药物别名： LEUPROLIDE ACETATE、ELIGARD
英文名称： Leuprorelin acetate
说　　明： 注射液
功用作用： 子宫内膜异位症;伴有月经过多、下腹痛、腰痛及贫血等的子宫肌瘤；绝经前乳腺癌，且雌激素受体阳性患者；前列腺癌；中枢性性早熟症。
用法用量： 皮下注射，成人3.75mg/次，1次/4周。
子宫内膜异位症：通常，成人每4周1次，皮下注射醋酸亮丙瑞林3.75mg。当患者体重低于50kg时，可以使用1.88mg的制剂。初次给药应从月经周期的1～5日开始。
子宫肌瘤：通常，成人每4周1次，皮下注射醋酸亮丙瑞林1.88mg。但对于体重过重或子宫明显肿大的患者，应注射3.75mg。初次给药应从月经周期的1～5日开始。
前列腺癌、闭经前乳腺癌：通常，成人每4周1次，皮下注射醋酸亮丙瑞林3.75mg。
中枢性性早熟症：通常，每4周1次，皮下注射醋酸亮丙瑞林30mg/kg，根据患者症状可增量至90mg/kg。
注意事项： 不良反应：内分泌系统：发热，颜面潮红，发汗，性欲减退，阳痿，男子女性化乳房，睾丸萎缩，会阴不适等现象。
肌肉骨骼系统：可见骨疼痛，肩腰四肢疼痛。
泌尿系统：可见排尿障碍，血尿等。
循环系统：可见心电图异常，心胸比例增大等。
消化系统：恶心，呕吐食欲不振等。过敏反应：可见皮疹搔痒等。
注射局部疼痛，硬结，发红。
其他：可见浮肿，胸部压迫感，发冷，疲倦，体重增加，知觉异常，听力衰退，耳鸣，头部多毛，尿酸，BUN，LDH，GOT，GPT上升等。由于雌激素降低作用而出现的更年期综合征样的精神抑郁状态。
对本药成份、合成的LH-RH或LH-RH衍生物有过敏史者禁用。孕妇或有可能怀孕的妇女，或哺乳期妇女；有性质不明的、异常的阴道出血者[有可能为恶性疾病]禁用 。 皮下注射部位选上臂部、腹部、臀部，注射后不得揉搓注射部位。
首次用药初期，由于高活性LH－RH衍生物对垂体－性腺系统的刺激作用，使血清睾丸素浓度上升，可见骨性疼痛暂时加重，尿储留或脊髓压迫症状，应对症处理。已存在由脊髓压迫或尿储留引起的肾功能障碍者或者是有重新发作可能性的患者及高龄者慎用。治疗时一定要确认患者未妊娠，且于月经周期的1-5天开始给药，在治疗期内应采用非激素性方法避孕。给药时应留心与类似疾患(恶性肿瘤等)鉴别，如给药过程中肿瘤增大，临床症状末见改善时应中止给药。由于雌激素降低可引起骨质的损失，故需长期给药或再次给药时，应尽可能检查骨密度，慎重用药。
对含有明胶的药物或含有明胶的食物有过敏史者，例如休克、过敏性症状（荨麻疹、呼吸困难、口唇浮肿、喉头水肿等）应慎重用药；已有因使用本品引起血栓形成及肺栓塞症的报告。

Eligard is related to a naturally occurring hormone called gonadotropin-releasing hormone (GnRH). GnRH influences the release of the hormones testosterone and estrogen in the body.

Eligard is used to reduce the amount of testosterone in the body. It is used to treat advanced prostate cancer.

Eligard may also be used for other purposes not listed in this medication guide.

Most important: Eligard can cause birth defects. Eligard is not to be used by women. You should not use this medication if you are allergic to leuprolide or similar medications such as buserelin (Suprefact, Suprecor), goserelin (Zoladex), histrelin (Supprelin), nafarelin (Synarel).

Before using Eligard, tell your doctor if you have epilepsy, asthma, migraines, heart or kidney disease, a history of depression, bone cancer affecting your spine, blood in your urine, or if you are unable to urinate.

Tell your doctor if you have a personal or family history of osteoporosis, or if you have any risk factors for bone loss such as smoking, alcohol use, or taking steroid or seizure medications long term. Long-term use of this medication may decrease bone density.
Dosage and Administration for Eligard
ELIGARD® is administered subcutaneously and provides continuous release of leuprolide acetate over a one-, three-, four- or six-month treatment period (Table 8). The injection delivers the dose of leuprolide acetate incorporated in a polymer formulation.

