DESVEN

What it is

DESVEN is desvenlafaxine 50 mg and 100 mg extended release tablets. DESVEN contains the active ingredient desvenlafaxine as the base drug. DESVEN is formulated as a modified release tablet for once-a-day oral administration.

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. Based on clinical judgment, if dose increases are indicated for individual patients, they should occur gradually and at intervals of not less than 7 days, with a maximum dose not exceeding 200 mg/day. The recommended starting dose in patients with severe renal impairment (24-hr CrCl < 30 mL/min) or end-stage renal disease is 50 mg every other day. No adjustment of dose is necessary in patients with mild, moderate, and severe hepatic impairment.

Key safety warnings

Patients with major depression may experience worsening of their depression and emergence of suicidal ideation and behaviour, and this risk may persist until significant remission occurs. Patients should be monitored appropriately and observed closely for clinical worsening and suicidality, especially at the beginning of a course of treatment or at the time of dose changes. A potentially life-threatening serotonin or neuroleptic malignant syndrome-like reactions may occur with desvenlafaxine treatment, particularly with concomitant use of other serotonergic drugs and with drugs that impair metabolism of serotonin. Serotonin syndrome 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, particularly with higher doses. Pre-existing hypertension should be controlled before treatment with desvenlafaxine, and patients receiving desvenlafaxine should have regular monitoring of blood pressure. Upon discontinuation of desvenlafaxine, adverse events have been reported including dysphoric mood, irritability, agitation, dizziness, sensory disturbances, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, seizures, visual impairment and hypertension. While these events are generally self-limiting, there have been reports of serious discontinuation symptoms and sometimes these effects can be protracted and severe. Selective serotonin reuptake inhibitors and serotonin-noradrenaline reuptake inhibitors, including desvenlafaxine, may increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, warfarin, and other anticoagulants may add to this risk. Bleeding events have ranged from ecchymosis, haematoma, epistaxis, and petechiae to life-threatening haemorrhages.

Contraindications

DESVEN is contraindicated in patients with hypersensitivity to desvenlafaxine, venlafaxine hydrochloride or to any excipients in the DESVEN formulation. DESVEN must not be used in combination with monoamine oxidase inhibitors or reversible MAOIs, or within 14 days of discontinuing treatment with a MAOI. Similarly, DESVEN must be discontinued for at least 7 days before starting treatment with a MAOI.

Regulatory history

DESVEN desvenlafaxine 50 mg and 100 mg extended release tablet blister packs were first listed on the ARTG on 3 May 2024.