中文药名: 莫拉司亭注射剂,沙格司亭

药品简介

药物名称: 莫拉司亭, 沙格司亭
别　名: 粒细胞-单核巨噬细胞集落刺激因子，生白能，先特能，沙格莫丁，生百能，重组人粒细胞巨噬细胞集落刺激因子、特尔立
英 文 名: Molgramostim, Sargramostim

药品说明:

贮于2-8℃，避光，可稳定保存36个月。用无菌溶媒溶解后，2-8℃，可保存1周。静注稀释液，2-8℃可保存24hr。必要时，本药用溶媒溶解后冻存28天。可以冻融2次。

适应症:

骨髓抑制疗法所引起的白细胞减少症、骨髓衰竭病人的白细胞低下，也用于预防白细胞减少时可能潜在的感染并发症。

用法用量:
 
皮下注射或静脉滴注，剂量视病情而定，使白细胞计数维持在期望的水平(通常<10×109/L)。
推荐剂量如下: 癌症化疗，5μg ～10μg/kg，皮下注射，1次/日，于化疗停药1日后开始使用，持续使用7～10日。停药后至少间隔48h后方进行下一疗程的抗癌化疗。
骨髓增生异常综合征(MDS)、再生障碍性贫血，3μg/kg，皮下注射1次/日，3～4日显效后调节剂量，使白细胞维持在<10×109/L。
骨髓移植，5μg ～10μg/kg，静滴4～6h，1次/日，持续用药至中性粒细胞绝对计数≥10×109/L达3日之久。
艾滋病(AIDS),1μg/kg，皮下注射，1次/日，如与叠氮胸苷（AZT）或AZT、(-干扰素合用，本品用量为每日1μg ～3μg/kg；如与更昔洛韦合用，每日3μg ～5μg/kg，皮下注射，1次/日。2～4日见效后，每隔3～5日调整1次剂量。
癌症化疗: 5-10 μg/kg体重，1次/日皮下注射。在化疗停止1日后使用，持续7-10天。
骨髓移殖: 5 μg/kg体重/日，静脉点滴4-6 hr，自骨髓移植后次日开始，持续使用不超过30天，或至连续3天中性粒细胞绝对值超过1 x 109/L。
骨髓异常增生综合征/再生障碍性贫血: 3 μg/kg体重，1次/日，一般需2-4日才能观察到白细胞增高的最初效应。以后应根据白细胞计数情况调节剂量。
艾滋病: 单独使用1 μg/kg体重，1次/日，皮下注射。与AZT或AZT/α干扰素合用，1-3 μg/kg体重，与甘昔洛韦合用3-5 μg/kg体重，1次/日，皮下注射。一般需2～4天才能观察到白细胞计数上升的最初效应。

注意事项:

妊娠C类。禁用于对本品或内在其他成分有过敏史的病人以及自身免疫性血小板减少性紫瘢的病人。
首次使用本药应在医疗监护下进行。用药期间应注意监测血象。
对妊娠和哺乳的影响: 孕期使用本药的安全性尚未建立。动物试验研究表明本药有生殖毒性。在灵长类动物模型中发现，剂量6-10μg/kg/日，可发生自发性流产。本药是否经乳汁分泌，尚不清楚。但由于对婴儿可能有不良作用，哺乳妇女在开始使用本药前应停止哺乳。

对儿童的影响: 本药对18岁以下病人的有效性和安全性尚未建立。

莫拉司亭注射剂[包装规格]

注：以下产品不同规格和不同价格，购买时请以电话咨询为准！

·250mcg/ml  5(支)Vials SDV  (注射干粉)

·500mcg/ml  5 Vials (支) (注射液)

LeukineGeneric Name: sargramostim (sar grah MOSS tim)Brand Names: Leukine

What is sargramostim?
Sargramostim is a protein that stimulates the production of white blood cells. Sargramostim is similar a substance in the body called granulocyte-macrophage colony stimulating factor (GM-CSF).

Sargramostim is used to increase white blood cells and decrease the risk of infection in conditions such as cancer, bone marrow transplant, and pre-chemotherapy blood cell collection.

Sargramostim may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about sargramostim?
Do not administer an injection if you are unsure how it should be injected, how much to inject, or how often to inject the medication. Call your doctor, nurse, or pharmacist to go over the instructions with you. Contact your doctor if you develop a fever, chills, sore throat, congestion, or other signs of infection or illness while using sargramostim.
What should I discuss with my healthcare provider before using sargramostim?
Do not use sargramostim without first talking to your doctor if you have an allergy to yeast. You may have an allergic reaction to this medication.
Before using sargramostim, tell your doctor if you

are undergoing radiation or chemotherapy;

have asthma or another lung disease;

have heart disease, especially an irregular heartbeat or congestive heart failure;

have fluid retention;

have myeloid (bone marrow) cancer;

have kidney disease; or

have liver disease.

You may not be able to use sargramostim or you may require a dosage adjustment or special monitoring if you have any of the conditions listed above.

Sargramostim is in the FDA pregnancy category C. This means that it is not known whether sargramostim will be harmful to an unborn baby. Do not use sargramostim without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether sargramostim passes into breast milk. Do not use this medication without first talking to your doctor if you are breast-feeding a baby.
How should I use sargramostim?
Use sargramostim exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Sargramostim can be used subcutaneously (SC) or intravenously (IV). Your doctor, nurse, or pharmacist will give you specific instructions on how and where to inject the medication.

Do not administer an injection if you are unsure how it should be injected, how much to inject, or how often to inject the medication. Call your doctor, nurse, or pharmacist to go over the instructions with you.
Rotate injection sites as directed and inject the medication slowly.

Do not shake any vial of sargramostim. It can be gently swirled if mixing is needed.

