#高警訊藥品

默克細胞癌、腎細胞癌、泌尿道上皮癌
1. Merkel cell carcinoma, metastatic (in adults and children >12 years of age)
2. Renal cell carcinoma, advanced (first-line treatment of advanced carcinoma, in combination with axitinib)
3. Urothelial carcinoma, locally advanced or metastatic (First-line maintenance treatment of carcinoma that has not progressed with first-line platinum-containing chemotherapy)<2021/8/16>
#仿單變更2021

Antineoplastic Agent: Anti-PD-L1 Monoclonal Antibody
PD-L1(programmed death ligand 1) is an immune check point protein expressed on tumor cells and tumor infiltrating cells and down regulates anti-tumor t-cell function by binding to PD-1(programmed cell death-1) and B7.1. Avelumab, a fully human monoclonal antibody, binds to PD-L1 to selectively prevent the interaction between the PD-1 and B7.1 receptors, while still allowing interaction between PD-L2 and PD-1 .

Distribution: Vdss: 4.72 L (10 mg/kg dose)
Half-life elimination: 6.1 days
Excretion: Total systemic clearance was 0.59 L/day in patients receiving a 10 mg/kg dose.

Hypersensitivity to avelumab or any component of the formulation.

1. Immunoglobulins are known to cross the placenta and fetal exposure to avelumab is expected.
2. Based on the mechanism of action, avelumab may cause fetal harm.
3. Immune-mediated fetal rejection causing increased abortion or stillbirth was observed in animal reproduction studies.

1. It is not known if avelumab is present in breast milk.
2. Due to the potential for serious adverse reactions in the breastfed infant, lactating females should not breastfeed during therapy and for at least 1 month after the last avelumab dose.

Hypertension, peripheral edema, skin rash, weight loss, abdominal pain, constipation, decreased appetite, diarrhea, increased serum lipase, nausea, vomiting, urinary tract infection (including urinary tract infection with sepsis), anemia, lymphocytopenia, thrombocytopenia, increased serum alanine aminotransferase, increased serum aspartate aminotransferase, dizziness, fatigue, arthralgia, musculoskeletal pain, cough, dyspnea, infusion-related reaction

800 mg once every 2 weeks until disease progression or unacceptable toxicity

Children ≥12 years and Adolescents: IV 800 mg once every 2 weeks until disease progression or unacceptable toxicity

Renal impairment prior to treatment initiation:
There are no dosage adjustments provided in the manufacturer's labeling; however, no clinically meaningful differences were observed in a population pharmacokinetic analysis in patients with CrCl 15 to 89 mL/minute.
Renal toxicity during treatment :
1. Grade 2 or grade 3 serum creatinine elevation: Withhold avelumab; resume avelumab after complete or partial (to grade 0 or 1) resolution after corticosteroid taper. Permanently discontinue avelumab if no complete or partial response within 12 weeks of initiating corticosteroids, or if unable to reduce prednisone to <10 mg/day (or equivalent) within 12 week of corticosteroid initiation.
2. Grade 4 serum creatinine elevation: Permanently discontinue avelumab.

No dosage adjustments provided in the manufacturer's labeling; however, no clinically meaningful differences were observed in a population pharmacokinetic analysis in patients with mild (bilirubin ULN or bilirubin between 1 to 1.5 times ULN) or moderate (bilirubin between 1.5 to 3 times ULN) impairment.