Before Using This Medication
Do not take Savella together with a monoamine oxidase inhibitor (MAOI) such as:
- Isocarboxazid (Marplan®)
- Phenelzine (Nardil®)
- Rasagiline (Azilect®)
- Selegiline (Eldepryl®, Emsam®)
- Tranylcypromine (Parnate®)
You must wait at least 14 days after stopping an MAOI before you can take Savella.
SSRI antidepressants may cause serious or life-threatening lung problems in newborn
babies whose mothers take the medication during pregnancy. However, you may have a relapse
of depression if you stop taking your antidepressant during pregnancy. If you are planning
a pregnancy, or if you become pregnant while taking Savella, do not stop taking the
medication without first talking to your doctor.
Blood pressure and heart rate should be monitored prior to initiating treatment with
Savella and periodically throughout treatment. SSRIs, including Savella, have been
associated with reports of increases in blood pressure and heart rate.
Pre-existing hypertension, tachyarrhythmias and other cardiac diseases should be
treated before starting therapy with Savella.
Savella should be used with caution in patients with significant hypertension or
cardiac disease. For patients who experience a sustained increase in blood pressure or
heart rate while receiving Savella, either dose reduction or discontinuation should
Savella should be prescribed with caution in patients with a history of:
- seizure disorder
- controlled narrow-angle glaucoma
Savella has been associated with mild elevations of ALT and AST. Rarely, fulminant
hepatitis has been reported in patients treated with milnacipran.
be discontinued in patients who develop jaundice or other evidence of liver dysfunction
and should not be resumed unless another cause can be established.
Savella should not be prescribed to patients with substantial alcohol use or evidence
of chronic liver disease.
As with other SNRIs and SSRIs withdrawal symptoms have been observed following
discontinuation of milnacipran. A gradual dose reduction is recommended.
Hyponatremia, (an electrolyte disturbance),
may occur as a result of treatment with SSRIs and SNRIs, including Savella.
Discontinuation should be considered for patients with symptomatic hyponatremia.
SSRIs and SNRIs, including Savella, may increase the risk of bleeding events. Patients
should be cautioned regarding the risk of bleeding associated with concomitant use of
Savella and NSAIDs, aspirin, warfarin or other drugs that affect coagulation.
Male patients with a history of obstructive uropathies may experience higher rates
of genitourinary adverse events.
Savella is unlikely to be involved in clinically significant pharmacokinetic
drug interactions. Pharmacodynamic interactions of Savella with other drugs can occur.
Savella contains FD&C Yellow No. 5, which may cause allergic-type reactions in
In clinical trials, the most frequently occurring adverse reaction was nausea. The
most commonly occurring adverse reactions (greater than or equal to 5% and twice that
of placebo) were:
- hot flush
- heart rate increased
- dry mouth