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Padcev Side Effects

Generic name: enfortumab vedotin

Medically reviewed by Drugs.com. Last updated on Jan 18, 2024.

Note: This document contains side effect information about enfortumab vedotin. Some dosage forms listed on this page may not apply to the brand name Padcev.

Applies to enfortumab vedotin: intravenous powder for solution.

Warning

Intravenous route (Powder for Solution)

Warning: Serious Skin ReactionsEnfortumab vedotin-ejfv 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.Immediately withhold enfortumab vedotin-ejfv and consider referral for specialized care for suspected SJS or TEN or severe skin reactions.Permanently discontinue enfortumab vedotin-ejfv in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions.

Serious side effects of Padcev

Along with its needed effects, enfortumab vedotin (the active ingredient contained in Padcev) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking enfortumab vedotin:

More common

Less common

Incidence not known

Other side effects of Padcev

Some side effects of enfortumab vedotin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common

For Healthcare Professionals

Applies to enfortumab vedotin: intravenous powder for injection.

General

The most common adverse reactions with a frequency of 20% or greater were rash, rash maculo-papular, increased aspartate aminotransferase, increased glucose, increased creatinine, fatigue, peripheral neuropathy, decreased lymphocytes, alopecia, decreased appetite, decreased hemoglobin, diarrhea, decreased sodium, nausea, pruritus, decreased phosphate, dysgeusia, increased alanine aminotransferase, anemia, decreased albumin, decreased neutrophils, increased urate, increased lipase, decreased platelets, decreased weight, dry eye, and dry skin.[Ref]

Dermatologic

Very common (10% or more): Rash (54%), alopecia (47%), pruritus (34%), dry skin (17%), maculo-papular rash (up to 24%)

Common (1% to 10%): Drug eruption, skin exfoliation, conjunctivitis, dermatitis bullous, blister, stomatitis, palmar-plantar erythrodysesthesia syndrome, eczema, erythema, rash erythematous, rash macular, rash papular, rash pruritic, rash vesicular

Uncommon (0.1% to 1%): Dermatitis exfoliative generalized, erythema multiforme, exfoliative rash, pemphigoid, maculovesicular rash, dermatitis, dermatitis allergic, dermatitis contact, intertrigo, skin irritation, stasis dermatitis, blood blister

Frequency not reported: Toxic epidermal necrolysis, Stevens-Johnson syndrome, epidermal necrosis, symmetrical drug-related intertriginous and flexural exanthema[Ref]

Gastrointestinal

Very common (10% or more): Nausea (45%), constipation (28%), abdominal pain (20%), diarrhea (42%), vomiting (18%)[Ref]

Diarrhea includes colitis and enterocolitis.

Abdominal pain includes abdominal pain upper, abdominal pain lower, abdominal discomfort, hepatic pain, abdominal tenderness, and gastrointestinal pain.[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (17%)[Ref]

Urinary tract infection includes urinary tract infection bacterial, urinary tract infection enterococcal, streptococcal urinary tract infection, Escherichia urinary tract infection, pyelonephritis acute, Escherichia pyelonephritis, urinary tract infection fungal, cystitis, urinary tract infection staphylococcal, and urinary tract infection pseudomonal.[Ref]

Hematologic

Very common (10% or more): Decreased hemoglobin (34%), decreased lymphocytes (32%), decreased neutrophils (14%), decreased leukocytes (14%), anemia (20%), hemorrhage (17%)

Uncommon (0.1% to 1%): Febrile neutropenia[Ref]

Hemorrhage includes hematuria, rectal hemorrhage, gastrointestinal hemorrhage, epistaxis, upper gastrointestinal hemorrhage, tumor hemorrhage, hemoptysis, vaginal hemorrhage, anal hemorrhage, hemorrhagic stroke, urethral hemorrhage, infusion site hemorrhage, conjunctival hemorrhage, hemorrhagic ascites, and hemorrhoidal hemorrhage.[Ref]

Hepatic

Very common (10% or more): Increased aspartate aminotransferase (12%)

Common (1% to 10%): Increased alanine aminotransferase[Ref]

Immunologic

Common (1% to 10%): Extravasation (e.g., erythema, swelling, increased temperature, pain), secondary cellulitis, bullae, exfoliation

Frequency not reported: Possible immunogenicity[Ref]

Local

Common (1% to 10%): Infusion site extravasation[Ref]

Metabolic

Very common (10% or more): Decreased appetite (52%), decreased phosphate (34%), decreased potassium (19%), increased lipase (14%)

Common (1% to 10%): Increased glucose, decreased sodium, increased urate[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (25%)[Ref]

Musculoskeletal pain includes myalgia, arthralgia, back pain, bone pain, pain in extremity, musculoskeletal pain, arthritis, neck pain, non-cardiac chest pain, musculoskeletal chest pain, spinal pain, musculoskeletal stiffness, and musculoskeletal discomfort.[Ref]

Nervous system

Dysgeusia includes ageusia and hypogeusia.[Ref]

Very common (10% or more): Peripheral neuropathy (56%), dysgeusia (26%), peripheral sensory neuropathy (50%)

Common (1% to 10%): Peripheral motor neuropathy, peripheral sensorimotor neuropathy, paresthesia, hypoesthesia, gait disturbance, muscular weakness

Uncommon (0.1% to 1%): Demyelinating polyneuropathy, polyneuropathy, neurotoxicity, motor dysfunction, dysesthesia, muscle atrophy, neuralgia, peroneal nerve palsy, sensory loss, skin burning sensation, burning sensation[Ref]

Ocular

Very common (10% or more): Ocular disorders (e.g., keratitis, blurred vision, limbal stem cell deficiency) (46%), dry eye (36%), blurred vision (14%)[Ref]

Dry eye includes blepharitis, conjunctivitis, dry eye, eye irritation, keratitis, keratopathy, increased lacrimation, meibomian gland dysfunction, ocular discomfort, and punctate keratitis.[Ref]

Other

Very common (10% or more): Fatigue/asthenia (56%), pyrexia (22%), decreased weight (16%)[Ref]

Pyrexia includes pyrexia, hyperthermia, hyperpyrexia, and increased body temperature.[Ref]

Renal

Very common (10% or more): Increased creatinine (20%)[Ref]

Respiratory

Common (1% to 10%): Pneumonitis

Frequency not reported: Interstitial lung disease[Ref]

References

1. Product Information. Padcev (enfortumab vedotin). Seattle Genetics Inc. 2019.

2. Product Information. Padcev (enfortumab vedotin). Astellas Pharma Australia Pty Ltd. 2023.

3. Product Information. Padcev (enfortumab vedotin). Astellas Pharma Ltd. 2022.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.