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.

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

• 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.

• 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.

Precautions

CONTRAINDICATIONS:

• None

Dialysis

Data not available

Other Comments

Administration advice:

• 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.

• Sterile water
• 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.