Product Information
Boxed Warning and Indications and Usage
Boxed Warning
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Cymbalta or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Cymbalta is not approved for use in pediatric patients. See Warnings and Precautions, Use in Specific Populations, and Information for Patients.
Indications and Usage
Major Depressive Disorder
Cymbalta is indicated for the acute and maintenance treatment of major depressive disorder (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.
Generalized Anxiety Disorder
Cymbalta is indicated for the acute treatment of generalized anxiety disorder (GAD).
Generalized anxiety disorder is defined by the DSM-IV as excessive anxiety and worry, present more days than not, for at least 6 months. The excessive anxiety and worry must be difficult to control and must cause significant distress or impairment in normal functioning. It must be associated with at least 3 of the following 6 symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and/or sleep disturbance.
Diabetic Peripheral Neuropathic Pain
Cymbalta is indicated for the management of neuropathic pain (DPNP) associated with diabetic peripheral neuropathy.
Fibromyalgia
Cymbalta is indicated for the management of fibromyalgia (FM).
Mechanism of Action
Cymbalta is believed to modulate both serotonin and norepinephrine in the brain and spinal cord. Learn more about the MOA of Cymbalta.
Formulary Access Finder
Cymbalta has been added to the Anthem Blue Cross Blue Shield National Preferred Formulary.
Get more information about the formulary access for Cymbalta. Download PDF files of insurance providers covering Cymbalta in your state.
