Padcev Side Effects

Generic name: enfortumab vedotin

Medically reviewed by Drugs.com. Last updated on Dec 8, 2024.

Note: This document provides detailed information about Padcev Side Effects associated with enfortumab vedotin. Some dosage forms listed on this page may not apply specifically to the brand name Padcev.

Applies to enfortumab vedotin: intravenous powder for solution.

Important warnings This medicine can cause some serious health issues

Intravenous route (powder for solution)

Warning: Serious Skin Reactions. Enfortumab 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 side effects

• blurred vision
• burning, dry, or itching eyes
• burning, numbness, tingling, or painful sensations
• discharge, excessive tearing
• dry eyes
• dry mouth
• eye redness, irritation, or pain
• flushed, dry skin
• fruit-like breath odor
• increased hunger
• increased thirst
• increased urination
• lack or loss of strength
• nausea
• rash with flat lesions or small raised lesions on the skin
• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
• stomach pain
• sweating
• trouble breathing
• unexplained weight loss
• unsteadiness or awkwardness
• unusual tiredness or weakness
• vomiting
• weakness in the arms, hands, legs, or feet

Less common side effects

• chest pain
• chills
• cough
• fever
• general feeling of discomfort or illness
• thickening of bronchial secretions

Incidence not known

• blistering, peeling, or loosening of the skin
• diarrhea
• itching
• joint or muscle pain
• red irritated eyes
• red skin lesions, often with a purple center
• redness, tenderness, itching, burning, or peeling of the skin
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips

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 side effects

• change in taste
• cracks in the skin
• decreased appetite
• dry skin
• hair loss or thinning of the hair
• loss of heat from the body
• loss of taste
• nausea
• painful blisters on the trunk of the body
• red, swollen skin redness, swelling, or pain of the skin
• scaling of the skin on the hands and feet
• skin blisters
• tingling of the hands and feet
• ulceration of the skin
• vomiting

Less common side effects

• pain, redness, or swelling at the injection site

For healthcare professionals

Applies to enfortumab vedotin: intravenous powder for injection.

General adverse events

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

• 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]

Dysgeusia includes ageusia and hypogeusia.^[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]

Further information

Padcev side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer