General Instructions for Use

One tablet (450 mg) of FORFIVO XL should be taken once daily without regard to meals. FORFIVO XL should be swallowed whole and not crushed, divided, or chewed.

Initial Treatment with FORFIVO XL

Do not initiate treatment with FORFIVO XL because the 450-mg tablet is the only available dose formulation. Use another bupropion formulation for initial dose titration (referring to prescribing information of other bupropion products).

FORFIVO XL can be used in patients who are receiving 300 mg/day of another bupropion formulation for at least 2 weeks, and require a dosage of 450 mg/day.

Patients who are currently being treated with other bupropion products at 450 mg/day can be switched to an equivalent dose of FORFIVO XL once daily.

Maintenance Treatment with FORFIVO XL

It is generally agreed that acute episodes of depression require several months or longer of sustained antidepressant treatment beyond the response in the acute episode. It is unknown whether the 450-mg dose needed for maintenance treatment is identical to the dose that provided an initial response. Periodically reassess the need for maintenance treatment and the appropriate dose for such treatment.

​2.4 To Discontinue FORFIVO XL, Taper the Dose

​Because the 450-mg tablet is the only available dose formulation, use another bupropion formulation for tapering the dose prior to discontinuation (referring to prescribing information of other bupropion products).

Patients with Impaired Hepatic Function

Because there is no lower dose strength for FORFIVO XL, FORFIVO XL is not recommended in patients with hepatic impairment [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

Patients with Impaired Renal Function

Because there is no lower dose strength for FORFIVO XL, FORFIVO XL is not recommended in patients with renal impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

​2.7 Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Antidepressant

​At least 14 days should elapse between discontinuation of an MAOI intended to treat depression and initiation of therapy with FORFIVO XL. Conversely, at least 14 days should be allowed after stopping FORFIVO XL before starting an MAOI antidepressant [see Contraindications (4) and Drug Interactions (7.6)].

​2.8 Use of FORFIVO XL with Reversible MAOIs Such as Linezolid or Methylene Blue

​Do not start FORFIVO XL in a patient who is being treated with a reversible MAOI such as linezolid or intravenous methylene blue. Drug interactions can increase the risk of hypertensive reactions. In a patient who requires more urgent treatment of a psychiatric condition, nonpharmacological interventions, including hospitalization, should be considered [see Contraindications (4)].

​In some cases, a patient already receiving therapy with FORFIVO XL 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 hypertensive reactions in a particular patient, FORFIVO XL should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with FORFIVO XL may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue.

​The risk of administering methylene blue by nonintravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with FORFIVO XL is unclear. The clinician should, nevertheless, be aware of the possibility of a drug interaction with such use [see Contraindications (4) and Drug Interactions (7.6)].