MEDVEN

What it is

MEDVEN contains desvenlafaxine as the active ingredient and is formulated as 50 mg and 100 mg modified release tablets. MEDVEN 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. 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. In patients with severe renal impairment (24-hr CrCl < 30 mL/min) or end-stage renal disease, the recommended starting dose 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/or emergence of suicidal ideation and behaviour, and antidepressants may have a role in inducing worsening of depression and emergence of suicidality in certain patients during 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 or neuroleptic malignant syndrome-like reaction may occur with MEDVEN treatment, particularly with concomitant use of other serotonergic drugs and 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, particularly with higher doses. Pre-existing hypertension should be controlled before treatment, and patients receiving MEDVEN should have regular monitoring of blood pressure. SNRIs including MEDVEN 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. Patients should be cautioned about the risk of bleeding associated with concomitant use of MEDVEN and NSAIDs, aspirin, or other drugs that affect coagulation or bleeding. Cases of hyponatraemia and/or the Syndrome of Inappropriate Anti-Diuretic Hormone secretion have been described with SNRIs including MEDVEN, usually in volume-depleted or dehydrated patients, including elderly patients and patients taking diuretics.

Contraindications

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

Regulatory history

MEDVEN received initial approval on 26 November 2014.