Desvenlafaxine

Desvenlafaxine is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies ( 14 )] . Desvenlafaxine is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) ( 1 ).

• Recommended dose: 50 mg once daily with or without food
• There was no evidence that doses greater than 50 mg per day confer any additional benefit
• The 25 mg per day dose is intended for a gradual reduction in dose when discontinuing treatment or dosing in severe renal and end-stage renal disease patients
• Discontinuation: Reduce dose gradually whenever possible
• Take tablets whole; do not divide, crush, chew, or dissolve
• Moderate renal impairment: Maximum dose 50 mg per day
• Severe renal impairment and end-stage renal disease: Maximum dose 25 mg per day or 50 mg every other day
• Moderate to severe hepatic impairment: Maximum dose 100 mg per day
• General Instructions for Use The recommended dose for desvenlafaxine is 50 mg once daily, with or without food
• The 50 mg dose is both a starting dose and the therapeutic dose
• Desvenlafaxine should be taken at approximately the same time each day
• Tablets must be swallowed whole with fluid and not divided, crushed, chewed, or dissolved
• In clinical studies, doses of 10 mg to 400 mg per day were studied
• In clinical studies, doses of 50 mg to 400 mg per day were shown to be effective, although no additional benefit was demonstrated at doses greater than 50 mg per day and adverse reactions and discontinuations were more frequent at higher doses

25 mg, light tan, square pyramid film coated tablet, debossed with “YH” and “137” on the flat side 50 mg, light pink, square pyramid film coated tablet, debossed with “YH” and “50” on the flat side 100 mg, red, square pyramid film coated tablet, debossed with “YH” and “100” on the flat side Desvenlafaxine Extended-Release Tablets: 25 mg, 50 mg and 100 mg ( 3 ). …

• The safety and effectiveness of desvenlafaxine have not been established
• In pediatric patients
• For the treatment of MDD
• Efficacy was not demonstrated in two adequate and well controlled, 8-week, randomized, double-blind, placebo-controlled, parallel group studies conducted in 587 patients (7 to 17 years of age)
• For the treatment of MDD
• Antidepressants, such as desvenlafaxine, increase the risk of suicidal thoughts and behaviors
• In pediatric patients [see the Boxed Warning and Warnings and Precautions ] . …

Of the 4,158 patients in pre-marketing clinical studies with desvenlafaxine, 6% 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

• Advise the patient to read the FDA-approved patient labeling (Medication Guide)
• Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dose is adjusted up or down, and instruct them to report such symptoms to the healthcare provider [see Boxed Warning and Warnings and Precautions ]
• Concomitant Medication Advise patients taking desvenlafaxine not to use concomitantly other products containing desvenlafaxine or venlafaxine. …

• Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or to any excipients in the desvenlafaxine formulation
• Angioedema has been reported in patients treated with desvenlafaxine [see Adverse Reactions ]
• The use of MAOIs intended to treat psychiatric disorders with desvenlafaxine or within 7 days of stopping treatment with desvenlafaxine is contraindicated because of an increased risk of serotonin syndrome. …

7.1 Drugs Having Clinically Important Interactions with Desvenlafaxine Table 8: Clinically Important Drug Interactions with Desvenlafaxine Monoamine Oxidase Inhibitors (MAOI) Clinical Impact The concomitant use of SSRIs and SNRIs including desvenlafaxine with MAOIs increases the risk of serotonin syndrome. Intervention Concomitant use of desvenlafaxine is contraindicated: With an MAOI intended to treat psychiatric disorders or within 7 days of stopping treatment with desvenlafaxine. Within 14 days of stopping an MAOI intended to treat psychiatric disorders. In a patient who is being treated with linezolid or intravenous methylene blue. …

Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents, but also when taken alone. If it occurs, discontinue desvenlafaxine and serotonergic agents and initiate supportive treatment ( 5.2 ). Elevated Blood Pressure: Control hypertension before initiating treatment. Monitor blood pressure regularly during treatment ( 5.3 ). Increased Risk of Bleeding: Concomitant use of aspirin, NSAIDs, other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk ( 5.4 ). Angle Closure Glaucoma: Avoid use of antidepressants, including desvenlafaxine, in patients with untreated anatomically narrow angles treated ( 5.5 ). …

The following adverse reactions are discussed in greater detail in other sections of the label. Hypersensitivity [see Contraindications ( 4 )] Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients [see Warnings and Precautions ( 5.1 )] Serotonin Syndrome [see Warnings and Precautions ( 5.2 )] Elevated Blood Pressure [see Warnings and Precautions ( 5.3 )] Increased Risk of Bleeding [see Warnings and Precautions ( 5.4 )] Angle Closure Glaucoma [see Warnings and Precautions ( 5.5 )] Activation of Mania/Hypomania [see Warnings and Precautions ( 5.6 )] Discontinuation Syndrome [see Warnings and Precautions ( 5.7 )] Seizure [see Warnings and Precautions ( 5.8 )] Hyponatremia [see W …

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185. …

10.1 Human Experience with Overdosage There is limited clinical trial experience with desvenlafaxine succinate overdosage in humans. However, desvenlafaxine is the major active metabolite of venlafaxine. Overdose experience reported with venlafaxine (the parent drug of desvenlafaxine) is presented below; the identical information can be found in the Overdosage section of the venlafaxine package insert. In postmarketing experience, overdose with venlafaxine (the parent drug of desvenlafaxine) has occurred predominantly in combination with alcohol and/or other drugs. …

9.1 Controlled Substance Desvenlafaxine is not a controlled substance.

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