Savella
Download the Savella product prescribing information.
Savella is the most recently approved product by the U.S. Food and Drug Administration (FDA) for the management of fibromyalgia. The FDA approved Savella in January 2009 following a thorough review and determined that it is safe and effective for the management of fibromyalgia when prescribed in accordance with the package insert.
Savella is supported by a large body of clinical evidence, involving more than 3,000 fibromyalgia patients. Four positive large-scale Phase III placebo controlled clinical trials have been completed. Two of the trials formed the basis of the FDA’s approval for efficacy and are described in the package insert. The two additional Phase III trials were completed post approval and are either published or otherwise publicly available.
Fibromyalgia is a serious and complicated condition and there are many variables that must be considered when choosing a treatment plan. It is important that physicians and their patients have FDA approved drug products that are safe and effective, such as Savella, when making treatment decisions.
Savella (milnacipran) is indicated for the management of fibromyalgia in adults. Savella is available by prescription only.
Important Risk Information About Savella
Savella is a selective serotonin and norepinephrine reuptake inhibitor (SNRI), similar to some drugs used for the treatment of depression and other psychiatric disorders. Patients on antidepressants and their families or caregivers should watch for new or worsening symptoms, unusual changes in behavior, thoughts of suicide, anxiety, agitation, panic attacks, difficulty sleeping, irritability, hostility, aggressiveness, impulsivity, restlessness, or extreme hyperactivity. Call your healthcare provider right away if you have thoughts of suicide or if any of these symptoms are severe or occur suddenly. Be especially observant within the first few months of treatment or whenever there is a change in dose, either increase or decrease. Savella is not approved for use in treating depression.
Who should NOT take Savella?
Do not take Savella if you:
- • Are taking or have recently taken a type of drug called a monoamine oxidase inhibitor (MAOI), such as Nardil® (phenelzine sulfate) or Parnate® (tranylcypromine sulfate)
- • Have uncontrolled narrow-angle glaucoma (an eye disease)
What should I tell my healthcare provider before taking Savella?
Before starting Savella, tell your healthcare provider about all of your medical conditions, including if you have:
- • Hypertension (high blood pressure), tachyarrhythmia (fast heart rate), or other cardiac diseases
- • Liver problems or a history of substantial alcohol use
- • Kidney problems, including dysuria (painful urination)
- • History of mania or seizure disorders
- • Bleeding disorders
- • Glaucoma
Also, to avoid a potentially serious or life-threatening condition, tell your healthcare provider if you are taking, or planning to take, any prescription or over-the-counter medications, including:
- • Other SNRIs, serotonin reuptake inhibitors (SSRIs), certain migraine or headache medications (triptans), or tryptophan
- • Medication prescribed for a psychiatric or neurological condition
- • NSAID pain relievers (such as ibuprofen or naproxen), aspirin, warfarin, or other blood thinners
- • Diuretics
Tell your healthcare provider if you are pregnant, planning to become pregnant during therapy, or are breastfeeding an infant.
What other important information should I discuss with my healthcare provider?
Your blood pressure and pulse should be monitored at regular intervals when receiving treatment with Savella.
You should not operate machinery or drive until you are reasonably certain that Savella treatment does not affect your ability to engage in such activities. Avoid drinking alcohol while taking Savella.
Call your doctor if you have very high fever, rigid muscles, shaking, confusion, or rapid changes in heart rate and blood pressure. These may be signs of a rare but serious side effect.
Talk with your healthcare provider before stopping Savella or changing your dose. Withdrawal symptoms can occur, particularly when discontinuation is abrupt.
What are the possible side effects of Savella?
The most common side effect associated with Savella treatment is nausea. In clinical trials, patients experiencing nausea described it as mild to moderate. Other common side effects were headache, constipation, dizziness, insomnia, hot flush, hyperhidrosis (excessive sweating), vomiting, palpitations, increased heart rate, dry mouth, and hypertension.
This is not a complete list of side effects.