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JEVTANA（卡巴他赛注射剂，CABAZITAXEL）

2011-11-28 23:41:10 作者：新特药房来源：中国新特药网天津分站浏览次数：1296 文字大小：【大】【中】【小】

简介：日前，美国FDA批准新型抗癌药-Jevtana(cabazitaxel)注射液上市，用于治疗男性前列腺癌，Jevtana被推荐在使用常用晚期前列腺癌药物多烯紫杉醇，无效甚至病情加重时，首选的用于治疗晚期、抗激素型前列腺 ...

关键字：JEVTANA（卡巴他赛注射剂 CABAZITAXEL）

日前，美国FDA批准新型抗癌药-Jevtana(cabazitaxel)注射液上市，用于治疗男性前列腺癌，Jevtana被推荐在使用常用晚期前列腺癌药物多烯紫杉醇，无效甚至病情加重时，首选的用于治疗晚期、抗激素型前列腺癌的药物。
前列腺癌是男性常见恶性肿瘤，常发病于老年男性，在美国是除在皮肤癌之外第二大常见男性癌症。据疾病防控中心最近统计报道，2006年约有203415名男性罹患前列腺癌，其中28372人死亡。Jevtana的上市，患者更多的治疗机会。
Jevtana是FDA优先审核的药物，因其在治疗上的优势而提前获得批准。对755名曾使用多烯紫杉醇的患者进行Jevtana的安全性及有效性临床研究，对比Jevtana与prednisone联用，及mitoxantrone与prednisone联用的患者生命持续时间，结果显示平均存活时间分别为15.1个月及12.7个月。
Jevtana的副作用有：嗜中性白血球减少症、贫血、白血球减少、血小板减少、腹泻、疲劳、恶心呕吐、便秘、无力及肾衰竭等。

JEVTANA

Manufacturer:

Sanofi Aventis

Pharmacological Class:

Antineoplastic (taxane antimicrotubule agent).

Active Ingredient(s):

Cabazitaxel 60mg/1.5mL; soln for IV infusion after dilution; contains polysorbate 80, diluent contains ethanol.

Indication(s):

In combination with prednisone, hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.

Pharmacology:

Cabazitaxel is a semisynthetic taxane antineoplastic agent prepared from an extract of yew needles. Cabazitaxel is a microtubule inhibitor that binds to tubulin and promotes its assembly into microtubules while simultaneously inhibiting disassembly. This leads to the stabilization of microtubules, which results in the inhibition of mitotic and interphase cellular functions. It has been shown to have activity in tumor models that were insensitive to docetaxel chemotherapy as well as in those that were docetaxel-sensitive.

Cabazitaxel is extensively metabolized by the liver, and it is not recommended for use in patients with impaired hepatic function due to a probable increase in cabazitaxel levels and toxicity.

Clinical Trials:

Cabazitaxel was compared to mitoxantrone in a multicenter, randomized, open-label study in 755 patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen. Patients were randomized to receive either cabazitaxel (25mg/m² every 3 weeks for up to 10 cycles with prednisone 10mg daily) or mitoxantrone (12mg/m² every 3 weeks for up to 10 cycles with prednisone 10mg daily). Patients with hepatic impairment, hypertension, and certain cardiac conditions were excluded from the trial.

In an intent-to-treat analysis, the median survival time for the cabazitaxel group was 15.1 months, compared to 12.7 months for mitoxantrone; 61.9% of the patients in the cabazitaxel group died by the 30^th month, compared to 74% in the mitoxantrone arm. The investigator-assessed tumor response was higher in the cabazitaxel group (14.4%) compared to the mitoxantrone group (4.4%).

Legal Classification:

Adults:

Pretreat with IV antihistamine, corticosteroid, and H₂ blocker 30 min before each dose (see literature) and with antiemetic (IV or oral as needed). 25mg/m² by IV infusion over 1 hour every 3 weeks, with oral prednisone 10mg/day during treatment. Do not treat if neutrophil count ≤1,500 cells/mm³. Prolonged grade ≥3 neutropenia (>1 week), febrile neutropenia, grade ≥3 diarrhea: delay treatment and/or reduce dose to 20mg/m² (see literature). Discontinue if reactions persist after dosing at 20mg/m².

Children:

Not recommended.

Contraindication(s):

Baseline neutrophil count ≤1,500cells/mm³. Allergy to polysorbate 80.

Warnings/Precautions:

Do CBC weekly in 1^st cycle and before each subsequent cycle. Increased risk of neutropenia complications; consider G-CSF prophylaxis. Hepatic impairment: not recommended. Severe renal impairment (CrCl <30mL/min) or ESRD. Elderly (increased susceptibility to adverse reactions); monitor closely. Pregnancy (Cat.D; avoid). Nursing mothers: not recommended.

