Enfortumab Vedotin Dosage
Medically reviewed by Drugs.com. Last updated on Mar 13, 2020.
Applies to the following strengths: 20 mg; 30 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Urothelial Carcinoma
1.25 mg/kg (up to a maximum of 125 mg for patients 100 kg or greater) IV over 30 minutes on Days 1, 8. and 15 of a 28-day cycle until disease progression or unacceptable toxicity
Use: For 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 in the neoadjuvant/adjuvant, locally advanced or metastatic setting
Renal Dose Adjustments
Mild (CrCL greater than 60 to 90 mL/min), moderate (CrCL 30 to 60 mL/min),
or severe (CrCL less than 30 mL/min) 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: Not recommended.
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
-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.
-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.
-Grade 3 (severe): 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 or recurrent Grade 3: 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.
-Grade 3 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.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-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 (36 F to 46 F). NOTE: Do not freeze.
-Do not administer this drug as an IV push or bolus.
-Do not mix this drug with, or administer as an infusion with, other medicinal products.
-Store unopened vials refrigerated at 2C to 8C (36F to 46F) in the original carton. --Do not freeze.
-Do not shake.
-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.
-Dextrose 5% injection
-Sodium chloride 0.9% injection
-This drug is cytotoxic. Follow applicable special handling and disposal procedures.
-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.
More about enfortumab vedotin
- Side Effects
- During Pregnancy
- Drug Interactions
- En Español
- 1 Review
- Drug class: miscellaneous antineoplastics
Other brands: Padcev