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SAVELLA (MILNACIPRAN): WARNINGS AND PRECAUTIONS

Suicide Risk

Milnacipran Hydrochloride (Savella) is a selective serotonin and norepinephrine re-uptake inhibitor (SNRI), similar to some drugs used for the treatment of depression and other psychiatric disorders.

Patients, both adult and pediatric, with depression or other psychiatric disorders may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking these medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants, including drugs that inhibit the reuptake of norepinephrine and/or serotonin, may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment.

In the placebo-controlled clinical trials of adults with fibromyalgia, among the patients who had a history of depression at treatment initiation, the incidence of suicidal ideation was 0.5% in patients treated with placebo, 0% in patients treated with Savella 100 mg per day, and 1.3% in patients treated with Savella 200 mg per day. No suicides occurred in the short-term or longer-term (up to 1 year) fibromyalgia trials.

Pooled analyses of short-term placebo-controlled trials of drugs used to treat depression (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18-24) with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with these drugs compared to placebo in adults beyond age 24; there was a reduction in suicidality risk with antidepressants compared to placebo in adults age 65 and older.

The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 drugs used to treat depression in over 4400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk of differences (drug versus placebo), however, were relatively stable within age strata and across indications.

No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide. It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression.

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 a course of drug therapy, or at times of dose changes, either increases or decreases.

The following symptoms, agitation, anxiety, panic attacks, irritability, insomnia, hostility, impulsivity, aggressiveness, akathisia (psychomotor restlessness), mania, hypomania, have been reported in adult and pediatric patients being treated with drugs inhibiting the reuptake of norepinephrine and/or serotonin for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.

Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients who may experience worsening depressive symptoms, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe or abrupt in onset, or were not part of the patient's presenting symptoms.

If the decision has been made to discontinue treatment due to worsening depressive symptoms or emergent suicidality, medication should be tapered, as rapidly as is feasible, but with recognition that abrupt discontinuation can produce withdrawal symptoms.

Families and caregivers of patients being treated with drugs inhibiting the reuptake of norepinephrine and/or serotonin for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for Savella (Milnacipran) should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.

Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-Like Reactions

The development of a potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions have been reported with SNRIs and SSRIs alone, including Savella, but particularly with concomitant use of serotonergic drugs (including triptans), with drugs which impair metabolism of serotonin (including MAOIs) or with antipsychotics or other dopamine antagonists. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Serotonin syndrome, in its most severe form can resemble neuroleptic malignant syndrome, which includes hyperthermia, muscle rigidity, autonomic instability with possible rapid fluctuation of vital signs, and mental status changes. Patients should be monitored for the emergence of serotonin syndrome or NMS-like signs and symptoms.

The concomitant use of Savella (Milnacipran HCl) with MAOIs is contraindicated. If concomitant treatment of this medicine with a 5-hydroxytryptamine receptor agonist (triptan) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.

The concomitant use of Savella (Milnacipran Hydrochloride) with serotonin precursors (such as tryptophan) is not recommended. Treatment with Savella and any concomitant serotonergic or antidopaminergic agents, including antipsychotics, should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated.

Effects on Blood Pressure

Inhibition of the reuptake of norepinephrine (NE) and serotonin (5-HT) can lead to cardiovascular effects. SNRIs, including Milnacipran (Savella), have been associated with reports of increase in blood pressure.

In a double-blind, placebo-controlled clinical pharmacology study in healthy subjects designed to evaluate the effects of milnacipran on various parameters, including blood pressure at supratherapeutic doses, there was evidence of mean increases in supine blood pressure at doses up to 300 mg twice daily (600 mg per day). At the highest 300 mg twice daily dose, the mean increase in systolic blood pressure was up to 8.1 mm Hg for the placebo group and up to 10.0 mm Hg for the Savella treated group over the 12 hour steady state dosing interval. The corresponding mean increase in diastolic blood pressure over this interval was up to 4.6 mm Hg for placebo and up to 11.5 mm Hg for the Savella treated group.

In the 3-month placebo-controlled fibromyalgia clinical trials, Milnacipran HCl (Savella) treatment was associated with mean increases of up to 3.1 mm Hg in systolic blood pressure (SBP) and diastolic blood pressure (DBP).

