When given in combination with pembrolizumab, the recommended dose of PADCEV is 1.25 mg/kg (up to a maximum of 125 mg for patients ≥100 kg) administered as an intravenous infusion over 30 minutes on Days 1 and 8 of a 21-day cycle until disease progression or unacceptable toxicity. Refer to the pembrolizumab Prescribing Information for the recommended dosing information of pembrolizumab.
The recommended dose of PADCEV as a single agent is 1.25 mg/kg (up to a maximum of 125 mg for patients ≥100 kg) administered as an intravenous infusion over 30 minutes on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
Adverse Reaction | Severity* | Dose Modification* |
---|---|---|
| ||
Skin Reactions [see Boxed Warning, Warnings and Precautions (5.1)] | For persistent or recurrent Grade 2 skin reactions | Consider withholding until Grade ≤1, then resume treatment at the same dose level or dose reduce by one dose level. |
Grade 3 skin reactions | Withhold until Grade ≤1, then resume treatment at the same dose level or dose reduce by one dose level. | |
Suspected SJS or TEN | Immediately withhold, consult a specialist to confirm the diagnosis. If not SJS/TEN, see Grade 2-4 skin reactions. | |
Confirmed SJS or TEN; Grade 4 or recurrent Grade 3 skin reactions | Permanently discontinue. | |
Hyperglycemia [see Warnings and Precautions (5.2)] | Blood glucose >250 mg/dL | Withhold until elevated blood glucose has improved to ≤250 mg/dL, then resume treatment at the same dose level. |
Pneumonitis/Interstitial Lung Disease (ILD) [see Warnings and Precautions (5.3)] | Grade 2 | Withhold until Grade ≤1, then resume treatment at the same dose level or consider dose reduction by one dose level. |
Grade ≥3 | Permanently discontinue. | |
Peripheral Neuropathy [see Warnings and Precautions (5.4)] | Grade 2 | Withhold until Grade ≤1, then resume treatment at the same dose level (if first occurrence). For a recurrence, withhold until Grade ≤1, then resume treatment reduced by one dose level. |
Grade ≥3 | Permanently discontinue. | |
Other nonhematologic toxicity [see Adverse Reactions (6)] | Grade 3 | Withhold until Grade ≤1, then resume treatment at the same dose level or consider dose reduction by one dose level. |
Grade 4 | Permanently discontinue. | |
Hematologic toxicity [see Adverse Reactions (6)] | Grade 3, or Grade 2 thrombocytopenia | Withhold until Grade ≤1, then resume treatment at the same dose level or consider dose reduction by one dose level. |
Grade 4 | Withhold until Grade ≤1, then reduce dose by one dose level or discontinue treatment. |
Dose Level | |
Starting dose | 1.25 mg/kg up to 125 mg |
First dose reduction | 1.0 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 |
Prior to administration, the PADCEV vial is reconstituted with Sterile Water for Injection (SWFI). The reconstituted solution is subsequently diluted in an intravenous infusion bag containing either 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer’s Injection, USP.
Reconstitution in Single-dose Vial
Dilution in Infusion Bag
Administration
DO NOT administer PADCEV as an intravenous push or bolus.
DO NOT mix PADCEV with, or administer as an infusion with, other medicinal products.
When given in combination with pembrolizumab, the recommended dose of PADCEV is 1.25 mg/kg (up to a maximum of 125 mg for patients ≥100 kg) administered as an intravenous infusion over 30 minutes on Days 1 and 8 of a 21-day cycle until disease progression or unacceptable toxicity. Refer to the pembrolizumab Prescribing Information for the recommended dosing information of pembrolizumab.
The recommended dose of PADCEV as a single agent is 1.25 mg/kg (up to a maximum of 125 mg for patients ≥100 kg) administered as an intravenous infusion over 30 minutes on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
Adverse Reaction | Severity* | Dose Modification* |
---|---|---|
| ||
Skin Reactions [see Boxed Warning, Warnings and Precautions (5.1)] | For persistent or recurrent Grade 2 skin reactions | Consider withholding until Grade ≤1, then resume treatment at the same dose level or dose reduce by one dose level. |
Grade 3 skin reactions | Withhold until Grade ≤1, then resume treatment at the same dose level or dose reduce by one dose level. | |
Suspected SJS or TEN | Immediately withhold, consult a specialist to confirm the diagnosis. If not SJS/TEN, see Grade 2-4 skin reactions. | |
Confirmed SJS or TEN; Grade 4 or recurrent Grade 3 skin reactions | Permanently discontinue. | |
Hyperglycemia [see Warnings and Precautions (5.2)] | Blood glucose >250 mg/dL | Withhold until elevated blood glucose has improved to ≤250 mg/dL, then resume treatment at the same dose level. |
Pneumonitis/Interstitial Lung Disease (ILD) [see Warnings and Precautions (5.3)] | Grade 2 | Withhold until Grade ≤1, then resume treatment at the same dose level or consider dose reduction by one dose level. |
Grade ≥3 | Permanently discontinue. | |
Peripheral Neuropathy [see Warnings and Precautions (5.4)] | Grade 2 | Withhold until Grade ≤1, then resume treatment at the same dose level (if first occurrence). For a recurrence, withhold until Grade ≤1, then resume treatment reduced by one dose level. |
Grade ≥3 | Permanently discontinue. | |
Other nonhematologic toxicity [see Adverse Reactions (6)] | Grade 3 | Withhold until Grade ≤1, then resume treatment at the same dose level or consider dose reduction by one dose level. |
Grade 4 | Permanently discontinue. | |
Hematologic toxicity [see Adverse Reactions (6)] | Grade 3, or Grade 2 thrombocytopenia | Withhold until Grade ≤1, then resume treatment at the same dose level or consider dose reduction by one dose level. |
Grade 4 | Withhold until Grade ≤1, then reduce dose by one dose level or discontinue treatment. |
Dose Level | |
Starting dose | 1.25 mg/kg up to 125 mg |
First dose reduction | 1.0 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 |
Prior to administration, the PADCEV vial is reconstituted with Sterile Water for Injection (SWFI). The reconstituted solution is subsequently diluted in an intravenous infusion bag containing either 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer’s Injection, USP.
Reconstitution in Single-dose Vial
Dilution in Infusion Bag
Administration
DO NOT administer PADCEV as an intravenous push or bolus.
DO NOT mix PADCEV with, or administer as an infusion with, other medicinal products.
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