INDICATIONS AND USAGE
Savella is indicated for the management of fibromyalgia.
Savella is not approved for use in pediatric patients.
DRUG INTERACTIONS
Savella is unlikely to be involved in clinically significant pharmacokinetic drug interactions.
Pharmacodynamic interactions of Savella with other drugs can occur.
USE IN SPECIFIC POPULATIONS
Pregnancy and nursing mothers: Use only if the potential benefit justifies the potential risk to the fetus or child.
To enroll in the Savella Pregnancy Registry call 1-877-643-3010 (toll free) or download data forms from the registry website: www.savellapregnancyregistry.com
DOSAGE AND ADMINISTRATION
DOSAGE AND ADMINISTRATION - SUMMARY
Administer Savella in two divided doses per day.
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)
Recommended dose is 100 mg/day.
May be increased to 200 mg/day based on individual patient response.
Dose should be adjusted in patients with severe renal impairment.
DOSAGE AND ADMINISTRATION
Savella is given orally with or without food.
Taking Savella with food may improve the tolerability of the drug.
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.
Savella should be tapered and not abruptly discontinued after extended use [see Discontinuing Savella and Warnings and Precautions]
Patients with Renal Insufficiency
No dosage adjustment is necessary in patients with mild renal impairment. Savella should be used 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), the maintenance dose should be reduced 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.
Patients with Hepatic Insufficiency
No dosage adjustment is necessary for patients with hepatic impairment.
As with any drug, caution should be exercised in patients with severe hepatic impairment.
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). Patients should be monitored for these symptoms when discontinuing treatment. Savella should be tapered and not abruptly discontinued after extended use [see Warnings and Precautions].
Switching patients to or from a Monoamine Oxidase Inhibitor (MAOI)
At least 14 days should elapse between discontinuation of a MAOI and initiation of therapy with Savella. In addition, at least 5 days should be allowed after stopping Savella before starting a MAOI [see Contraindications].
HOW SUPPLIED
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;
25 mg tablets are round, white, "FL" on one side, "25" on the reverse;
50 mg tablets are oval, white, "FL" on one side, "50" on the reverse;
100 mg tablets are oval, pink, "FL" on one side, "100" on the reverse
Storage
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]. |
