What Is Savella?
Savella is a drug used for the management of fibromyalgia. While it was in clinical trials, it was known by its generic name, milnacipran HCl. Savella is a selective serotonin and norepinephrine dual reuptake inhibitor.
What Is a Selective Serotonin and Norepinephrine Dual Reuptake Inhibitor?
As a selective serotonin and norepinephrine dual reuptake inhibitor, also known as SSNRI, Savella increases norepinephrine and serotonin activity in the brain. In the test tube, Savella seems to have more effect on norepinephrine activity. This is important for fibromyalgia patients because low brain norepinephrine levels are thought to be related to increased pain and cognitive difficulties ("brain fog").
How Is Savella Given?
Savella is administered in two divided doses per day. The dosage is gradually increased over the course of the first week to get to the recommended dose of 100 mg/day.
Savella is available as 12.5 mg, 25 mg, 50 mg, and 100 mg tablets. On day 1, you take 12.5 mg once. On days 2 to 3, you take 12.5 mg/twice daily. On days 4 to 7, you take 25 mg/twice daily. After day 7, the usual dose is 50 mg/twice daily. Some patients may require 200 mg/day -- and some may require a lower dose if they have renal (kidney) impairment.
How Has Savella Performed in Clinical Trials?
The safety and efficacy of Savella was determined from the results of two phase III clinical trials in the U.S. There were more than 2,000 patients with fibromyalgia involved in the studies.
What Side Effects and Warnings Have Been Associated With Savella?
Savella is contraindicated (should not be used) in patients with uncontrolled narrow-angle glaucoma. Savella should also not be used by patients taking MAOIs (monoamine oxidase inhibitors), typically used for depression. Savella is not approved for use in children.
Warnings and precautions exist for patients taking Savella, including the following:
- worsening depressive symptoms and suicide risk are possible with Savella
- serotonin syndrome (a life-threatening drug reaction that causes the body to have too much serotonin) is possible
- elevated blood pressure and heart rate may occur with Savella
- seizures have been reported in patients taking Savella
- hepatotoxicity has been reported (patients with excessive alcohol use or chronic liver disease should avoid Savella)
- withdrawal symptoms may occur if Savella is not discontinued gradually
- Savella may increase the risk of bleeding especially in patients taking NSAIDs, aspirin, or other drugs that affect bleeding
- higher rates of genitourinary adverse events
Nausea, headache, constipation, dizziness, insomnia, hot flush, increased perspiration, vomiting, palpatations, and dry mouth are other adverse reactions associated with Savella.
Is Savella FDA-Approved and Available?
On January 14, 2009, the FDA approved Savella for the management of fibromyalgia.
Savella Prescribing Information. Savella.com. 01/08/2009.
Forest and Cypress Announce FDA Approval of Savella(TM) for the Management of Fibromyalgia. January 14, 2009.