In the placebo-controlled trials, among fibromyalgia patients who were non-hypertensive at baseline, approximately twice as many patients in the Milnacipran Hydrochloride (Savella) treatment arms became hypertensive at the end of the study (SBP >= 140 mmHg or DBP >= 90 mmHg) compared with the placebo patients: 7.2% of patients in the placebo arm versus 19.5% of patients treated with Savella 100 mg per day and 16.6% of patients treated with Savella 200 mg per day. Among patients who met systolic criteria for pre-hypertension at baseline (SBP 120-139 mmHg), more patients became hypertensive at the end of the study in the Savella treatment arms than placebo: 9% of patients in the placebo arm versus 14% in both the Savella 100 mg per day and the Savella 200 mg per day treatment arms.

Among fibromyalgia patients who were hypertensive at baseline, more patients in the Savella treatment arms had a >15 mmHg increase in SBP than placebo at the end of the study: 1% of patients in the placebo arm versus 7% in the Savella 100 mg per day and 2% in the Savella 200 mg per day treatment arms. Similarly, more patients who were hypertensive at baseline and were treated with this medication had DBP increases > 10 mmHg than placebo at the end of study: 3% of patients in the placebo arm versus 8% in the Savella 100 mg per day and 6% in the Savella 200 mg per day treatment arms.

Sustained increases in SBP (increase of >= 15 mmHg on three consecutive post-baseline visits) occurred in 2% of placebo patients versus 9% of patients receiving Savella (Milnacipran) 100 mg per day and 6% of patients receiving Savella 200 mg per day. Sustained increases in DBP (increase of >= 10 mmHg on 3 consecutive post-baseline visits) occurred in 4% of patients receiving placebo versus 13% of patients receiving Savella 100 mg per day and 10% of patients receiving Savella (Milnacipran HCl) 200 mg per day.

Sustained increases in blood pressure could have adverse consequences. Cases of elevated blood pressure requiring immediate treatment have been reported.

Concomitant use of Savella (Milnacipran Hydrochloride) with drugs that increase blood pressure and pulse has not been evaluated and such combinations should be used with caution.

Effects of Milnacipran (Savella) on blood pressure in patients with significant hypertension or cardiac disease have not been systematically evaluated. Savella should be used with caution in these patients.

Blood pressure should be measured prior to initiating treatment and periodically measured throughout Milnacipran HCl (Savella) treatment. Pre-existing hypertension and other cardiovascular disease should be treated before starting therapy with this drug. For patients who experience a sustained increase in blood pressure while receiving Savella, either dose reduction or discontinuation should be considered.

Effects on Heart Rate

SNRIs have been associated with reports of increase in heart rate. In clinical trials, relative to placebo, Savella treatment was associated with mean increases in pulse rate of approximately 7 to 8 beats per minute.

Increases in pulse >= 20 bpm occurred more frequently in Savella-treated patients when compared to placebo: 0.3% in the placebo arm versus 8% in the Milnacipran Hydrochloride (Savella) 100 mg per day and 8% in the 200 mg per day treatment arms. The effect of this medication on heart rate did not appear to increase with increasing dose.

Savella has not been systematically evaluated in patients with a cardiac rhythm disorder.

Heart rate should be measured prior to initiating treatment and periodically measured throughout Savella (Milnacipran) treatment. Pre-existing tachyarrhythmias and other cardiac disease should be treated before starting therapy with this drug. For patients who experience a sustained increase in heart rate while receiving Savella (Milnacipran HCl), either dose reduction or discontinuation should be considered.

Seizures

Savella (Milnacipran Hydrochloride) has not been systematically evaluated in patients with a seizure disorder. In clinical trials evaluating this medicine in patients with fibromyalgia, seizures/convulsions have not been reported. However, seizures have been reported infrequently in patients treated with Savella (Milnacipran Hydrochloride) for disorders other than fibromyalgia. This medicine should be prescribed with care in patients with a history of a seizure disorder.

Hepatotoxicity

In the placebo-controlled fibromyalgia trials, increases in the number of patients treated with Milnacipran (Savella) with mild elevations of ALT or AST (1-3 times the upper limit of normal, ULN) were observed. Increases in ALT were more frequently observed in the patients treated with Milnacipran HCl (Savella) 100 mg per day (6%) and Savella 200 mg per day (7%), compared to the patients treated with placebo (3%). One patient receiving Savella 100 mg per day (0.2%) had an increase in ALT greater than 5 times the upper limit of normal but did not exceed 10 times the upper limit of normal. Increases in AST were more frequently observed in the patients treated with Savella 100 mg per day (3%) and Milnacipran Hydrochloride (Savella) 200 mg per day (5%) compared to the patients treated with placebo (2%).

