VALDOXAN

What it is

VALDOXAN contains agomelatine as its active ingredient. Each film-coated tablet contains 25 mg of agomelatine. Agomelatine is a melatonin receptor (MT1 and MT2) agonist and 5-HT2C receptor antagonist.

Approved indications VALDOXAN is indicated for the treatment in adults of:

— Major depressive disorder (MDD) including prevention of relapse — Generalised anxiety disorder (GAD)

Dosing overview

The recommended daily dose is one 25 mg tablet taken orally at bedtime for both MDD and GAD. If there is no improvement in symptoms the dose may be increased to 50 mg once daily, taken as a single dose of two tablets at bedtime: 2 weeks after treatment initiation in patients with MDD or 4 weeks after treatment initiation in patients with GAD. Dose escalation has been associated with an increased incidence of serum transaminase elevations, and dose increases to 50 mg should only occur following an assessment of the benefits and risk and assessment of liver function. Liver function tests should be performed in all patients before initiation of treatment and before a dose increase to 50 mg.

Key safety warnings

**Liver injury risk.** In post-marketing experience cases of liver injury, including elevations of liver enzymes (greater than 10 times upper limit of the normal range), hepatic failure, hepatitis and jaundice have been reported in patients treated with agomelatine, most often during the first months of treatment. Isolated cases of transplantation or death in patients with hepatic failure have been reported following the use of agomelatine. In clinical trials, elevations of serum transaminases (greater than 3 times the upper limit of the normal range) have been observed in patients treated with agomelatine more commonly on a 50 mg dose. During treatment transaminases should be monitored periodically after around 3, 6 (end of acute phase), 12, and 24 (end of maintenance phase) weeks with regimen to be repeated following dose increase to 50 mg and thereafter when clinically indicated. **Suicidality.** Patients with depression may experience worsening of their depressive symptoms and/or the emergence of suicidal ideation and behaviours whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored for clinical worsening and suicidality, especially at the beginning of a course of treatment, or at the time of dose changes, either increases or decreases.

Contraindications

VALDOXAN is contraindicated in patients with a history of previous hypersensitivity to the active ingredient or any of the excipients. VALDOXAN is contraindicated in patients with hepatic impairment (cirrhosis or active liver disease) or transaminases exceeding 3 times the upper limit of normal. VALDOXAN is contraindicated in patients taking potent CYP1A2 inhibitors (for example, fluvoxamine, ciprofloxacin).

PBS listing

No PBS listing information is provided in the source documents.

Regulatory history

VALDOXAN agomelatine 25 mg film coated tablet was first listed on the ARTG on 9 August 2010.