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Padcev Side Effects

Generic name: enfortumab vedotin

Medically reviewed by Drugs.com. Last updated on Feb 9, 2022.

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

For the Consumer

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.

Side effects requiring immediate medical attention

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

  • 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

Side effects not requiring immediate medical attention

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

Hematologic

Very common (10% or more): Hemoglobin decreased (34%), lymphocytes decreased (32%), neutrophils decreased (14%), leukocytes decreased (14%)[Ref]

Immunologic

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

Frequency not reported: Possible immunogenicity[Ref]

Ocular

Very common (10% or more): Ocular disorders (e.g., keratitis, blurred vision, limbal stem cell deficiency) (46%), dry eye (e.g., blepharitis, conjunctivitis, dry eye, eye irritation, keratitis, keratopathy, lacrimation increased, limbal stem cell deficiency, Meibomian gland dysfunction, ocular discomfort, punctate keratitis, tear break up time decreased) (36%), blurred vision (14%), dysgeusia (42%)[Ref]

Metabolic

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

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

Other

Very common (10% or more): Fatigue/asthenia (56%)[Ref]

General

The most common adverse reactions (20% or greater) included fatigue, peripheral neuropathy, decreased appetite, rash, alopecia, nausea, dysgeusia, diarrhea, dry eye, pruritus and dry skin.[Ref]

Nervous system

Very common (10% or more): Peripheral neuropathy (e.g., hypoesthesia, gait disturbance, muscular weakness, neuralgia, paresthesia, peripheral motor neuropathy, peripheral sensory neuropathy, peripheral sensorimotor neuropathy) (56%)[Ref]

Renal

Very common (10% or more): Creatinine increased (20%)[Ref]

Dermatologic

Very common (10% or more): Rash (e.g., dermatitis acneiform, dermatitis contact, dermatitis exfoliative, drug eruption, erythema, erythema multiforme, photosensitivity reaction, rash, rash erythematous, rash generalized, rash macular, rash papular, rash pustular, rash pruritic, rash vesicular, skin exfoliation, stasis dermatitis, urticaria (52%), alopecia (50%), pruritus (30%), maculopapular rash (26%), dry skin (26%), symmetrical drug-related intertriginous and flexural exanthema (SDRIFE) (10%), bullous dermatitis (10%), exfoliative dermatitis (10%), palmar-plantar erythrodysesthesia (10%)[Ref]

Gastrointestinal

Very common (10% or more): Nausea (45%), diarrhea (e.g., colitis, diarrhea, enterocolitis) (42%), vomiting (18%)[Ref]

References

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

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.