新生物制品Xeomin(肉毒毒素类型A[incobotulinumtoxinA])治疗颈部肌张力障碍和眼睑痉挛
——新的适应症获得FDA批准
XEOMIN（incobotulinumtoxinA）注射，肌肉注射用
最初美国批准时间：2010年
警告：
完整黑框警告毒素EFFECTSee完整的处方信息的远处扩散。
XEOMIN和所有肉毒杆菌毒素制品的效果可能从注射，以产生与肉毒杆菌毒素的效果症状一致的区域扩散。注射后，这些症状已经报道小时到几周。吞咽和呼吸困难可危及生命，也有过死亡的报告。症状的风险可能是最大的在痉挛症状，但治疗的儿童也可发生于成年人，特别是在那些谁拥有，将他们易患这些症状基本条件的患者。
目前的主要变化
适应症和用法，上肢痉挛  12/2015
用法与用量，  上肢痉挛  12/2015
作用机理
XEOMIN块由从外周胆碱能神经末梢抑制乙酰胆碱的释放在神经肌肉接头处的胆碱能传输。按照以下顺序发生这种抑制：神经毒素结合于胆碱能神经末梢的神经毒素内化进入神经终端，该分子进入神经终端的胞质溶胶，和SNAP25的酶裂解的轻链部分的易位，突触前靶蛋白的乙酰胆碱的释放至关重要。由新的神经末梢的形成脉冲传输重新建立
适应症和用法
XEOMIN是乙酰胆碱释放抑制剂和神经肌肉阻断剂，用于治疗或成年患者的改善表示：
上肢痉挛
颈部肌张力障碍
眼睑痉挛与onabotulinumtoxinA（肉毒杆菌）治疗前
在温和的外表，重度眉间纹与瓦楞和/或降眉间肌活动暂时改善
用法用量
上肢痉挛，颈部肌张力障碍，和眼睑痉挛：最佳剂量，频率和在处理过的肌肉（多个）注射部位的数目应根据严重程度和先前治疗的反应;个性化给药为每一个病人：
上肢痉挛成人：推荐总剂量达400单位不早于每12周
颈部肌张力障碍：推荐的初始总剂量为每疗程120单位
眼睑痉挛：在以前的剂量为onabotulinumtoxinA（肉毒杆菌）基地初始计量;如果不知道，建议的起始剂量是1.25单位-2.5％注射部位单元
眉间纹：推荐剂量为每疗程分为每4台五等分肌肉注射（每个皱眉肌两次注射，并在鼻锥肌注射一次20台;复治前等待至少三个月
重组XEOMIN：
旨在用于肌内注射仅
用于只有一个喷射会话和只有一个病人
指令是特定于50单位，100单位，200单位小瓶
在冰箱中（2℃至8℃）存储并在24小时内使用
剂型和规格
注射：50单位，100单位，或200单位冻干粉末在单一剂量小瓶用于重建与无防腐剂的0.9％的氯化钠注射液，USP
禁忌症
已知过敏活性物质肉毒毒素A型或任何赋形剂
在感染建议注射部位
警告和注意事项
呼吸，语音或吞咽困难：如果需要或具有预先存在的肌肉疾病双侧颈肌肉注射风险增加;可能需要立即就医
XEOMIN的效力单位是用A型肉毒毒素产品等准备工作不能互换
角膜暴露和溃疡：可能需要保护措施
上睑下垂的风险：遵循建议剂量。
不良反应
比安慰剂以下和更大的指定的速率的最常观察到的不良反应是：
上肢痉挛（患者≥2％）癫痫发作，鼻咽炎，口干，上呼吸道感染。
颈部肌张力障碍：（患者≥5％），吞咽困难，颈部疼痛，肌肉无力，注射部位疼痛，肌肉骨骼疼痛。
眼睑：眼睑下垂，眼干，口干，腹泻，头痛，视力障碍，呼吸困难，鼻咽炎，和呼吸道感染（患者≥5％）
眉间纹：（> 1％的患者），头痛
药物相互作用
氨基糖苷类抗生素或与神经肌肉传导，会增强XEOMIN的效果干扰其他代理;共辖只有谨慎和密切观察。
特殊人群中使用
妊娠：根据动物实验数据，可能会对胎儿造成伤害。
儿童用药：XEOMIN尚未研究的儿童组，因此没有在儿童患者推荐。
包装规格
美国包装：
XEOMIN INJ 100UNIT LYP PWD D/S  INCOBOTULINUMTOXINA     00259-1610-01
XEOMIN INJ 50 UNIT LYP PWD D/S  INCOBOTULINUMTOXINA     00259-1605-01

英国和德国包装
XEOMIN INJ 50UNIT    PWD   INCOBOTULINUMTOXINA
XEOMIN INJ 100UNIT  PWD   INCOBOTULINUMTOXINA

生产厂家：MERZ PHARMACEUTICALS
XEOMIN® IMPORTANT CONSUMER SAFETY INFORMATION
Read the Medication Guide before you start receiving XEOMIN® (Zeo-min) and each time XEOMIN® is given to you as there may be new information. The risk information provided here is not comprehensive. To learn more:
Talk to your health care provider or pharmacist
Visit www.xeominaesthetic.com to obtain the FDA-approved product labeling
Call 1-866-862-1211
Uses XEOMIN® is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults for a short period of time (temporary).
