Enfortumab Vedotin Dosage

Medically reviewed by Drugs.com. Last updated on Oct 4, 2023.

Usual Adult Dose for Urothelial Carcinoma

1.25 mg/kg (up to a maximum of 125 mg for patients weighing 100 kg or greater) IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle

Duration: Until disease progression or unacceptable toxicity.

Comment:

• Combination therapy with pembrolizumab is approved under accelerated approval based on tumor response rate and durability of response.

Use:
For the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who:

• have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy
• are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy

In combination with pembrolizumab, for the treatment of adult patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapy

Renal Dose Adjustments

Mild to severe renal impairment: No adjustment recommended.

Liver Dose Adjustments

Mild (Child-Pugh A) hepatic impairment: No adjustment recommended.
Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment: Use should be avoided.

Dose Adjustments

RECOMMENDED DOSE REDUCTION SCHEDULE:

• Starting dose: 1.25 mg/kg up to 125 mg
• First dose reduction: 1 mg/kg up to 100 mg
• Second dose reduction: 0.75 mg/kg up to 75 mg
• Third dose reduction: 0.5 mg/kg up to 50 mg

DOSE MODIFICATIONS:
HYPERGLYCEMIA:

• Blood glucose greater than 250 mg/dL: Withhold this drug until elevated blood glucose has improved to 250 mg/dL or less, then resume therapy at the same dose level.

PERIPHERAL NEUROPATHY:

• Grade 2: Withhold until Grade 1 or less, then resume therapy at the same dose level (if first occurrence); for a recurrence, withhold until Grade 1 or less then, resume therapy reduced by one dose level.
• Grade 3 or greater: Permanently discontinue this drug.

SKIN REACTIONS:

• Persistent or recurrent Grade 2; Grade 3: Withhold this drug until Grade 1 or less, then resume therapy at the same dose level or consider dose reduction by one dose level.
• Suspected SJS or TEN: Withhold this drug and consult a specialist to confirm the diagnosis. If not SJS/TEN, see Grade 2 to 4 skin reactions.
• Grade 4 or recurrent Grade 3; Confirmed SJS or TEN: Permanently discontinue this drug.

OTHER NONHEMATOLOGIC TOXICITY:

• Grade 3: Withhold this drug until Grade 1 or less, then resume therapy at the same dose level or consider dose reduction by one dose level.
• Grade 4: Permanently discontinue this drug.

HEMATOLOGIC TOXICITY:

• Grade 2 or 3 thrombocytopenia: Withhold this drug until Grade 1 or less, then resume therapy at the same dose level or consider dose reduction by one dose level.
• Grade 4 thrombocytopenia: Withhold until Grade 1 or less, then reduce dose by one dose level or discontinue therapy.

Pneumonitis/Interstitial Lung Disease (ILD):

• Grade 2: Withhold this drug until Grade 1 or less, then resume therapy at the same dose level or consider dose reduction by one dose level.
• Grade 3 or greater: Permanently discontinue this drug.

Precautions

US BOXED WARNING:
Serious skin reactions:

• Severe and fatal cutaneous adverse reactions, such as Stevens-Johnson syndrome (SJS) and Toxic epidermal necrolysis (TEN), may occur during or after the first cycle of treatment.

Recommendations:

• Monitor for skin reactions.
• Withhold this drug, consult a specialist to confirm the diagnosis for suspected SJS, TEN or severe skin reactions.
• Permanently discontinue this drug in patients with confirmed SJS, TEN, Grade 4 or recurrent Grade 3 skin reactions.

CONTRAINDICATIONS:

• None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Avoid use in patients with moderate or severe hepatic impairment.
• Do not administer this drug as an IV push or bolus.
• After reconstitution, immediately administer the infusion IV over 30 minutes.
• If the infusion is not administered immediately, the prepared infusion bag should not be stored longer than 8 hours at 2C to 8C (36F to 46F). NOTE: Do not freeze.
• Do not mix this drug with, or administer as an infusion with, other medicinal products.

Storage requirements:

• Store unopened vials refrigerated at 2C to 8C (36F to 46F) in the original carton.
• Do not freeze.
• Do not shake the vial.

Reconstitution/preparation techniques:

• Prior to administration, the vial is reconstituted with Sterile Water for Injection (SWFI).
• The reconstituted solution is subsequently diluted in an IV infusion bag containing either 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringer's Injection.
• The manufacturer product information should be consulted.

IV compatibility:

• Sterile water
• Dextrose 5% injection
• Sodium chloride 0.9% injection
• Lactated Ringer's injection

General:

• This drug is cytotoxic. Follow applicable special handling and disposal procedures.

Monitoring:
Dermatologic: Skin reactions
Metabolic: Blood glucose levels or hyperglycemia
Nervous System: Peripheral neuropathy
Ocular: Ocular disorders
Local: Extravasation
Respiratory: Pneumonitis or ILD

Patient advice:

• Breastfeeding is not recommended during use of this drug.
• Contact your healthcare provider immediately if you experience numbness and tingling of the hands or feet or muscle weakness.
• Contact your healthcare provider immediately if you experience any visual changes.
• To prevent or treat dry eyes, use artificial tear substitutes.
• This drug may cause rashes and severe skin reactions.
• This drug can harm a developing fetus.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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