Enfortumab vedotin: Drug information

(For additional information see "Enfortumab vedotin: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)

ALERT: US Boxed Warning

Dermatologic toxicity

Enfortumab vedotin can cause severe and fatal cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which occurred predominantly during the first cycle of treatment, but may occur later. Closely monitor patients for skin reactions. Immediately withhold enfortumab vedotin and consider referral for specialized care for suspected SJS or TEN, or severe skin reactions. Permanently discontinue enfortumab vedotin in patients with confirmed SJS or TEN, or grade 4 or recurrent grade 3 skin reactions.

Brand Names: US

Padcev

Brand Names: Canada

Padcev

Pharmacologic Category

Antineoplastic Agent, Anti-Nectin-4;
Antineoplastic Agent, Antibody Drug Conjugate;
Antineoplastic Agent, Antimicrotubular;
Antineoplastic Agent, Monoclonal Antibody

Dosing: Adult

Dosage guidance:

Dosing: Actual body weight (up to the maximum dose of 125 mg for patients ≥100 kg) was used to calculate the dose in the clinical trials (Ref).

Urothelial cancer, locally advanced or metastatic, combination therapy

Urothelial cancer, locally advanced or metastatic, combination therapy: IV: 1.25 mg/kg (maximum dose: 125 mg) on days 1 and 8 of a 21-day cycle (in combination with pembrolizumab); continue until disease progression or unacceptable toxicity (Ref).

Urothelial cancer, locally advanced or metastatic, single-agent treatment

Urothelial cancer, locally advanced or metastatic, single-agent treatment: IV: 1.25 mg/kg (maximum dose: 125 mg) on days 1, 8, and 15 of a 28-day cycle; continue until disease progression or unacceptable toxicity (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling; however, kidney impairment had no clinically significant difference in enfortumab vedotin (antibody drug conjugate or monomethyl auristatin E) pharmacokinetics. The effect of end-stage kidney disease (with or without dialysis) is unknown.

Dosing: Hepatic Impairment: Adult

Mild impairment (total bilirubin 1 to 1.5 times ULN and any AST, or total bilirubin ≤ ULN and AST > ULN): There are no dosage adjustments provided in the manufacturer’s labeling; however, mild impairment had no clinically significant difference in enfortumab vedotin (antibody drug conjugate or monomethyl auristatin E) pharmacokinetics.

Moderate to severe impairment (total bilirubin >1.5 times ULN and any AST): Avoid enfortumab vedotin use.

Dosing: Obesity: Adult

Note : Per the manufacturer's labeling, the maximum dose for patients ≥100 kg is 125 mg. Actual body weight (up to the maximum dose of 125 mg) was used to calculate the dose in the clinical trials (Ref).

American Society of Clinical Oncology guidelines for appropriate systemic therapy dosing in adults with cancer with a BMI ≥30 kg/m²: Utilize patient's actual body weight for calculation of BSA- or weight-based dosing ; manage regimen-related toxicities in the same manner as for patients with a BMI <30 kg/m²; if a dose reduction is utilized due to toxicity, may consider resumption of full, weight-based dosing (or previously tolerated dose level) with subsequent cycles only if dose escalations are allowed in the prescribing information, if contributing underlying factors (eg, hepatic or kidney impairment) are sufficiently resolved, AND if performance status has markedly improved or is considered adequate (Ref).

Dosing: Adjustment for Toxicity: Adult

**Recommended Enfortumab Vedotin Dosage Reduction Levels**
Initial (usual) dose	1.25 mg/kg up to a maximum of 125 mg
First dose reduction level	1 mg/kg up to a maximum of 100 mg
Second dose reduction level	0.75 mg/kg up to a maximum of 75 mg
Third dosage reduction level	0.5 mg/kg up to a maximum of 50 mg

