部份中文促性腺素处方资料（仅供参考）
英文名：menotropins for injection
商品名：MENOPUR
中文名：促性腺激素冻干粉注射剂
生产商：辉凌制药
药品介绍
MENOPUR（促性腺激素[menotropins]）注射，用于皮下使用
最初的美国批准：1975年
作用机制
MENOPUR，给药7至20天，在没有原发性卵巢功能衰竭的女性中产生卵巢卵泡生长和成熟。在大多数情况下，使用MENOPUR治疗仅导致卵泡生长和成熟。已经发生了足够的卵泡成熟，必须给予hCG以诱导排卵。
适应症和用法
MENOPUR®（注射用促性腺激素）是一种促性腺激素，适用于：
•作为辅助生殖技术（ART）周期的一部分，在卵巢妇女中开发多个卵泡和妊娠。
剂量和给药
•第一个周期的初始起始剂量 - 每天225国际单位，皮下注射。
•5天后的剂量调整，每次调整不超过150个国际单位。
•不要每天服用超过450国际单位的剂量。
•MENOPUR可与BRAVELLE一起给药（注射用尿嘧啶，纯化）。在临床试验中仅研究了225个国际单位（150个国际单位的MENOPUR和75个国际单位的BRAVELLE或75个国际单位的MENOPUR和150个国际单位的BRAVELLE）的总起始剂量。
剂量形式和强度
注射用冻干粉：含75IU FSH和75IU LH活性，以无菌小瓶的形式提供冻干粉末或颗粒，配有稀释剂和Q•Cap®样品瓶适配器。
禁忌症
MENOPUR禁用于表现出以下情况的女性：
•先前对MENOPUR或促性腺激素产品或其中一名受试者过敏。
•高水平的FSH表明原发性卵巢功能衰竭。
•怀孕。
•存在不受控制的非性腺内分泌病。
•生殖道和附属器官的性激素依赖性肿瘤。
•脑垂体或下丘脑肿瘤。
•未确定原因的子宫异常出血
•卵巢囊肿或未确定来源的扩大，不是由于多囊性
卵巢综合症
警告和注意事项
•异常卵巢扩大
•卵巢过度刺激综合症（OHSS）
•肺和血管并发症
•卵巢扭转
•多胎妊娠和出生
•先天性畸形
•异位妊娠
• 自然流产
•卵巢肿瘤
不良反应
ART中最常见的不良反应（≥2％）包括：腹肌;腹部扩大;腹痛;头痛;注射部位疼痛和反应;注射部位发炎; OHSS。
要报告可疑的不良反应，请联系Ferring
Pharmaceuticals Inc.在1-888-FERRING（1-888-337-7464）或FDA在1-800-FDA-1088或www.fda.gov/medwatch。
药物相互作用
尚未对MENOPUR非人类进行药物/药物相互作用研究。
用于特定人群
•妊娠类别X.不要在孕妇中使用MENOPUR。
•哺乳母亲：目前尚不清楚这种药物是否在人类乳汁中排出。
•儿科用途：未建立安全性和有效性。
•肾脏和肝脏功能不全：尚未发现肾脏或肝功能不全女性的MENOPUR的安全性，有效性和药代动力学。
包装提供/存储和处理
提供
MENOPUR（注射用促性腺激素）作为冻干的白色至灰白色粉末或颗粒在无菌小瓶中提供。
每瓶MENOPUR都配有一瓶含有2mL 0.9％注射用氯化钠的无菌稀释液，USP：
75个国际单位FSH和75个国际单位的LH活动，以
NDC 55566-7501-2：5个样品瓶+ 5个样品瓶稀释剂+ 5个Q•盖子样品瓶适配器
存储和处理
冻干粉末可以冷藏或在室温（3°至25°C/37°至77°F）下储存直至分配。防止光线。重建后立即使用。丢弃未使用的材料。
完整说明资料附件：
http://www.ferringusa.com/wp-content/uploads/2019/04/Menopur-PI-Rev.-05.2018-20Mar2019.pdf 
MENOPUR®(menotropins for injection)
MENOPUR® (menotropins for injection) is a prescription medicine that contains hormones. MENOPUR contains follicle stimulating hormone and luteinizing hormone activity. These hormones stimulate healthy ovaries to make eggs. MENOPUR is used for women who need medical help to get pregnant. Your doctor may prescribe more than one medicine as part of a pregnancy plan.
