DESVENLAFAXINE-WGR XR

What it is

DESVENLAFAXINE-WGR XR is a modified release tablet formulation containing desvenlafaxine 50 mg and 100 mg for once-a-day oral administration. Desvenlafaxine is a selective serotonin and noradrenaline reuptake inhibitor (SNRI).

Approved indications

— Treatment of major depressive disorder, including the prevention of relapse.

Dosing overview

The recommended dose for desvenlafaxine is 50 mg once daily, with or without food. In clinical trials, no additional benefit was demonstrated at doses greater than 50 mg/day. If dose increases are indicated for individual patients based on clinical judgment, they should occur gradually and at intervals of not less than 7 days. The maximum dose should not exceed 200 mg/day. Tablets must be swallowed whole with fluid and not divided, crushed, chewed, or dissolved.

Key safety warnings

Patients with major depression may experience worsening of their depression and/or emergence of suicidal ideation and behaviour, and antidepressants may have a role in inducing such worsening during the early phases of treatment. Patients should be monitored appropriately and observed closely for clinical worsening and suicidality, especially at the beginning of treatment or at the time of dose changes. A potentially life-threatening serotonin syndrome may occur with desvenlafaxine treatment, particularly with concomitant use of other serotonergic drugs or drugs that impair metabolism of serotonin. Symptoms may include mental status changes, autonomic instability, neuromuscular aberrations and gastrointestinal symptoms. Increases in blood pressure were observed in some patients in clinical trials. Pre-existing hypertension should be controlled before treatment, and patients should have regular monitoring of blood pressure. SNRIs including desvenlafaxine may increase the risk of bleeding events, and concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, warfarin, and other anticoagulants may add to this risk.

Contraindications

Hypersensitivity to desvenlafaxine, venlafaxine hydrochloride or to any excipients in the formulation. DESVENLAFAXINE-WGR XR must not be used in combination with monoamine oxidase inhibitors (MAOIs) or reversible MAOIs (RIMAs) such as moclobemide, linezolid and intravenous methylene blue, or within 14 days of discontinuing treatment with a MAOI. Similarly, DESVENLAFAXINE-WGR XR must be discontinued for at least 7 days before starting treatment with a MAOI.

Regulatory history

DESFAX (an earlier variant of desvenlafaxine) received initial Australian approval on 26 November 2014. DESVENLAFAXINE-WGR XR desvenlafaxine 50 mg and 100 mg extended release tablets were first listed on the Australian Register of Therapeutic Goods on 3 May 2024.