英文药名: Cosmegen Lyovac(Dactinomycin Injection)
中文药名: 更生霉素注射液, 放线菌素D
药品说明
通用名称: 放线菌素D
常用名称: 更生霉素, 更新霉素, 放线菌D 放线菌素, 放线菌素23-21, 放线菌素C1
英语名称: ACTD, Actinomycin, Auranthin C, Dactinomycin D, Daitinomycinum, Lyovac, Lyovac-Cosmegen Meractinomycin, NBF-386, NSC-3053
商品名称: Actinomycin D, Cosmegen, 新福菌素, 可美净
药物类别: 特异性药物, 肿瘤科药物, 抗肿瘤药, 抗生素类抗微生物药, 破坏DNA的抗生素类药物, 癌化疗药物, 干扰转录过程和阻止RNA合成类药物
[药物毒理]
体外研究显示放线菌素D主要作用于RNA，高浓度时则同时影响RNA与DNA合成。作用机理为嵌合于DNA双链内与其鸟嘌呤基团结合，抑制DNA依赖的RNA聚合酶活力，干扰细胞的转录过程，从而抑制mRNA合成。为细胞周期非特异性药物，以G1期尤为敏感，阻碍G1期细胞进入S期。
[药代动力学]
静注后迅速分布至组织，10分钟即可在主要脏器如肝、肾、颌下腺中出现，难以透过血脑屏障。体内代谢很少，12%～20%经尿排出，50%～90%经胆道随粪便排出。t1/2β约36小时。
[适应症]
1．对霍奇金病(HD)及神经母细胞瘤疗效突出，尤其是控制发热；
2．对无转移的绒癌初治时单用本药，治愈率达90%～100%，与单用MTX的效果相似；
3．对睾丸癌亦有效，一般均与其它药物联合应用；
4．与放疗联合治疗儿童肾母细胞瘤(Wilms瘤)可提高生存率，对尤文肉瘤和横纹肌肉瘤亦有效。
[用法用量]
静脉给药：
静注：一般成人每日300～400μg(6～8μg/Kg)，溶于0.9%氯化钠注射液20～40ml中，每日一次，10日为一疗程，间歇期两周，一疗程总量4～6mg。
腔内给药：
本品也可作腔内注射。在联合化疗中，剂量及时间尚不统一。
[不良反应]
1．骨髓抑制为剂量限制性毒性，血小板及粒细胞减少，最低值见于给药后10～21天，尤以血小板下降为著。
2．胃肠道反应多见于每次剂量超过500μg时，表现为恶心、呕吐、腹泻，少数有口腔溃疡，始于用药数小时后，有时严重，为急性剂量限制性毒性；
3．脱发始于给药后7～10天，可逆。
4．少数出现胃炎、肠炎或皮肤红斑、脱屑、色素沉着、肝肾功能损害等，均可逆。
5．漏出血管对软组织损害显著。
[禁忌]
有出血倾向者慎用或不用本品，有患水痘病史者忌用。本品有致突变、致畸和免疫抑制作用，孕妇禁用。
[注意事项]
1．当本品漏出血管外时，应即用1%普鲁卡因局部封闭，或用50～100mg氢化可的松局部注射，及冷湿敷；
2．骨髓功能低下、有痛风病史、肝功能损害、感染、有尿酸盐性肾结石病史、近期接受过放疗或抗癌药物者慎用本品。
[孕妇及哺乳期妇女用药]
孕妇及哺乳期妇女慎用本品。
[儿童用药]
每日0.45mg/m2，连用五日，3～6周为一疗程。一岁以下幼儿慎用。
[老年患者用药]
酌情减量。
[药物相互作用]
维生素K可降低其效价，故用本品时慎用维生素K类药物；有放疗增敏作用，但有可能在放疗部位出现新的炎症，而产生“放疗再现”的皮肤改变，应予注意。
包装规格：
·500mcg 1支 x 3ml
Cosmegen Generic Name: Dactinomycin (DAK-tin-oh-MYE-sin)Brand Name: Cosmegen
Cosmegen is very toxic. Do not inhale the dust or vapors of Cosmegen . Do not get Cosmegen in your eyes, nose, mouth, or onto your skin. Do not come into contact with Cosmegen if you are pregnant. Cosmegen is given through a vein. If Cosmegen leaks out of the vein (extravasation), severe damage to the area around the injection site will occur. Tell your doctor or health care provider immediately if you notice any discomfort, pain, or redness at the injection site.
