Patient

Who is eligible to enroll?

What are the patient participation steps?

Step 1: The patient will contact the Registry (Contact Us) and the Registry personnel will provide the patient with information on the goals, eligibility, requirements, and procedures.

Step 2: The patient will be asked to give her consent (Patient Information Sheet) to participate in the Registry, sign medical releases (OB Release Form and Pediatric Release Form), and provide the Registry with her healthcare provider contact information.

Step 3: The patient will receive a $25 inconvenience fee at initial registration, and $25 at the time of the outcome report. Payment will be made by mailed check.

Step 4: The Registry personnel collects general information about patient history and pregnancy from the patient at enrollment and confirms it with the health care provider to complete registration.

Step 5: During the patient’s participation in the registry, the patient’s healthcare provider will contact the patient to obtain the following Information Collected:

Step 6: The healthcare provider is responsible for completing the Data Forms and sending the data forms to the Registry at the designated timepoints.

Indications and Important Safety Information

Indications

Cymbalta is a prescription medicine used to treat a certain type of depression called Major Depressive Disorder (MDD). Cymbalta belongs to a class of medicines known as SNRIs (or serotonin-norepinephrine reuptake inhibitors).

Cymbalta is also used to treat or manage:

Important Safety Information for Cymbalta®

The most important information you should know about Cymbalta:

Antidepressants can increase suicidal thoughts and behaviors in children, teens, and young adults. Suicide is a known risk of depression and some other psychiatric disorders. Call your doctor right away or seek emergency help if you have new or worsening depression symptoms; unusual changes in behavior, such as agitation, irritability, impulsivity, or restlessness; or thoughts of suicide. Be especially observant within the first few months of treatment or after a change in dose.

The most important information you should know about antidepressant medicines, depression, other serious mental illnesses, and suicidal thoughts or actions:

  1. Depression and other serious mental illnesses are the most important causes of suicidal thoughts or 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).
  2. How can I watch for and try to prevent suicidal thoughts and actions?
    • Pay close attention to any changes in mood, behavior, actions, thoughts, or feelings, especially sudden changes. This is very important when an antidepressant medicine is started or when the dose is changed.
      • Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call your healthcare provider right away if you have any of the following symptoms or feelings, especially if they are new, worse, or worry you. In an emergency, call 911.

What else do I need to know about antidepressant medicines?

Cymbalta is not for everyone. Do not take Cymbalta if you:

Cymbalta may be associated with serious side effects. Call your healthcare provider right away or seek emergency help if you experience any of the following:

Before taking Cymbalta, talk with your healthcare provider:

Most common side effects of Cymbalta (this is not a complete list):

Nausea, dry mouth, sleepiness, fatigue, constipation, decreased appetite, increased sweating, and dizziness. Common side effects for children and adolescents who take Cymbalta include nausea, decreased weight, and dizziness. Side effects in adults may also occur in children and teens who take Cymbalta. Children and adolescents should have height and weight monitored during treatment.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Other safety information about Cymbalta:

How to take Cymbalta:

Take Cymbalta exactly as directed by your healthcare provider. Swallow Cymbalta whole; do not open, break, or chew capsule.
Cymbalta is available by prescription only.

See Prescribing Information, including Boxed Warning about antidepressants and risk of suicide, and Medication Guide.

DD CON ISI 09OCT2019