**Enfortumab Vedotin Dosage Adjustment for Toxicities**
Adverse reaction	Severity^a	Enfortumab Vedotin Dose Modification
^aGrade 1 is mild, grade 2 is moderate, grade 3 is severe, and grade 4 is life-threatening.
Hematologic toxicities	Grade 3, or grade 2 thrombocytopenia	Withhold enfortumab vedotin until ≤ grade 1, then resume treatment at the same dose level or consider dose reduction by 1 dose level.
Hematologic toxicities	Grade 4	Withhold enfortumab vedotin until ≤ grade 1, then reduce dose by 1 dose level or discontinue treatment.
Hyperglycemia	Blood glucose >250 mg/dL	Withhold enfortumab vedotin until elevated blood glucose has improved to ≤250 mg/dL, then resume treatment at the same dose level. May require insulin.
Peripheral neuropathy	Grade 2	Withhold enfortumab vedotin until ≤ grade 1, then resume treatment at the same dose level (if first occurrence). For a recurrence, withhold until ≤ grade 1, then resume treatment with the dose reduced by 1 dose level.
Peripheral neuropathy	Grade 3 or higher	Permanently discontinue enfortumab vedotin.
Dermatologic toxicity (skin reactions)	Consider topical corticosteroids and antihistamines as clinically indicated.
	Suspected Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN)	Immediately withhold enfortumab vedotin; consult specialist to confirm the diagnosis. If not SJS/TEN, refer to grade 2 to 4 skin reactions.
	Persistent or recurrent grade 2 skin reactions	Consider withholding enfortumab vedotin until ≤ grade 1, then resume treatment at the same dose level or reduce dose by 1 dose level.
	Grade 3 skin reactions	Withhold enfortumab vedotin until ≤ grade 1, then resume treatment at the same dose level or reduce dose by 1 dose level.
	Confirmed SJS or TEN; grade 4 or recurrent grade 3 skin reactions	Permanently discontinue enfortumab vedotin.
Pulmonary toxicity: Pneumonitis/Interstitial lung disease	Signs/symptoms indicative of pneumonitis/interstitial lung disease	Evaluate and exclude infectious, neoplastic, and other causes.
	Grade 2	Withhold enfortumab vedotin until ≤ grade 1, then resume at the same dose level or consider dose reduction by 1 dose level.
	Grade 3 or higher	Permanently discontinue enfortumab vedotin.
Ocular toxicity	Any	Consider artificial tears for dry eye prophylaxis and ophthalmologic evaluation if ocular symptoms occur or do not resolve. Ophthalmic topical steroids may be considered (after ophthalmic exam) if clinically indicated. Consider enfortumab vedotin dose interruption or dose reduction for symptomatic ocular disorders.
Other nonhematologic toxicity	Grade 3	Withhold enfortumab vedotin until ≤ grade 1, then resume treatment at the same dose level or consider dose reduction by 1 dose level.
Other nonhematologic toxicity	Grade 4	Permanently discontinue enfortumab vedotin.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions (Significant): Considerations

Dermatologic toxicity

Skin reactions and skin rash are very common with therapy, particularly maculopapular rash and pruritus. Other reactions include exfoliation of skin, skin photosensitivity, urticaria, vesicular eruption, and xeroderma. Severe skin reactions (grade 3 to 4) have occurred in up to 10% of treated patients (Ref), including symmetrical drug-related intertriginous and flexural exanthema, bullous dermatitis, exfoliative dermatitis, and palmar-plantar erythrodysesthesia. Fatal cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported (Ref). Dermatologic toxicities frequently require therapy interruption, dose reduction, and/or discontinuation. Of patients who experienced rash, nearly two-thirds experienced complete resolution and approximately one-fifth experienced partial improvement (Ref). Events occurred at a higher rate when enfortumab vedotin was given concurrently with pembrolizumab.

Mechanism: Not clearly established; Nectin-4 (targeted by enfortumab vedotin and also expressed in skin) disturbance may impair cell-cell adhesion leading to epidermal detachment (Ref). Alternatively, delivery of monomethyl auristatin E (MMAE), a microtubule disruption agent conjugated to enfortumab vedotin, may be the sole attributable factor for dermatologic toxicities (Ref).

Onset: Varied; median time to onset of severe skin reactions was 0.7 months (range: 0.1 to 6 months). Median time to onset for SJS and TEN was 11 days (range: 9 to 21 days) (Ref).

