Padcev
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Omid Afkhami-Ardakani
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Black Box Warning
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Serious Skin Reactions
See full prescribing information for complete Boxed Warning.
Padcev can cause severe and fatal skin reactions, including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). Monitor patients for skin reactions, and discontinue Padcev permanently in patients with confirmed SJS or TEN.
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Overview
Padcev is an Antineoplastic Agent that is FDA approved for the treatment of Locally advanced or metastatic urothelial cancer (mUC) in adult patients and Locally advanced or metastatic urothelial cancer (mUC) in adult patients who are ineligible for cisplatin-containing chemotherapy.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include Rash, alopecia, dry skin, pruritus, peripheral neuropathy, dysgeusia, decreased appetite, diarrhea, nausea, dry eye, and fatigue..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
1.25 mg/kg (up to a maximum of 125 mg for patients ≥100 kg) administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of a 28-day cycle.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Padcev in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Padcev in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Padcev is not approved for use in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Padcev in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Padcev in pediatric patients.
Contraindications
There is limited information regarding Padcev Contraindications in the drug label.
Warnings
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Serious Skin Reactions
See full prescribing information for complete Boxed Warning.
Padcev can cause severe and fatal skin reactions, including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). Monitor patients for skin reactions, and discontinue Padcev permanently in patients with confirmed SJS or TEN.
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Serious Skin Reactions: Monitor for signs of SJS or TEN. Discontinue Padcev permanently in patients with confirmed SJS or TEN.
Hyperglycemia: Monitor blood glucose levels, especially in patients with or at risk for diabetes mellitus.
Peripheral Neuropathy: Monitor for symptoms of peripheral neuropathy. Consider dose interruption or reduction if neuropathy occurs.
Ocular Disorders: Monitor for ocular disorders. Consider artificial tears for dry eyes.
Infusion Site Reactions: Monitor for infusion site extravasation.
Embryo-Fetal Toxicity: Padcev can cause fetal harm. Advise females of reproductive potential to use effective contraception.
Adverse Reactions
Clinical Trials Experience
Skin and Subcutaneous Tissue Disorders:
Rash (52%)
Alopecia (50%)
Dry skin (26%)
Pruritus (26%)
Nervous System Disorders:
Peripheral neuropathy (56%)
Dysgeusia (42%)
Gastrointestinal Disorders:
Decreased appetite (52%)
Diarrhea (43%)
Nausea (30%)
Ocular Disorders:
Dry eye (40%)
General Disorders:
Fatigue (48%)
Postmarketing Experience
There is limited information regarding Padcev Postmarketing Experience in the drug label.
Drug Interactions
CYP3A4 Inhibitors: Concomitant use with strong CYP3A4 inhibitors may increase exposure to MMAE, leading to increased toxicity. Monitor patients closely.
CYP3A4 Inducers: Concomitant use with strong CYP3A4 inducers may decrease exposure to MMAE, potentially reducing efficacy.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Padcev in women who are pregnant.
Pregnancy Category (AUS): D
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Padcev in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Padcev during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Padcev in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Padcev in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Padcev in geriatric settings.
Gender
There is no FDA guidance on the use of Padcev with respect to specific gender populations.
Race
There is no FDA guidance on the use of Padcev with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Padcev in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Padcev in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Padcev in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Padcev in patients who are immunocompromised.
Administration and Monitoring
Administration
Monotherapy: Administer 1.25 mg/kg (up to a maximum of 125 mg for patients ≥100 kg) as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of a 28-day cycle.
Combination with Pembrolizumab: Administer 1.25 mg/kg (up to a maximum of 125 mg for patients ≥100 kg) as an intravenous infusion over 30 minutes on Days 1 and 8 of a 21-day cycle.
Monitoring
Monitor for signs of serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
Regularly assess blood glucose levels, especially in patients with or at risk for diabetes mellitus.
Evaluate for peripheral neuropathy symptoms; adjust dosage as necessary.
Monitor ocular health; advise patients to report any visual changes.
Assess renal function periodically.
IV Compatibility
Dilute the reconstituted solution with 0.9% Sodium Chloride Injection, 5% Dextrose Injection, or Lactated Ringer's Injection to achieve a final concentration of 0.3 mg/mL to 4 mg/mL.
Administer the diluted solution over 30 minutes through an intravenous line.
Overdosage
Overdose may result in exacerbated adverse reactions, including severe skin reactions, peripheral neuropathy, and hyperglycemia.
Pharmacology
There is limited information regarding Padcev Pharmacology in the drug label.
Mechanism of Action
Padcev is a Nectin-4-directed antibody-drug conjugate (ADC) composed of a fully human monoclonal antibody linked to the microtubule-disrupting agent monomethyl auristatin E (MMAE). Upon binding to Nectin-4-expressing cells, the ADC is internalized, and MMAE is released to induce cell cycle arrest and apoptosis.
Structure
There is limited information regarding Padcev Structure in the drug label.
Pharmacodynamics
Padcev exhibits antitumor activity by delivering MMAE directly to Nectin-4-expressing cancer cells, leading to cell death.
Pharmacokinetics
Absorption: Administered intravenously; bioavailability is 100%.
Distribution: The volume of distribution is approximately 8.3 L.
Metabolism: MMAE is primarily metabolized by CYP3A4.
Elimination: The terminal half-life is approximately 3.4 days for enfortumab vedotin-ejfv and 2.4 days for MMAE.
Nonclinical Toxicology
There is limited information regarding Padcev Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Padcev Clinical Studies in the drug label.
How Supplied
Formulation:
Lyophilized powder for injection.
Strength:
20 mg and 30 mg single-dose vials.
Storage
Store vials refrigerated at 2°C to 8°C (36°F to 46°F).
Do not freeze.
Protect from light.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
Skin Reactions:
Inform patients about the risk of severe skin reactions and advise them to report any skin changes promptly.
Peripheral Neuropathy:
Advise patients to report symptoms such as numbness, tingling, or muscle weakness.
Hyperglycemia:
Inform patients about the risk of elevated blood sugar levels and the importance of monitoring.
Ocular Disorders:
Advise patients to report any visual changes and consider using artificial tears for dry eyes.
Reproductive Risks:
Discuss the potential for fetal harm and advise on effective contraception during treatment and for a specified period after the last dose.
Precautions with Alcohol
Alcohol-Padcev interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
Padcev®
Look-Alike Drug Names
There is limited information regarding Padcev Look-Alike Drug Names in the drug label.
Price
References
The contents of this FDA label are provided by the National Library of Medicine.