Sublocade Injection

Sublocade (buprenorphine) is used to treat opioid dependence (addiction to opioid drugs, including heroin and narcotic painkillers) in people who have received buccal or sublingual buprenorphine for at least 7 days.

Sublocade extended-release injection belongs in a class of medications called opiate partial agonists. Buprenorphine works to prevent withdrawal symptoms when someone stops taking opioid drugs by producing similar effects to these drugs.

Sublocade is only available under a special program. You must be registered in the program and understand the risks and benefits of this medicine.

Sublocade is not for use as a pain medication.

This medication guide provides information about the Sublocade brand of buprenorphine injection. Buprenex is another brand of buprenorphine injection that is used to treat moderate to severe pain.

活性成分：丁丙诺啡。
非活性成分：ATRIGEL递送系统：可生物降解的50:50聚(DL-乳酸-共-乙二醇)聚合物和一种生物相容性溶剂，N-甲基-2-吡咯烷酮(NMP)。

如果您同时饮酒或使用其他导致嗜睡或呼吸减慢的药物，可能会发生致命的副作用。

怀孕期间使用阿片类药物可能会导致新生儿出现危及生命的戒断症状。

Sublocade 只能在特殊计划下获得。您必须在该计划中注册，并了解这种药物的风险和益处。

如果您出现对 Sublocade 过敏反应的症状，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。

阿片类药物可能会减慢或停止您的呼吸，甚至导致死亡。如果您呼吸缓慢且有长时间停顿、嘴唇发青或难以醒来，照顾您的人应立即给予纳洛酮并/或寻求紧急医疗救助。

Sublocade 可能会引起严重的副作用。如果您出现以下任何情况，请立即联系医生：

• 呼吸浅弱或停止；

• 极度嗜睡或眩晕，协调能力丧失；

• 感觉头晕，好像要昏倒；

• 阿片戒断症状 - 寒战、鸡皮疙瘩、出汗增多、感觉冷热交替、流鼻涕、流泪、腹泻、呕吐；

• 肝脏问题 - 食欲不振、右上腹部疼痛、疲劳、瘙痒、尿色深、大便颜色变浅、黄疸（皮肤或眼睛发黄）；或

• 肾上腺激素减少 - 恶心、呕吐、腹痛、食欲不振、感到疲劳或头晕、肌肉或关节疼痛、皮肤色素沉着变化、渴望咸食。

如果您出现血清素综合征的症状，请立即就医：如坐立不安、幻觉、发热、出汗、寒战、心跳加快、肌肉僵硬、抽搐、协调能力丧失、恶心、呕吐或腹泻。

即使在最后一次使用 Sublocade 几周或几个月后，如果出现戒断症状或过敏反应，请立即告知医生。

Sublocade 的常见副作用可能包括：

• 感到疲倦；

• 恶心、呕吐、便秘；

• 注射部位疼痛、红肿、瘙痒、烧灼感、刺激或皮肤变化；

• 排尿时疼痛和烧灼感；

• 睡眠障碍；

• 头痛；或

• 肝功能异常。

这并不是副作用的完整列表，其他副作用也可能发生。有关副作用的医疗建议，请咨询您的医生。

如果您对丁丙诺啡过敏，则不应使用Sublocade。

如果您还使用兴奋剂、阿片类药物、草药产品或治疗抑郁症、精神疾病、帕金森病、偏头痛、严重感染或预防恶心和呕吐的药物，请告知您的医生。与Sublocade的相互作用可能会导致一种称为血清素综合征的严重状况。

为了确保Sublocade对您是安全的，请告知您的医生您是否曾经有过：

• 呼吸问题、睡眠呼吸暂停；

• 头部损伤或脑部问题；

• 酒精依赖、精神疾病；

• 对乳胶过敏；

• 前列腺肥大；

• 排尿问题；

• 心脏问题；

• 电解质失衡（如钾或镁水平低）；

• 影响呼吸的脊柱弯曲；

• 艾迪生病（或其他肾上腺问题）；

• 胆囊或甲状腺问题；或

• 肝或肾疾病。

丁丙诺啡可能会影响男性或女性的生育能力。在任何一方使用这种药物期间，怀孕可能会更难实现。

如果您在怀孕期间使用丁丙诺啡，您的婴儿可能会出生时有危及生命的戒断症状，并且可能需要几周的医疗治疗。 告知您的医生您是否怀孕或计划怀孕。

如果您正在哺乳，请告知您的医生。如果您正在哺乳，并且注意到婴儿出现严重的嗜睡或呼吸缓慢，请告知您的医生。

有时同时使用某些药物可能不安全。一些药物会影响您使用的其他药物的血液水平，这可能会增加副作用或使药物效果降低。如果您还使用了抗生素、抗真菌药、抗癫痫药或治疗艾滋病或丙型肝炎的药物，请告知您的医生。

许多其他药物在与阿片类药物联合使用时可能是危险的。 如果您还使用以下药物，请告知您的医生：

• 用于过敏、哮喘、心脏问题、晕动病、肠易激综合症或膀胱过度活动症的药物；

• 其他阿片类药物；

• 如地西泮、克洛托西泮或阿普唑仑等苯二氮卓类镇静剂；

• 助眠药、肌肉松弛剂或其他让您昏昏欲睡的药物；或者

• 影响血清素的药物，如抗抑郁药、兴奋剂或偏头痛或帕金森病的药物。

此列表并不完整，许多其他药物可能与丁丙诺啡相互作用。这包括处方药和非处方药、维生素和草药产品。这里并未列出所有可能的药物相互作用。

Sublocade is injected under the skin. A healthcare provider will give you this injection.

After each injection, you may see or feel a small lump under your skin where the medicine was injected. This could last for several weeks but the lump should eventually get smaller. Avoid rubbing or massaging the skin where an injection was given and wearing tight clothing over the area.

Your doctor will determine how often you will receive Sublocade.

You will need frequent blood tests to check your liver function.

Sublocade is only part of a complete treatment program that may also include counseling and other types of addiction support. Tell your doctor if you feel that this medicine is not helping to improve your symptoms of addiction.

In an emergency, your family or caregivers should tell medical personnel that you are using this medicine. Make sure any follow-up doctor knows you use this medicine.

Do not stop using Sublocade suddenly, or you could have unpleasant symptoms (such as agitation, confusion, tingling or electric shock feelings).

Usual Adult Dose for Opiate Dependence - Maintenance:

Sublocade injection: following a minimum of 7-days of treatment with a transmucosal product delivering the equivalent of 8 to 24 mg buprenorphine per day:
-Initial dose: 300 mg subcutaneously once a month for 2 months
-Maintenance dose: 100 mg subcutaneously once a month
-Maintenance dose may be increased to 300 mg monthly for those tolerating lower dose and demonstrating a less than satisfactory clinical response, e.g. self-reported illicit opioid use or positive urine drug screens.

Comments:
Initiating therapy with subcutaneous injections has not been studied; subcutaneous injections should only be initiated following induction and dose-adjustment with a transmucosal buprenorphine-containing product.
Monthly doses should allow for a minimum of 26 days between doses; occasional delays in dosing of up to 2 weeks are not expected to have a clinically significant impact on treatment effect.

In a medical setting an overdose would be treated quickly.

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don't wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

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