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Enfortumab vedotin parenteral

Updated 2 Feb 2023 | Enfortumab vedotin


Infusions of enfortumab vedotin

Drugs List

  • enfortumab vedotin 20mg powder for concentrate for soln for infusion vial
  • enfortumab vedotin 30mg powder for concentrate for soln for infusion vial
  • PADCEV 20mg powder for concentrate for soln for infusion vial
  • PADCEV 30mg powder for concentrate for soln for infusion vial
  • Therapeutic Indications


    Advanced/metastatic transitional cell carcinoma of the urothelial tract

    Monotherapy for adults with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed death-ligand 1 inhibitor.


    Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.


    1.25mg/kg (up to a maximum of 125mg for patients greater than or equal to 100kg) over 30 minutes on Days 1, 8 and 15 of a 28 day cycle until disease progression or unacceptable toxicity.

    Additional Dosage Information

    Dose reductions for adverse reactions
    Starting dose: 125mg/kg up to 125mg.

    First dose reduction: 1mg/kg up to 100mg.

    Second dose reduction: 0.75mg/kg up to 75mg.

    Third dose reduction: 0.5mg/kg up to 50mg.

    Dose interruption, reduction and discontinuation in patients with locally advanced or metastatic urothelial cancer
    Adverse Reaction:
    Skin reactions
    Suspected Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) or bullous lesions: Immediately withhold and refer to specialised care.

    Confirmed SJS or TEN; Grade 4 or recurrent Grade 3: Permanently discontinue.

    Grade 2 or worsening, Grade 2 with fever or Grade 3: Withhold until Grade 1 or less. Referral to specialised care should be considered. Resume at the same dose level or consider dose reduction by one dose level as suggested above.

    Blood glucose greater than 13.9mmol/L (greater than 250mg/dL): Withhold until elevated blood glucose has improved to less than 13.9mmol/L (less than or equal to 250mg/dL), resume treatment at the same dose level.

    Peripheral neuropathy
    Grade 2: Withhold until less than or equal to Grade 1. For first occurrence, resume treatment at the same dose level. For a reccurence, withhold until Grade 1 or less then, resume treatment reduced by one dose level.

    Grade 3+: Permanently discontinue.


    For intravenous infusion over 30 minutes.


    Children under 18 years

    Precautions and Warnings

    Obese patients with a BMI equal or greater than 30kg/m2
    Diabetes mellitus
    End stage renal disease
    Moderate hepatic impairment

    Give pre-treatment counselling and consideration of sperm cryopreservation
    Treatment to be initiated and supervised by a specialist
    Contains polysorbate
    Consult local policy on the safe use of anti-cancer drugs
    If extravasation occurs follow local policy & seek expert help immediately
    Record name and batch number of administered product
    Staff: Not to be handled by pregnant staff
    Ensure negative pregnancy test in week preceding initiation of treatment
    If rash develops, consider possibility of Stevens-Johnson Syndrome
    Monitor blood glucose in high risk patients
    Monitor closely for signs and symptoms of toxic epidermal necrolysis
    Monitor for ocular disorders
    Monitor for symptoms of peripheral neuropathy
    Monitor visual status
    Advise patient to report unexplained fever, sore throat, bruising, bleeding
    Advise patient to seek medical advice if severe skin reaction occurs
    Discontinue if Grade 3 peripheral neuropathy occurs
    Discontinue if recurrent Grade 3 skin reaction occurs
    Discontinue treatment if Stevens-Johnson syndrome is confirmed
    Discontinue treatment if toxic epidermal necrolysis is confirmed
    Withhold if Grade 2 skin reaction worsening or with fever
    Discontinue if grade 4 skin reaction occurs
    Withhold if blood glucose greater than 13.9mmol/L
    Advise patient not to take St John's wort concurrently
    Female: Contraception required during and for 1 year after treatment
    Male: Contraception required during and for 9 months after treatment
    Breastfeeding: Do not breastfeed during & for 6 months after treatment

    Hyperglycaemia and diabetic ketoacidosis (DKA), including fatal events, occurred in patients with and without pre-existing diabetes mellitus, treated with enfortumab vedotin. Hyperglycaemia occurred more frequently in patients with pre-existing hyperglycaemia or high body mass index.

    Ocular disorders predominately dry eye, have occurred in patients treated with enfortumab vedotin. Consider artificial tears for prophylaxis of dry eye and referral for ophthalmologic evaluation if ocular symptoms do not resolve or worsen.

    Pregnancy and Lactation


    Enfortumab vedotin is contraindicated during pregnancy.

    The manufacturer does not recommend using enfortumab vedotin during pregnancy and in women of childbearing potential not using effective contraception.

    Animal studies have shown that enfortumab vedotin can cause foetal harm when administered to pregnant women based upon findings from animal studies. Embryo foetal development studies in female rats have shown that intravenous administration of enfortumab vedotin resulted in reduced numbers of viable foetuses, reduced litter size, and increased early resorptions.


    Enfortumab vedotin is contraindicated during breastfeeding.

    The manufacturer does not recommend breastfeeding whilst taking enfortumab vedotin and for at least 6 months after last dose.

    It is unknown whether enfortumab vedotin is excreted in human milk. A risk to breastfed children cannot be excluded.

    Side Effects

    Bullous dermatoses
    Burning sensation (local)
    Decreased appetite
    Demyelinating polyneuropathy
    Dermatological disturbances
    Dry eyes
    Dry skin
    Epidermal necrolysis
    Erythema multiforme
    Febrile neutropenia
    Gait abnormality
    Increase in ALT level
    Increase in AST level
    Infusion site leakage
    Maculopapular rash
    Motor disturbances
    Muscle weakness
    Muscular atrophy
    Palmar-Plantar Erythrodysaesthesia syndrome
    Pemphigoid reaction
    Peripheral motor neuropathy
    Peripheral neuropathy
    Peripheral sensory neuropathy
    Peroneal nerve palsy
    Reduced neutrophil count
    Sensory loss
    Skin exfoliation
    Stevens-Johnson syndrome
    Weight loss


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: October 2022

    Reference Sources

    Summary of Product Characteristics: Padcev 20 mg powder for concentrate for solution for infusion. Astellas Pharma Ltd. Revised April 2022.

    Summary of Product Characteristics: Padcev 30 mg powder for concentrate for solution for infusion. Astellas Pharma Ltd. Revised April 2022.

    NICE Evidence Services Available at: Last accessed: 12 October 2022

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