EFEXOR-XR

What it is

EFEXOR-XR is a modified release capsule containing venlafaxine hydrochloride available in strengths of 37.5 mg, 75 mg or 150 mg. Venlafaxine hydrochloride is released from spheroids within the capsule, with drug release controlled by diffusion through the coating membrane on the spheroids and not pH dependent. EFEXOR-XR is recommended to be taken with food at approximately the same time each day, and each capsule must be swallowed whole with fluid.

Approved indications EFEXOR-XR is indicated for the treatment of:

— Major Depression, including prevention of relapse and recurrence where appropriate — Generalised Anxiety Disorder — Social Anxiety Disorder — Panic Disorder, including prevention of relapse

Dosing overview

For Major Depression, Generalised Anxiety Disorder and Social Anxiety Disorder, the usual recommended dose is 75 mg per day given once daily. After two weeks, the dose may be increased to 150 mg per day given once daily if further clinical improvement is required. If needed, this can be increased up to 225 mg given once daily. Dose increments should be made at intervals of approximately 2 weeks or more, but not less than 4 days. For Panic Disorder, the recommended dose is 75 mg of EFEXOR-XR once daily. Treatment should be started with a dose of 37.5 mg per day for the first 4 to 7 days, after which the dose should be increased to 75 mg once daily. Patients not responding to the 75 mg/day dose may benefit from dose increases to a maximum of 225 mg/day. Dosage increases can be made in increments of 75 mg per day at intervals of approximately 2 weeks or more, but not less than 4 days.

Key safety warnings

Patients with major depression, both adult and paediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behaviour whether or not they are taking antidepressant medications. Antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. As improvement may not occur during the first few weeks or more of treatment, 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. Serotonin syndrome, a potentially life-threatening condition or neuroleptic malignant syndrome-like reactions may occur with venlafaxine treatment, particularly with concomitant use of other serotonergic drugs including SSRIs, SNRIs, amphetamines, triptans, opioids, with drugs that impair metabolism of serotonin such as MAOIs including reversible MAOIs, linezolid and intravenous methylene blue, or with antipsychotics or other dopamine antagonists. Dose-related increases in blood pressure have been reported in some patients treated with venlafaxine. Among patients treated with 75 to 375 mg per day of EFEXOR-XR in pre-marketing depression studies, 3% experienced sustained hypertension. It is recommended that patients receiving EFEXOR-XR have regular monitoring of blood pressure. The use of venlafaxine has been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move, often accompanied by an inability to sit or stand still. This is most likely to occur within the first few weeks of treatment.

Contraindications

EFEXOR-XR is contraindicated in patients with hypersensitivity to venlafaxine or any excipients in the formulation. EFEXOR-XR should not be used in combination with monoamine oxidase inhibitors (MAOIs) or reversible MAOIs such as moclobemide, linezolid and intravenous methylene blue, or within 14 days of discontinuing treatment with a MAOI.

PBS listing

EFEXOR-XR is listed on the PBS in capsule (modified release) formulations of 37.5 mg, 75 mg and 150 mg as hydrochloride salts. The 75 mg and 150 mg strengths each have 2 PBS items, and the 37.5 mg strength has 1 PBS item. All listings are restricted. The ex-manufacturer prices are A$2.72 for the 37.5 mg capsule, A$5.50 for the 75 mg capsule, and A$5.92 for the 150 mg capsule.

Regulatory history

EFEXOR-XR 75 mg and 150 mg modified release capsules were first listed on the ARTG on 11 May 1998, whilst the 37.5 mg formulation was first listed on 14 October 2004.