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Enfortumab vedotin Side Effects

Medically reviewed by Drugs.com. Last updated on Oct 19, 2020.

For the Consumer

Applies to enfortumab vedotin: parenteral powder for injection

Side effects include:

Fatigue, peripheral neuropathy, decreased appetite, rash, alopecia, nausea, dysgeusia, diarrhea, dry eye, pruritus, dry skin, anemia, lymphopenia, hypophosphatemia, elevated concentrations of lipase, hyperglycemia, hyponatremia, hyperuricemia, neutropenia.

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, Bothell, WA.

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.