Cosmegen is used for:
Treating certain types of cancer. It may be used alone or with other medicines.
Cosmegen is an antineoplastic. It works by killing certain cancer cells.
Do NOT use Cosmegen if:
you are allergic to any ingredient in Cosmegen
you have chickenpox (varicella infection), or shingles (herpes zoster infection), or if you have had either of these infections recently
Contact your doctor or health care provider right away if any of these apply to you.
Before using Cosmegen :
Some medical conditions may interact with Cosmegen . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have bone marrow problems or an infection, are scheduled to receive a vaccine, or are very overweight
if you are scheduled to have radiation therapy, have had radiation therapy in the last several months, or are receiving any other cancer therapy
Some MEDICINES MAY INTERACT with Cosmegen . However, no specific interactions with Cosmegen are known at this time.
Ask your health care provider if Cosmegen may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Cosmegen :
Use Cosmegen as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Cosmegen is usually given as an injection at your doctor's office, hospital, or clinic. Ask your doctor or pharmacist any questions you may have about Cosmegen .
If you get Cosmegen in your eyes or on your skin, rinse the area with water for 15 minutes. Remove any contaminated clothing and do not reuse. Contaminated shoes must be cleaned completely before reuse.
If you miss a dose of Cosmegen , contact your doctor right away.
Ask your health care provider any questions you may have about how to use Cosmegen .
Important safety information:
If nausea, vomiting, or loss of appetite occurs, ask your doctor about ways to lessen these effects.
Cosmegen may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
Cosmegen may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
Cosmegen may increase the risk of developing other cancers (eg, leukemia) when it is used along with radiation therapy. Talk to your doctor if you have questions about your risk of developing other cancers after using Cosmegen .
Do not receive a live vaccine (eg, measles, mumps) while you are taking Cosmegen . Talk with your doctor before you receive any vaccine.
Lab tests, including liver function, kidney function, and blood counts, may be performed while you use Cosmegen . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Cosmegen with caution in the ELDERLY; they may be more sensitive to its effects, especially bone marrow problems.
Cosmegen should be used with extreme caution in CHILDREN younger than 6 months old; they are more sensitive to the serious side effects of Cosmegen .
Caution is advised when using Cosmegen in CHILDREN; they may be more sensitive to its effects, especially severe liver problems.
Cosmegen may slow growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Cosmegen .
PREGNANCY and BREAST-FEEDING: Cosmegen may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cosmegen while you are pregnant. It is not known if Cosmegen is found in breast milk. Do not breast-feed while using Cosmegen .
Possible side effects of Cosmegen :
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Acne; hair loss; lack of energy; loss of appetite; mild nausea or vomiting; stomach pain; tiredness; weakness.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; chest pain; dark urine; diarrhea; fever, chills, or sore throat; flushing; leg pain or swelling; muscle pain or aches; pale stools; redness, swelling, pain, or blistering near the injection site; severe or persistent nausea or vomiting; shortness of breath; swelling, sores, or ulcers of the mouth or lips; trouble swallowing; unusual bruising or bleeding; unusual tiredness or weakness; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately. Symptoms may include decreased amount of urine; mouth pain or swelling; red, swollen, or blistered skin; severe or persistent nausea, vomiting, or diarrhea.
Proper storage of Cosmegen :
Cosmegen is usually handled and stored by a health care provider. If you are using Cosmegen at home, store Cosmegen as directed by your pharmacist or health care provider.
General information:
If you have any questions about Cosmegen , please talk with your doctor, pharmacist, or other health care provider.
Cosmegen is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Cosmegen . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider