Savella Information
Savella (Milnacipran hcl)
Savella (Milnacipran hcl) Indications And Usage
Savella (Milnacipran hcl) is indicated for the management of fibromyalgia.
Savella (Milnacipran hcl) is not approved for use in pediatric patients [].
Savella (Milnacipran hcl) Dosage And Administration
Savella (Milnacipran hcl) is given orally with or without food.
Taking Savella (Milnacipran hcl) with food may improve the tolerability of the drug.
Savella (Milnacipran hcl) Dosage Forms And Strengths
Film-coated, immediate release tablets in four strengths: 12.5 mg, 25 mg, 50 mg, and 100 mg of milnacipran hydrochloride.
12.5 mg tablets are round, pink, "F" on one side, "L" on the reverse;
25 mg tablets are round, white, "FL" on one side, "25" on the reverse;
50 mg tablets are oval, green, "FL" on one side, "50" on the reverse;
100 mg tablets are oval, blue, "FL" on one side, "100" on the reverse
[ () ].
Savella (Milnacipran hcl) Warnings And Precautions
Savella (Milnacipran hcl) 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 (Milnacipran hcl) 100 mg/day, and 1.3% in patients treated with Savella (Milnacipran hcl) 200 mg/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. These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in .
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, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, 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 ), and
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 hcl) should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.
Inhibition of the reuptake of norepinephrine (NE) and serotonin (5-HT) can lead to cardiovascular effects. SNRIs, including Savella (Milnacipran hcl) , 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/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 (Milnacipran hcl) 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 (Milnacipran hcl) treated group.
In the 3-month placebo-controlled fibromyalgia clinical trials, Savella (Milnacipran hcl) 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 Savella (Milnacipran hcl) 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 (Milnacipran hcl) 100 mg/day and 16.6% of patients treated with Savella (Milnacipran hcl) 200 mg/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 (Milnacipran hcl) treatment arms than placebo: 9% of patients in the placebo arm versus 14% in both the Savella (Milnacipran hcl) 100 mg/day and the Savella (Milnacipran hcl) 200 mg/day treatment arms.
Among fibromyalgia patients who were hypertensive at baseline, more patients in the Savella (Milnacipran hcl) 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 (Milnacipran hcl) 100 mg/day and 2% in the Savella (Milnacipran hcl) 200 mg/day treatment arms. Similarly, more patients who were hypertensive at baseline and were treated with Savella (Milnacipran hcl) had DBP increases > 10 mmHg than placebo at the end of study: 3% of patients in the placebo arm versus 8% in the Savella (Milnacipran hcl) 100 mg/day and 6% in the Savella (Milnacipran hcl) 200 mg/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 hcl) 100 mg/day and 6% of patients receiving Savella (Milnacipran hcl) 200 mg/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 (Milnacipran hcl) 100 mg/day and 10% of patients receiving Savella (Milnacipran hcl) 200 mg/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 hcl) with drugs that increase blood pressure and pulse has not been evaluated and such combinations should be used with caution
Effects of Savella (Milnacipran hcl) on blood pressure in patients with significant hypertension or cardiac disease have not been systematically evaluated. Savella (Milnacipran hcl) should be used with caution in these patients.
Blood pressure should be measured prior to initiating treatment and periodically measured throughout Savella (Milnacipran hcl) treatment. Pre-existing hypertension and other cardiovascular disease should be treated before starting therapy with Savella (Milnacipran hcl) . For patients who experience a sustained increase in blood pressure while receiving Savella (Milnacipran hcl) , either dose reduction or discontinuation should be considered.
SNRIs have been associated with reports of increase in heart rate.
In clinical trials, relative to placebo, Savella (Milnacipran hcl) 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 (Milnacipran hcl) -treated patients when compared to placebo: 0.3% in the placebo arm versus 8% in the Savella (Milnacipran hcl) 100 mg/day and 8% in the 200 mg/day treatment arms. The effect of Savella (Milnacipran hcl) on heart rate did not appear to increase with increasing dose.
