Savella：(通用名：milnacipran HCl，米那普仑)

适应症:纤维肌痛（Fibromyalgia）

生产公司: 森林实验室公司和Cypress 公司（Forest Laboratories Cypress Bioscience）

批准日期：1月14日

该药主要用于治疗纤维肌痛，这是一种会逐渐影响患者生理功能的慢性肌肉和关节疼痛，大约有600万美国人受此折磨，之前只有辉瑞公司的Lyrical和礼来公司的Cymbalta被批准用于治疗该病，Savella的安全性和有效性经过两个共计超过2000病例数的临床Ⅲ期试验证实有效。

SAVELLA

Generic Name for SAVELLA

Milnacipran HCl 12.5mg, 25mg, 50mg, 100mg; tabs.

Legal Classification:

Rx

Pharmacological Class for SAVELLA

Serotonin and norepinephrine reuptake inhibitor (SNRI).

Manufacturer of SAVELLA

Forest Laboratories and Cypress Bioscience

Indications for SAVELLA

Fibromyalgia.

Adult dose for SAVELLA

May take with food. Titrate dose. Day 1: 12.5mg once. Days 2–3: 12.5mg twice daily. Days 4–7: 25mg twice daily. After Day 7: 50mg twice daily (recommended dose); max 100mg twice daily. Severe renal impairment (CrCl 5–29mL/min): maintenance 25mg twice daily; max 50mg twice daily. Withdraw gradually.

Children's dosing for SAVELLA

<17yrs: not recommended.

Contraindications for SAVELLA

Allow at least 14 days after MAOI discontinuance before starting milnacipran; allow at least 5 days after discontinuing milnacipran before starting an MAOI. Uncontrolled narrow-angle glaucoma.

Warnings/Precautions for SAVELLA

Substantial alcohol abuse, chronic liver disease, end stage renal disease: not recommended. Hypertension. Heart disease. Arrhythmias. Monitor BP and heart rate; reduce dose or discontinue if elevated BP persists. Controlled narrow-angle glaucoma. Seizure disorder. Suicidal ideation (monitor). Mania. Severe hepatic dysfunction. Discontinue if liver dysfunction develops. Volume depleted. GU obstruction. Risk of bleeding. Reevaluate periodically. Write Rx for smallest practical amount. Pregnancy (Cat.C; see literature for effects on fetus). Labor & delivery, nursing mothers: not recommended.

Interactions for SAVELLA

See Contraindications. Concomitant serotonin precursors (eg, tryptophan), serotonergics (eg, triptans, tramadol): not recommended. Avoid IV digoxin (postural hypotension, tachycardia). May potentiate anticoagulants (eg, aspirin, NSAIDs, coumadin). May antagonize certain antihypertensives (eg, clonidine). Serotonin syndrome with SSRIs, SNRIs, lithium, tramadol, triptans (monitor). Caution with other CNS-active drugs or those that can increase BP. Arrhythmias, hypertension with epinephrine, norepinephrine.

Adverse Reactions for SAVELLA

GI upset, headache, constipation, dizziness, insomnia, hot flush, hyperhidrosis, palpitations, increased heart rate, dry mouth, hypertension; rare: GU effects in men; hyponatremia (esp. in elderly); serotonin syndrome; seizure.

How is SAVELLA supplied?

Tabs 12.5mg—60; 25mg, 50mg, 100mg—60, 180; Titration Pack (4 week supply)—1

Introduction of New MedicineMilnacipran (Savella)

最近，一个治疗纤维性肌痛的新药Savella在美国上市。美国FDA在今年年初批准了这个药物可用于临床治疗纤维性肌痛。其疗效已被3期临床试验所证实。2084例患者参加了这个试验，其中1460例患者服用Savella，624例服用安慰剂。Savella组每天服用100mg或200mg，显著降低疼痛，缓解30%以上，增强身体功能状态以及病人的自我满意度。

Savella的详细作用机制还不十分清楚。但它能抑制5-羟色胺或去甲肾上腺素的再摄取，对去甲肾上腺素更具选择性，从而缓解疼痛。服用Sevella要从小剂量开始，缓慢加量，停药亦要缓慢。

具体用法是：第一天每天一次，每次12.5毫克，第二，三天每天二次，每次12.5毫克；然后第四到第八天每天二次，每次25毫克；如果病人能耐受，再加量到50毫克Bid；最大用量200毫克/天。
肝功能不良者要酌情减量。

常见的副作用包括：恶心，呕吐，头痛，便秘，心慌，失眠，血压增高等。

毒性作用包括：加重抑郁症，自杀倾向，过敏反应，5-羟色胺综合症，高血压，心律失常，肝肾毒性等。