组氨瑞林是一种促黄体激素释放激素（LHRH）激动剂，美国学者萧尔（Shore）等报告，对于晚期前列腺癌患者，每年一次给予组氨瑞林长效埋植剂皮下埋植，能长期稳定地抑制睾酮，使其保持去势水平（＜50
ng/dl）。
[别名]：LHRH-Hydrogel implant，RL 0903
[商品名]：Vantas
[用机制]：促性腺激素释放激素类似物，前列腺癌治疗药物。
[开发公司]：Endo制药；西尔制药公司/Hydro Med Sciences公司（美国）（原开发公司）
[开发阶段]：已上市
[给药方式]：皮下植入
[简要评述]：SPD 424（促黄体激素释放激素(LHRH)－凝胶植入剂，RL 0903）是由Roberts制药公司（现在的西尔制药集团）作为前列腺癌治疗药物进行开发。1999年12月23日，Roberts制药公司并入西尔制药集团。SPD 424是合成的黄体生成素释放激素类似物，通过长期抑制垂体促性腺激素的释放来阻断卵巢和睾丸功能。西尔公司在美国开始SPD 424的III期临床试验，于2001年进行NDA申请。III期临床试验中，SPD 424采用Hydro Med Sciences公司（2003年更名为Valera制药）的凝胶植入给药技术以皮下植入方式给药。该植入剂用局麻方式放入，也可取出，能以缓慢恒定速率在1年内释药。为了交换用此专利技术开发的LHRH激动剂的独家权，Hydro
Med Sciences公司将从Roberts制药公司获得阶段性付款以及将来药物销售的优先权。Roberts制药公司的财政报告预计SPD
424在美国的销售额将为3亿美元。
[批准上市及授权]：10月13日，Valera制药宣布，美国FDA已经批准长效植入剂组氨瑞林（商品名：Vantas）上市，作为晚期前列腺癌的姑息疗法用药。Vantas利用了Valera公司的Hydron（吸水性丙烯酸聚合物）植入专利技术，使组氨瑞林持续给药12个月。组氨瑞林是一种黄体生成素释放激素（LHRH）的合成九肽拮抗剂。
2005年11月21日，丹麦药品监管机构批准Vantas用于接受姑息治疗的局部进展期或转移性前列腺癌。
2007年Vantas获得英国上市批准，目前正在进行欧洲其它国家的上市申请，2008年四月签订协议授予Orion Corporation在欧洲和其它一些国家市场经营权。
2006年12月Indevus 制药 购入Valera制药，获得Vantas 在美国市场的共同开发权。2009年1月，Endo 制药收购Indevus
制药，Vantas归于Endo 制药名下。
[市场前景]：Valera公司称LHRH拮抗剂已经成为美国市场上局部晚期及转移性前列腺癌的主要治疗药，年销售额超过10亿美元。但是，该市场以4个月的短期注射剂及植入剂占据主导地位，主要产品有TAP制药公司的醋酸亮丙瑞林长效混悬注射剂（leuprolide acetate，Lupron Depot）和阿斯利康制药有限公司的醋酸戈舍瑞林植入剂 (goserelin acetate implant，Zoladex)。
2007年底，拜尔医药宣布停止Viadur(R) (醋酸亮丙瑞林植入剂)的销售，Vantas成为美国市场上唯一一年植入一次的前列腺癌植入剂。

