【藥品庫存】 本藥品為臨時採購藥品，經院長核可後，限定特定科別、病人使用。

1. 非小細胞肺癌 / Non-Small Cell Lung Cancer (NSCLC)

治療患有局部晚期、無法手術切除的非小細胞肺癌，且接受放射治療合併含鉑化療後病情未惡化的病人。
與含鉑化療藥物併用，做為可切除、無已知的表皮生長因子受體 (EGFR) 突變或間變性淋巴瘤激激 (ALK) 重組的非小細胞肺癌成人病人的前導性治療用藥，並於手術後繼續單獨使用做為輔助治療用藥。

For the treatment of patients with locally advanced, unresectable non-small cell lung cancer whose disease has not progressed following platinum-based chemoradiotherapy.
Used in combination with platinum-based chemotherapy as neoadjuvant treatment for resectable non-small cell lung cancer in adults without known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, followed by continued use as adjuvant monotherapy after surgery.

2. 小細胞肺癌 / Small Cell Lung Cancer (SCLC)

併用 etoposide 以及 carboplatin 或 cisplatin 兩者之一，適用於擴散期小細胞肺癌病人的第一線治療。

Used in combination with etoposide and either carboplatin or cisplatin for the first-line treatment of patients with extensive-stage small cell lung cancer.

3. 膽道癌 / Biliary Tract Cancer

與 cisplatin 及 gemcitabine 併用於治療局部晚期或轉移性膽道癌之成人病人。

Used in combination with cisplatin and gemcitabine for the treatment of adults with locally advanced or metastatic biliary tract cancer.

4. 肝細胞癌 / Hepatocellular Carcinoma (HCC)

與 tremelimumab 併用，適用於治療未曾接受全身性療法之晚期或無法切除之肝細胞癌成人病人。

Used in combination with tremelimumab for the treatment of adults with advanced or unresectable hepatocellular carcinoma who have not received prior systemic therapy.

<2024/10/18>

Antineoplastic Agent, Anti-PD-L1 Monoclonal Antibody

Distribution: Vdss: 5.6 L
Half-life elimination: Terminal half-life: ~18 days
Excretion: Steady-state clearance: 8.2 mL/hour

Hypersensitivity to durvalumab or any component of the formulation.

Based on the mechanism of action, and data from animal reproduction studies, in utero exposure to durvalumab may cause fetal harm.

Due to the potential for adverse events in a breastfed infant, breastfeeding is not recommended by the manufacturer during therapy or for at least 3 months after the last durvalumab dose.

Pruritus, skin rash, hyperglycemia, hyperkalemia, hypocalcemia, hyponatremia, hypothyroidism, increased gamma-glutamyl transferase, diarrhea, lymphocytopenia, increased serum AST or ALT, fatigue, cough, dyspnea, pneumonia, pneumonitis, radiation pneumonitis, upper respiratory tract infection, fever

Non-small cell lung cancer (stage 3), unresectable:
1. Patients ≥30 kg: 10 mg/kg once every 2 weeks or 1,500 mg once every 4 weeks; continue until disease progression or unacceptable toxicity or a maximum of 12 months.
2. Patients <30 kg: 10 mg/kg once every 2 weeks; continue until disease progression or unacceptable toxicity or a maximum of 12 months.
Small cell lung cancer, extensive stage:
1. Patients ≥30 kg: 1,500 mg once every 3 weeks (in combination with etoposide and either carboplatin or cisplatin) for 4 cycles, followed by 1,500 mg once every 4 weeks as a single agent; continue until disease progression or unacceptable toxicity.
2. Patients <30 kg: 20 mg/kg once every 3 weeks (in combination with etoposide and either carboplatin or cisplatin) for 4 cycles, followed by 10 mg/kg once every 2 weeks as a single agent; continue until disease progression or unacceptable toxicity.

Renal impairment prior to treatment initiation:
1. CrCl 30-89 mL/min: There are no dosage adjustments provided in the manufacturer's labeling; however, there is no clinically relevant effect on pharmacokinetics.
2. CrCl 15-29 mL/min: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Renal toxicity during treatment:
1. Grade 2 or grade 3 serum creatinine elevation: Withhold durvalumab; resume durvalumab after complete or partial (to grade 0 or 1) resolution after corticosteroid taper. Permanently discontinue durvalumab 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 weeks of corticosteroid initiation.
2. Grade 4 serum creatinine elevation: Permanently discontinue durvalumab.

1. Mild impairment (bilirubin ≤ULN and AST >ULN OR bilirubin >1-1.5 times ULN and any AST): There are no dosage adjustments provided in the manufacturer's labeling; however, there is no clinically relevant effect on pharmacokinetics.
2. Moderate impairment (bilirubin >1.5-3 times ULN and any AST) or severe (bilirubin >3 times ULN and any AST): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).