Hyperglycemia

Hyperglycemia occurred in patients treated with enfortumab vedotin, including severe (grade 3 or 4) and fatal events; therapy interruption is warranted for blood glucose >250 mg/dL. Diabetic ketoacidosis (DKA) was also observed, including DKA in patients without preexisting diabetes mellitus.

Onset: Varied; median time to onset of hyperglycemia was 0.6 months (range: 0.1 to 20 months).

Risk factors:

• Higher BMI

• Higher baseline HbA1c (patients with HbA1c ≥8% were excluded from initial trials)

Ocular effects

Ocular disorders are common in patients treated with enfortumab vedotin. Most ocular events involve the cornea and include keratitis, blepharitis, blurred vision, limbal stem cell deficiency, and other events associated with dry eye syndrome.

Onset: Varied; median time to onset of symptomatic ocular disorder was 1.6 months (range: 0 to 19 months).

Peripheral neuropathy

Peripheral neuropathy, predominantly peripheral sensory neuropathy, peripheral motor neuropathy, and asthenia, occurred in nearly half of patients treated with enfortumab vedotin in clinical trials. Peripheral neuropathy was usually low grade and manageable, although grade 3 toxicity was reported in a small percentage of patients (Ref). Therapy interruption, dosage reduction, and/or permanent discontinuation may be warranted, depending on the severity. Complete resolution occurred in 14% of patients, and 46% of patients had partial improvement (at the time of their last evaluation). Events occurred at a higher rate when enfortumab vedotin was given concurrently with pembrolizumab.

Onset: Varied; median time to onset of grade ≥2 peripheral neuropathy was 4.9 months (range: 0.1 to 20 months).

Pneumonitis/interstitial lung disease

Pneumonitis/interstitial lung disease (ILD) occurred in patients treated with enfortumab vedotin, including severe (grade 3 or 4) and fatal events. Events occurred at a higher rate when enfortumab vedotin was given concurrently with pembrolizumab. Events occurred at a higher rate when enfortumab vedotin was given concurrently with pembrolizumab.

Onset: Varied; median time to onset of pneumonitis/ILD was 2.7 months (range: 0.6 to 6 months).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.

>10%:

Dermatologic: Alopecia (47% to 53%), maculopapular rash (24%), pruritus (26% to 35%), skin rash (52% to 66%; including symmetrical drug-related intertriginous and flexural exanthema [Keerty 2020]), xeroderma (17% to 26%)

Endocrine & metabolic: Decreased serum phosphate (25% to 39%), decreased serum potassium (16% to 19%), hyperglycemia (10% to 16%), weight loss (16% to 35%)

Gastrointestinal: Abdominal pain (20%), constipation (28%), decreased appetite (40% to 52%), diarrhea (35% to 42%; grades 3/4: 4% to 6%), dysgeusia (26% to 42%), increased serum lipase (11% to 18%), nausea (30% to 45%; grades 3/4: 1% to 3%), vomiting (13% to 18%; grades 3/4: 2%)

Genitourinary: Urinary tract infection (17%)

Hematologic & oncologic: Anemia (20% to 38%; grade 3/4: 6% to 11%), decreased neutrophils (14% to 27%; grade 3/4: 5% to 12%), hemorrhage (17%; grade 3/4: 3%), lymphocytopenia (32% to 43%; grade 3/4: 10% to 15%)

Hepatic: Increased serum aspartate aminotransferase (12%)

Nervous system: Fatigue (48% to 56%; including asthenia), peripheral neuropathy (50% to 58%; grade 3/4: 4% to 8%; including abnormal gait and hypoesthesia), peripheral sensory neuropathy (40%)

Neuromuscular & skeletal: Musculoskeletal pain (25%)

Ophthalmic: Blurred vision (13%), dry eye syndrome (24% to 40%; including limbal stem cell deficiency), ocular toxicity (40%)

Renal: Increased serum creatinine (18% to 23%)

Miscellaneous: Fever (22%)

1% to 10%:

Dermatologic: Cellulitis (5%)

Endocrine & metabolic: Decreased serum sodium (7% to 8%), increased serum potassium (8%), increased uric acid (7% to 9%)

Hematologic & oncologic: Febrile neutropenia (4%)

