骨科药物Prolia获准用于骨折风险高的某些癌症患者
2011年9月19日，安进宣布美国食品药品管理局(FDA)已批准了Prolia(狄诺塞麦)的2项新适应证。
该药以RANK配体——破骨细胞的一个关键调控子——为靶点。
本次批准的新适应证为：用于正在接受芳香酶抑制剂辅助治疗的乳腺癌患者，以及正在接受雄激素剥夺治疗的非转移性前列腺癌患者，以增加这些骨折高危人群的骨量。Prolia之前已被批准用于治疗绝经后骨质疏松症。
Prolia的给药剂量、方式为单次皮下注射60mg，每6个月注射1次
Prolia®（狄诺塞麦）注射，皮下使用
美国首次批准：2010
目前的主要变化
警告和注意事项（5.3）02/2015
警告和注意事项（5.4）02/2015
警告和注意事项（5.8）06/2014
适应症和用法
Prolia是一种RANK配体（RANKL）抑制剂用于指明：
绝经后妇女骨质疏松的高风险骨折的治疗）
治疗以增加男性骨量与骨质疏松症高风险的骨折
治疗以增加男性骨量高风险的骨折接受雄激素剥夺治疗转移性前列腺癌
处理以增加骨质量的妇女在高风险为骨折接受辅助芳香酶抑制剂治疗乳腺癌
【用法用量】
应的Prolia由专业医护人员进行管理。
辖60毫克每6个月以皮下注射于上臂，大腿上部，或腹部。
指导患者服用钙1000mg的每天至少400国际单位的维生素D的每日。
剂型和规格
含在1毫升溶液60毫克单次使用的预充式注射器。
单次使用的小瓶含有60mg在1毫升溶液。
禁忌
低钙血症
怀孕
已知过敏的Prolia。
警告和注意事项
相同的活性成分：接收的Prolia不应该接受XGEVA®患者。
过敏症，包括可能发生过敏性反应。如果临床显著反应发生中断永久。
低钙血症：必须启动前的Prolia予以纠正。可能会恶化，尤其是在肾功能不全患者。充分补充患者钙和维生素D。
骨坏死的下巴：有报道用的Prolia。监测症状。
非典型股骨骨折的报道。评估患者的大腿或腹股沟疼痛以排除股骨骨折。
可能发生，包括那些导致住院：严重感染包括皮肤感染等。建议患者及时寻求医疗照顾，如果他们开发的标志或感染的症状，包括蜂窝织炎。
皮肤病反应：皮炎，皮疹和​​湿疹的报道。考虑停止的Prolia如果症状较重开发。
严重的骨骼，关节，肌肉疼痛可能发生。如果症状严重的发展，停止使用。
抑制骨转换：明显的抑制作用已被证明。监测骨oversuppression后果。
不良反应
绝经后骨质疏松症：最常见的不良反应（> 5％，比安慰剂更常见）分别为：腰痛，痛在下肢，高胆固醇血症，肌肉骨骼痛，膀胱炎。胰腺炎据报道，在临床试验中。
男性骨质疏松症：最常见的不良反应（> 5％，比安慰剂更常见）分别为：背痛，关节痛和鼻咽炎。
骨质流失是由于激素消融治疗肿瘤：最常见不良反应（≥10％，比安慰剂更常见）分别为：关节痛和腰痛​​。疼痛在肢体和肌肉骨骼疼痛也已报道在临床试验中。
特殊人群中使用
哺乳母亲：请停止药物或哺乳考虑到药物对母亲重要性的考虑。
儿童患者：安全性和有效性不成立。
肾损害：无需调整剂量是必要的，患者的肾功能损害。患者的肌酐清除率<30 mL / min或接受透析是在危险中为低钙血症。补充钙和维生素D和考虑监测血清钙。

ProliaPronunciation
Generic Name: denosumab (Prolia) (den OH sue mab)
Brand Names: Prolia
What is Prolia?
Prolia (denosumab) is a monoclonal antibody. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.
