Xiaflex

Xiaflex 是由从某种细菌中提取的蛋白质混合物制成。

Xiaflex 用于治疗成人 杜宾斯挛缩。这种状况会导致手掌部位的组织异常增厚。该状况可能会随着时间推移而恶化，并在掌中形成“绳索”，导致手指永久弯曲。

Xiaflex 也用于治疗成年男性的一种相关病症——佩罗尼氏病。这种状况会导致阴茎皮肤下形成瘢痕组织或“斑块”，从而导致阴茎在勃起时异常弯曲。

Xiaflex 治疗佩罗尼氏病仅在名为 Xiaflex REMS 的特殊计划下的认证药房提供。您必须注册该计划并了解服用此药物的风险。

在您使用 Xiaflex 之前，请告知您的医生您是否患有出血或凝血障碍，例如血友病。

Xiaflex 可能会损伤注射部位手部的神经、肌腱或韧带。 注射肿胀消退后，如果您出现麻木、刺痛、疼痛加剧、手指向手腕弯曲困难，或手部治疗区域出现新的或加重的运动问题，请及时联系您的医生。

Xiaflex 也可能损伤男性阴茎内的勃起组织，这可能需要手术矫正。 如果您出现以下情况，请立即联系您的医生：阴茎出现瘀伤和肿胀、排尿时疼痛、血尿、突然出现勃起功能障碍，或在勃起期间阴茎发出“砰”的声音或感觉。

如果您出现对Xiaflex的过敏反应迹象，请立即寻求紧急医疗帮助：荨麻疹；呼吸困难；脸部、嘴唇、舌头或喉咙肿胀。

注射了胶原酶梭菌组织蛋白酶后可能会损伤手部的神经、肌腱或韧带。 如果您出现以下情况，请立即联系您的医生：

• 发烧、发冷、红斑增加或肿胀；

• 治疗的手指麻木或刺痛；或

• 在肿胀消退后手指弯曲困难。

Xiaflex 可能还会损伤男性阴茎内的勃起组织，这可能需要手术矫正。 如果您有以下情况，请立即联系您的医生：

• 阴茎出现瘀伤和肿胀；

• 排尿时疼痛或尿中带血；

• 突然出现勃起功能障碍；或

• 在勃起期间阴茎发出“砰砰”声或感觉异常。

如果您出现以下情况也应立即联系您的医生：

• 注射后突然出现背痛、胸痛或行走困难；或

• 感觉要昏倒（即使躺下也会）。

Xiaflex 的常见副作用可能包括：

• 注射部位肿胀、瘀伤、出血、疼痛或触痛；

• 肘部或腋窝淋巴结肿大；

• 皮肤瘙痒、红斑或发热；

• 皮肤开裂；

• 腋窝疼痛；

• 治疗手部疼痛或触痛；

• 阴茎或阴囊瘀伤、勃起功能障碍；或

• 阴茎皮肤变色，在注射部位出现瘀伤或水疱。

这并非副作用的完整列表，其他症状也可能发生。有关副作用的医疗建议，请咨询您的医生。

如果您对胶原酶梭状芽孢杆菌过敏，则不应使用夏夫莱克斯。本品不应用于治疗影响尿道（您膀胱的排尿管道）的佩罗尼氏病。

如果您出现以下情况，请立即停止使用夏夫莱克斯并呼叫医生：

• 有出血或凝血障碍，例如血友病；

• 曾因其他情况接受夏夫莱克斯治疗；

• 有任何其他医疗问题。

目前尚不清楚胶原酶梭状芽孢杆菌是否会危害未出生的婴儿。如果您怀孕或计划怀孕，请告知您的医生。

在使用夏夫莱克斯期间是否可以安全哺乳，请咨询医生。

告诉您的医生您正在使用的所有其他药物，尤其是：

• 一种血液稀释剂 - 华法林，可迈丁，Jantoven。

此列表并不完整。其他药物可能与胶原酶梭菌溶素相互作用，包括处方药和非处方药、维生素 和 草药产品。这里没有列出所有可能的药物相互作用。

Xiaflex is injected directly into the "cord" of the affected hand or into a "plaque" of the penis. A healthcare provider will give you this injection. Follow your doctor's instructions very carefully.

For Dupuytren's contracture:

• Do not bend or straighten the fingers of the treated hand until your doctor tells you to.

• Keep the treated hand elevated until bedtime.

• You may need to wear a splint on your hand for a short time to keep your fingers straight. You may also need to perform daily finger exercises.

• One to 3 days after injection into your hand, your doctor will need to examine the hand to see if your condition has improved.

For Peyronie's disease:

• Your penis may need to be wrapped in a bandage for a short time after each injection. Follow your doctor's instructions about how long to wear the bandage.

• One to 3 days after your second Xiaflex injection, your doctor will perform a stretching procedure to help straighten the curve in your penis.

• You may also need to perform gentle exercises to stretch and straighten the penis at home. Carefully follow all directions about how to perform these exercises.

• You should not have any sexual activity between the first and second Xiaflex injections and for at least 4 weeks after your second injection and after any pain or swelling in your penis has gone away.

Usual Adult Dose of Xiaflex for Dupuytren's Contracture:

0.58 mg injected into a palpable cord with a contracture of a metacarpophalangeal (MP) joint or a proximal interphalangeal (PIP) joint

Comments:
-This drug should be administered by a healthcare provider experienced in injection procedures of the hand and in the treatment of patients with Dupuytren's contracture.
-Up to 2 joints in the same hand may be treated during a treatment visit. Two palpable cords affecting 2 joints may be injected or one palpable cord affecting 2 joints in the same finger may be injected at 2 locations during a treatment visit. If a patient has other palpable cords with contractures of MP or PIP joints, these cords may be injected at other treatment visits approximately 4 weeks apart.
-Approximately 24 to 72 hours following an injection, a finger extension procedure should be performed if a contracture persists. Consult manufacturer product information or local protocol for information on the finger extension procedure.
-Injections and finger extension procedures may be administered up to 3 times per cord at approximately 4-week intervals.
-Up to 2 cords in the same hand may be injected at a treatment visit. If a patient has other cords with contractures, those cords should be injected at another treatment visit.
-Vital signs should be monitored and appropriate equipment should be available to address any severe local or systemic reactions including the potential for anaphylaxis that may occur following injection.

Usual Adult Dose of Xiaflex for Peyronie's Disease:

0.58 mg injected into the target plaque once on each of two days, 1 to 3 days apart

Comments:
-This drug should be administered by a healthcare provider experienced in the treatment of male urological diseases, who has completed required training for use of this drug in the treatment of Peyronie's disease.
-A treatment cycle consists of 2 injection procedures and a penile modeling procedure.
-For each plaque causing the curvature deformity, up to 4 treatment cycles may be administered. Each treatment cycle may be repeated at approximately 6 week intervals. If the curvature deformity is less than 15 degrees after the first, second or third treatment cycle, or if further treatment is not indicated, then subsequent treatment cycles should not be administered.
-The safety of more than one treatment course for Peyronie's disease is not known.

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