英文药名: Savella(Milnacipran Tablets)

中文药名: 米那普伦片

药品介绍

Forest与Cypress宣布美国FDA已批准米那普伦盐酸盐(milnacipran Hcl，Savella)用于治疗纤维肌痛。纤维肌痛是一种以全身性疼痛与疲劳为主的疾病。根据美国风湿病学会估计大约有6百万美国人患有纤维肌痛。
虽然对于本品改善纤维肌痛症状的确切机制尚不明确，但一些研究者认为：某些脑部神经递质的异常可能是纤维肌痛的关键所在。本品可能是通过对5-羟色胺与去甲肾上腺素(NE)再摄取的双重抑制(在体外对NE再摄取抑制的选择性更强)来改善纤维肌痛症状。
在美国进行的2项关键性III期临床研究中，共纳入2084例患者，其中1460例患者接受本品治疗，624例患者则使用安慰剂。结果显示：与安慰剂相比，本品(剂量为100mg/天、200mg/天)能同时显著改善疼痛(视觉模拟评分)、患者整体评价(患者对变化的整体印象评分)与生理功能 (Short Form-36 总体生理健康)。预期，本品将于2009年3月上市。
本品的安全性与耐受性良好。最常见的不良反应为恶心。其他常见不良反应包括便秘、潮热、多汗、呕吐、心悸、心率上升、口干与高血压。本品所报道的大多数不良反应为轻微至中等程度。

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

Related Disease:

Fibromyalgia

 

The Food and Drug Administration (FDA) has just approved a new drug called Savella (milnacipran HCL) for the treatment of fibromyalgia.
Savella is categorized as an antidepressant, belonging to a class of drugs called serotonin and norepinephrine reuptake inhibitors (SNRI).  Savella was developed by Forest Laboratories Inc. and Cypress Bioscience Inc., and its FDA approval is based on two clinical trials that, when combined, included 2,084 fibromyalgia patients (1,460 who took Savella and 624 who took a placebo).
An interesting aspect of these studies is that the outcome to determine whether the drug was better than a placebo was that the individual patients had to demonstrate concurrent improvement to multiple measures, including pain, the patient’s global impression of change, and physical function.
The two studies were double-blind, placebo-controlled, multicenter studies in adult patients (18-74 years of age) diagnosed with fibromyalgia. Approximately 35% of patients enrolled reported a history of depression. The first study was six months long and the second was three months long.
In each study, a greater proportion of patients in the Savella treatment arms (100 mg/day and 200 mg/day) compared with placebo experienced at least a 30% reduction in pain from baseline and also rated themselves as "very much improved" or "much improved" after 3 months. In addition, more patients treated with Savella as compared with placebo met the criteria for a treatment response as measured by concurrent improvements in pain, physical function, and patient global assessment.  Some patients who rated themselves as globally "much" or "very much" improved experienced a decrease in pain as early as the first week of treatment and it persisted throughout the study.  Finally, the larger 200 mg/day dose of Savella did not appear to produce greater benefit than the 100 mg/day dose.
The exact mechanism by which Savella improves the symptoms of fibromyalgia is unknown.  However, some researchers believe that abnormalities in certain brain chemicals may be central to fibromyalgia, and that Savella blocks the reuptake of both norepinephrine and serotonin.  These brain chemicals appear to play an important role in pain perception and sensitivity.
Savella was shown to be safe and generally well tolerated. The most frequently occurring adverse reaction was nausea. Other common adverse reactions reported were constipation, hot flush, hyperhidrosis, vomiting, palpitations, heart rate increased, dry mouth and hypertension. The majority of adverse reactions reported were mild to moderate.
The FDA has approved the administration of Savella in two divided doses per day, starting at 12.5 on the first day and increasing to 100 mg/day over a one week period: Day 1: 12.5 mg once Days 2-3: 25 mg/day (12.5 mg twice daily) Days 4-7: 50 mg/day (25 mg twice daily) After Day 7: 100 mg/day (50 mg twice daily).  The recommended dose is 100 mg/day but may be increased to 200 mg/day based on patient response.
Savella is expected to be available by prescription in March, 2009.

Savella（米那普仑）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，Savella（米那普仑）的安全性和有效性经过临床Ⅲ期试验证实有效。
Savella（米那普仑）治疗纤维肌痛综合症的新药——隆重上市，拯救万千纤维肌痛综合症患者。
纤维肌痛综合症（fibromyalgia syndrome,FS）是一种非关节性风湿病，临床表现为肌肉骨骼系统多处疼痛与发僵，并在特殊部位有压痛点。纤维肌痛综合征可继发于外伤，各种风湿病，如骨性关节炎、类风湿关节炎及各种非风湿病（如甲状腺功能低下、恶性肿瘤）等。这一类纤维肌痛综合征被称为继发性纤维肌痛综合征)，如不伴有其他疾患，则称为原发性纤维肌痛综合症。
Savella（米那普仑）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。