The SUBOXONE Film, SUBOXONE Tablet, and SUBUTEX Tablet Medication Guides are a core component of the REMS program. Each respective Medication Guide contains important information about the product, including proper administration, potential adverse events, and other precautions.
You should review the medication guide with patients for whom you prescribe SUBOXONE Film, SUBOXONE Tablet, or SUBUTEX Tablet to ensure that they understand the proper use and safety precautions associated with these products. You have received a tear pad with medication guides that you can distribute to patients. If you require additional copies of the medication guide, you can request them through your Clinical Liaison or by calling 1-866-463-4846.
Additionally, tear pads of the medication guides are provided to pharmacies that order and dispense SUBOXONE Film, SUBOXONE Tablet or SUBUTEX Tablet with reminders that they should provide the correct Medication Guide with every prescription.
Communicate the following messages to patients about the risks of accidental overdose, misuse, and abuse:
- Warn patients that it is extremely dangerous to self-administer non-prescribed benzodiazepines or other central nervous system (CNS) depressants (including alcohol) while taking these products. Caution patients prescribed benzodiazepines or other CNS depressants to use them only as directed by their prescriber.
- Instruct patients never to give these products to anyone else, even if he or she has the same signs and symptoms. They may cause harm or death.
- Advise patients that these products contain an opioid that can be a target for people who abuse prescription medications or street drugs.
- Caution patients to keep their products in a safe and secure place, out of the reach of children, and to protect them from theft.
- Advise patients that selling or giving away these products is against the law.
- Strongly encourage patients to seek psychosocial counseling and support for safe and effective treatment.
Additional information about safe use conditions and patient monitoring can be found in the Prescriber Brochure and in the warning and precautions sections of the product-specific Prescribing Information.