The powdered form of Leukine must be reconstituted (mixed) with sterile water, or bacteriostatic water to form a solution for injection. Solutions made with sterile water (no preservative) must be used within 6 hours of mixing, then thrown away. Leukine Liquid and solutions mixed with bacteriostatic water can be kept for up to 20 days under refrigeration.

The vial of medication can be allowed to reach room temperature by leaving it out of the refrigerator for about 30 minutes before injecting a dose. Do not leave the vial in direct sunlight.
Properly store and discard all syringes and needles.

It is important to use sargramostim regularly to get the most benefit.

Your doctor may want you to have blood tests or other medical evaluations during treatment with sargramostim to monitor progress and side effects.

Store this medication in the refrigerator between 2 and 8 degrees Celsius (36 to 46 degrees Fahrenheit) away from light, moisture, and the reach of children. Discard all medication on the expiration date.
What happens if I miss a dose?
Contact your doctor if you miss a dose of this medication by more than a few hours.

What happens if I overdose?
Seek emergency medical attention if an overdose is suspected.
Symptoms of a sargramostim overdose include shortness of breath, a feeling of discomfort or illness (malaise), nausea, fever, a rash, a fast heartbeat, headache, and chills.

What should I avoid while using sargramostim?
There are no restrictions regarding foods, beverages, or activities during treatment with sargramostim unless your doctor directs otherwise.

Sargramostim side effects
If you experience any of the following serious side effects, stop using sargramostim and seek emergency medical treatment or contact your doctor immediately:
an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

dizziness or fainting;

a fever (over 100.5 degrees Fahrenheit or 38 degrees Celsius);

signs of infection including chills, sore throat, or congestion or redness, pain, or swelling around a wound or sore;

swelling of the feet or lower legs;

sudden weight gain (5 pounds or more); or

chest pain, chest discomfort, or a fast, irregular pulse.

Other, less serious side effects may be more likely to occur. Continue to use sargramostim and talk to your doctor if you experience:

bone pain;

"flu-like" feeling;

chills;

muscle aching or weakness;

tiredness;

headache;

diarrhea;

nausea, upset stomach, or loss of appetite;

rash; or

swelling, redness, or pain at the injection site.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect sargramostim?
Before using this medication, tell your doctor if you

are taking lithium (Eskalith, Lithobid, Lithane, others);

are taking a steroid such as prednisone (Deltasone, others), methylprednisolone (Medrol, others), prednisolone (Prelone, others), dexamethasone (Decadron, others), and others; or

are undergoing radiation or chemotherapy.

You may not be able to use sargramostim or you may require special monitoring if you are taking any of the medications listed above.

Drugs other than those listed here may also interact with sargramostim. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

Where can I get more information?
Your pharmacist has additional information about sargramostim written for health professionals that you may read.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2006 Cerner Multum, Inc. Version: 1.04. Revision Date: 4/12/2009 4:37:31 PM.
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Indication
Leukine® is indicated for the following uses: (i) following induction chemotherapy in older adult patients with acute myelogenous leukemia (AML) to shorten time to neutrophil recovery; (ii) for mobilization and following transplantation of autologous peripheral blood progenitor cells; (iii) for myeloid reconstitution after autologous or allogeneic bone marrow transplantation (BMT); (iv) for use in bone marrow transplantation failure or engraftment delay.

Important Safety Considerations
Leukine is contraindicated in patients with excessive leukemic myeloid blasts in bone marrow or peripheral blood (≥10%); in patients with known hypersensitivity to GM-CSF, yeast-derived products, or any component of Leukine; and for concomitant use with chemotherapy and radiotherapy.
Serious allergic or anaphylactic reactions have been reported with Leukine. If any serious allergic or anaphylactic reactions occur, Leukine therapy should be immediately discontinued and appropriate therapy initiated.
Liquid solutions containing benzyl alcohol (including liquid Leukine) or lyophilized Leukine reconstituted with Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol) should not be administered to neonates.
Leukine should be used with caution and monitored in patients with preexisting fluid retention, pulmonary infiltrates, or congestive heart failure, respiratory symptoms or disease; cardiac symptoms or disease; and renal or hepatic dysfunction.
Edema, capillary leak syndrome, pleural and/or pericardial effusion, sequestration of granulocytes in the pulmonary circulation, and dyspnea have been reported in patients after Leukine administration. Occasional transient supraventricular arrhythmia has been reported during Leukine administration. Leukine has induced the elevation of serum creatinine or bilirubin and hepatic enzymes in some patients. Monitoring of renal and hepatic function in patients with preexisting renal or hepatic dysfunction is recommended at least every other week during Leukine administration.
Adverse events occurring in >10% of patients receiving Leukine in controlled clinical trials and reported in a higher frequency than placebo were: in AML patients – (fever, skin reactions, metabolic disturbances, nausea, vomiting, weight-loss, edema, anorexia); in Autologous BMT patients – (asthenia, malaise, diarrhea, rash, peripheral edema, urinary tract disorder); and in Allogeneic BMT patients – (abdominal pain, chills, chest pain, diarrhea, nausea, vomiting, hematemesis, dysphagia, GI hemorrhage, pruritus, bone pain, arthralgia, eye hemorrhage, hypertension, tachycardia, bilirubinemia, hyperglycemia, increased creatinine, hypomagnesemia, edema, pharyngitis, epistaxis, dyspnea, insomnia, anxiety, high BUN, and high cholesterol).
If ANC > 20,000 cells/mm3 or if platelet counts > 500,000/mm3, LEUKINE administration should be interrupted or the dose reduced by half. Twice weekly monitoring of CBC with differential should be performed.
Leukine therapy should be discontinued if disease progression is detected during treatment.