The Prolia brand of denosumab is used to treat osteoporosis in postmenopausal women who have high risk of bone fracture.
Prolia is also used to increase bone mass in women and men with a high risk of bone fracture caused by receiving treatments for certain types of cancer.
Important information
This medication guide provides information about the Prolia brand of denosumab. Xgeva is another brand of denosumab used to prevent bone fractures and other skeletal conditions in people with tumors that have spread to the bone.
You should not receive Prolia if you have low levels of calcium in your blood (hypocalcemia).
Prolia can harm an unborn baby or cause birth defects. Do not use if you are pregnant.
Before you receive Prolia, tell your doctor if you have kidney disease (or if you are on dialysis), a weak immune system, a history of hypoparathyroidism or thyroid surgery, a history of intestinal surgery, a condition that makes it hard for your body to absorb nutrients from food, or if you are allergic to latex.
Serious infections may occur during treatment with Prolia. Call your doctor right away if you have signs of infection such as: severe skin irritation; swelling or redness anywhere on your body; pain or burning when you urinate; severe stomach pain; ear pain, trouble hearing; cough, feeling short of breath; purple or red spots under your skin; or fever, chills, night sweats, flu symptoms, or weight loss.
Some people using Prolia have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.
If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are receiving Prolia. You may need to stop using the medicine for a short time.
Before receiving this medicine?
You should not receive Prolia if you are allergic to denosumab, or if you have low levels of calcium in your blood (hypocalcemia).
To make sure Prolia is safe for you, tell your doctor if you have:
•kidney disease (or if you are on dialysis);
•a weak immune system (caused by disease or by using certain medicines);
•a history of hypoparathyroidism (decreased functioning of the parathyroid glands);
•a history of thyroid surgery;
•a history of surgery to remove part of your intestine;
•any condition that makes it hard for your body to absorb nutrients from food (malabsorption); or
•if you are allergic to latex.
Prolia may cause bone loss (osteonecrosis) in the jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, gum infection, or slow healing after dental work.
Osteonecrosis of the jaw may be more likely if you have cancer or received chemotherapy, radiation, or steroids. Other risk factors include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.
FDA pregnancy category X. Prolia can harm an unborn baby or cause birth defects. Do not use Prolia if you are pregnant. Tell your doctor right away if you become pregnant during treatment.
See also: Pregnancy and breastfeeding warnings (in more detail)
If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to eva luate any effects of Prolia on the baby.
It is not known whether denosumab passes into breast milk or if it could harm a nursing baby. This medicine may also slow the production of breast milk. You should not breast-feed while using this medicine.
How is Prolia given?
Prolia is injected under the skin of your stomach, upper thigh, or upper arm. A healthcare provider will give you this injection.
Prolia is usually given once every 6 months.
Your doctor may have you take extra calcium and vitamin D while you are being treated with Prolia. Take only the amount of calcium and vitamin D that your doctor has prescribed.
If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are receiving Prolia. You may need to stop using the medicine for a short time.
Pay special attention to your dental hygiene. Brush and floss your teeth regularly while receiving this medication. You may need to have a dental exam before you begin treatment with Prolia. Follow your doctor's instructions.
If you keep this medicine at home, store it in the original container in a refrigerator. Protect from light and do not freeze.
You may take Prolia syringe out of the refrigerator and allow it to reach room temperature before the injection is given. Do not heat the medicine before using.
Do not shake the the prefilled syringe or you may ruin the medicine. Do not use the medicine if it looks cloudy or has particles in it. Call your pharmacist for a new prescription.
Each prefilled syringe of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.
After you have taken Prolia out of the refrigerator, you may keep it at room temperature for up to 14 days. Store in the original container away from heat and light.
Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.
Do not share this medicine with another person, even if they have the same symptoms you have.
What happens if I miss a dose?
Call your doctor for instructions if you miss a dose or miss an appointment for your Prolia injection. You should receive your missed injection as soon as possible.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while receiving Prolia?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
http://www.proliahcp.com/why-prolia/dosing-and-administration/index.html