Savella (Milnacipran hcl) 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 hcl) treatment. Pre-existing tachyarrhythmias and other cardiac disease should be treated before starting therapy with Savella (Milnacipran hcl) . For patients who experience a sustained increase in heart rate while receiving Savella (Milnacipran hcl) , either dose reduction or discontinuation should be considered.
In the placebo-controlled fibromyalgia trials, increases in the number of patients treated with Savella (Milnacipran hcl) 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 Savella (Milnacipran hcl) 100 mg/day (6%) and Savella (Milnacipran hcl) 200 mg/day (7%), compared to the patients treated with placebo (3%). One patient receiving Savella (Milnacipran hcl) 100 mg/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 (Milnacipran hcl) 100 mg/day (3%) and Savella (Milnacipran hcl) 200 mg/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 hcl) should be discontinued in patients who develop jaundice or other evidence of liver dysfunction. Treatment with Savella (Milnacipran hcl) 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.
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), anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, 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 hcl) . Savella (Milnacipran hcl) 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 may occur as a result of treatment with SSRIs and SNRIs, including Savella (Milnacipran hcl) . 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 Savella (Milnacipran hcl) . Also, patients taking diuretics or who are otherwise volume-depleted may be at greater risk []. Discontinuation of Savella (Milnacipran hcl) should be considered in patients with symptomatic hyponatremia.
Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to falls. Signs and symptoms associated with more severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death.
SSRIs and SNRIs, including Savella (Milnacipran hcl) , 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 hcl) and NSAIDs, aspirin, or other drugs that affect coagulation.
Mydriasis has been reported in association with SNRIs and Savella (Milnacipran hcl) ; therefore, Savella (Milnacipran hcl) should be used cautiously in patients with controlled narrow-angle glaucoma.
Do not use Savella (Milnacipran hcl) in patients with Uncontrolled Narrow-Angle Glaucoma
Savella (Milnacipran hcl) Adverse Reactions
Savella (Milnacipran hcl) was evaluated in three double-blind placebo-controlled trials involving 2209 fibromyalgia patients (1557 patients treated with Savella (Milnacipran hcl) and 652 patients treated with placebo) for a treatment period up to 29 weeks.
The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed. A reaction was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In the placebo-controlled fibromyalgia patient trials the most frequently occurring adverse reaction in clinical trials was nausea. The most common adverse reactions (incidence ≥ 5% and twice placebo) in patients treated with Savella (Milnacipran hcl) were constipation, hot flush, hyperhidrosis, vomiting, palpitations, heart rate increased, dry mouth, and hypertension.
Table 2
Following is a list of frequent (those occurring on one or more occasions in at least 1/100 patients) treatment-emergent adverse reactions reported from 1824 fibromyalgia patients treated with Savella (Milnacipran hcl) for periods up to 68 weeks. The listing does not include those events already listed in , those events for which a drug cause was remote, those events which were so general as to be uninformative, and those events reported only once which did not have a substantial probability of being acutely life threatening.
Adverse reactions are categorized by body system and listed in order of decreasing frequency. Adverse reactions of major clinical importance are described in the section ().
