近日，美国FDA批准Bynfezia（octreotide acetate，醋酸奥曲肽）预填充注射笔，用于成人肢端肥大症患者，对反应不足或无法治疗的生长激素（GH）和胰岛素样生长因子1（IGF-1）[somatomedin C]的降低 手术切除，垂体照射和最大耐受剂量的甲磺酸溴隐亭；治疗成年患者与转移性类癌相关的严重腹泻/潮红发作；成年患者与血管活性肠肽肿瘤（VIPomas）相关的大量水样腹泻的治疗和治疗。
批准日期：2020年04月29日 公司：太阳制药
BYNFEZIA PEN（醋酸奥曲肽[octreotide acetate]）注射液，用于皮下使用
美国初次批准：1988年
作用机理
BYNFEZIA Pen（醋酸奥曲肽）具有类似于天然激素生长抑素的药理作用。与生长抑素相比，它是生长激素，胰高血糖素和胰岛素的更有效抑制剂。与生长抑素一样，它也抑制LH对GnRH的反应，减少内脏血流量，并抑制5-羟色胺，胃泌素，血管活性肠肽，促胰液素，胃动素和胰多肽的释放。
适应症和用途
BYNFEZIA Pen是一种生长抑素类似物，用于：
成年肢端肥大症患者对手术切除，垂体照射和甲磺酸溴隐亭的反应不充分或无法治疗时，其生长激素（GH）和胰岛素样生长因子1（IGF-1）[somatomedin C]的降低耐受剂量。
成人患者转移性类癌相关的严重腹泻/潮红发作的治疗。
成人成年人血管活性肠肽肿瘤（VIPomas）引起的大量水样腹泻的治疗。
使用限制：
在肢端肥大症患者中，尚未确定BYNFEZIA Pen对改善临床体征和症状，减小肿瘤大小和生长速率的作用。
在类癌综合征和VIPomas患者中，尚未确定BYNFEZIA Pen对转移瘤的大小，生长速率和转移的影响。
剂量和给药
肢端肥大症：每天三次以50mcg的剂量开始服用。典型剂量是每天三天100mcg。
类癌肿瘤：前2周，每天2-4剂，每天100-600mcg。
VIPomas：前2周每天2-4次，每天200-300mcg。
有关实验室监控的建议，请参见“完整处方信息”。
皮下给药；定期更换注射部位。
剂量形式和强度
注射：2500mcg/mL的奥曲肽，作为2.8mL的单人用笔。
禁忌症
对奥曲肽或BYNFEZIA Pen的任何成分过敏。
警告和注意事项
胆石症和胆石症的并发症：定期监测。如果怀疑有胆石症并发症，请中止治疗。
低血糖或高血糖：监测血糖并根据需要调整抗糖尿病治疗。
甲状腺功能异常：可能发生甲状腺功能减退。在开始之前评估甲状腺的基线功能并定期进行监测。
心功能：可能发生心动过缓，心律不齐或传导异常，具有心动过缓作用的药物可能需要调整剂量。
不良反应使用BYNFEZIA Pen的不良反应包括：>30％的肢端肥大症患者和>5％的类癌瘤和VIPomas患者出现腹泻，大便稀疏，恶心和腹部不适肢端肥大症患者的胆结石和窦性心动过缓> 25％。
要报告可疑的不良反应，请致电1-800-818-4555与Sun Pharmaceutical Industries，Inc.或致电1-800-FDA-1088与FDA联系，或访问www.fda.gov/medwatch
药物相互作用
环孢菌素：与BYNFEZIA Pen并用可能会降低环孢菌素的浓度。
溴隐亭：与BYNFEZIA Pen并用可能会增加溴隐亭的浓度。
其他伴随药物：可能需要调整钙通道阻滞剂的剂量和控制体液和电解质平衡的药物。
在特定人群中的使用
生殖能力的男性和女性：建议绝经前的女性可能会意外怀孕。
包装供应/存储和处理方式
供应方式
BYNFEZIA笔（醋酸奥曲肽）注射液，2500mcg/mL奥曲肽是一种澄清的无色溶液，可通过以下方式获得：
剂量单位                    包装尺寸    NDC
2.8mL一次性使用的预填充笔    1箱     NDC 62756-452-36
2.8mL一次性使用的预填充笔    2箱     NDC 62756-452-37
储存和处理
将BYNFEZIA钢笔存放在纸箱中2°至8°C（36°至46°F）的冰箱中。保护笔避光。首次使用后，请将笔存放在20°C至25°C（68°F至77°F）的受控室温下。允许在15°C（59°F）和30°C（86°F）之间的旅行长达28天。首次使用后28天将其丢弃。
完整说明资料附件：
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=20ed4e79-ad4c-426f-859d-83790c00439b
--------------------------------------------
Bynfezia Pen（octreotide acetate）
Bynfezia Pen
Bynfezia Pen(octreotide)is used to reduce blood levels of growth hormone in patients with a condition called acromegaly. This medicine also reduces flushing and watery diarrhea caused by certain types of cancer.Bynfezia Pen is slightly less popular than other somatostatin analogues. There are currently no generic alternatives to Bynfezia Pen.
Dosing
The dose of this medicine will be different for different patients.Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine.If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine.
Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For long-acting injection dosage form:
For treatment of acromegaly:
Adults—At first, 20 milligrams(mg)injected into the buttocks once every 4 weeks for 3 months. Your doctor will adjust your dose as needed and tolerated.
Children—Use and dose must be determined by your doctor.
For treatment of severe diarrhea and other symptoms that occur with certain types of intestinal tumors:
Adults—At first, 20 milligrams(mg)injected into the muscles once every 4 weeks for 2 months. Your doctor will adjust your dose as needed and tolerated.
Children—Use and dose must be determined by your doctor.
For short-acting injection dosage form(solution):
For treatment of acromegaly:
Adults—At first, 50 micrograms(mcg)given as a shot under the skin 3 times a day.Your doctor will adjust your dose as needed.
Children—Use and dose must be determined by your doctor.
For treatment of carcinoid tumors:
Adults—At first, 100 to 600 micrograms(mcg)per day, given in 2 to 4 divided doses, injected under the skin for the first 2 weeks. Your doctor will adjust your dose as needed. However, the dose is usually not more than 1500 mcg per day.
Children—Use and dose must be determined by your doctor.
For treatment of severe diarrhea that occurs with certain types of intestinal tumors:
Adults—At first, 200 to 300 micrograms (mcg) per day, given in 2 to 4 divided doses, injected under the skin for the first 2 weeks. Your doctor will adjust your dose as needed. However, the dose is usually not more than 450 mcg per day.
Children—Use and dose must be determined by your doctor.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 62756-452-37
Bynfezia PenTM(octreotide acetate Injection)
2,500mcg/mL
Two 2.8mL disposable single-patient-use prefilled pens Subcutaneous use only
For doses of 50mcg, 100mcg, 150mcg, and 200mcg.
For Single Patient Use Only
SUN PHARMA