Warnings
XEOMIN® may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems anytime (hours to week) after treatment with XEOMIN®:
Problems with swallowing, speaking, or breathing. These problems can happen hours to weeks after an injection of XEOMIN® if the muscles that you use to breathe and swallow become weak after the injection. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with XEOMIN®.
People with certain breathing problems may need to use muscles in their neck to help them breathe and may be at greater risk for serious breathing problems with XEOMIN®.
Swallowing problems may last for several months. People who cannot swallow well may need a feeding tube to receive food and water. If swallowing problems are severe, food or liquids may go into your lungs. People who already have swallowing or breathing problems before receiving XEOMIN® have the highest risk of getting these problems.
Spread of toxin effects. In some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. The symptoms of botulism include: loss of strength and muscle weakness all over the body, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing.
These problems could make it unsafe for you to drive a car or do other dangerous activities.
Do not use XEOMIN if you are allergic to XEOMIN® or any of the ingredients in XEOMIN® (see the end of this Guide for a list of ingredients in XEOMIN®), had an allergic reaction to any other botulinum toxin products such as rimabotulinumtoxinB (MYOBLOC®), onabotulinumtoxinA (BOTOX®, BOTOX® COSMETIC), or abobotulinumtoxinA (DYSPORT®) or have a skin infection at the planned injection site.
Ask a doctor before use if you
have a disease that affects your muscles and nerves (such as amyotrophic lateral sclerosis [ALS or Lou Gehrig's disease], myasthenia gravis or Lambert-Eaton syndrome)
have had any side effect from any other botulinum toxin in the past
have a breathing problem such as asthma or emphysema
have a history of swallowing problems or inhaling food or fluid into your lungs (aspiration)
have bleeding problems
have drooping eyelids
have plans to have surgery
have had surgery on your face
are pregnant or plan to become pregnant. It is not known if XEOMIN® can harm your unborn baby
are breastfeeding or plan to breastfeed. It is not known if XEOMIN® passes into breast milk.
XEOMIN is not recommended for use in children younger than 18 years of age.
Tell your doctor about all of your medical conditions and all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Using XEOMIN® with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received XEOMIN in the past.
Especially tell your doctor if you
have received any other botulinum toxin product in the last four months
have received injections of botulinum toxin such as rimabotulinumtoxinB (MYOBLOC®), onabotulinumtoxinA (BOTOX®, BOTOX® COSMETIC) and abobotulinumtoxinA (DYSPORT®) in the past. Be sure your doctor knows exactly which product you received. The dose of XEOMIN® may be different from other botulinum toxin products that you have received.
have recently received an antibiotic by injection
take muscle relaxants
take an allergy or cold medicine
take a sleep medicine
take a blood thinner medicine
Ask your doctor if you are not sure if your medicine is one that is listed above.
Possible Side Effects
XEOMIN can cause serious side effects that can be life threatening. See “Warnings.”
Headache was the most common side effect of XEOMIN for treatment of glabellar lines. Other possible side effects include:
dry mouth
discomfort or pain at the injection site
tiredness
neck pain
muscle weakness
eye problems, including: double vision, blurred vision, drooping eyelids, swelling of your eyelids, and dry eyes. Reduced blinking can also occur. Tell your doctor or get medical help right away if you have eye pain or irritation following treatment.
XEOMIN may cause other serious side effects including allergic reactions. Symptoms of an allergic reaction to XEOMIN® may include: itching, rash, redness, swelling, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or get medical help right away if you get wheezing or asthma symptoms, or if you get dizzy or faint.
These are not all the possible side effects of XEOMIN®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Directions
XEOMIN® is a shot (injection) that your doctor will give you.
XEOMIN® is injected into your affected muscles.
Your doctor may change your dose of XEOMIN® until you and your doctor find the best dose for you.
General information about the safe and effective use of XEOMIN
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use XEOMIN for a condition for which it was not prescribed. Do not give XEOMIN to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about XEOMIN that is written for health professionals.
Active Ingredient: incobotulinumtoxinA
Inactive Ingredients: human albumin and sucrose
1）：https://www.medicines.org.uk/emc/medicine/24582
2）：https://www.medicines.org.uk/emc/medicine/20666
3）：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3f35d6e0-3450-4abc-a0da-cc7b277e7c6e