Gastrointestinal Disorders - diarrhea, dyspepsia, gastroesophageal reflux disease, flatulence, abdominal distension
General Disorders - fatigue, peripheral edema, irritability, pyrexia
Infections - urinary tract infection, cystitis
Injury, Poisoning, and Procedural Complications - contusion, fall
Investigations - weight decreased or increased
Metabolism and Nutrition Disorders - hypercholesterolemia
Nervous System Disorders - somnolence, dysgeusia
Psychiatric Disorders - depression, stress
Skin Disorders - night sweats
The following additional adverse reactions have been identified from spontaneous reports of Savella (Milnacipran hcl) received worldwide. These adverse reactions have been chosen for inclusion because of a combination of seriousness, frequency of reporting, or potential causal connection to Savella (Milnacipran hcl) . However, because these adverse reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events include:
Blood and Lymphatic System Disorders - leukopenia, neutropenia, thrombocytopenia
Cardiac Disorders - supraventricular tachycardia
Eye Disorders - accommodation disorder
Endocrine Disorders - hyperprolactinemia
Hepatobiliary Disorders - hepatitis
Metabolism and Nutrition Disorders - anorexia, hyponatremia
Musculoskeletal and Connective Tissue Disorders - rhabdomyolysis
Nervous System Disorders - convulsions (including grand mal), loss of consciousness, neuroleptic malignant syndrome, Parkinsonism, serotonin syndrome
Psychiatric Disorders - delirium, hallucination
Renal and Urinary Disorders - acute renal failure
Reproductive System and Breast Disorders - galactorrhea
Skin Disorders - erythema multiforme, Stevens Johnson syndrome
Vascular Disorders - hypertensive crisis
Savella (Milnacipran hcl) Drug Interactions
Milnacipran undergoes minimal CYP450 related metabolism, with the majority of the dose excreted unchanged in urine (55%), and has a low binding to plasma proteins (13%). In vitro and in vivo studies showed that Savella (Milnacipran hcl) is unlikely to be involved in clinically significant pharmacokinetic drug interactions .
[See Contraindications ()]
Due to the mechanism of action of SNRIs and SSRIs, including Savella (Milnacipran hcl) , and the potential for serotonin syndrome or Neuroleptic Malignant Syndrome (NMS) – like reactions, caution is advised when Savella (Milnacipran hcl) is co-administered with other drugs that may affect the serotonergic neurotransmitter systems. This includes drugs such as triptans, lithium, tryptophan, antipsychotics and dopamine antagonists.
Co-administration of Savella (Milnacipran hcl) with other inhibitors of serotonin re-uptake may result in hypertension and coronary artery vasoconstriction, through additive serotonergic effects. Concomitant use of Savella (Milnacipran hcl) with other SSRIs, SNRIs, or tryptophan is not recommended .
Savella (Milnacipran hcl) Use In Specific Populations
In controlled clinical studies of Savella (Milnacipran hcl) , 402 patients were 60 years or older, and no overall differences in safety and efficacy were observed between these patients and younger patients.
In view of the predominant excretion of unchanged milnacipran via kidneys and the expected decrease in renal function with age renal function should be considered prior to use of Savella (Milnacipran hcl) in the elderly [].
SNRIs, SSRIs, and Savella (Milnacipran hcl) , have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event [].
Savella (Milnacipran hcl) Overdosage
There is limited clinical experience with Savella (Milnacipran hcl) overdose in humans. In clinical trials, cases of acute ingestions up to 1000 mg, alone or in combination with other drugs, were reported with none being fatal.
In postmarketing experience, fatal outcomes have been reported for acute overdoses primarily involving multiple drugs but also with Savella (Milnacipran hcl) only. The most common signs and symptoms included increased blood pressure, cardio-respiratory arrest, changes in the level of consciousness (ranging from somnolence to coma), confusional state, dizziness, and increased hepatic enzymes.
Savella (Milnacipran hcl) Description
Milnacipran hydrochloride is a selective norepinephrine and serotonin reuptake inhibitor; it inhibits norepinephrine uptake with greater potency than serotonin. It is a racemic mixture with the chemical name: (±)-[1R(S),2S(R)]-2-(aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide hydrochloride. The structural formula is:
Milnacipran hydrochloride is a white to off-white crystalline powder with a melting point of 179°C.
It is freely soluble in water, methanol, ethanol, chloroform, and methylene chloride and sparingly soluble in diethyl ether. It has an empirical formula of C15H23ClN2O and a molecular weight of 282.8 g/mol.
