EQUETRO
Details
- Status
- Prescription
- First Approved
- 2004-12-10
- Routes
- ORAL
- Dosage Forms
- CAPSULE, EXTENDED RELEASE
EQUETRO Approval History
What EQUETRO Treats
5 indicationsEQUETRO is approved for 5 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Bipolar Disorder
- Trigeminal Neuralgia
- Epilepsy
- Partial Seizures
- Generalized Tonic-Clonic Seizures
EQUETRO Boxed Warning
SERIOUS DERMATOLOGIC REACTIONS AND APLASTIC ANEMIA AND AGRANULOCYTOSIS 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 occurredb in patients treated with carbamazepine. These syndromes may be accompanied by mucous membrane ulcers, fever, or painful rash. These reactions are estimated to occur in 1 to 6 per 10,000 new users in countries with mainly Caucasian...
WARNING:SERIOUS DERMATOLOGIC REACTIONS AND APLASTIC ANEMIA AND AGRANULOCYTOSIS 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 occurredb in patients treated with carbamazepine. These syndromes may be accompanied by mucous membrane ulcers, fever, or painful rash. 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 patients of Asian descent is estimated to be about 10 times higher. There is 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. Test for HLA-B*1502, prior to initiating EQUETROin patients with an increased likelihood of carrying this allele. Avoid use of EQUETRO in patients testing positive for the allele unless the benefit clearly outweighs the risk. Discontinue EQUETRO if you suspect that the patient has a serious dermatologic reaction [see Warnings and Precautions ( 5.1 )]. Aplastic Anemia and Agranulocytosis Aplastic anemia and agranulocytosis can occurduring treatment with EQUETRO. The risk of developing these reactions with EQUETRO is 5-8 times greater than in the general population. However, the overall risk in the general population is low (6 cases in a population of one million per year for agranulocytosis and two cases in a population of one million per year for aplastic anemia). Obtain a complete blood count before beginning treatment with EQUETRO, and monitor CBC periodically. Consider discontinuing EQUETRO if significant bone marrow depression develops [see Warnings and Precautions ( 5.2 ) ]. WARNING:SERIOUS DERMATOLOGIC REACTIONSAND APLASTIC ANEMIA AND AGRANULOCYTOSIS See full prescribing information for complete boxed warning. Serious Dermatologic Reactions • Serious and sometimes fatal dermatologic reactions, including toxic epidermal
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Key Completed Trials
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Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
EQUETRO FDA Label Details
ProIndications & Usage
FDA Label (PDF)EQUETRO is: A mood stabilizer indicated for the treatment of acute manic or mixed episodes associated with bipolar I disorder Indicated for the treatment of the pain associated with trigeminal neuralgia An anti-epileptic drug (AED) indicated for the treatment of partial seizures with complex symptomatology, generalized tonic-clonic seizures, and mixed seizures 1.1Acute Manic or Mixed Episodes associated with Bipolar I Disorder EQUETRO is indicated for treatment of patients with acute manic or mixed episodes associated with bipolar I disorder [see Clinical Studies ] . 1.2 Pain of Trigeminal Neu...
WARNING:SERIOUS DERMATOLOGIC REACTIONS AND APLASTIC ANEMIA AND AGRANULOCYTOSIS 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 occurredb in patients treated wi...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.