Interaction(s):

Avoid strong CYP3A4 inhibitors (eg, ketoconazole, clarithromycin, atazanavir, nefazodone, nelfinavir, ritonavir, saquinavir, voriconazole) (may potentiate cabazitaxel); caution with moderate CYP3A4 inhibitors. Avoid strong CYP3A4 inducers (eg, phenytoin, carbamazepine, rifampin, phenobarbital) (may antagonize cabazitaxel). Avoid St. John’s Wort.

Adverse Reaction(s):

Bone marrow suppression (esp. neutropenia, anemia, leukopenia, thrombocytopenia), febrile neutropenia, GI upset (esp. diarrhea, may be fatal), renal failure, fatigue, constipation, asthenia, abdominal pain, hematuria, back pain, anorexia, peripheral neuropathy, pyrexia, dyspnea, dysgeusia, cough, arthralgia, alopecia, hypersensitivity reactions (eg, rash, hypotension, bronchospasm).

How Supplied:

Kit (single-use vial + diluent)—1

Last Updated:

8/12/2011

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原产地英文商品名:
JEVTANA KIT 60MG/1.5ML/VIAL SDV+1VIAL DILUENT/KIT
原产地英文药品名:
CABAZITAXEL
中文参考商品译名:
JEVTANA套装 60毫克/1.5毫升/瓶 SDV+1瓶稀释液/套
中文参考药品译名:
卡巴他赛
生产厂家中文参考译名:
美国赛诺菲安万特
生产厂家英文名:
SANOFI AVENTIS US

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新药获FDA批准-为晚期前列腺癌患者带来福音

6月17日，美国食品和药物管理局（FDA）批准化疗药物Jevtana（cabazitaxel）联合类固醇泼尼松治疗男性前列腺癌。Jevtana是晚期的、激素难治性、多西他赛治疗期间或之后恶化的前列腺癌的首选药物。多西他赛常用于晚期前列腺癌的治疗。

对于前列腺癌患者，雄激素睾酮可以导致前列腺肿瘤的生长。药物、手术或其他激素用于减少睾酮产生或阻止它。对于有些患激素难治性前列腺癌的男性，意味着尽管睾酮被抑制，但前列腺癌细胞继续生长。该类型的癌症患者需要不同的治疗方法。

根据FDA的优先评审方案（其为可能会提供重大进展的药物或在无足够治疗时提供的一种治疗而提供的快速的6个月评审），Jevtana得到了优先评审。 Jevtana的获准日期早于其原计划的目标日期2010年9月30日。

“这种疾病患者的治疗选择很少，”FDA的药物评价和研究中心的肿瘤药物产品办公室主任Richard Pazdur博士说。“美国FDA能够在11个星期内对Jevtana进行评审和批准，这加快了这一药物对前列腺癌男性供应。”

在一项纳入755例患者的研究中确立了Jevtana的安全性和有效性。所有受试者曾接受多西他赛治疗。这项研究旨在研究比较接受Jevtana联合泼尼松的患者与那些接受化疗药物米托蒽醌联合泼尼松患者之间的总体生存期（即死亡前的时间）。接收Jevtana方案的患者的中位总体生存期为15.1月，而那些接手米托蒽醌方案的患者的中位总体生存期为12.7月。

接受Jevtana治疗的患者出现的副作用，包括抗感染白细胞减少（中性粒细胞减少）、贫血、白细胞（白细胞减少）、低水平的血小板（血小板减少）、腹泻、疲劳、恶心、呕吐、便秘、虚弱（乏力）和肾功能衰竭。

前列腺癌通常见于老年男性，在美国男性中其是第二个最常见的癌症，位居皮肤癌之后。根据美国疾病控制和预防中心，2006年有203415名男性罹患前列腺癌和28372例男性死于该种疾病。

药物名称：Jevtana (cabazitaxel)
适应症：前列腺癌
公司：赛诺菲安万特（Sanofi-Aventis）
批准日期：2010年6月17日
药品类型：小分子药物
简要说明：Jevtana适用于多烯紫杉醇（晚期前列腺癌常用药）治疗期间或之后病情已发生恶化的转移性激素难治性前列腺癌(mHRPC)患者。

JEVTANA®(cabazitaxel) Injection
JEVTANA (cabazitaxel) Injection, a treatment for hormone-refractory metastatic prostate cancer.

JEVTANA is a prescription anti-cancer medicine used with the steroid medicine prednisone. JEVTANA is used to treat people with prostate cancer that has worsened (progressed) after treatment with other anti-cancer medicines, including docetaxel

Important Safety Information
Read this Patient Information before you start receiving JEVTANA and each time before you receive your infusion. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What is the most important information I should know about JEVTANA?
JEVTANA may cause serious side effects including:
1.Low white blood cells. Low white blood cells can cause you to get serious infections, and may lead to death. People who are 65 years or older may be more likely to have these problems. Your doctor:
•will do blood tests regularly to check your white blood cell counts during your treatment with JEVTANA.
•may lower your dose of JEVTANA, change how often you receive it, or stop JEVTANA until your doctor decides that you have enough white blood cells.
•may prescribe a medicine for you called G-CSF, to help prevent complications if your white blood cell count is too low.

