Important Safety Information
Prescribing Information | Medication Guide

SAVELLA is a selective serotonin and norepinephrine reuptake inhibitor (SNRI), similar to some drugs used for the treatment of depression and other psychiatric disorders. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of such drugs in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on SAVELLA should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. SAVELLA is not approved for use in the treatment of major depressive disorder. SAVELLA is not approved for use in pediatric patients. See additional Important Safety Information below

SAVELLA (milnacipran HCl) is indicated for the management of fibromyalgia. SAVELLA is not approved for use in pediatric patients.
INFORMATION FOR HEALTHCARE PROFESSIONALS

Offer your patients Savella for the management of fibromyalgia

Dosing & Administration

Dosing may be titrated according to the following schedule, but titration can be adjusted based on efficacy and tolerability:

1-Week
titration1
Day 1 12.5 mg
Days 2-3 25 mg/day (12.5 mg twice daily)
Days 4-7 50 mg/day (25 mg twice daily)
Recommended
dose
100 mg/day (50 mg twice daily) The dose may be increased to 200 mg/day (100 mg twice daily), based on individual patient response. Doses above 200 mg/day have not been studied1
  • Twice-daily (AM/PM) dosing with or without a meal1
    • Taking Savella with a meal may improve tolerability
  • Savella should be tapered and not abruptly discontinued after extended use1
Savella Availability Chart

Savella is non-narcotic and is not scheduled.1

No dosage adjustment needed for patients with hepatic impairment or mild renal impairment1

