#高警訊藥品

Colorectal cancer, metastatic:
1. As a ingle agent or combined with Ipilimumab
2. Treatment of microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) in adults and pediatric patients 12 years and older that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
Head and neck cancer, squamous cell:
Treatment of recurrent or metastatic squamous cell carcinoma of the head and neck in patients with disease progression on or after platinum-based therapy. Hodgkin lymphoma, classical:
Treatment of classical Hodgkin lymphoma (cHL) in adult patients that have relapsed or progressed following autologous hematopoietic stem cell transplant (HSCT) and brentuximab vedotin, or 3 or more lines of systemic therapy that includes autologous HSCT.
Melanoma, unresectable or metastatic:
1. As a ingle agent or combined with Ipilimumab
2. Treatment of BRAF V600 wild-type or BRAF V600 mutation-positive unresectable or metastatic melanoma.
Non-small cell lung cancer:
1. Treatment of metastatic NSCLC that has progressed on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression (on approved EGFR- or ALK-directed therapy) prior to receiving nivolumab.
2. With Ipilimumab: First line treatment in adults whose tumors express PD-L1 ((1%) as determined by an approved test, and with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.<2021/7/27>
3. With Ipilimumab and 2 cycles of platinum doublet chemotherapy: First line treatment in adults with no EGFR or ALK genomic tumor aberrations.<2021/7/21>
Renal cell cancer, advanced:
Treatment of advanced renal cell cancer in patients who have received prior anti-angiogenic therapy.
Urothelial carcinoma, locally advanced or metastatic:
Treatment of locally advanced or metastatic urothelial carcinoma in patients with disease progression during or following a platinum-containing therapy or disease progression within 12 months of neoadjuvant or adjuvant treatment with a platinum-containing therapy.
Gastric cancer and gastroesophageal junction cancer:
1. In combination with fluoropyrimidine- and platinum-containing chemotherapy.
2. Treatment of advanced or metastatic gastric cancer and gastroesophageal junction cancer.
Hepatocellular carcinoma:
1. As a single agent or combined with Ipilimumab.
2. Treatment of hepatocellular carcinoma in patients who have been previously treated with sorafenib.
Esophageal carcinoma, squamous cell:
Treatment of unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy.<2020/10/30>
#仿單變更2020 #仿單變更2021

Anti-PD-1 Monoclonal Antibody; Antineoplastic Agent
Nivolumab selectively inhibits programmed cell death-1 (PD-1) activity by binding to the PD-1 receptor to block the ligands PD-L1 and PD-L2 from binding. The negative PD-1 receptor signaling that regulates T-cell activation and proliferation is therefore disrupted.
Combining nivolumab (anti-PD-1) with ipilimumab (anti-CTLA-4) results in enhanced T-cell function that is greater than that of either antibody alone, resulting in improved anti-tumor responses in metastatic melanoma and advanced renal cell carcinoma.

Distribution:
Vdss: 6.8 L (single-agent); ~8 L (combination therapy with ipilimumab)
Half-life elimination:
~25 days (single-agent and combination therapy with ipilimumab)

There are no contraindications listed in the manufacturer's US labeling.

Women of reproductive potential should use highly effective contraception during therapy and for at least 5 months after the last nivolumab dose.

It is not known if nivolumab is present in breast milk. Due to the potential for serious adverse reactions in the breastfed infant, the manufacturer recommends to discontinue breastfeeding during treatment.

Dermatologic: Pruritus, Rash
Endocrine metabolic: Hyperglycemia, Hyperkalemia, Hypocalcemia, Hyponatremia, cholesterol or triglycerides raised
Gastrointestinal: Constipation, Decrease in appetite, Nausea, Vomiting
Hematologic: Anemia, Lymphocytopenia
Hepatic: Alkaline phosphatase raised, ALT/SGPT level raised or AST/SGOT level raised
Musculoskeletal: Arthralgia, Backache, Musculoskeletal pain
Neurologic: Asthenia, Headache, Peripheral neuropathy
Renal: Serum creatinine raised
Respiratory: Cough, Dyspnea
Other: Fatigue

Renal impairment prior to treatment initiation:
No dosage adjustment necessary.
Renal toxicity during treatment:
1. Creatinine >1.5 to 6 times ULN: Withhold treatment; administer corticosteroids (prednisone 0.5 to 1 mg/kg daily or equivalent); may resume therapy upon recovery
2. Creatinine >6 times ULN or life-threatening: Permanently discontinue; initiate high-dose systemic corticosteroids (prednisone 1 to 2 mg/kg daily or equivalent)

Hepatic impairment prior to treatment initiation:
1. Mild impairment (total bilirubin and AST >ULN OR total bilirubin <1 to 1.5 times ULN and any AST): No dosage adjustment necessary.
2. Moderate (total bilirubin >1.5 to 3 times ULN and any AST) to severe (total bilirubin >3 times ULN and any AST) impairment: Has not been studied.
Hepatotoxicity during treatment:
1. AST or ALT >3 to 5 times ULN OR total bilirubin >1.5 to 3 times ULN: Withhold treatment; may resume therapy upon recovery to grade 0 or 1 toxicity.
2. AST or ALT >5 times ULN or total bilirubin >3 times ULN: Permanently discontinue.
Immune-mediated hepatitis:
1. Grade 2 transaminase elevations: Withhold treatment and initiate high-dose systemic corticosteroids (prednisone 0.5 to 1 mg/kg daily or equivalent)
2. Severe (grade 3) or life-threatening (grade 4) transaminase elevations: Permanently discontinue treatment and initiate high-dose systemic corticosteroids (prednisone 1 to 2 mg/kg daily or equivalent).