Savella (Milnacipran hcl) is available for oral administration as film-coated tablets containing 12.5 mg, 25 mg, 50 mg, and 100 mg milnacipran hydrochloride. Each tablet also contains dibasic calcium phosphate, povidone, carboxymethylcellulose calcium, colloidal silicon dioxide, magnesium stearate, and talc as inactive ingredients. Additionally, the following inactive ingredients are also present as components of the film coat:
12.5 mg:
FD&C Red #40 Aluminum Lake dye, hypromellose, polyethylene glycol, titanium dioxide
25 mg:
Hypromellose, polyethylene glycol, titanium dioxide
50 mg:
FD&C Blue #1, Blue #2, and Yellow #5 Aluminum Lake dyes; hypromellose; polyethylene glycol; titanium dioxide
100 mg:
FD&C Blue #1 Aluminum Lake dye, hypromellose, polyethylene glycol, titanium dioxide
Savella (Milnacipran hcl) Clinical Pharmacology
Cardiovascular Electrophysiology
Savella (Milnacipran hcl) Clinical Studies
Management of Fibromyalgia
The efficacy of Savella (Milnacipran hcl) for the management of fibromyalgia was established in two double-blind, placebo-controlled, multicenter studies in adult patients (18-74 years of age). Enrolled patients met the American College of Rheumatology (ACR) criteria for fibromyalgia (a history of widespread pain for 3 months and pain present at 11 or more of the 18 specific tender point sites). Approximately 35% of patients had a history of depression. Study 1 was six months in duration and Study 2 was three months in duration.
A larger proportion of patients treated with Savella (Milnacipran hcl) than with placebo experienced a simultaneous reduction in pain from baseline of at least 30% (VAS) and also rated themselves as much improved or very much improved based on the patient global assessment (PGIC). In addition, a larger proportion of patients treated with Savella (Milnacipran hcl) met the criteria for treatment response, as measured by the composite endpoint that concurrently evaluated improvement in pain (VAS), physical function (SF-36 PCS), and patient global assessment (PGIC), in fibromyalgia as compared to placebo.
Study 1: This 6-month study compared total daily doses of Savella (Milnacipran hcl) 100 mg and 200 mg to placebo. Patients were enrolled with a minimum mean baseline pain score of ≥ 50 mm on a 100 mm visual analog scale (VAS) ranging from 0 (“no pain”) to 100 (“worst possible pain”). The mean baseline pain score in this trial was 69. The efficacy results for Study 1 are summarized in .
Figure 1
Study 2: This 3-month study compared total daily doses of Savella (Milnacipran hcl) 100 mg and 200 mg to placebo. Patients were enrolled with a minimum mean baseline pain score of ≥ 40 mm on a 100- mm VAS ranging from 0 (“no pain”) to 100 (“worst possible pain”). The mean baseline pain score in this trial was 65. The efficacy results for Study 2 are summarized in .
Figure 2
In both studies, some patients who rated themselves as globally “much” or “very much” improved experienced a decrease in pain as early as week 1 of treatment with a stable dose of Savella (Milnacipran hcl) that persisted throughout these studies.
Savella (Milnacipran hcl) How Supplied/storage And Handling
White, round, film-coated tablets, debossed with “FL” on one side and “25” on the reverse
Bottles of 60: NDC 0456-1525-60
White, oval-shaped, film-coated tablets, debossed with “FL” on one side and “50” on the reverse
Bottles of 60: NDC 0456-1550-60
Store at 25°C (77°F); excursions permitted between 15°C and 30°C (between 59°F and 86°F) [See USP Controlled Room Temperature].
Savella (Milnacipran hcl) Patient Counseling Information
See
Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Savella (Milnacipran hcl) and should counsel them in its appropriate use. A patient Medication Guide is available for Savella (Milnacipran hcl) . 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 Savella (Milnacipran hcl) :
Patients and their families and caregivers should be advised that Savella (Milnacipran hcl) 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 Savella (Milnacipran hcl) 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. [].
Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during Savella (Milnacipran hcl) therapy [].
8.1
Savella (Milnacipran hcl)
Savella (Milnacipran hcl)
Savella (Milnacipran hcl)