Hepatic: Increased serum alanine aminotransferase (9% to 10%)

Immunologic: Antibody development (3%)

Infection: Herpes zoster infection (3%), sepsis (3% to 5%)

Nervous system: Myasthenia (7%), peripheral motor neuropathy (7%)

Renal: Acute kidney injury (3% to 7%)

Respiratory: Dyspnea (3%), pneumonia (5%), pneumonitis (2% to 4%; including interstitial lung disease)

Frequency not defined:

Dermatologic: Acneiform eruption, contact dermatitis, erythema multiforme, palmar-plantar erythrodysesthesia, pustular rash, skin photosensitivity, stasis dermatitis, urticaria, vesicular eruption

Endocrine & metabolic: Diabetic ketoacidosis

Ophthalmic: Blepharitis, conjunctivitis, eye irritation, increased lacrimation, keratitis, punctate keratitis

Postmarketing:

Dermatologic: Bullous dermatitis (Enescu 2022), dermatitis (vacuolar interface dermatitis with maturation disarray of keratinocytes) (Wu 2019), erythematous rash (Dobry 2021), exfoliation of skin (Enescu 2022), exfoliative dermatitis (Enescu 2022), indurated plaques of the skin (Dobry 2021), pruritic rash (Dobry 2021), Stevens-Johnson syndrome (Francis 2020; Viscuse 2021), toxic epidermal necrolysis (Francis 2020; Viscuse 2021)

Ophthalmic: Cataract (bilateral anterior subcapsular) (Thibodeau 2021)

Contraindications

There are no contraindications listed in the manufacturer's US labeling.

Canadian labeling: Hypersensitivity to enfortumab vedotin or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Extravasation: May be an irritant. Skin and soft tissue reactions secondary to extravasation have been observed after enfortumab vedotin administration, including grade 3 or 4 reactions. A small percentage of patients experienced skin and soft tissue reactions. Extravasation reactions may be delayed. Erythema, swelling, increased temperature, and pain worsened until 2 to 7 days after extravasation and resolved within 1 to 4 weeks of peak. A small percentage of patients also developed extravasation reactions with secondary cellulitis, bullae, or exfoliation.

Special populations:

• Older adults: Patients ≥75 years of age experienced higher incidences of fatal adverse reactions with enfortumab vedotin (either as a single agent or in combination with pembrolizumab), compared to patients <75 years of age.

Disease-related concerns:

• Hepatic impairment: In another antibody drug conjugate also containing monomethyl auristatin E, the incidence of ≥ grade 3 adverse events and fatalities was increased in patients with moderate or severe hepatic impairment (compared to normal hepatic function).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous [preservative free]:

Padcev: enfortumab vedotin-ejfv 20 mg (1 ea); enfortumab vedotin-ejfv 30 mg (1 ea)

Generic Equivalent Available: US

Pricing: US

Solution (reconstituted) (Padcev Intravenous)

20 mg (per each): $3,304.80

30 mg (per each): $4,957.20

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous:

Padcev: 20 mg (1 ea); 30 mg (1 ea)

Administration: Adult

IV: Infuse over 30 minutes. Do not administer as an IV push or bolus. Do not mix with or administer with other medications.

May be an irritant. Ensure adequate venous access prior to infusion. Monitor infusion site during administration for possible extravasation. If extravasation occurs, stop infusion and monitor for adverse reactions.

When used in combination with pembrolizumab, on the days that both enfortumab vedotin and pembrolizumab are administered, in the clinical trial, enfortumab vedotin was administered first, followed by pembrolizumab ~30 minutes after completion of enfortumab vedotin on the same day (Ref).

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH [group 1]).

Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2016; USP-NF 2020).

Use: Labeled Indications

Urothelial cancer, locally advanced or metastatic:

Treatment (as a single agent) of locally advanced or metastatic urothelial cancer in adults who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinum-containing chemotherapy, or who are ineligible for cisplatin-containing chemotherapy and have previously received 1 or more prior lines of therapy.

Treatment (in combination with pembrolizumab) of locally advanced or metastatic urothelial cancer in adults.

