BUTRANS
Details
- Status
- Prescription
- First Approved
- 2010-06-30
- Routes
- TRANSDERMAL
- Dosage Forms
- FILM, EXTENDED RELEASE
BUTRANS Approval History
What BUTRANS Treats
1 indicationsBUTRANS is approved for 1 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pain
BUTRANS Boxed Warning
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF BUTRANS Addiction, Abuse, and Misuse Because the use of BUTRANS ® exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1) ]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respirator...
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF BUTRANS Addiction, Abuse, and Misuse Because the use of BUTRANS ® exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1) ]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of BUTRANS, especially during initiation or following a dosage increase . To reduce the risk of respiratory depression, proper dosing and titration of BUTRANS are essential. Misuse or abuse of BUTRANS by chewing, swallowing, snorting or injecting buprenorphine extracted from the transdermal system will result in the uncontrolled delivery of buprenorphine and pose a significant risk of overdose and death [see Warnings and Precautions (5.2) ]. Accidental Exposure Accidental exposure of even one dose of BUTRANS, especially in children, can result in a fatal overdose of buprenorphine [see Warnings and Precautions (5.2) ] . Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of BUTRANS and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions (5.3) , Drug Interactions (7) ]. Neonatal Opioid Withdrawal Syndrome (NOWS) Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery [see Warnings and Precautions (5.4) ] . Opi
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Active Pipeline
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Key Completed Trials
Completed studies with published results, ranked by significance
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.
BUTRANS FDA Label Details
ProIndications & Usage
FDA Label (PDF)BUTRANS is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions ] , reserve opioid analgesics, including BUTRANS, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficien...
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF BUTRANS Addiction, Abuse, and Misuse Because the use of BUTRANS ® exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and re...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.