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Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy.

Teratogenic effects - Pregnancy Category C

When desvenlafaxine succinate was administered orally to pregnant rats and rabbits during the period of organogenesis, there was no evidence of teratogenicity in rats at any doses tested, up to 10 times a human dose of 100 mg per day (on a mg / m2 basis) in rats, and up to 15 times a human dose of 100 mg per day (on a mg / m2 basis) in rabbits. However, fetal weights were decreased in rats, with a no-effect dose 10 times a human dose of 100 mg per day (on a mg / m2 basis).

When desvenlafaxine succinate was administered orally to pregnant rats throughout gestation and lactation, there was a decrease in pup weights and an increase in pup deaths during the first four days of lactation. The cause of these deaths is not known. The no-effect dose for rat pup mortality was 10 times a human dose of 100 mg per day (on a mg / m2 basis). Post-weaning growth and reproductive performance of the progeny were not affected by maternal treatment with desvenlafaxine at a dose 29 times a human dose of 100 mg per day (on a mg / m2 basis).

There are no adequate and well-controlled studies of Pristiq (Desvenlafaxine) in pregnant women. Therefore, this medication should be used during pregnancy only if the potential benefits justify the potential risks.

Non-teratogenic effects

Neonates exposed to SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors), or SSRIs (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 respiratory cyanosis, apnea, distress, seizures, temperature instability, vomiting, hypoglycemia, feeding difficulty, hypotonia, hypertonia, hyperreflexia, jitteriness, tremor, irritability, and constant crying. These features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome. When treating a pregnant woman with Pristiq (Desvenlafaxine Succinate) during the third trimester, the physician should carefully consider the potential risks and benefits of treatment.

Labor and Delivery

The effect of Pristiq (Desvenlafaxine) on labor and delivery in humans is unknown. This drug should be used during labor and delivery only if the potential benefits justify the potential risks.

Nursing Mothers

Desvenlafaxine (Pristiq) is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Pristiq, a decision should be made whether or not to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Only administer this medicine to breastfeeding women if the expected benefits outweigh any possible risk.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established. Anyone considering the use of Pristiq (Desvenlafaxine) in a child or adolescent must balance the potential risks with the clinical need.

Geriatric Use

Of the 3,292 patients in clinical studies with Pristiq (Desvenlafaxine Succinate), 5% were 65 years of age or older. No overall differences in safety or efficacy were observed between these patients and younger patients; however, in the short-term, placebo-controlled studies, there was a higher incidence of systolic orthostatic hypotension in patients . 65 years of age compared to patients < 65 years of age treated with this medicine. For elderly patients, possible reduced renal clearance of desvenlafaxine should be considered when determining dose. If Pristiq is poorly tolerated, every other day dosing can be considered.

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

Greater sensitivity of some older individuals cannot be ruled out.

Renal Impairment

In subjects with renal impairment the clearance of Pristiq (Desvenlafaxine) was decreased. In subjects with severe renal impairment (24-hr CrCl < 30 mL/min) and end-stage renal disease, elimination half-lives were significantly prolonged, increasing exposures to PRISTIQ; therefore, dosage adjustment is recommended in these patients.

Hepatic Impairment

The mean t1/2 changed from approximately 10 hours in healthy subjects and subjects with mild hepatic impairment to 13 and 14 hours in moderate and severe hepatic impairment, respectively. The recommended dose in patients with hepatic impairment is 50 mg per day. Dose escalation above 100 mg per day is not recommended.

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