Medication Safety Issues

Sound-alike/look-alike issues:

Enfortumab vedotin may be confused with brentuximab vedotin, elotuzumab, encorafenib, polatuzumab vedotin, tisotumab vedotin.

High alert medication:

This medication is in a class the Institute for Safe Medication Practices includes among its list of drug classes which have a heightened risk of causing significant patient harm when used in error.

Metabolism/Transport Effects

Substrate of CYP3A4 (minor), P-glycoprotein/ABCB1 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

CYP3A4 Inducers (Strong): May decrease the serum concentration of Enfortumab Vedotin. Specifically, concentrations of the active monomethyl auristatin E (MMAE) component may be decreased. Risk C: Monitor therapy

Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Inhibitors of CYP3A4 (Strong) and P-glycoprotein: May increase the serum concentration of Enfortumab Vedotin. Specifically, concentrations of the active monomethyl auristatin E (MMAE) component may be increased. Risk C: Monitor therapy

Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Reproductive Considerations

Evaluate pregnancy status prior to use in patients who could become pregnant. Patients who could become pregnant should use effective contraception during therapy and for 2 months after the last enfortumab vedotin dose. Patients with partners who can become pregnant should use effective contraception during therapy and for 4 months after the last dose of enfortumab vedotin.

Based on data from animal studies, enfortumab vedotin may impair male fertility.

Pregnancy Considerations

Based on the mechanism of action and data from animal reproduction studies, in utero exposure to enfortumab vedotin may cause fetal harm.

Breastfeeding Considerations

It is not known if enfortumab vedotin is present in breast milk.

Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during therapy and for 3 weeks after the last enfortumab vedotin dose.

Monitoring Parameters

Monitor CBC with differential, blood glucose (monitor closely in patients with, or at risk for, diabetes mellitus or hyperglycemia), and LFTs. Evaluate pregnancy status prior to use in patients who could become pregnant. Monitor for symptoms of new or worsening peripheral neuropathy, ocular disorders, and/or dermatologic toxicity. Monitor for signs/symptoms of pneumonitis or interstitial lung disease (eg, hypoxia, cough, dyspnea, or interstitial infiltrates); evaluate and exclude infectious, neoplastic, or other causes. Consider ophthalmologic evaluation for ocular symptoms that do not resolve. Monitor infusion site during infusion for possible extravasation; if extravasation occurs, monitor extravasation site for adverse reactions.

The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.

Mechanism of Action

Enfortumab vedotin is an antibody drug conjugate (ADC) directed at Nectin-4 (an adhesion protein located on cell surfaces). Nectin-4 is highly expressed in urothelial carcinoma as well as breast, gastric, and lung cancers (Rosenberg 2019). It contains an IgG1 anti-Nectin-4 antibody conjugated to a microtubule-disrupting agent, monomethyl auristatin E (MMAE). MMAE is attached to the antibody via a protease cleavable linker. The ADC binds to Nectin-4 expressing cells to form a complex which is internalized within the cell. Released MMAE binds to the tubules and disrupts the cellular microtubule network, inducing cell cycle arrest and apoptosis of Nectin-4 expressing cells (Rosenberg 2019). In animal models, the combination of enfortumab vedotin with an anti-PD-1 monoclonal antibody resulted in immune function upregulation and increased antitumor activity.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: V_dss: Antibody drug conjugate (ADC): 12.8 L.

Protein binding: Unconjugated monomethyl auristatin E (MMAE): 68% to 82%.

Metabolism: Enfortumab vedotin is expected to undergo catabolism to small peptides, amino acids, unconjugated MMAE, and unconjugated MMAE-related catabolites. Unconjugated MMAE is released from the ADC via proteolytic cleavage and is primarily metabolized by CYP3A4.

Half-life elimination: ADC: 3.6 days; MMAE: 2.6 days.

Time to peak: ADC: at the end of the infusion; unconjugated MMAE: At ~2 days after a dose.

Excretion: Unconjugated MMAE: Feces: 17%; urine: 6%; primarily as unchanged form (data extrapolated from another ADC product).

Clearance: ADC: 0.11 L/hour; Unconjugated MMAE: 2.11 L/hour.

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Enfortumab vedotin: Drug information