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男性睾酮缺乏症外用新药"Axiron"在美获准上市

2011-05-07 16:39:52  作者:新特药房  来源:中国新特药网天津分站  浏览次数:226  文字大小:【】【】【
简介: 美国食品和药品管理局已经批准Axiron目前可作为18以上男性睾酮缺乏症的替补疗法。这是首次批准用于腋下的睾酮药物.日前,美国FDA批准了Acrux所研发的睾丸激素溶液—Axiron上市,用于男性睾酮缺乏症的替 ...

美国食品和药品管理局已经批准Axiron目前可作为18以上男性睾酮缺乏症的替补疗法。这是首次批准用于腋下的睾酮药物.
日前,美国FDA批准了Acrux所研发的睾丸激素溶液—Axiron上市,用于男性睾酮缺乏症的替补疗法。这些疾病包括原发性性腺机能减退症(先天性或获得性)和低促性腺激素性性腺功能减退症(先天性或获得性)。

Axiron是一种快速干燥且有芳香气味的溶液制剂,每天用药一次,使用时通过一种便于使用的“无接触”型喷药器给药,在腋窝处喷洒少量药品。

早在2010年1月,Acrux制药公司就向FDA递交了Axiron的销售申请。在递交这份申请之前,Acrux公布了Axiron的3期临床实验结果,实验数据表明,患者采用Axiron进行为期4个月的治疗之后,84%的人血液睾酮平均含量达到正常水平,超过FDA要求的比例(75%)。

此外,在实验中还发现,仅仅经过2周的治疗之后,已有76%的受试患者血液睾酮含量达到正常水平。而且通过对患者情绪、性欲、性活动、性能力等方面的分析发现,用药治疗后他们在这些方面均有所改善。

AXIRON

Manufacturer:

Lilly, Eli and Company

Pharmacological Class:

Androgen.

Active Ingredient(s):

Testosterone 30mg/1.5mL pump actuation; solution; contains alcohol; latex-free.

Indication(s):

Testosterone replacement therapy.

Pharmacology:

Endogenous androgens, including testosterone and dihydrotestosterone, are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics.

Male hypogonadism results from insufficient secretion of testosterone and is characterized by low serum testosterone concentrations. Signs/symptoms associated with male hypogonadism include erectile dysfunction and decreased ­sexual desire, fatigue and loss of energy, mood depression, regression of secondary sexual characteristics and osteoporosis. Male hypogonadism has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter’s Syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH).

Axiron is a clear, colorless, single phase solution containing 30mg of testosterone in 1.5mL of solution for topical administration through the axilla. In general, steady-state serum concentrations are achieved by approximately 14 days of daily dosing.

Legal Classification:

CIII

Adults:

Advise patients to strictly adhere to recommended instructions. Apply to clean, dry intact skin of the axilla; do not apply to the scrotum, penis, abdomen, shoulders or upper arms. ≥18yrs: Initially apply 60mg (30mg per axilla) once daily in the AM; measure serum testosterone levels to ensure response. May adjust dose based on serum testosterone concentration 2 to 8 hours after applying and at least 14 days after starting therapy or following dose adjustment. May increase dose in 30mg increments if serum testosterone <300ng/dL up to 120mg; reduce dose to 30mg if levels >1050ng/dL, discontinue if serum testosterone remains >1050ng/dL. Wash hands after application. Allow soln to dry before it touches clothing. Not interchangeable with other topical testosterone products.

Children:

<18yrs: not recommended.

Contraindication(s):

Male breast or prostate cancer. Use in women. Pregnancy (Cat.X). Nursing mothers.

Warnings/Precautions:

Other persons (esp. children) must avoid contact with application site. Secondary exposure to testosterone; promptly discontinue if signs of virilization in children and women occurs, until cause is identified. Increased risk for worsening BPH. Evaluate for prostate cancer before starting therapy (esp. elderly). Cardiac, renal, or hepatic disease (discontinue if edema occurs). Sleep apnea. Monitor hemoglobin, hematocrit, liver function, PSA, thyroid function, cholesterol, HDL-C, and serum testosterone. Risk of hypercalcemia; monitor. Men with BMI >35kg/m2: not studied. Avoid showering or swimming for at least 2 hours after application.

Interaction(s):

Monitor INR and PT with anticoagulants. May affect insulin requirements. Increased risk of edema with ACTH, corticosteroids.

Adverse Reaction(s):

Local reactions, increased hematocrit, headache, diarrhea, vomiting, increased serum PSA; gynecomastia, virilization in children.

How Supplied:

Pump—90mL (60 metered doses) (w. applicator)

Last Updated:

5/5/2011

责任编辑:admin


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