Milnacipran

Fibromyalgia — the only FDA-approved indication for the US brand Savella

This is milnacipran's US-approved use. (2)

Major Depressive Disorder (MDD) — NOT an FDA-approved use of the US product Savella

CORRECTED: the FDA label for Savella states explicitly, "SAVELLA is not approved for use in the treatment of major depressive disorder." Milnacipran is used for depression under different brand names (e.g., Ixel, Toledomin) in some other countries, but this is not the case for the US-labeled Savella product. Do not treat MDD as a US-approved indication. (2)

Nausea

Incidence: Reported in the clinician-authored database; frequency not established

Headache

Incidence: Reported in the clinician-authored database; frequency not established

Insomnia

Incidence: Reported in the clinician-authored database; frequency not established

Constipation

Incidence: Reported in the clinician-authored database; frequency not established

Dizziness

Incidence: Reported in the clinician-authored database; frequency not established

Increased blood pressure

Incidence: Reported in the clinician-authored database; frequency not established

Serotonin syndrome

Incidence: Reported in the clinician-authored database; frequency not established

FDA BOXED WARNING (ELEVATED — an earlier draft of this record had this only as an ordinary warning line) — serious

Symptoms: FDA BOXED WARNING (ELEVATED — an earlier draft of this record had this only as an ordinary warning line): antidepressants, including milnacipran, increased the risk of suicidal thinking and behavior compared with placebo in short-term studies in children, adolescents, and young adults (up to age 24) with major depressive disorder and other psychiatric disorders. This increased risk was not seen in adults over 24, and there was a reduction in risk in patients 65 and older. Patients, families, and caregivers should watch for anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (restlessness), hypomania, or other unusual behavior changes, worsening mood, and suicidal thoughts, especially early in treatment and after dose changes. Milnacipran is not approved for pediatric use.

Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)

May increase blood pressure and heart rate — serious

Symptoms: May increase blood pressure and heart rate; monitor regularly. Risk of serotonin syndrome, especially when combined with other serotonergic drugs. Use caution in patients with a history of seizures or bipolar disorder.

Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)

Contraindications recorded in the clinician database — serious

Symptoms: Contraindications recorded in the clinician database: Contraindications include hypersensitivity to milnacipran, use with or within 14 days of MAOIs, and uncontrolled narrow-angle glaucoma. Caution is advised in patients with hypertension, tachyarrhythmias, seizure disorders, hepatic or severe renal impairment, and those at risk for bleeding or suicidality.

Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)

Pregnancy

Data are insufficient to assess milnacipran's risk of birth defects. Third-trimester exposure may increase the risk of neonatal complications (respiratory distress, temperature instability, feeding difficulty, low muscle tone, tremor, irritability). SNRI use in the month before delivery has been associated with a less-than-twofold increase in postpartum hemorrhage risk. Discuss any pregnancy or plan to become pregnant with the prescribing clinician. (2)

Breastfeeding

Milnacipran transfers into breast milk. A breastfed infant should be monitored for agitation, irritability, poor feeding, and poor weight gain. The developmental and health benefits of breastfeeding should be weighed against potential infant exposure — a decision for the clinician managing your or your baby's care. (2)

Children

Frequency: Not applicable. Weight Based: Not recommended for pediatric use. Max Daily Dose: Not applicable. Max Single Dose: Not applicable. Age Restrictions: Not approved for pediatric use (under 18 years). (2)

Renal_impairment

The FDA label states no dosage adjustment is necessary for mild renal impairment; Savella should be used with caution in moderate renal impairment; for severe renal impairment (estimated creatinine clearance 5-29 mL/min), the maintenance dose should be reduced by 50% to 50 mg/day (25 mg twice daily), which may be increased to 100 mg/day based on response; Savella is not recommended in end-stage renal disease. No dosage adjustment is necessary for hepatic impairment, though caution should still be exercised in patients with severe hepatic impairment. (2)

Hepatic_impairment

The FDA label states no dosage adjustment is necessary for mild renal impairment; Savella should be used with caution in moderate renal impairment; for severe renal impairment (estimated creatinine clearance 5-29 mL/min), the maintenance dose should be reduced by 50% to 50 mg/day (25 mg twice daily), which may be increased to 100 mg/day based on response; Savella is not recommended in end-stage renal disease. No dosage adjustment is necessary for hepatic impairment, though caution should still be exercised in patients with severe hepatic impairment. (2)

United States

• Savella100 mg, 50 mg, 25 mg, 12.5 mg · allergan, inc.