  • As with any drug, caution should be exercised in patients with severe hepatic impairment
    • Savella should ordinarily not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease
  • Savella should be used with caution in patients with moderate renal impairment
    • In patients with severe renal impairment, the maintenance dose should be reduced by 50%
  • Savella is not recommended for patients with end-stage renal disease
SAVELLA is indicated for the management of fibromyalgia. SAVELLA is not approved for use in pediatric patients.
Important Safety Information
SAVELLA is a selective serotonin and norepinephrine reuptake inhibitor (SNRI), similar to some drugs used for the treatment of depression and other psychiatric disorders. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of such drugs in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on SAVELLA should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. SAVELLA is not approved for use in the treatment of major depressive disorder. SAVELLA is not approved for use in pediatric patients.
Contraindications
  • The use of MAOIs intended to treat psychiatric disorders with SAVELLA or within 5 days of stopping treatment with SAVELLA is contraindicated because of an increased risk of serotonin syndrome. The use of SAVELLA within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated.
  • Starting SAVELLA in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome.
  • SAVELLA is contraindicated in patients with uncontrolled narrow-angle glaucoma. In clinical trials, SAVELLA was associated with an increased risk of mydriasis.
Warnings and Precautions
  • All patients being treated with drugs inhibiting the reuptake of norepinephrine and/or serotonin for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of treatment and when increasing or decreasing the dose. Consider changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is worsening or includes symptoms of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, mania, or suicidality that are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Families and caregivers of patients being treated with drugs that inhibit the reuptake of norepinephrine and/or serotonin should be alerted about the need to monitor patients daily. Prescriptions for SAVELLA should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose.
  • Development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including SAVELLA alone, but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort), and with drugs that impair metabolism of serotonin (in particular MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Symptoms may include mental status changes (eg, agitation, hallucinations, delirium, and coma), autonomic instability (eg, tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular syndrome (eg, tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhea). If symptoms of serotonin syndrome occur, discontinue SAVELLA and initiate supportive treatment. If concomitant use of SAVELLA with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk of serotonin syndrome, particularly during treatment initiation and dose increases.
  • SAVELLA may increase blood pressure. In an ambulatory blood pressure monitoring (ABPM) study, a substantially higher proportion of SAVELLA- treated patients had a hypertensive blood pressure measurement at the Week 4, 50 mg BID visit and at the Week 6, 100 mg BID visit as compared to placebo-treated patients. Blood pressure should be measured prior to initiating treatment and periodically throughout SAVELLA treatment. Cases of elevated blood pressure requiring immediate treatment have been reported. Treat pre-existing hypertension and other cardiovascular disease before starting therapy with SAVELLA. Use with caution in patients with pre-existing hypertension, cardiovascular, or cerebrovascular conditions that might be compromised by increases in blood pressure. Concomitant use of SAVELLA with drugs that increase blood pressure and heart rate has not been evaluated and such combinations should be used with caution. For patients who experience a sustained increase in blood pressure while receiving SAVELLA, either reduce the dose or discontinue.
  • SAVELLA may increase heart rate. In an ABPM study in patients who were normotensive at baseline the mean increase in mean 24-hour heart rate from baseline was 13 beats per minute. Measure heart rate prior to initiating treatment and periodically monitor the heart rate throughout SAVELLA treatment. Treat pre-existing tachyarrhythmias and other cardiac disease before starting therapy with SAVELLA. For patients who experience a sustained increase in heart rate while receiving SAVELLA, either reduce the dose or discontinue treatment with SAVELLA, if clinically warranted.
  • SAVELLA should be prescribed with care in patients with a history of seizure disorder or mania.
  • SAVELLA has been associated with mild elevations of ALT and AST (1 to 3 times the upper limit of normal). Rarely, reports of serious liver injury, including fulminant hepatitis, have been reported in patients treated with milnacipran. SAVELLA should be discontinued in patients who develop jaundice or other evidence of liver dysfunction and should not be resumed unless another cause can be established.
  • As with other SNRIs and SSRIs, withdrawal symptoms have been observed following discontinuation of milnacipran. A gradual dose reduction is recommended.
  • Hyponatremia may occur as a result of treatment with SSRIs and SNRIs, including SAVELLA. Elderly patients may be at greater risk. Discontinuation should be considered for patients with symptomatic hyponatremia.
  • SSRIs and SNRIs, including SAVELLA, may increase the risk of bleeding events. Patients should be cautioned regarding the risk of bleeding associated with concomitant use of SAVELLA and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation.
  • SAVELLA can affect urethral resistance and micturition. Caution is advised in the use of SAVELLA in patients with a history of dysuria, notably in male patients with a history of obstructive uropathies as these patients may experience higher rates of genitourinary adverse events.
  • SAVELLA should not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease.
Use in Specific Populations
  • There are no adequate and well-controlled studies in pregnant women. SAVELLA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
  • Milnacipran is present in the milk of lactating women treated with SAVELLA. Because of the limited data regarding infant exposure to SAVELLA, caution should be exercised when SAVELLA is administered to a nursing woman.
Adverse Reactions
  • In clinical trials, the most frequently occurring adverse reaction was nausea (37% vs 20% for placebo). The most commonly occurring adverse reactions (≥5% and greater than placebo) were headache (18% vs 14%), constipation (16% vs 4%), dizziness (10% vs 6%), insomnia (12% vs 10%), hot flush (12% vs 2%), hyperhidrosis (9% vs 2%), vomiting (7% vs 2%), palpitations (7% vs 2%), heart rate increased (6% vs 1%), dry mouth (5% vs 2%), and hypertension (5% vs 2%).
References
  1. Savella (milnacipran HCl) [package insert]. St. Louis, MO: Forest Pharmaceuticals, Inc.
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Pregnancy Registry Information

Forest Laboratories, Inc. maintains a registry to monitor the pregnancy outcomes of women exposed to Savella while pregnant. Data collected from this study will be shared with the FDA and may be added to Savella labelling to provide prescribers with additional prescribing and consulting information. Healthcare providers are encouraged to register any patient who is or will be exposed to Savella during pregnancy by calling 1-877-643-3010 or by visiting www.savellapregnancyregistry.com.

Because there are no adequate and well-controlled studies in pregnant women taking Savella, it should be used during pregnancy only if your doctor thinks the potential treatment benefit outweighs any safety risk to the baby.

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