部分中文FUSILEV处方资料（仅供参考）
FUSILEV (levoleucovorin)注射剂用于转移性结直肠癌新药
Levoleucovorin注射剂。该药用于使用高剂量甲氨蝶呤治疗之后的骨肉瘤患者的药物治疗，可以减少高剂量甲氨蝶呤和过量叶酸拮抗剂类药物的毒性，增强这些药物的疗效。该药是唯一获FDA批准销售的含甲酰四氢叶酸异构体[Levoleucovorin或（6S）-leucovorin]药品，
向美国FDA提交新药上市申请(NDA)补件，以注射剂FUSILEV合并5-FU containing regimens，治疗恶性直肠大肠癌病患。
FDA已批准其Levoleucovorin注射剂。骨肉瘤患者用高剂量甲氨蝶呤之后进而用这种药物进行治疗，可以减少高剂量甲氨蝶呤和过量叶酸拮抗剂类药物的毒性，增强这些药物的疗效。Levoleucovorin是Spectrum制药公司近日宣布，FDA已批准其Levoleucovorin注射剂。骨肉瘤患者用高剂量甲氨蝶呤之后进而用这种药物进行治疗，可以减少高剂量甲氨蝶呤和过量叶酸拮抗剂类药物的毒性，增强这些药物的疗效。Levoleucovorin是唯一获准销售的含甲酰四氢叶酸异构体（Levoleucovorin或(6S)-leucovorin）药品，它有望于今年6月份上市。
Spectrum公司负责人称，Levoleucovorin是2008年通过FDA批准的第一种癌症治疗药。这给患者带来了一种全新的选择，有了这种药物，正在接受化疗的患者无需再使用非活性右旋异构体药物进行治疗。前临床实验结果显示，若同时使用非活性异构体药物和活性异构体药物，则两者在进入细胞过程中会互相竞争。
Levoleucovorin：骨肉瘤治疗药物            
Spectrum制药公司近日宣布，美国FDA批准了该公司的Levoleucovorin注射剂上市销售。该药用于使用高剂量甲氨蝶呤治疗之后的骨肉瘤患者的药物治疗，可以减少高剂量甲氨蝶呤和过量叶酸拮抗剂类药物的毒性，增强这些药物的疗效。该药是唯一获FDA批准销售的含甲酰四氢叶酸异构体[Levoleucovorin或(6S)-leucovorin]药品，该公司希望可以在今年6月份完成该药的上市工作。
Levoleucovorin不能用于之前有对叶酸或者甲酰四氢叶酸过敏经历的患者。由于该药含钙，因此在静脉注射时，每分钟不能超过16mL（160mg）。该药会增加氟脲嘧啶的毒性。在安慰剂对照试验中发现，甲酰四氢叶酸和甲氧苄氨嘧啶-磺胺甲异噁唑同时用于HIV患者中卡氏肺囊虫肺炎的治疗时，可能会增加治疗的失败率。在接受该药注射的患者中有过敏反应发生。在高剂量甲氨蝶呤治疗之后注射该药的患者报告有呕吐（38%）、口腔炎（38%）和恶心（19%）发生。注射该药可能会抵消镇静安眠剂、苯妥英和扑米酮的抗癫痫作用，有癫痫史或存在癫痫风险的患者需要注意。

Fusilev (Levoleucovorin)
Fusilev (levoleucovorin) is a recent medication on the medical market. It has just been approved by the FDA, in 2008. It is indicated as a side treatment in the patients suffering from cancer. Those with bone cancer are usually treated with methotrexate. Most cancer drugs are harmful enough and leave major marks on the patients, but this one is above the limits. It is almost imperative for the specialist doctor to prescribe a medicine to deal with the side effects. The active substance levoleucovorin seems to be the most appropriate solution. Aside from the general side effects, the patients may also end up with a methotrexate retention, as well as an overdose.
Fusilev (levoleucovorin) is indicated in all these situations. It may be taken with a medical prescription, after the patient is initially evaluated. It cannot treat other problems or issues.
Administration
Fusilev (levoleucovorin) is administered intravenously, through an IV line. Unlike other injections, this one can only be administered in a clinic or a hospital. This way, the specialist doctor can constantly monitor you, while the side effects can be treated as soon as they arise, if they do. Besides, the overdose risks are eliminated since the drug is given by a professional. The drug must be administered very slowly. The infusion can take up to 4 hours.
The frequency of these infusions also indicate the hospital. You will most likely have to be retained in the hospital for the duration of the treatment. Such long infusions are taken at every 6 hours. You need 10 of them. Therefore, your free time is quite limited. The frequency and duration of the treatment may differ, according to your condition.
The treatment should begin one day after you start the methotrexate therapy. In case of an overdose, it should be started within one day. When treating the drug retention, it must be started as soon as the problem is diagnosed.
During the Fusilev (levoleucovorin) treatment, your blood requires continuous monitoring.
Warnings
The levoleucovorin allergic patients are supposed to get a different treatment for their condition. Such tests should be performed before initializing the treatment. Tell the doctor if you suffer from any renal or hepatic dysfunctions or dehydration. You might need a smaller dose.
The effects of Fusilev (levoleucovorin) are not known in pregnant or nursing women, so they must be careful.
Adverse reactions
Some of the adverse reactions you might experience consist of fever, nausea, diarrhea, rash or stomach upset. They should be mild or moderate.
INDICATIONS AND USAGE
FUSILEV is a folate analog indicated for:
Rescue after high-dose methotrexate therapy in osteosarcoma.
Diminishing the toxicity and counteracting the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists.
Use in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer.
LIMITATIONS OF USE
FUSILEV is not approved for pernicious anemia and megaloblastic anemias. Improper use may cause a hematologic remission while neurologic manifestations continue to progress.
IMPORTANT SAFETY INFORMATION
Contraindications
FUSILEV is contraindicated for patients who have had previous allergic reactions attributed to folic acid or folinic acid.
Warnings and Precautions
Due to Ca++ content, no more than 16 mL (160 mg) of levoleucovorin solution should be injected intravenously per minute
FUSILEV enhances the toxicity of fluorouracil.
Concomitant use of d,l-leucovorin with trimethoprim-sulfamethoxazole for Pneumocystis carinii pneumonia in HIV patients
was associated with increased rates of treatment failure in a placebo-controlled study.
Adverse Reactions
Allergic reactions were reported in patients receiving FUSILEV.
Vomiting (38%), stomatitis (38%) and nausea (19%) were reported in patients receiving FUSILEV as rescue after high dose methotrexate therapy.
The most common adverse reactions (>50%) in patients with advanced colorectal cancer receiving Fusilev in combination with 5-FU were diarrhea, nausea and stomatitis.
Drug Interactions
FUSILEV may counteract the antiepileptic effect of phenobarbital, phenytoin and primidone, and increase the frequency of seizures in susceptible patients.
Reporting of Suspected Adverse Reactions
You are encouraged to report side effects of prescription drugs to the FDA.

FUSILEV Rx