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Levomilnacipran Hydrochloride

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Last Updated: 22 October 2020

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General | Latest Info

A small number of children, teenagers, and young adults who take antidepressants such as levomilnacipran during clinical studies become suicidal. Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. This risk should be considered and compared with potential benefit in treatment of depression, in deciding whether a child or teenager should take antidepressant.S Children younger than 18 years of age should not normally take levomilnacipran, but in some cases, doctor may decide that levomilnacipran is the best medication to treat children's condition. You should know that your mental health may change in unexpected ways when you take levomilnacipran, or other antidepressants, even if you are an adult over 24 years of age. You may become suicidal, especially at the beginning of your treatment and any time that your dose increases or decrease. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious, so they can call the doctor if you are unable to seek treatment on your own. Your healthcare provider will want to see you often while you are taking levomilnacipran, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor. Your doctor or pharmacist will give you the manufacturer's patient information sheet when you begin treatment with levomilnacipran and each time you refill your prescription. Read information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration website or manufacturer's website to obtain a Medication Guide. No matter what your age, before you take antidepressant, you, your parent,s or your caregiver should talk to your doctor about the risks and benefits of treating your condition with antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder or mania or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you. Levomilnacipran comes as an extended-release capsule to take by mouth. It is usually take once daily with or without food. Take levomilnacipran at around the same time every day.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Side Effects

Efficacy of LVM in patients with MDD has been evaluated in seven randomise, double-blind clinical trials, without considering results from smaller studies presented as case reports, posters, and proceedings of congresses. These studies include one Phase II trial, four Phase III trials, two long-term efficacy studies, and four secondary and post-hoc analyses. In Phase II, randomize, placebo-control, multicenter study by Montgomery et al., Full analysis set was formed by 553 patients who met criteria for major depressive episode. Results show that levomilnacipran sustain release of 75 mg / day or 100 mg / day was more effective than placebo on depressive and disability symptoms, as assessed by changes in MADRS, HDRS scores, and SDS scores at end of trial. Furthermore, significantly more levomilnacipran-treat patients than placebo patients achieved remission as defined by complete and sustained criteria. Regarding functional impairment, proportion of patients who achieved remission and response was significantly greater in the levomilnacipran group than in the placebo group. 8-week, randomize, double-blind study by Asnis et al. Evaluate in 713 outpatients with ongoing major depressive episode 8 weeks duration efficacy and tolerability of fixed-dose levomilnacipran SR versus placebo. Results evidence that levomilnacipran SR at all doses was significantly more effective than placebo for reducing MADRS total score from baseline to end of trial. Regarding secondary and additional outcomes, best results were seen with 80 and 120 mg / day doses of levomilnacipran SR versus placebo. Multicenter, randomize, double-blind, placebo-control, fix-dose study by Bakish et al. Evaluate efficacy and tolerability of levomilnacipran ER 40 mg / day or 80 mg / day versus placebo in outpatients affected by recurrent MDD. Both levomilnacipran ER doses were significantly superior to placebo in improving clinical symptoms and functional impairment, as assessed by change in MADRS total score from baseline to end of trial. A greater proportion of patients in levomilnacipran ER 40 mg / day and 80 mg / day groups than in the placebo group achieved MADRS response. Moreover, significantly greater percentage of patients assuming levomilnacipran ER 40 mg / day and 80 mg / day encounter remission criterion when compared to the placebo group. A multicenter, randomize, double-blind, flexible-dose study comparing 40 80 and 120 mg / day of levomilnacipran ER with placebo in outpatients with MDD show that levomilnacipran ER was significantly superior to placebo in reducing clinical and functional symptoms, as documented by changes in primary and additional efficacy measures from baseline to Week 8. Negative results were reported by randomized, double-blind, placebo-control, flexible doses study of levomilnacipran ER for MDD; although levomilnacipran ER-treated patients demonstrated greater reduction in MADRS total score from baseline endpoint compared to the placebo group, difference from placebo do not reach statistical significance. Phase II and Phase III studies document that LVM is generally more effective than placebo for treatment of MDD in the short-term, whereas no firm evidence exists on long-term efficacy for relapse prevention.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

CONTRAINDICATIONS

There is a Pregnancy exposure Registry that monitors pregnancy outcomes in women exposed to Antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https: / womensmentalhealth. Org / Clinical-and-research-programs / pregnancyregistry / Antidepressants /. Available Data on FETZIMA use in pregnant women is insufficient to evaluate for drug-associate risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are risks associated with untreated depression in pregnancy and with exposure to SNRIs and SSRIs, including FETZIMA, during pregnancy. In animal reproduction studies, levomilnacipran was not associated with malformations in rats or rabbits when given during period of organogenesis at dose up to 8 or 16 times the maximum recommended human dose of 120 mg on a mg / m 2 basis, respectively. However, increase in early post-natal rat pup mortality was seen at dose equivalent to 5 times MRHD given during pregnancy and lactation. Estimate background risk of major birth defects and miscarriage for indicated population is unknown. All pregnancies have background risk of birth defect, loss, or other adverse outcomes. In the US general population, estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Women who discontinued Antidepressants during pregnancy were more likely to experience relapse of major depression than women who continued Antidepressants. This finding is from a prospective, longitudinal study that followed 201 pregnant women with history of major depressive disorder who were euthymic and taking Antidepressants at beginning of pregnancy. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Use of SNRIs in late pregnancy may be associated with increased risk of postpartum hemorrhage. Neonates exposed to SNRIs or SSRIs, including FETZIMA, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Report Clinical findings include respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These findings are consistent with either direct toxic effect of SSRIs and SNRIs or possibly, drug discontinuation Syndrome. It should be noted that, in some cases, clinical picture is consistent with serotonin Syndrome. No malformations were observed when levomilnacipran was administered to pregnant rats or rabbits during period of organogenesis at oral doses up to 100 mg / kg / day. This dose is 8 and 16 times the maximum recommended human dose of 120 mg on a mg / m 2 basis. Fetal body weight was reduced in rats, and skeletal ossification was delayed in both rats and rabbits at this dose; these effects were not observed in either species at doses up to 30 mg / kg / Day, 2. 4 times MRHD in rats or 5 times MRHD in rabbits on a mg / m 2 basis.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

