion over 30mins. 1.25mg/kg (max 125mg) on Days 1, 8 and 15 of a 28-day cycle; continue until disease progression or unacceptable toxicity. Dose modifications: see full labeling.

Children:

Not established.

Warnings/Precautions:

Monitor blood glucose levels in patients with, or at risk of, diabetes or hyperglycemia; withhold dose if blood glucose >250mg/dL. Monitor for new or worsening symptoms of peripheral neuropathy; consider dose interruption/reduction if occurs; permanently discontinue if Grade ≥3 reaction. Monitor for ocular disorders; if symptoms occur, consider ophthalmologic exam; interrupt/reduce dose if needed. Monitor for skin reactions; withhold if Grade 3 reaction; permanently discontinue if Grade 4 or recurrent Grade 3 reaction occurs. Moderate or severe hepatic impairment: avoid. Embryo-fetal toxicity. Advise to use effective contraception during and for 2 months (females) and for 4 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for ≥3 weeks after the last dose).

Pharmacologic Class:

Nectin-4 directed antibody-drug conjugate.

Interactions:

May be potentiated by strong CYP3A4 inhibitors (eg, ketoconazole); monitor closely.

Adverse Reactions:

Fatigue, peripheral neuropathy, decreased appetite, rash, alopecia, nausea, dysgeusia, diarrhea, dry eye, pruritus, dry skin; infusion-site extravasation (discontinue if occurs).

Generic Availability:

NO

How Supplied:

Single-dose vial—1

Pricing for PADCEV

30mg vial (Qty: 6)
Appx. price $20132
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