阿维鲁单抗(Avelumab)用法用量:推荐剂量,剂量调整、不良反应剂量调整

The standard treatment regimen of avelumab needs to be formulated by doctors based on the patient's individual circumstances (such as disease type, stage, weight and tolerance). It usually uses a fixed dose or weight-adjusted intravenous infusion and is administered every two weeks.

Recommended dosage of avelumab

1. Recommended dose for metastatic Merkel cell carcinoma

The recommended dose of avelumab is 800 mg, which should be infused intravenously for 60 minutes every 2 weeks until disease progression or unacceptable toxicity occurs.

2. Recommended dose for locally advanced or metastatic urothelial carcinoma

The recommended dose of avelumab is 800 mg, administered as a 60-minute intravenous infusion every 2 weeks until disease progression or unacceptable toxicity occurs.

3. Recommended dose of advanced renal cell carcinoma

The recommended dose of avelumab is 800 mg, intravenous infusion, 60 minutes every 2 weeks, combined with axitinib 5 mg, orally, twice a day (12 hours apart), with food or alone, until disease progression or unacceptable toxicity occurs.

When axitinib is used in combination with avelumab, consideration may be given to escalating the axitinib dose above the initial 5 mg dose every two weeks or more. View full prescribing information for axitinib before starting.

Avelumab dose adjustment

1. Recommended single drug dose adjustment for adverse reactions

It is not recommended to reduce the dose of avelumab. In general, discontinue avelumab for serious (Grade 3) immune-mediated adverse reactions. For life-threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune-mediated reactions requiring systemic immunosuppressive therapy, or inability to reduce the corticosteroid dose to 10 mg per day or less of prednisone or equivalent, permanently discontinue avelumab within 12 weeks of initiating corticosteroids.

2. Recommended specific dose adjustments for adverse reactions of combined drugs

(1) If ALT or AST is 3 times the upper limit of normal (ULN) or greater than but less than 5xULN or total bilirubin is 1.5xULN or greater than but less than 3xULN: Stop using the drug and axitinib until the adverse reactions return to grade 0 or 1.

(2) If it persists (more than 5 days), please consider corticosteroid treatment (initial dose is 0.5-1mg/kg/day), prednisone or equivalent drugs, and then gradually reduce the dose. Consider rechallenge with a single agent or sequential rechallenge with two agents after recovery. If axitinib is reinstituted, reduce dose according to the full axitinib prescribing information.

(3) If ALT or AST is 5xULN or greater than or greater than 3xULN and total bilirubin is 2xULN or greater or total bilirubin is 3xULN or greater, permanently discontinue the drug and axitinib and consider corticosteroid therapy (initial dose 1 to 2 mg/kg/day prednisone or equivalent, then tapered).

(4) When this drug is administered with axitinib, please review the full prescribing information for axitinib for recommended dosage adjustments of axitinib.

Avelumab medication management

1. Preoperative medication

Before the first 4 infusions of avelumab, the patient was premedicated with antihistamines and acetaminophen. Premedication for subsequent avelumab doses should be based on clinical judgment and the presence/severity of prior infusion reactions.

2. Preparation management

(1) Preparation

a. Visually inspect the vial for particles and discoloration. Avelumab is a clear, colorless to slightly yellow solution. If the solution is cloudy, discolored, or contains particulate matter, discard the vial.

b. Take the required volume of BAVENCIO from the vial and inject it into a 250mL infusion bag containing 0.9% Sodium Chloride Injection or 0.45% Sodium Chloride Injection.

c. Gently invert the bag to mix the dilute solution, avoiding foaming or excessive shearing.

d. Check the solution to make sure it is clear, colorless and has no visible particles.

e. Discard any partially used or empty vials.

(2)Storage

The diluted avelumab solution should be stored at room temperature (not exceeding 25°C) for no more than 4 hours since dilution; if refrigerated storage (2°C to 8°C) is chosen, the storage time can be extended to 24 hours, but the solution must be warmed to room temperature before use. Do not freeze or shake diluted solutions.

(3) Administration

Administer the diluted solution over 60 minutes through an intravenous line containing a sterile, nonpyrogenic, low protein-binding in-line filter (0.2 micron pore size). Do not coadminister other medications through the same intravenous line.