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 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.
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]