Tell your doctor right away if you have any of these symptoms of infection while receiving JEVTANA:
•fever. Take your temperature often during treatment with JEVTANA.
•cough
•burning on urination
•muscle aches

Also, tell your doctor if you have any diarrhea during the time that your white blood cell count is low. Your doctor may prescribe treatment for you as needed.

2.Severe allergic reactions. Severe allergic reactions can happen within a few minutes after your infusion of JEVTANA starts, especially during the first and second infusions. Your doctor should prescribe medicines before each infusion to help prevent severe allergic reactions.

Tell your doctor or nurse right away if you have any of these symptoms of a severe allergic reaction during or soon after an infusion of JEVTANA:
•rash or itching
•skin redness
•feeling dizzy or faint
•breathing problems
•chest or throat tightness
•swelling of face

3.Gastrointestinal symptoms. Vomiting and diarrhea can happen when you take JEVTANA. Severe vomiting and diarrhea with JEVTANA can lead to loss of too much body fluid (dehydration), or too much of your body salts (electrolytes). Death has happened from having severe diarrhea and losing too much body fluid or body salts with JEVTANA. Tell your doctor if you have vomiting or diarrhea. Your doctor will prescribe medicines to prevent or treat vomiting and diarrhea, as needed with JEVTANA. Tell your doctor if your symptoms get worse or do not get better. You may need to go to the hospital for treatment.

4.Kidney failure. Kidney failure may happen with JEVTANA, because of severe infection, loss of too much body fluid (dehydration), and other reasons, which may lead to death. Your doctor will check you for this problem and treat you if needed. Tell your doctor if you develop:
•swelling of your face or body
•decrease in the amount of urine that your body makes each day.

What is JEVTANA?
JEVTANA is a prescription anti-cancer medicine used with the steroid medicine prednisone. JEVTANA is used to treat people with prostate cancer that has worsened (progressed) after treatment with other anti-cancer medicines, including docetaxel.

It is not known if JEVTANA is safe and works in children.

Who should not receive JEVTANA?
Do not receive JEVTANA if:
•your white blood cell (neutrophil count) is too low
•you have had a severe allergic reaction to cabazitaxel or other medicines that contain polysorbate 80. Ask your doctor if you are not sure.

What should I tell my doctor before receiving JEVTANA?
Before receiving JEVTANA, tell your doctor if you:
•had allergic reactions in the past
•have kidney or liver problems
•are over the age of 65
•have any other medical conditions
•if you are a female and:
◦are pregnant or plan to become pregnant. JEVTANA can harm your unborn baby. Talk to your doctor about the best way for you to prevent pregnancy while you are receiving JEVTANA.
◦are breastfeeding or plan to breastfeed. It is not known if JEVTANA passes into your breast milk. You and your doctor should decide if you will take JEVTANA or breastfeed. You should not do both.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. JEVTANA can interact with many other medicines. Do not take any new medicines without asking your doctor first. Your doctor will tell you if it is safe to take the new medicine with JEVTANA.

How will I receive JEVTANA?
•JEVTANA will be given to you by an intravenous (IV) infusion into your vein.
•Your treatment will take about 1 hour.
•JEVTANA is usually given every 3 weeks. Your doctor will decide how often you will receive JEVTANA.
•Your doctor will also prescribe another medicine called prednisone, for you to take by mouth every day during treatment with JEVTANA. Your doctor will tell you how and when to take your prednisone.

It is important that you take prednisone exactly as prescribed by your doctor. If you forget to take your prednisone, or do not take it on schedule, make sure to tell your doctor or nurse. Before each infusion of JEVTANA, you may receive other medicines to prevent or treat side effects.

What are the possible side effects of JEVTANA?
JEVTANA may cause serious side effects including:
•See “What is the most important information I should know about JEVTANA?”

Common side effects of JEVTANA include:
•Low red blood cell count (anemia). Your doctor will regularly check your red blood cell count. Symptoms of anemia include shortness of breath and tiredness.
•Low blood platelet count. Tell your doctor if you have any unusual bruising or bleeding.
•tiredness
•nausea
•constipation
•weakness
•blood in the urine. Tell your doctor or nurse if you see blood in your urine.
•back pain
•decreased appetite
•fever
•shortness of breath
•stomach (abdominal) pain
•change in your sense of taste
•cough
•joint pain
•hair loss
•numbness, tingling, burning or decreased sensation in your hands or feet

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of JEVTANA. For more information, ask your doctor or pharmacist.

General information about JEVTANA
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.

This leaflet summarizes the most important information about JEVTANA. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about JEVTANA that is written for health professionals.