Savella

SAVELLA- milnacipran hydrochloride tablet, film coated
SAVELLA- milnacipran hydrochloride
Allergan, Inc.

WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS

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 Indications and Usage ( 1 ), Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.4 )].

1 INDICATIONS AND USAGE

SAVELLA is indicated for the management of fibromyalgia.

SAVELLA is not approved for use in pediatric patients [see Use in Specific Populations ( 8.4)].

2 DOSAGE AND ADMINISTRATION

SAVELLA is given orally with or without food.

Taking SAVELLA with food may improve the tolerability of the drug.

2.1 Recommended Dosing

The recommended dose of SAVELLA is 100 mg/day (50 mg twice daily).

Based on efficacy and tolerability dosing may be titrated according to the following schedule:

Day 1: 12.5 mg once

Days 2-3: 25 mg/day (12.5 mg twice daily)

Days 4-7: 50 mg/day (25 mg twice daily)

After Day 7: 100 mg/day (50 mg twice daily)

Based on individual patient response, the dose may be increased to 200 mg/day (100 mg twice daily).

Doses above 200 mg/day have not been studied.

Taper SAVELLA and do not abruptly discontinue after extended use [see Dosage and Administration ( 2.4) , Warnings and Precautions ( 5.7)].

2.2 Patients with Renal Insufficiency

No dosage adjustment is necessary in patients with mild renal impairment.

Use SAVELLA with caution in patients with moderate renal impairment.

For patients with severe renal impairment (indicated by an estimated creatinine clearance of 5-29 mL/min), reduce the maintenance dose by 50% to 50 mg/day (25 mg twice daily).

Based on individual patient response, the dose may be increased to 100 mg/day (50 mg twice daily).

SAVELLA is not recommended for patients with end-stage renal disease.

2.3 Patients with Hepatic Insufficiency

No dosage adjustment is necessary for patients with hepatic impairment.

As with any drug, exercise caution in patients with severe hepatic impairment.

2.4 Discontinuing SAVELLA

Withdrawal symptoms have been observed in clinical trials following discontinuation of milnacipran, as with other serotonin and norepinephrine re-uptake inhibitors (SNRIs) and selective serotonin re-uptake inhibitors (SSRIs). Monitor patients for these symptoms when discontinuing treatment. Taper SAVELLA and do not abruptly discontinue after extended use [see Warnings and Precautions ( 5.7)].

2.5 Switching a P atient to or from a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

At least 14 days should elapse between discontinuation of a MAOI intended to treat psychiatric disorders and initiation of therapy with SAVELLA. Conversely, allow at least 5 days after stopping SAVELLA before starting a MAOI intended to treat psychiatric disorders [see Contraindications ( 4.1)].

2.6 Use of SAVELLA with other MAOIs such as Linezolid or Methylene Blue

Do not start SAVELLA in a patient being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, consider other interventions, including hospitalization [ see Contraindications ( 4.1) ].

In some cases, a patient already receiving SAVELLA therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, discontinue SAVELLA promptly, and consider administering linezolid or intravenous methylene blue. Monitor the patient for symptoms of serotonin syndrome for 5 days or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with SAVELLA may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [ see Warnings and Precautions ( 5.2)].

The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with SAVELLA is unclear. The clinician should nevertheless be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions ( 5.2)].

3 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, blue, “F” on one side, “L” on the reverse side;

25 mg tablets are round, white, “FL” on one side, “25” on the reverse side;

50 mg tablets are oval, white, “FL” on one side, “50” on the reverse side;

100 mg tablets are oval, pink, “FL” on one side, “100” on the reverse side.

4 CONTRAINDICATIONS

4.1 Monoamine Oxidase Inhibitors (MAOIs)

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 [see Dosage and Administration ( 2.5), Warnings and Precautions ( 5.2)].

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 [see Dosage and Administration ( 2.6), Warnings and Precautions ( 5.2)].

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