Important Safety Information
Do not use MENOPUR if you: have ovaries that are not able to make eggs even with the use of hormones, are pregnant or think you may be pregnant, have problems with your thyroid gland or adrenal gland that are not controlled by taking medicine, have tumors in your female organs (including breasts), have a tumor of your pituitary gland or any other tumor in your brain, or have heavy or irregular vaginal bleeding and the cause is not known. Do not use MENOPUR if you have a known previous allergic reaction to these medications.
MENOPUR may cause serious side effects. They sometimes stimulate the ovaries too much. This is called ovarian hyperstimulation syndrome (OHSS) and can be a serious medical problem. OHSS may cause pelvic pain or breathing problems, or it may make you urinate less. In rare cases, patients with this problem have had serious lung problems. MENOPUR can also cause blood clots and strokes. Call your doctor or get medical help right away if you have: severe pelvic pain, nausea, vomiting, diarrhea, sudden weight gain, trouble breathing, or decreased or no urination. MENOPUR may cause pregnancies with twins or more than two babies at the same time, miscarriages, birth defects, and pregnancies located outside the uterus. Do not use MENOPUR if you are nursing. The most common side effects with MENOPUR are headache, stomach pain, and upset stomach. Sometimes there is an injection-site reaction that can cause bruising, pain, or redness.
Please see full Prescribing Information for MENOPUR.
ENDOMETRIN® (progesterone)
ENDOMETRIN® (progesterone) is a vaginal insert that contains the hormone progesterone, one of the hormones essential for helping you to become and to stay pregnant. ENDOMETRIN is for women who need extra progesterone while undergoing treatment in an Assisted Reproductive Technology (ART) program.
Important Safety Information
Do not use ENDOMETRIN if you:
•Are allergic to anything in ENDOMETRIN
•Have unusual vaginal bleeding that has not been eva luated by a doctor
•Currently have or have had liver problems
•Have or have had blood clots in the legs, lung, eyes, or elsewhere in your body
Progesterone can increase your chance of getting blood clots. Blood clots can be serious and lead to death. Serious blood clots include those in the legs, lungs, eyes, heart, and brain.
Call your doctor and get medical help right away if you have: persistent lower leg pain, sudden shortness of breath, coughing up blood, sudden blindness (partial or complete), severe chest pain, sudden severe headache, vomiting, dizziness, or fainting, weakness in an arm or leg, or trouble speaking, yellowing of the skin and/or white of the eyes indicating possible liver problems.
Common side effects seen with ART and ENDOMETRIN included pelvic pain after surgery, abdominal pain, nausea, and swollen ovaries (ovarian hyperstimulation syndrome).
Please see full Prescribing Information for ENDOMETRIN.
NOVAREL® (chorionic gonadotropin for injection, USP)
NOVAREL® (chorionic gonadotropin for injection, USP) is a prescription medicine that contains a hormone to help stimulate healthy ovaries to make eggs. NOVAREL is used for women who need medical help to get pregnant. Your doctor may prescribe more than one medicine as part of a pregnancy plan.
Important Safety Information
Do not use NOVAREL if you have begun puberty at an unusually early age, have prostate cancer, or have had a prior allergic reaction to this hormone. This hormone may cause harm to an unborn baby when given to a pregnant woman.
NOVAREL may cause serious side effects. It sometimes stimulates the ovaries too much. This is called ovarian hyperstimulation syndrome (OHSS) and can be a serious medical problem. OHSS may cause pelvic pain or breathing problems, or it may make you urinate less. In rare cases, patients with this problem have had serious lung problems. NOVAREL can also cause blood clots and strokes. Call your doctor or get medical help right away if you have: severe pelvic pain, nausea, vomiting, diarrhea, sudden weight gain, trouble breathing, or decreased or no urination. NOVAREL may cause you to be pregnant with twins or more than two babies at the same time.
Other side effects of NOVAREL include headache, irritability, restlessness, depression, fatigue, swelling, and pain at the site of injection.
Anaphylaxis has been reported with urinary-derived hCG products.