Generic Name and Formulations:
Peginterferon alfa-2b 296mcg, 444mcg, 888mcg; per vial; pwd for SC inj after reconstitution.
Company:
Merck & Co., Inc.
Indications for SYLATRON:
Adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy.
Adult Dose for SYLATRON:
≥18yrs: Give by SC inj. Rotate inj sites. Premedicate with acetaminophen. 6mcg/kg/week for 8 doses, followed by 3mcg/kg/week for up to 5 years. Withhold dose if ANC <0.5x109/L, platelets <50x109/L, ECOG PS ≥2, or for non-hematologic toxicity ≥ Grade 3. Resume at reduced dose (see literature) when: ANC ≥0.5x109/L, platelets ≥50x109/L, ECOG PS 0–1, and non-hematologic toxicity has completely resolved or improved to Grade 1.
Children's Dose for SYLATRON:
<18yrs: not established.
Pharmacological Class:
Alpha interferon.
Contraindications:
Anaphylaxis to peginterferon alfa-2b or interferon alfa-2b. Autoimmune hepatitis. Hepatic decompensation (Child-Pugh score >6 [Class B and C]).
Warnings/Precautions:
Increased risk of depression and other neuropsychiatric disorders. Permanently discontinue for: persistent severe or worsening neuropsychiatric disorders (eg, depression, psychosis, encephalopathy); new onset ventricular arrhythmia or cardiovascular decompensation; new or worsening retinopathy; severe (Grade 3) hepatic injury or hepatic decompensation; hypothyroidism, hyperthyroidism, or diabetes mellitus that cannot be effectively managed; or if unable to tolerate a dose of 1mcg/kg/week. Monitor for signs/symptoms of depression/psychosis every 3 weeks during first 8 weeks, then every 6 months, continue for at least 6 months after last dose. Perform eye exam in patients with retinopathy and those with vision changes during therapy. Monitor hepatic function with serum bilirubin, ALT/AST, alkaline phosphate, and LDH at 2 and 8 weeks, and 2 and 3 months following initiation, then every 6 months. Obtain TSH levels within 4 weeks prior to initiation, at 3 and 6 months following initiation, then every 6 months. Moderate-to-severe renal impairment (monitor). Pregnancy (Cat.C). Nursing mothers: not recommended.
Interactions:
Therapeutic effect of drugs metabolized by CYP2C9 or CYP2D6 may be altered.
Adverse Reactions:
Fatigue, increased ALT/AST, pyrexia, headache, anorexia, myalgia, nausea, chills, inj site reactions; neuropsychiatric disorders.
Elimination:
Renal.
Generic Availability:
NO
How Supplied:
Single-use vial—1, 4 (w. diluent)
批准日期：2011年4月11日；公司：Merck和先灵子公司
适应证和用途
SYLATRON是一种α干扰素适用于显微镜或大体肉眼累及淋巴结黑色素瘤与84天内最终手术切除包括完整的淋巴结清扫术的辅助治疗。(1)
剂量和给药方法
（1）6 μg/kg/周皮下共8剂随后；
（2）3 μg/kg/周皮下直至5年。(2.1)
剂型和规格
（1）296 μg冻干粉每单次使用小瓶
（2）444 μg冻干粉每单次使用小瓶
（3）888 μg冻干粉每单次使用小瓶
禁忌证
（1）已知对聚乙二醇干扰素α-2b或干扰素α-2b严重超敏反应。(4)
（2）自身免疫性肝炎。(4)
（3）肝失代偿(Child-Pugh评分 >6 [类别B和C])。(4)
警告和注意事项
（1）抑郁和其它严重神经精神不良反应。(5.1)
（2）重要或不稳定心脏病史。(5.2)
（3）视网膜疾病。(5.3)
（4）Child-Pugh评分>6(类别B和C)。(4, 5.4)
（5）不能用药物有效治疗的甲状腺功能减退，甲状腺功能亢进，高血糖，糖尿病。(4, 5.5)
不良反应
最常见不良反应(>60%)是：疲乏，ALT增高，AST增高，发热，头痛，厌食，肌肉痛，恶心，畏寒，和注射部位反应。(6.1)
为报告怀疑不良反应，联系Schering Corpor