Once mixed, ELIGARD® should be discarded if not administered within 30 minutes.

As with other drugs administered by subcutaneous injection, the injection site should vary periodically. The specific injection location chosen should be an area with sufficient soft or loose subcutaneous tissue. In clinical trials, the injection was administered in the upper- or mid-abdominal area. Avoid areas with brawny or fibrous subcutaneous tissue or locations that could be rubbed or compressed (i.e., with a belt or clothing waistband).

Mixing Procedure

IMPORTANT: Allow the product to reach room temperature before using. Once mixed, the product must be administered within 30 minutes.

Follow the instructions as directed to ensure proper preparation of ELIGARD® prior to administration:

ELIGARD® is packaged in either thermoformed trays or pouches. Each carton contains:

• One sterile Syringe A pre-filled with the ATRIGEL® Delivery System
• One Syringe B pre-filled with leuprolide acetate powder
• One long white plunger rod for use with Syringe B
• One sterile needle
• Desiccant pack(s)

1.

On a clean field, open all of the packages and remove the contents. Discard the desiccant pack(s).

2.

Pull out the blue-tipped short plunger rod and attached stopper from Syringe B and discard (Figure 9). Gently insert the long, white replacement plunger rod into the gray primary stopper remaining in Syringe B by twisting it in place (Figure 10).

3.

Unscrew the clear cap from Syringe A (Figure 11). Remove the gray rubber cap from Syringe B (Figure 12).

4.

Join the two syringes together by pushing in and twisting until secure (Figure 13).
 

5.

Inject the liquid contents of Syringe A into Syringe B containing the leuprolide acetate. Thoroughly mix the product by pushing the contents of both syringes back and forth between syringes (approximately 45 seconds) to obtain a uniform suspension (Figure 14). (7.5 mg PI, 22.5 mg PI, 30 mg PI, 45 mg PI) When thoroughly mixed, the suspension will appear light tan to tan (ELIGARD® 7.5 mg) or colorless to pale yellow (ELIGARD®, 22.5 mg, 30 mg and 45 mg) in color. PleaseNote: Product must be mixed as described; shaking will not provide adequate mixing of the product.

6.

Hold the syringes vertically with Syringe B on the bottom. The syringes should remain securely coupled. Draw the entire mixed product into Syringe B (short, wide syringe) by depressing the Syringe A plunger and slightly withdrawing the Syringe B plunger. Uncouple Syringe A while continuing to push down on the Syringe A plunger (Figure 15). Note: Small air bubbles will remain in the formulation – this is acceptable.

7.

Hold Syringe B upright. Remove the cap on the bottom of the sterile needle cartridge by twisting it (Figure 16). Attach the needle cartridge to the end of Syringe B (Figure 17) by pushing in and turning the needle until it is firmly seated. Do not twist the needle onto the syringe until it is stripped. Pull off the clear needle cartridge cover prior to administration (Figure 18).

Administration Procedure

IMPORTANT: Allow the product to reach room temperature before using. Once mixed, the product must be administered within 30 minutes.

1. Choose an injection site on the abdomen, upper buttocks, or anywhere with adequate amounts of subcutaneous tissue that does not have excessive pigment, nodules, lesions, or hair. Since you can vary the injection site with a subcutaneous injection, choose an area that hasn't recently been used.
2. Cleanse the injection-site area with an alcohol swab.
3. Using the thumb and forefinger of your nondominant hand, grab and bunch the area of skin around the injection site.
   

   

4. Using your dominant hand, insert the needle quickly at a 90° angle. The approximate angle you use will depend on the amount and fullness of the subcutaneous tissue and the length of the needle. After the needle is inserted, release the skin with your nondominant hand.

   

5. Inject the drug using a slow, steady push. Press down on the plunger until the syringe is empty.
6. Withdraw the needle quickly at the same angle used for insertion.
7. Discard all components safely in an appropriate biohazard container.

【—原产地英文商品名—】ELIGARD-22.5mg/Syringe
【—原产地英文药品名—】LEUPROLIDE ACETATE
【—中文参考商品—】艾里咖-22.5毫克/支
【—中文参考药品—】利普安
【—临床试验期—】完成
【—中文适应病症参考—】前列腺癌
【—中文适应病症参考—】癌症
【—生产厂家中文参考—】QLT公司
【—生产厂家英文名—】QLT Inc.
【—产地国家—】 美国