enfortumab vedotin (Rx)

Dosing & Uses
Dosage Forms & Strengths
injection, lyophilized powder for reconstitution
20mg single-dose vial
30mg single-dose vial
Urothelial Carcinoma
Single-agent therapy
Indicated for locally advanced or metastatic urothelial cancer in adults previously treated with a programmed death receptor-1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor and platinum-containing chemotherapy OR adults who are ineligible for cisplatin-containing chemotherapy and previously received ≥1 prior lines of therapy
1.25 mg/kg (maximum dose, 125 mg) IV on Days 1, 8, and 15 of 28-day cycle
Continue until disease progression or unacceptable toxicity
Combination with pembrolizumab
Indicated in combination with pembrolizumab or pembrolizumab/berahyaluronidase for locally advanced or metastatic urothelial carcinoma
1.25 mg/kg (maximum dose, 125 mg) IV on Days 1 and 8 of 21-day cycle
Continue until disease progression or unacceptable toxicity
Refer to prescribing information for dosing information of pembrolizumab or pembrolizumab/berahyaluronidase
Combination with pembrolizumab products (neoadjuvant and adjuvant) with cystectomy
Indicated in combination with pembrolizumab or pembrolizumab/berahyaluronidase, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for treatment of patients with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy
Refer to prescribing information for dosing information of pembrolizumab or pembrolizumab/berahyaluronidase
Administer enfortumab vedotin ~30 minutes before pembrolizumab when given on same day
Neoadjuvant
1.25 mg/kg (maximum of 125 mg for patients weighing >=100 kg) IV on Days 1 and 8 of 21-day cycle x 3 cycles, OR
Until disease progression that precludes curative-intent cystectomy or unacceptable toxicity
Adjuvant
1.25 mg/kg (maximum of 125 mg for patients weighing >=100 kg) IV on Days 1 and 8 of 21-day cycle x 6 cycles, OR
Until disease recurrence or unacceptable toxicity
Dosage Modifications
Recommended dose reductions
First dose reduction: 1 mg/kg (maximum dose, 100 mg)
Second dose reduction: 0.75 mg/kg (maximum dose, 75 mg)
Third dose reduction: 0.5 mg/kg (maximum dose, 50 mg)
Hematologic toxicity
Grade 3 or Grade 2 thrombocytopenia
Hold until Grade ≤1
Resume at same dose level or consider reducing by 1 dose level
Grade 4
Hold until Grade ≤1
Resume at reduced dose by 1 dose level or discontinue treatment
Skin reactions
Persistent or recurrent Grade 2
Consider holding until Grade ≤1
Resume at same dose level or reduce by 1 dose level
Grade 3
Hold until Grade ≤1
Resume at same dose level or reduce by 1 dose level
Grade 4 or recurrent Grade 3
Permanently discontinue
Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN)
Suspected SJS/TEN: Immediately hold, consult specialist to confirm diagnosis
Confirmed SJS/TEN: Permanently discontinue
Hyperglycemia
Blood glucose >250 mg/dL
Hold until blood glucose ≤ 250 mg/dL
Resume at same dose level
Pneumonitis/interstitial lung disease (ILD)
Grade 2
Hold until Grade ≤1
Resume at same dose level or consider reducing by 1 dose level
Grade 3 or 4
Permanently discontinue
Peripheral neuropathy
Grade 2
Hold until Grade ≤1
Resume at same dose level for first occurrence
Recurrent grade 2
Hold until Grade ≤1
Resume at reduced dose by 1 dose level
Grade 3 or 4
Permanently discontinue
Other nonhematologic toxicity
Grade 3
Hold until Grade ≤1
Resume at same dose level or consider reducing by 1 dose level
Grade 4
Permanently discontinue
Renal impairment
Mild, moderate, or severe: No significant impact on pharmacokinetics (PK) compared with normal renal function
End stage renal disease (with or without dialysis): Not studied
Hepatic impairment
Mild (total bilirubin [TB] 1-1.5x ULN and any AST OR TB ≤ULN and AST >ULN): No significant impact on PK compared with normal hepatic function
Moderate or severe (TB >1.5x ULN and any AST): Avoid use; only studied in limited number of patients and effects on PK.
……see more….

https://reference.medscape.com/drug/padcev-enfortumab-vedotin-4000028#0

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