Forfivo XL

Generic name:bupropion hydrochloride
Drug class:Miscellaneous antidepressants
Approval date: November 10, 2011
Company: IntelGenx Corp.
Treatment for: Major Depressive Disorder

Medically reviewed by Drugs.com. Last updated on May 13, 2022.

FDA Approves Forfivo XL

The U.S. Food and Drug Administration (FDA) has approved Forfivo XL, for patients with Major Depressive Disorder. Forfivo XL is a novel, high-strength formulation of bupropion hydrochloride, the active ingredient in Wellbutrin XL. Forfivo XL is the only single dose 450 mg formulation of bupropion hydrochloride approved by the FDA.

Forfivo XL Medication Guide

Read this Medication Guide carefully before you start using Forfivo XL and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. If you have any questions about Forfivo XL, ask your healthcare provider or pharmacist.

IMPORTANT: Be sure to read the three sections of this Medication Guide. The first section is about the risk of suicidal thoughts and actions with antidepressant medicines; the second section is about the risk of changes in thinking and behavior, depression and suicidal thoughts or actions with medicines used to quit smoking; and the third section is entitled Important information about Forfivo XL.

Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions

This section of the Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, healthcare provider or your family member’s healthcare provider about:

• all risks and benefits of treatment with antidepressant medicines
• all treatment choices for depression or other serious mental illness

What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?

1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.
3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
   • Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
   • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
   • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you or your ..