Enfortumab vedotin Side Effects

Medically reviewed by Drugs.com. Last updated on Mar 25, 2023.

Applies to enfortumab vedotin: intravenous powder for solution.

Serious side effects of Enfortumab vedotin

Along with its needed effects, enfortumab vedotin 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

• 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

• 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 Enfortumab vedotin

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

• 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

• Pain, redness, or swelling at the injection site

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]

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.

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