The increases of bilirubin observed in the fibromyalgia clinical trials were not clinically significant.

No case met the criteria of elevated ALT > 3x ULN and associated with an increase in bilirubin >= 2x ULN.

There have been cases of increased liver enzymes and reports of severe liver injury, including fulminant hepatitis with milnacipran from foreign postmarketing experience. In the cases of severe liver injury there were significant underlying clinical conditions and/or the use of multiple concomitant medications. Because of underreporting, it is impossible to provide an accurate estimate of the true incidence of these reactions.

Savella (Milnacipran) should be discontinued in patients who develop jaundice or other evidence of liver dysfunction. Treatment with this medicine should not be resumed unless another cause can be established.

Savella (Milnacipran HCl) should ordinarily not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease.

Discontinuation of Treatment with Savella

Withdrawal symptoms have been observed in clinical trials following discontinuation of milnacipran, as with other SNRIs and SSRIs.

During marketing of milnacipran, and other SNRIs and SSRIs, there have been spontaneous reports of adverse events indicative of withdrawal and physical dependence occurring upon discontinuation of these drugs, particularly when discontinuation is abrupt. The adverse events include the following: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesias such as electric shock sensations), confusion, anxiety, headache, emotional lability, lethargy, insomnia, tinnitus, hypomania, and seizures. Although these events are generally self-limiting, some have been reported to be severe.

Patients should be monitored for these symptoms when discontinuing treatment with Savella (Milnacipran Hydrochloride). This medication should be tapered and not abruptly discontinued after extended use. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.

Hyponatremia

Hyponatremia may occur as a result of treatment with SSRIs and SNRIs, including Milnacipran (Savella). In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH). Cases with serum sodium lower than 110 mmol / l have been reported. Elderly patients may be at greater risk of developing hyponatremia with SNRIs, SSRIs, or Milnacipran HCl (Savella). Also, patients taking diuretics or who are otherwise volume-depleted may be at greater risk. Discontinuation of Milnacipran Hydrochloride (Savella) should be considered in patients with symptomatic hyponatremia.

Signs and symptoms of hyponatremia include headache, memory impairment, difficulty concentrating, confusion, weakness, and unsteadiness, which may lead to falls. Signs and symptoms associated with more severe and/or acute cases have included syncope, hallucination, seizure, respiratory arrest, coma, and death.

Abnormal Bleeding

SSRIs and SNRIs, including Savella, may increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, warfarin, and other anti-coagulants may add to this risk. Case reports and epidemiological studies (case-control and cohort design) have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Bleeding events related to SSRIs and SNRIs use have ranged from ecchymoses, hematomas, epistaxis, and petechiae to life-threatening hemorrhages.

Patients should be cautioned about the risk of bleeding associated with the concomitant use of Savella (Milnacipran) and NSAIDs, aspirin, or other drugs that affect coagulation.

Activation of Mania

No activation of mania or hypomania was reported in the clinical trials evaluating effects of Savella (Milnacipran HCl) in patients with fibromyalgia. However those clinical trials excluded patients with current major depressive episode. Activation of mania and hypomania have been reported in patients with mood disorders who were treated with other similar drugs for major depressive disorder. As with these other agents, Savella (Milnacipran Hydrochloride) should be used cautiously in patients with a history of mania.

Patients with a History of Dysuria

Because of their noradrenergic effect, SNRIs including Milnacipran (Savella), can affect urethral resistance and micturition. In the controlled fibromyalgia trials, dysuria occurred more frequently in patients treated with Savella (1%) than in placebo-treated patients (0.5%). Caution is advised in use of this drug in patients with a history of dysuria, notably in male patients with prostatic hypertrophy, prostatitis, and other lower urinary tract obstructive disorders. Male patients are more prone to genitourinary adverse effects, such as dysuria or urinary retention, and may experience testicular pain or ejaculation disorders.

Controlled Narrow-Angle Glaucoma

Mydriasis has been reported in association with SNRIs and Savella; therefore, Milnacipran HCl (Savella) should be used cautiously in patients with controlled narrow-angle glaucoma.

Do not use this medicine in patients with Uncontrolled Narrow-Angle Glaucoma.

Concomitant Use with Alcohol

In clinical trials, more patients treated with Milnacipran Hydrochloride (Savella) developed elevated transaminases than did placebo treated patients. Because it is possible that milnacipran may aggravate pre-existing liver disease, Savella should not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease.

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