美国FDA批准法国益普生（Ipsen）公司的兰瑞肽储库型控释注射剂（lanreotide，Somatuline Depot）上市，用于长期治疗不宜手术和（或）放疗的肢端肥大症患者。本品为预填充注射器，不需复溶，因而可非常方便地用于患者。本品剂量规格：兰瑞肽60 mg/支、90 mg/支和120 mg/支。
本品为含有抑制生长激素释放的生长激素释放抑制因子同系物兰瑞肽。本品初始开发且目前继续主要用于治疗肢端肥大症（由垂体前叶良性肿瘤引起生长激素或泌乳素产生过度造成的疾病）。益普生公司认为本品拥有的技术代表了重大技术发展。因兰瑞肽本身可控制缓缓释出药物，故本品是第1个除水外无任何辅料的半固体注射剂，可持续释药28日，一月1次，而原制剂需2～3次。益普生公司已在近60个国家里销售本品（在美国外的商品名为Somatuline Autogel），用于治疗肢端肥大症和神经内分泌瘤或单独治疗肢端肥大症。
SOMATULINE® AUTOGEL®
60, 90 AND 120 mg
Lanreotide
Instructions for administration of the productThe following instructions explain how to inject Somatuline Autogel.
PLEASE READ ALL THE INSTRUCTIONS CAREFULLY BEFORE STARTING THE INJECTION.
Somatuline Autogel is supplied in a ready to use pre-filled syringe fitted with an automatic safety system that automatically locks in place following administration of the product, to help prevent needle stick injury after use.
1.Ensure that the medication has been refrigerated in its original package.
2.Remove Somatuline Autogel from the refrigerator 30 minutes prior to administration. Keep pouch sealed until just prior to injection.
3.Before opening the pouch, check that it is intact and that the medication has not expired. The expiration date is printed on the outer carton and the pouch. DO NOT USE IF THE MEDICATION HAS EXPIRED OR IF THE LAMINATED POUCH IS DAMAGED IN ANY WAY.
4.Wash hands with soap and ensure there is a clean area for preparation.
5.Tear open the pouch and take out the pre-filled syringe.
6.Select an injection site:
6a. .the superior external quadrant of the buttock (for injection by healthcare professional (HCP) or carer like a trained family member or friend), or
6b. the upper outer part of your thigh (if you will be injecting yourself).
- Alternate the injection site
between the right and left side each time you receive an injection of Somatuline Autogel.
7.Clean the injection site without rubbing the skin excessively and let it dry.
8.Twist and pull off the plunger protector and discard it.
9.Remove the needle cap and discard it.
10.Stretch and hold the skin around the injection site flat using your thumb and index finger. Without folding or pressing on the skin at the injection site, rapidly insert the needle to its full length (deep subcutaneous injection), perpendicular (90°) to the skin.
11.Inject the drug SLOWLY
Typically 20 seconds are needed.
Inject the full dose until the plunger cannot be depressed any further. At this point, you will hear a "click".
Note: maintain pressure on the plunger with your thumb to avoid activation of the automatic safety system.
12.Without releasing the pressure on the plunger, withdraw the needle from the injection site.
13.Then release pressure on the plunger. The needle will automatically retract into the needle guard where it will be locked permanently.
14.Apply gentle pressure to the injection site with a dry cotton ball or sterile gauze to prevent any bleeding. DO NOT rub or massage the injection site after administration.
15.Dispose of the used syringe in the syringe disposal container as instructed by your doctor or healthcare provider. DO NOT dispose of the device in your general household rubbish.
Keep the disposal container and Somatuline Autogel out of reach and sight of children.