美国FDA批准Zolinza（通用名：vorinostat）胶囊用于治疗皮肤T细胞淋巴瘤

部分中文伏立诺他处方资料（仅供参考）
FDA批准治疗皮肤癌新药Zolinza
日前，美国食品药品管理局（FDA）批准了一种治疗皮肤癌新药Zolinza胶囊(vorinostat)。用于治疗皮肤T细胞淋巴瘤（CTCL），该药可用于皮肤癌持续恶化、其他药物治疗期间或以后复发。该药由美国默克公司生产。
皮肤T细胞淋巴瘤（CTCL）发病率较低，全美每年每100万人中约有3人诊断为CTCL。多数CTCL患者为男性，平均年龄50岁。根据相关法规，FDA按照罕见病治疗药物审批程序批准Zolinza，目的在于激励制药公司投资开发每年影响约20万美国人的罕见性疾病。
Zolinza的安全性和有效性的证据来自两项临床试验，其中包括对接受其他药物治疗后又复发的107名CTCL患者。按皮肤损伤评分等级的改善确定的标准分析，接受Zolinza治疗的30％患者有所改善，疗效平均持续168天。最常见的严重不良反应为肺栓塞、脱水、深度静脉血栓和贫血。常见的不良反应有胃肠症状（包括腹泻，恶心，食欲减退，呕吐和便秘）；疲惫，寒战和味觉障碍。动物实验结果显示，孕妇禁用该药。
Zolinza的副作用药品不良反应
Zolinza（Vorinostat）是用于治疗一种名为皮肤T细胞淋巴瘤的疾病的处方药。患此病的患者如使用其他药物治疗后症状恶化并未好转，或者又复发的时候可选用Zolinza进行治疗。Zolinza还未进行在18岁以下儿童身上的应用研究。以下列举的是使用Zolinza疗法可能面临的主要风险及副作用。列表中的内容并不能完全列举，如果患者在使用中出现以下任何症状请立即告知医生：
1.腿部出现血块凝集（深静脉血栓形成）
2.一条腿出现突然肿胀
3.腿部出现疼痛或触痛，且只有在站立或行走时才能感觉到这种疼痛
4.局部出现发热，且肿胀部位的皮肤出现发红或颜色改变
5.血液凝块游走至肺部（肺栓塞）
6.突然发作的尖锐胸痛
7.脉搏急促
8.气短
9.晕厥
10.咳出血性分泌物
11.焦躁不安
12.多汗
13.脱水，这可能发生在患者出现恶心、呕吐或腹泻后没能及时补液的情况
14.全血细胞计数降低：患者的医生应定期为患者做血液检测以检查血细胞计数
15.红细胞降低。红细胞降低可能让患者容易疲倦或感觉疲劳。患者可能出现苍白，气短
16.血小板降低。血小板降低可能导致皮下的异常出血或容易碰伤，这种情况出现时应立即告知医生
17.高血糖。如果患者本身有高血糖或糖尿病，应在医生指导下时常监测血糖。如果患者血糖高于正常应立即告知医生
18.心电图异常。心电图（又叫EKG）是用于记录心脏心电活动的方式。医生应定期检查患者的血电解质及心电图。
Zolinza最常见的副作用还包括：肠胃问题（如腹泻、恶心、呕吐、纳差，便秘和体重降低），疲乏，头晕，头痛，口干及味觉异常，肌肉疼痛，脱发，寒战，发热，上呼吸道感染，咳嗽，血肌酐升高，以及足部、踝部或腿部的肿胀或搔痒。
Zolinza
(Zo-LEN-zah)
Generic Name: Vorinostat
Drug Type:
Zolinza is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Zolinza is classified as an "Histone Deacetylase Inhibitor". For more detail, see How Zolinza Works below.
What Zolinza Is Used For:
Zolinza is used to treat relapsed or refractory cutaneous T-cell lymphoma (CTCL).
Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.
How Zolinza Is Given:
The amount of Zolinza that you will receive depends on many factors, including your general health or other health problems, and the type of cancer or condition you have. Your doctor will determine your exact dosage and schedule.
Zolinza Side Effects:
Important things to remember about the side effects of Zolinza:
•Most people will not experience all of the Zolinza side effects listed. 
•Zolinza side effects are often predictable in terms of their onset, duration, and severity.
•Zolinza side effects are almost always reversible and will go away after therapy is complete.
•There is no relationship between the presence or severity of Zolinza side effects and the effectiveness of the medication.
•Zolinza  side effects may be quite manageable. There are many options to minimize or prevent them.