Vantas
Generic Name: histrelin (implant) (his TREL in)
Brand Names: Vantas
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Print | Save or Share Vantas
Generic Name: histrelin (implant) (his TREL in)
Brand Names: Vantas
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What is Vantas?
Vantas is a man-made form of a hormone that regulates many processes in the body. Histrelin verstimulates the body\'s own production of certain hormones, which causes that production to shut down temporarily.
Vantas is used to treat symptoms of prostate cancer in men and should not be used in women or children. Vantas treats only the symptoms of prostate cancer but does not treat the cancer itself. Use any other medications your doctor has prescribed to best treat your condition.
Vantas may also be used for other purposes not listed in this medication guide.
Important information about VantasYou should not receive Vantas if you are allergic to histrelin or other medications that affect gonadotropin hormones. The Vantas brand of histrelin is used to treat symptoms of prostate cancer in men and should not be used in women or children.
Before you receive Vantas, tell your doctor if you have painful or difficult urination, osteoporosis, or a condition affecting your spine.
You may have a temporary increase in symptoms of your condition for a week or so after you have received the Vantas implant. Call your doctor if any of these symptoms become severe.
Call your doctor at once if you have a serious side effect such as severe numbness or tingling in your legs or feet, muscle weakness, problems with balance or coordination, loss of bladder or bowel control, urinating more or less than usual, fast or pounding heartbeats, pale skin, easy bruising or bleeding, feeling short of breath, swelling in your hands or feet, or jaundice (yellowing of your skin or eyes).
To be sure this medication is helping your condition, your blood will need to be tested often. Donotmissanyscheduledappointments.
A Vantas implant is usually left in place for 12 months and then removed. Your doctor will determine at that time whether you need to receive another implant for treatment of your symptoms.
When using Vantas to treat prostate cancer, use any other medications your doctor has prescribed to best treat your condition. Vantas treats only the symptoms of prostate cancer but does not treat the cancer itself.
What should I discuss with my health care provider before I receive Vantas?
You should not receive Vantas if you are allergic to histrelin or to similar hormone medications such as leuprolide (Lupron, Eligard, Viadur), nafarelin (Synarel), or ganirelix (Antagon).
Before you receive Vantas, tell your doctor if you are allergic to any drugs, or if you have:
painful or difficult urination;
osteoporosis; or
a condition affecting your spine.
If you have any of these conditions, you may need special tests to safely use Vantas.
FDA pregnancy category X. This medication can cause a miscarriage or birth defects. Do not use if you are pregnant. Use effective birth control while you are using this medication and tell your doctor right away if you become pregnant during treatment. It is not known whether histrelin passes into breast milk or if it could harm a nursing baby. Before you receive this medication, tell your doctor if you are breast-feeding a baby.

How is Vantas given?
Vantas is given in a tiny implant that is inserted under the skin on the inside of your upper arm. You will receive this implant with a minor surgical procedure in a clinic or doctor\'s office.
It is best to place the Vantas implant into your non-dominant arm (your left arm if you are right-handed). Be sure to tell your doctor which arm you use most often.
You should be lying on your back during insertion of the Vantas implant. Your arm will be positioned with your elbow bent and held still while the implant is inserted.
The skin of your upper arm will be treated with a numbing medicine to keep you from feeling pain during the insertion. Once your arm is numb, your doctor will use a scalpel to cut a small incision where the implant will be inserted.
The Vantas implant is inserted using a special tool that pushes the implant into place through the incision in your skin. After injecting the implant and removing the insertion tool, your doctor will then feel your arm to make sure the implant has been correctly placed.
The incision in your skin may be closed with a small number of stitches or surgical strips. Follow your doctor\'s instructions about caring for the incision and keeping it bandaged and clean until it heals completely. After receiving your implant, keep the arm dry for at least 24 hours.
You will most likely be able to feel the implant through your skin, but it should not cause pain or discomfort. Call your doctor if you have any pain, swelling, tenderness, itching, bruising, or redness where the implant was inserted.
Call your doctor if any part of the implant comes through the skin, or if the entire implant falls out.
You may have a temporary increase in symptoms of your condition for a week or so after you have received the Vantas implant. Call your doctor if any of these symptoms become severe.
To be sure this medication is helping your condition, your blood will need to be tested often. Donotmissanyscheduledappointments.
A Vantas implant is usually left in place for 12 months and then removed. Your doctor will determine at that time whether you need to receive another implant for continued relief of prostate cancer symptoms.
Whether or not you receive a new Vantas implant, the old one must be removed after 12 months of use. A Vantas implant must be removed through a surgical incision in your doctor\'s office.
What happens if I miss a dose?
Since Vantas is given as an implant by a healthcareprofessional, you will not be on a frequent dosing schedule.

The implant should not be left in your arm for longer than 12 months. Call your doctor when it is time for your implant to be removed.
What happens if I overdose?
An overdose of Vantas is not expected to produce life-threatening symptoms.

What should I avoid after receiving a Vantas implant?
For at least 7 days after your implant is inserted, avoid strenuous exercise or heavy lifting.

Vantas side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:
severe numbness or tingling in your legs or feet;

muscle weakness, problems with balance or coordination;

loss of bladder or bowel control;

urinating more or less than usual, or not at all;

fast or pounding heartbeats;

pale skin, easy bruising or bleeding;

feeling short of breath, even with mild exertion;

swelling in your hands or feet; ornausea, vomiting, loss or appetite, or jaundice (yellowing of your skin or eyes).

Less serious Vantas side effects may include:

tired feeling;

weight gain or loss;

pain or swelling in your testicles;

impotence, loss of interest in sex, trouble having an orgasm;

breast swelling or tenderness;

night sweats, feeling hot or cold;

warmth, redness, or tingly feeling under your skin;

sleep problems (insomnia);

headache, dizziness, depressed mood;

stomach pain, constipation; or

joint or muscle pain.