PRISTIQ EXTENDED-RELEASE TABLET 50MG [SIN13859P]

Product Info

PRISTIQ EXTENDED-RELEASE TABLET 50MG

[SIN13859P]

4.1 Therapeutic indications

PRISTIQ is indicated for the treatment of major depressive disorder (MDD) (see sections 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information and 4.2). The efficacy of PRISTIQ has been established in four 8-week, placebo-controlled studies of outpatients who met DSM-IV criteria for MDD.

A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation.

Pediatrics (<18 years of age): PRISTIQ is not indicated for use in children under the age of 18.

4.2 Posology and method of administration

Initial treatment of major depressive disorder

The recommended dose for PRISTIQ is 50 mg once daily, with or without food. PRISTIQ should be taken at approximately the same time each day. Tablets must be swallowed whole with fluid and not divided, crushed, chewed, or dissolved.

In clinical studies, doses of 50 to 400 mg/day were shown to be effective, although no additional benefit was demonstrated at doses greater than 50 mg/day and adverse events and discontinuations were more frequent at higher doses. 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. The maximum dose should not exceed 200 mg/day.

When discontinuing therapy, gradual dose reduction is recommended whenever possible to minimize discontinuation symptoms (see ‘Discontinuing PRISTIQ’ below and section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Use in patients with renal impairment

No dosage adjustment is necessary in patients with mild renal impairment (24-hr CrCl = 50–80 mL/min).

The recommended dose in patients with moderate renal impairment (24-hr CrCl = 30–50 mL/min) is 50 mg/day. The recommended dose in patients with severe renal impairment (24-hr CrCl <30 mL/min) or end-stage renal disease (ESRD) is 50 mg every other day. Because of individual variability in clearance in these patients, individualization of dosage may be desirable. Supplemental doses should not be given to patients after dialysis. The doses should not be escalated in patients with moderate or severe renal impairment, or ESRD (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Use in patients with hepatic impairment

The recommended dose in patients with hepatic impairment is 50 mg/day. Dose escalation above 100 mg/day is not recommended (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Pediatric use

Two placebo-controlled studies in 587 pediatric patients 7 to 17 years of age with MDD did not demonstrate efficacy.

Use in elderly patients

No dosage adjustment is required solely on the basis of age; however, the possibility of reduced renal clearance of PRISTIQ should be considered when determining the dose (see sections 4.8 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Greater sensitivity of some older individuals cannot be ruled out.

Maintenance/continuation/extended treatment

It is generally agreed that acute episodes of MDD require several months or longer of sustained pharmacologic therapy. However, the longer-term efficacy of PRISTIQ at a dose of 50 mg/day that was effective in short-term, controlled studies has not been studied. Patients should be periodically reassessed to determine the need for continued treatment.

Discontinuing PRISTIQ

Symptoms associated with discontinuation of PRISTIQ, other SNRIs and SSRIs have been reported (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate. In some patients, discontinuation may need to occur over periods of months or longer.

Switching patients from other antidepressants to PRISTIQ

Discontinuation symptoms have been reported when switching patients from other antidepressants, including venlafaxine, to PRISTIQ. Tapering of the initial antidepressant may be necessary to minimize discontinuation symptoms.

Switching a patient to or from a monoamine oxidase inhibitor (MAOI) intended to treat psychiatric disorders

At least 14 days should elapse between discontinuation of a MAOI intended to treat psychiatric disorders and initiation of therapy with PRISTIQ. Conversely, at least 7 days should be allowed after stopping PRISTIQ before starting a MAOI intended to treat psychiatric disorders (see section 4.3).

Use of PRISTIQ with reversible MAOIs such as linezolid or methylene blue

Do not start PRISTIQ in a patient who is being treated with a reversible MAOI such as linezolid or in whom intravenous methylene blue has been administered because there is increased risk of serotonin syndrome (see section 4.3). In a patient who requires more urgent treatment of a psychiatric condition, non-pharmacological interventions, including hospitalization, should be considered.

In some cases, a patient already receiving PRISTIQ therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, PRISTIQ should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for two weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Therapy with PRISTIQ may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue.

The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with PRISTIQ is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3 Contraindications

Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or to any excipients in the PRISTIQ formulation.

Desvenlafaxine is an inhibitor of both norepinephrine and serotonin reuptake. Desvenlafaxine succinate must not be used in combination with a monoamine oxidase inhibitor (MAOI), or within at least 14 days of discontinuing treatment with a MAOI. Based on the half-life of desvenlafaxine succinate, at least 7 days should be allowed after stopping desvenlafaxine succinate before starting a MAOI. Starting PRISTIQ in a patient who is being treated with a reversible MAOI such as linezolid or in whom intravenous methylene blue has been administered is also contraindicated because of an increased risk of serotonin syndrome (see sections 4.2 and 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).