The following Zolinza side effects are common (occurring in greater than 30%) for patients taking Zolinza:
•Fatigue
•Diarrhea
•Nausea
•Taste changes
•Increased blood glucose level (hyperglycemia)
•Increased creatinine level (transient)
•Increased level of protein in the urine
•Low platelet count (thrombocytopenia)
These are less common side effects (occurring in about 10-29%) of patients receiving Zolinza:
•Loss of appetite (anorexia)
•Weight loss
•Muscle spasms
•Hair loss (alopecia)
•Dry mouth
•Chills
•Fever
•Vomiting
•Dizziness
•Constipation
•Low red blood cell count (anemia)
•Headache
•Itching
•Swelling in hands or feet
•Cough
•Upper respiratory infection
•Dehydration
•Shortness of breath
A rare, but serious side effect of Zolinza is blood clots, including deep vein thrombosis (DVT) and pulmonary embolus.  You should seek emergency help and notify your health care provider immediately if you develop sudden chest pain and shortness of breath.  Notify your health care provider within 24 hours if you notice that one leg is swollen, red, painful and/or warm to touch and the other is not.
This list includes common and less common side effects for those taking Zolinza. Zolinza side effects that are very rare -- occurring in less than about 10 percent of patients -- are not listed here. But you should always inform your health care provider if you experience any unusual symptoms.
When To Contact Your Doctor or Health Care Provider:
Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:
•Chest pain
•Sudden onset of shortness of breath
•Severe bleeding
The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:
•Nausea (interferes with ability to eat and unrelieved with prescribed medication).
•Vomiting (vomiting more than 4-5 times in a 24 hour period).
•Diarrhea (4-6 episodes in a 24-hour period).
•Unusual bleeding or bruising
•Black or tarry stools, or blood in your stools.
•Blood in the urine.
•Pain or burning with urination.
•Extreme fatigue (unable to carry on self-care activities).
•Swelling, redness and/or pain in one leg or arm and not the other
•Unable to eat or drink for 24 hours or have signs of dehydration: tiredness, thirst, dry mouth, dark and decreased amount of urine, or dizziness (particularly with standing).
Always inform your health care provider if you experience any unusual symptoms.
Zolinza Precautions:
•Before starting Zolinza treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.). 
•Do not receive any kind of immunization or vaccination without your doctor’s approval while taking Zolinza.
•Inform your health care professional if you are pregnant or may be pregnant prior to starting Zolinza. Pregnancy category D (zolinza may be hazardous to the fetus. Women who are pregnant or become pregnant must be advised of the potential hazard to the fetus.)
•For both men and women: Do not conceive a child (get pregnant) while taking Zolinza.  Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.
•Do not breast feed while taking Zolinza.
Zolinza Self-Care Tips:
•Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
•You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your health care provider.
•Wash your hands often.
•Use an electric razor and a soft toothbrush to minimize bleeding.
•Avoid contact sports or activities that could cause injury.
•To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals.
•Avoid sun exposure. Wear SPF 15 (or higher) sunblock and protective clothing.
•In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
•Get plenty of rest.
•Maintain good nutrition.
•If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.
•For flu-like symptoms, keep warm with blankets and drink plenty of liquids. There are medications that can help reduce the discomfort caused by chills.
•Acetaminophen or ibuprophen may help relieve discomfort from fever, headache and/or generalized aches and pains. However, be sure to talk with your doctor before taking it.
Monitoring and Testing While Taking Zolinza:
You will be checked regularly by your doctor while you are taking Zolinza, to monitor side effects and check your response to therapy. Periodic blood work will be obtained to monitor your complete blood count (CBC) as well as the function of other organs (such as your kidneys and liver) will also be ordered by your doctor.
How Zolinza Works:
Cancerous tumors are characterized by cell division, which is no longer controlled as it is in normal tissue.   "Normal" cells stop dividing when they come into contact with like cells, a mechanism known as contact inhibition.  Cancerous cells lose this ability.  Cancer cells no longer have the normal checks and balances in place that control and limit cell division.  The process of cell division, whether normal or cancerous cells, is through the cell cycle.  The cell cycle goes from the resting phase, through active growing phases, and then to mitosis (division).
The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division.  Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division.  If the cells are unable to divide, they die.  The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink.  They also induce cell suicide (self-death or apoptosis).
Chemotherapy drugs that affect cells only when they are dividing are called cell-cycle specific.  Chemotherapy drugs that affect cells when they are at rest are called cell-cycle non-specific.  The scheduling of chemotherapy is set based on the type of cells, rate at which they divide, and the time at which a given drug is likely to be effective. This is why chemotherapy is typically given in cycles.
Chemotherapy is most effective at killing cells that are rapidly dividing.  Unfortunately, chemotherapy does not know the difference between the cancerous cells and the normal cells. The "normal" cells will grow back and be healthy but in the meantime, side effects occur.  The "normal" cells most commonly affected by chemotherapy are the blood cells, the cells in the mouth, stomach and bowel, and the hair follicles; resulting in low blood counts, mouth sores, nausea, diarrhea, and/or hair loss.  Different drugs may affect different parts of the body.
Zolinza is a Histone Deacetylase (HDAC) Inhibitor.  Histone Deacetylase is an enzyme that is normally present in the cells.  In some cancer cells, there is an overexpression of HDACs.  It is believed that inhibition of the HDAC activity causes cell cycle arrest and cell death.  The exact mechanism of action has not been fully described.
Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.