Please See Important Safety Information, Including Boxed Warning Below

Links to Resources for
Bipolar Disorder Information & Support

Organizations that Provide Patient Advocacy & Support

Contact these organizations to access additional information on Bipolar I Disorder and to find the patient and caregiver support groups in your area:

Substance Abuse and Mental Health Services Administration (SAMHSA)

1-877-SAMHSA-7 (1-877-726-4727)
www.samhsa.gov

Utilizing its sub-division, The Center for Mental Health Services, SAMSHA supports efforts to prevent the development or worsening of mental illness and substance abuse by helping provide services for people with mental illness, and their families and communities.

Depression and Bipolar Support Alliance (DBSA)

1-800-826-2632
www.dbsalliance.org

Formerly called the National Depression and Manic Depression Association, the DBSA offers local and on-line support groups along with information, podcasts and other resources for people living with Bipolar Disorder.

National Alliance on Mental Illness (NAMI)

1-800-950-NAMI (1-800-950-6264)
www.nami.org

NAMI is the nation's largest patient/family advocacy and support organization for mental illnesses. Active local chapters and a national hot line provide multiple channels of support and information services for patients and families, including information on medications.

Mental Health America (nMHA)

1-800-969-6642
www.nmha.org

Formerly known as the National Mental Health Association, this group is the nation's oldest Mental Health Advocacy organization (founded in 1909). They provide Mental Health Awareness information, advocacy, support services, and are the sponsors of the annual National Depression Screening Day.

National Suicide Prevention Lifeline

1-800-273-TALK (1-800-273-8255)
www.suicidepreventionlifeline.org

This confidential lifeline service for patients contemplating suicide immediately routes callers to one of 140 local intervention centers where they can talk to trained crisis workers in their area. Family members are also welcome to use these resources.

WARNING

Important Safety Information about Equetro® (carbamazepine) Extended-Release Capsules

Warning Serious Dermatologic Reactions and HLA-B*1502 Allele

Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), have been reported during treatment with carbamazepine. These reactions are estimated to occur in 1 to 6 per 10,000 new users in countries with mainly caucasian populations, but the risk in some Asian countries is estimated to be about 10 times higher. Studies in patients of Chinese ancestry have found a strong association between the risk of developing SJS/TEN and the presence of HLA-B*1502, an inherited allelic variant of the HLA-B gene. HLA-B*1502 is found almost exclusively in patients with ancestry across broad areas of Asia. Patients with ancestry in genetically at-risk populations should be screened for the presence of HLA-B*1502 prior to initiating treatment with Equetro® (carbamazepine) Extended-Release Capsules. Patients testing positive for the allele should not be treated with Equetro® (carbamazepine) Extended-Release Capsules unless the benefit clearly outweighs the risk (see warnings and precautions, laboratory tests).

Aplastic Anemia and Agranulocytosis

Aplastic Anemia and Agranulocytosis have been reported in association with the use of carbamazepine. Data from a population based case-control study demonstrate that the risk of developing these reactions is 5–8 times greater than in the general population. However, the overall risk of these reactions in the untreated general population is low, approximately six patients per one million population per year for Agranulocytosis and two patients per one million population per year for Aplastic Anemia.

Although reports of transient or persistent decreased platelet or white blood cell counts are not uncommon in association with the use of carbamazepine, data are not available to estimate accurately their incidence or outcome. However, the vast majority of the cases of leukopenia have not progressed to the more serious conditions of Aplastic Anemia or Agranulocytosis.

Because of the very low incidence of Agranulocytosis and Aplastic Anemia, the vast majority of minor hematologic changes observed in monitoring of patients on carbamazepine are unlikely to signal the occurrence of either abnormality. Nonetheless, complete pretreatment hematological testing should be obtained as a baseline. If a patient in the course of treatment exhibits low or decreased white blood cell or platelet counts, the patient should be monitored closely. Discontinuation of the drug should be considered if any evidence of significant bone marrow depression develops.

Anti-epileptic drugs (AEDs), including Equetro®, may increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence of worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

Please see FULL PRESCRIBING INFORMATION including contraindications, warnings and precautions, and boxed warning for additional safety information on Equetro® (carbamazepine) Extended-Release Capsules.

Please see Medication Guide for additional information.