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SAVELLA (MILNACIPRAN): PATIENT COUNSELING INFORMATION

Information in Medication Guide

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Savella (Milnacipran Hydrochloride) and should counsel them in its appropriate use. A patient Medication Guide is available for Savella. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.

Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking Milnacipran (Savella):

Suicide Risk

Patients and their families and caregivers should be advised that Milnacipran HCl (Savella) is a selective norepinephrine and serotonin reuptake inhibitor and therefore belongs to the same class of drugs as antidepressants. Patients, their families and their caregivers should be advised that patients with depression may be at increased risk for clinical worsening and/or suicidal ideation if they stop taking anti-depressant medication, change the dose, or start a new medication.

Patients, their families and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania or other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during treatment with Milnacipran Hydrochloride (Savella) or other drugs that inhibit the reuptake of norepinephrine and/or serotonin, and when the dose is adjusted up or down. Families and caregivers of patients should be advised to observe for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms.

Serotonin Syndrome

Patients should be cautioned about the risk of serotonin syndrome with concomitant use of Savella (Milnacipran) and triptans, tramadol, or other serotonergic agents.

Effect on Blood Pressure and Pulse

Patients should be advised that their blood pressure and pulse should be monitored at regular intervals when receiving treatment with Savella (Milnacipran HCl).

Abnormal Bleeding

Patients should be cautioned about the concomitant use of Savella (Milnacipran Hydrochloride) and NSAIDs, aspirin, or other drugs that affect coagulation, since the combined use of agents that interfere with serotonin reuptake and these agents has been associated with an increased risk of abnormal bleeding.

Ability to Drive and Use Machinery

Milnacipran (Savella) might diminish mental and physical capacities necessary to perform certain tasks such as operating machinery, including motor vehicles. Patients should be cautioned about operating machinery or driving motor vehicles until they are reasonably certain that Savella treatment does not affect their ability to engage in such activities.

Alcohol

Patients should be advised to avoid consumption of alcohol while taking Milnacipran HCl (Savella).

Discontinuation

Patients should be advised that withdrawal symptoms can occur when discontinuing treatment with Milnacipran Hydrochloride (Savella), particularly when discontinuation is abrupt.

Pregnancy

Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during Savella therapy.

Patients should be encouraged to enroll in the Savella Pregnancy Registry if they become pregnant, preferably before any prenatal testing is done. This registry is collecting information about the safety of milnacipran during pregnancy.

Nursing

Patients should be advised to notify their physician if they are breast-feeding.

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