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Pregnancy Category C

Milnacipran Hydrochloride (Savella) increased the incidence of dead fetuses in utero in rats at doses of 5 mg / kg per day (0.25 times the MRHD on a mg / m2 basis). Administration of milnacipran to mice and rabbits during the period of organogenesis did not result in embryotoxicity or teratogenicity at doses up to 125 mg / kg per day in mice (3 times the maximum recommended human dose [MRHD] of 200 mg per day on a mg / m2 basis) and up to 60 mg / kg per day in rabbits (6 times the MRHD of 200 mg per day on a mg m2 basis). In rabbits, the incidence of the skeletal variation, extra single rib, was increased following administration of milnacipran at 15 mg / kg per day during the period of organogenesis. There are no adequate and well-controlled studies in pregnant women. Savella should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

To provide information regarding the exposure to Savella (Milnacipran) during pregnancy, Physicians are advised to recommend that pregnant patients taking this medication enroll in the Savella Pregnancy Registry. Enrollment is voluntary and may be initiated by pregnant patients or their healthcare providers.

Nonteratogenic Effects

Neonates exposed to dual reuptake inhibitors of serotonin and norepinephrine, or selective serotonin reuptake inhibitors late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Reported clinical findings have included cyanosis, respiratory distress, apnea, temperature instability, seizures, feeding difficulty, hypoglycemia, vomiting, hypotonia, hyperreflexia, hypertonia, tremor, irritability, jitteriness, and constant crying. These features are consistent with either a direct toxic effect of these classes of drugs or, possibly, a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome.

In rats, a decrease in pup body weight and viability on postpartum day 4 were observed when milnacipran, at a dose of 5 mg / kg per day (approximately 0.2 times the MRHD on a mg / m2 basis), was administered orally to rats during late gestation. The no-effect dose for maternal and offspring toxicity was 2.5 mg / kg per day (approximately 0.1 times the MRHD on a mg / m2 basis).

Labor and Delivery

The effect of milnacipran on labor and delivery is unknown. The use of Savella (Milnacipran HCl) during labor and delivery is not recommended.

Nursing Mothers

There are no adequate and well-controlled studies in nursing mothers. It is not known if milnacipran is excreted in human milk. Studies in animals have shown that milnacipran or its metabolites are excreted in breast milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from milnacipran, a decision should be made whether to discontinue the drug, taking into account the importance of the drug to the mother. Because the safety of Savella in infants is not known, nursing while on Savella is not recommended.

Pediatric Use

Safety and effectiveness of Savella (Milnacipran Hydrochloride) in a fibromyalgia pediatric population below the age of 17 have not been established. The use of Milnacipran (Savella) is not recommended in pediatric patients.

Geriatric Use

In controlled clinical studies of Milnacipran HCl (Savella), 402 patients were 60 years or older, and no overall differences in safety and efficacy were observed between these patients and younger patients. In view of the predominant excretion of unchanged milnacipran via kidneys and the expected decrease in renal function with age renal function should be considered prior to use of Savella in the elderly.

SNRIs, SSRIs, and Milnacipran Hydrochloride (Savella), have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event.

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