New Drug Update 2009-2010 - LAFP

Drugs that interfere with hemostasis (eg, aspirin, NSAIDs, warfarin) X X
CYP1A2 inhibitors (eg, cimetidine, ciprofloxacin, fluvoxamine)
CYP2D6 inhibitors (eg, fluoxetine, paroxetine, sertraline, quinidine)
CYP2D6 substrates (eg, tricyclic antidepressants, phenothiazines,
propafenone, flecainide)
Clomipramine
Digoxin
Clonidine
X
X
X
X
X
X
RECOMMENDED MONITORING: In addition to monitoring for therapeutic response and general adverse
reaction monitoring, blood pressure monitoring is advised. Blood pressure and heart rate should be
determined prior to initiating therapy and periodically throughout therapy.
DOSING: The milnacipran dose should be titrated over 1 week to the recommended dosage of 50 mg
twice daily. Therapy should be initiated with a single 12.5 mg dose on the first day, 12.5 mg twice daily on
days 2 and 3, 25 mg twice daily on days 4 through 7, and 50 mg twice daily thereafter. The dose may be
subsequently increased to 100 mg twice daily based on individual response. Milnacipran may be taken
with or without food; however, administration with food may improve tolerability.
No dosage adjustments are necessary in patients with mild renal impairment. Milnacipran should be used
with caution in patients with moderate renal impairment. In patients with severe renal impairment (CrCl
less than 30 mL/min), the usual maintenance dosage should be reduced 50% to 25 mg twice daily, with
increase to 50 mg twice daily based on individual patient response. Use is not recommended in patients
with end-stage renal disease. 1,8 Dosage adjustments are not necessary in patients with hepatic function
impairment; however, caution is advised with the use of milnacipran in patients with severe hepatic
impairment.
Table 9. Comparative Dosing Regimens in Fibromyalgia
Normal Dose
Duloxetine Initiate at 30 mg once daily. May increase to 60
mg once daily after 1 week.
Milnacipran Initiate at 12.5 mg on the first day. Increase to
50 mg twice daily over the first week. May
further increase to 100 mg twice daily.
Special Populations
Avoid use in patients with severe renal
impairment (CrCl < 30 mL/min) or any
hepatic function impairment
Reduce dose by 50% in severe renal
impairment. Avoid use in end-stage renal
disease.
PRODUCT AVAILABILITY/COST and STORAGE: Milnacipran was originally developed as an
antidepressant in France, and has been available in that country since 1997. 12 Milnacipran received FDA
approval January 14, 2009. It is available as 12.5, 25, 50, and 100 mg film-coated tablets. Milnacipran
should be stored at room temperature (25°C; 77°F), with excursions permitted between 15°C and 30°C
(59°F and 86°F). The cost of Savella AWP is $127.00/60 tabs (all strengths) Vs. Cymbalta (duloxetine)
60mg $140.27/30; 30mg $139.13/30 and 20mg $129.00/30 enteric coated capsules Vs. Lyrica
(pregabalin) $80.10 per 30 capsules of all strengths 25,50,75,100, 150, 200,225 and 300mg
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