Malignant melanoma, Unresectable or metastatic.
Vd: 7.21 L
Elimination Half Life:
15.4 days
Dermatologic: Pruritus (Unresectable or metastatic melanoma, 21% to 31% ; cutaneous melanoma with lymph node involvement, 45% ), Rash (Unresectable or metastatic melanoma, 25% to 29% ; cutaneous melanoma with lymph node involvement, 50% )
Gastrointestinal: Colitis (Unresectable or metastatic melanoma, 5% to 8% ; cutaneous melanoma with lymph node involvement, 16% ), Diarrhea (Unresectable or metastatic melanoma, 32% to 37% ; cutaneous melanoma with lymph node involvement, 49% )
Other: Fatigue (Unresectable or metastatic melanoma, 34% to 41% ; cutaneous melanoma with lymph node involvement, 46% )
Serious:
Cardiovascular: Myocarditis, Pericarditis
Dermatologic: Dermatitis
Endocrine metabolic: Adrenal insufficiency, Disorder of endocrine system, Hypogonadism, Hypopituitarism Gastrointestinal: Enterocolitis (Unresectable or metastatic melanoma, 5% to 7% ; cutaneous melanoma with lymph node involvement, 16% ), Pancreatitis (1.3% ), Perforation of intestine (1% )
Hematologic: Eosinophil count raised (2.1% ), Hemolytic anemia (Less than 1% )
Hepatic: Hepatitis, Hepatotoxicity
Musculoskeletal: Myositis (Less than 1% ), Polymyositis (Less than 1% )
Neurologic: Encephalitis (Less than 1% ), Guillain-Barr? syndrome, Meningitis, Neuropathy, Peripheral motor neuropathy
Ophthalmic: Iritis (Less than 1% ), Orbital myositis (Less than 1%), Uveitis (Less than 1% )
Renal: Nephritis, Renal failure (less than 1% )
Respiratory: Pneumonitis
10 mg/kg IV over 90 minutes every 3 weeks for 4 doses followed by 10 mg/kg every 12 weeks for up to 3 years. In the event of toxicity, omit doses, do not delay .
Malignant melanoma, Unresectable or metastatic:
3 mg/kg IV infusion over 90 minutes every 3 weeks for a maximum of 4 doses; treatment can be delayed for toxicities, but all doses must be administered within 16 weeks of the first dose (FDA dosage)
Increased infusion rate, 3 mg/kg IV infusion over 30 minutes followed by a 1-hour observation period after the first dose; if an infusion reaction occurs, give additional doses with standard premedication for biologic therapy (off-label dosage) .
10 mg/kg IV infusion over 90 minutes every 3 weeks for MAX 4 doses; may retreat patients who subsequently progress, if had stable disease for at least 3 months or a partial or complete response, and absence of unacceptable toxicity after the last dose (off-label dosage).
(12 years or older) 3 mg/kg IV infusion over 90 minutes every 3 weeks for a maximum of 4 doses; treatment can be delayed for toxicities, but all doses must be administered within 16 weeks of the first dose.
靜脈輸注。
Intravenous (IV) infusion.
0.9% 生理食鹽水或 5% 葡萄糖注射液。
0.9% Sodium Chloride Injection or 5% Dextrose Injection.
本藥品為濃度 5 mg/mL 之即用溶液。不需初次稀釋，直接計算所需劑量體積後，加入輸液袋中。
The drug is a 5 mg/mL ready-to-use solution. No initial reconstitution is required; calculate the require
建議輸注時間為 30 或 90 分鐘（具體視治療方案與劑量而定）。
The recommended infusion duration is 30 or 90 minutes (depending on the specific treatment regimen and dosage).
必須使用具備低蛋白質結合率之 0.2 至 1.2 微米線上過濾器。不可使用靜脈推注或快速注射。不可與其他藥物經由同一條輸注管路同時給藥。製備時請勿劇烈搖晃。若發生外滲，應立即停止輸注並依院內標準程序處置（通常視為非發皰性）。原液小瓶應避光儲存於外包裝中。
Must be administered through an intravenous line containing a sterile, non-pyrogenic, low-protein-binding, in-line filter (pore size 0.2 to 1.2 micron). Do not administer as an IV push or bolus injection. Do not co-administer other drugs through the same intravenous line. Do not shake the vial during preparation. In case of extravasation, stop infusion immediately and manage according to institutional protocols (generally considered non-vesicant). Store vials in the original package to protect from light.