WARNINGS AND PRECAUTIONS

No dose adjustment is recommended on the basis of age. In a multiple-dose clinical pharmacokinetic study, elderly subjects had slightly higher exposure to levomilnacipran than younger subjects. Of the total number of subjects in clinical studies of FETZIMA, 2. 8% of patients were aged 65 or older. Because levomilnacipran is predominately excreted by kidney, renal clearance of levomilnacipran should be considered when determining dose. Ssris and SNRIs, including FETZIMA, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

8 USE IN SPECIFIC POPULATIONS

There are no adequate and well-control studies of FETZIMA in pregnant women. Neonates exposed to dual reuptake inhibitors of serotonin and norepinephrine, or selective serotonin reuptake inhibitors late in the third trimester have developed complications that can arise immediately upon delivery. Levomilnacipran was not teratogenic in rats or rabbits when given during period of organogenesis at dose up to 8 or 16 times the maximum recommended human dose of 120 mg on a mg / m2 basis, respectively. However, increase in early post natal rat pup mortality was seen at dose equivalent to 5 times MRHD given during pregnancy and lactation. Fetzima should be used during pregnancy only if potential benefit justifies potential risk to the fetus. Neonates exposed to SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. The Report clinical findings include respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These features are consistent with either the direct toxic effect of these classes of drugs or, possibly, drug discontinuation syndrome. It should be noted that, in some cases, clinical picture is consistent with serotonin syndrome. A prospective longitudinal study of 201 women with a history of major depression who were euthymic at beginning of pregnancy, shows women who discontinued antidepressant medication during pregnancy were more likely to experience relapse of major depression than women who continued antidepressant medication. No teratogenic effects were observed when levomilnacipran was administered to pregnant rats or rabbits during period of organogenesis at oral doses up to 100 mg / kg / day. This dose is 8 and 16 times the maximum recommended human dose of 120 mg on a mg / m2 basis. Fetal body weight was reduced in rats, and skeletal ossification was delayed in both rats and rabbits at this dose; these effects were not observed in either species at doses up to 30 mg / kg / day, 2. 4 times MRHD in rats or 5 times MRHD in rabbits. When levomilnacipran was administered to pregnant rats at an oral dose of 60 mg / kg / day, 5 times MRHD, during organogenesis and throughout pregnancy and lactation, there was an increase in early postnatal pup mortality; no pup mortality was seen at 20 mg / kg / day, 1. 6 times MRHD. Among surviving pups, pre-and post-weaning pup weight gain was reduced up to at least 8 weeks of age; however, physical and functional development, including reproductive performance of progeny, was not affect. Effects on body weight gain were not seen at 7 mg / kg / day, 0. 6 times MRHD. It is not know if FETZIMA is present in human milk. Studies have shown that levomilnacipran is present in the milk of lactating rats. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from FETZIMA, decision should be made whether to discontinue drug, taking into account the importance of drug to mother.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

12 CLINICAL PHARMACOLOGY

Levomilnacipran is a potent and selective serotonin-norepinephrine reuptake inhibitor with greater potency for inhibition of norepinephrine relative to serotonin reuptake. Approval for treatment of MDD was based on a clinical development program that included one 10week Phase II and four 8week Phase III randomise placebocontrolled clinical trials in patients with MDD where Levomilnacipran was titrated to target doses ranging from 40 to 120 mg taken once daily. Four of five trials demonstrate efficacy as measured by Montgomery Asberg Depression Rating Scale, with NNT for response vs. Placebo of 9, and for remission, 14. Levomilnacipran also demonstrate superiority over placebo as measured by improvement in Sheehan Disability Scale functional impairment total score. Nnh vs. Placebo for discontinuation because adverse events across all five trials was 19. Most commonly encountered AEs as identified in product labelling were nausea, hyperhidrosis, constipation, heart rate increase, erectile dysfunction in men, vomiting, tachycardia and palpitations, with NNH values vs. Placebo of 10, 15, 17, 21, 20, 25, 25 and 30, respectively. Levomilnacipran was not associated with clinically relevant weight change in shortterm trials or in the 48week openlabel extension trial. Mean changes from baseline in systolic blood pressure, diastolic BP and heart rate were + 3. 0 mmHg, + 3. 2 mm Hg and + 7. 4 bpm for Levomilnacipran, and 0. 4 mmHg, no change and 0. 3 bpm for placebo, respectively. The categorical shift in BP from normal or prehypertension at baseline to Stage 1 or Stage 2 hypertension at end of study was 10. 4% for Levomilnacipran vs. 7. 1% for placebo, for NNH of 31.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Sources

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

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