· 【产品名称】紫杉醇注射液

· 【商品名/商标】

泰素

· 【规格】5ml:30mg

· 【主要成份】本品主要成分为紫杉醇。

· 【适应症】

初疗或其后化疗失败的转移性卵巢癌的一线化疗。联合化疗失败或辅助化疗6个月内复发的转移性乳腺癌，一线治疗晚期非小细胞肺癌，乳腺癌淋巴结阳性术后的辅助治疗。

· 【用法用量】卵巢癌：135 mg/m2或175 mg/m2，3小时滴完，每三周重复。乳腺癌 175 mg/m2，3小时滴完，每3周重复。非小细胞肺癌：1175-250 mg/m2，3小时静滴，每3周重复。乳腺癌淋巴结阳性，阿雷素60 mg/m2，环磷酰胺600 mg/m2，联合化疗每3周重复，4个周期后该用泰素175 mg/m2，3小时静滴，每3周重复，共4个周期。为防止病人发生过敏反应，所有病人通常在给予本药之前的12和6小时事先给予地塞米松20 mg口服，在接受本药之前30-60分钟，静注苯海拉明(或其它的类似药)50 mg，西米替丁300 mg或雷尼替丁50 mg。在本药治疗期间，病人出现严重的中性白细胞减少(<500个/mm31周或1周以上)，严重的神经病变时，随后的剂量应减少20%。

· 【不良反应】骨髓抑制是主要的受剂量限制的毒性，中性白细胞减少与剂量相关。通常很快地恢复。在第一疗程期间，严重的中性白细胞减少(<500个/mm3)发生于52%病人中，在整个治疗期间，严重的中性白细胞减少见于67%病人中，在用所推荐的剂量时，严重的中性白细胞减发生于47%的病人。骨髓抑制在接受过放疗的病人中更为常见和严重。血小板减少比白细胞减少少见也较不明显。可见发热，并发感染和出血，贫血见于90%的病人，其发病率和严重性随着剂量的增多而增加。严重贫血(Hb<8 g/dL)的出现占全数病人的16%。偶见严重过敏反应，表现为呼吸困难，低血压，血管神经性水肿，全身性荨麻疹，胸痛。此外还可见潮红、皮疹。本药还可致心律过缓及ECG异常。常见周围神经病变，表现为轻度麻木，少数病人有严重的神经症状，症状的严重性随剂量而加剧。在中断本药治疗的几个月内，症状常获得改善或完全消失。除周围神经病变外，也可能发生癫痫大发作。关节痛，肌肉痛，肝功能异常。其它副作用有恶心、呕吐、腹泻和粘膜炎。

· 【禁忌】对本药过敏者及中性白细胞数小于1500个/mm3的患者。

· 【注意事项】中性白细胞和血液系统毒性的发生率和严重性随着剂量而增加，尤其是剂量超过190 mg/m2时更为明显，中性白细胞降低平均发生在治疗的第11天，在给予本药期间，应经常检查白细胞计数，直到在中性白细胞计数升到>1500个/mm3，血小板计数升到>100000个/mm3，才能开始另一个疗程。本药还可导致严重的传导异常(<1%)。对此应给予适当的治疗，并在随后的治疗中对心脏传导功能予以密切监视。

· 【药物相互作用】在使用过顺铂的病人骨髓抑制更为严重。当本药在顺铂使用之后给药时，本药的清除率大约降低33%。酮康唑有可能抑制本药的代谢。

· 【孕妇及哺乳期妇女用药】动物实验表明本药对胚胎和胎儿有危害，可引起流产，减少黄体生成，降低着床数和胎儿的存活数，并增加胎儿的死亡率。本药是否经乳汁分泌尚不清楚。本药需慎用于孕妇及哺乳妇女。

Taxol

Generic Name: paclitaxel (PAK li TAK sel)
       Brand Names: Onxol, Taxol

 What is Taxol?

Taxol is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.

Taxol is used to treat breast cancer, lung cancer, and ovarian cancer. It is also used to treat AIDS-related Kaposi's sarcoma.

Taxol may also be used for other purposes not listed in this medication guide.

Important information

Do not use Taxol without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. You should not be given Taxol if you are allergic to paclitaxel, or to other medications that contain an ingredient called Cremophor EL (polyoxyethylated castor oil). This includes cyclosporine (Gengraf, Neoral, Sandimmune) and teniposide (Vumon).

Before you receive Taxol, tell your doctor if you have liver disease, heart disease, or a severely weak immune system.

Taxol can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

There are many other medicines that can interact with Taxol. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Before receiving Taxol

You should not be given Taxol if you are allergic to paclitaxel, or to other medications that contain an ingredient called Cremophor EL (polyoxyethylated castor oil). This includes cyclosporine (Gengraf, Neoral, Sandimmune) and teniposide (Vumon).

Before you receive Taxol, tell your doctor if you are allergic to any drugs, or if you have:

.         liver disease;

·         heart disease; or

·         a severely weak immune system.

If you have any of these conditions, you may need a dose adjustment or special tests to safely receive Taxol.

FDA pregnancy category D. Taxol can cause harm to an unborn baby. Do not receive Taxol without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. It is not known whether Taxol passes into breast milk or if it could harm a nursing baby. Do not receive Taxol without telling your doctor if you are breast-feeding a baby.

See also: Pregnancy and breastfeeding warnings (in more detail)

How is Taxol given?

Taxol is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. Taxol must be given slowly through an IV infusion, and can take up to 24 hours to complete.

Taxol is usually given every 3 weeks. Follow your doctor's instructions.

Before your injection, you may be given other medications to help prevent a serious allergic reaction to Taxol.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when the Taxol is injected.

If any of Taxol gets on your skin, wash the area with soap and warm water right away.

Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely while you are receiving Taxol.

Your heart rate may also be monitored through electrocardiograph or ECG (sometimes called an EKG). This machine measures electrical activity of the heart.

Taxol can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

See also: Dosage Information (in more detail)

What happens if I miss a dose?

Contact your doctor if you miss an appointment for your Taxol injection.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much Taxol.

Overdose symptoms may include numbness or tingling, fever, chills, mouth sores, unusual bleeding or weakness, or any signs of infection.

What should I avoid?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are being treated with Taxol.

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Taxol side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

·         slow heart rate;

·         seizure (black-out or convulsions);

·         pale skin, easy bruising or bleeding, unusual weakness;

·         fever, chills, body aches, flu symptoms;

·         white patches or sores inside your mouth or on your lips;

·         numbness, tingling, or burning pain in your hands or feet;

·         increased blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats); or

·         warmth or redness under your skin.

Less serious side effects may include:

·         pain, swelling, redness, or skin color changes where the Taxol was injected;

·         joint or muscle pain;

·         mild nausea, vomiting, diarrhea; or

·         hair loss.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Taxol?

There are many other medicines that can interact with Taxol. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.