Fu Laimei(Polyethylene Glycol Loxenatide Injection)
Polyethylene Glycol Loxenatide Injection

English Name: Polyethylene Glycol Loxenatide Injection

Chinese Pinyin: Juyi’erchun Luosainatai Zhusheye

The main component of this product is Polyethylene Glycol Loxenatide.


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【Name】

Common Name: Polyethylene Glycol Loxenatide Injection

Brand Name: Fu Laimei

English Name: Polyethylene Glycol Loxenatide Injection

Chinese Pinyin: Juyi’erchun Luosainatai Zhusheye

【Ingredients】

The main component of this product is Polyethylene Glycol Loxenatide.

Chemical Name: Histidyl-D-alanyl-glutamyl-glycyl-threonyl-phenylalanyl-threonyl-seryl-aspartyl-leucyl-seryl-lysyl-glytamyl-norleucyl-glutamyl-glutamyl-glutamyl-alanyl-valyl-arginyl-leucyl-phenylalanyl-isoleucyl-alanyl-tryptophyl-leucyl-lysyl-glutamyl-glycyl-prolyl-seryl-seryl-glycyl-alanyl-prolyl-prolyl-prolyl-S-[(3RS)-1-{3-[2-{Nα,Nε-di[ω- methoxyl-poly-(oxyethylene)-carbonyl]-lysylamide}-ethyl]-amino]-3-oxypropyl}-2,5-dioxpyrrolidone-3-radical]-cysteinylamide.

Structural Formula:

Molecular Formula:  C210H325N55O69S·(C2H4O)2n 

Molecular Weight: 44212.65±4000Da

【Description】

This product is a colorless or practically colorless transparent liquid.

【Indication】

Monotherapy of this drug or combined therapy with Metformin, along with supplemental treatment including diet control and exercise, is used to improve the blood glucose control in adult patients with Type II Diabetes Mellitus.

【Strength】

(1)0.5ml:0.1mg (calculated on C187H288N50O59S)

(2) 0.5ml:0.1mg (calculated on C187H288N50O59S)

【Dosage and Administration】

Monotherapy: For patients with poor blood glucose control after diet control and exercise, the recommended starting dose is 0.1mg, once a week (7 days) , abdominal subcutaneous injection. If the effect on blood glucose control cannot be satisfactory, increase the dose to 0.2mg for once a week (7 days).

Combined Therapy: For patients with poor blood glucose control after treated by basic Metformin regimen, the recommended starting dose is 0.1mg once a week (7 days).

This product should be injected once a week (7 days) and can be injected at any time during the day (before or after meal). In case of a missing dose, if there are still over 3 days remaining before the next scheduled dose, immediately administer it; If there are less than 3 days remaining, skip the supplementary dose. There should be at least 3 days between two doses.  The regimen should be rescheduled if changing the administering schedule.

This product must not be injected intravenously or intramuscularly. The abdominal injection sites is suggested to be switched frequently to avoid a long-term administration on a same injection site.

Check the solution thoroughly before each administration,. Do not use it if there are precipitations and cloudy particles in the solution.

Instructions on Prefilling Syringe: before administration, gently pinch the skin and subcutaneous fat tissue with thumb and index finger of one hand. Hold the syringe with the other hand and put the needle slant upward. Quickly insert the needle at 30-40° (recommended for low-weight patients) or 90°into the skin. The depth of insertion is depended on the depth of subcutaneous fat. Generally, the needle can be inserted by 0.5 to 1.0cm of depth. Only if  no blood has been withdrawn, inject the drug solution.

Instructions on Pen Syringe: This drug is not intended to be used with Insulin Pen Syringes commonly available on the market. It can only be used with matched Pen Syringe. Detailed usage and notifications refer to the Instructions for Use of matched Pen Syringe.


Note: Please refer to the Product Manual for details.



Classified into China Class 1.1 Innovative Drug

2018: Classified into China National 863 Program

2010: Awarded as National Major Science and Technology Project

2012: Awarded as National Major Science and Technology Project

2019: Launched in China