HCP Resources: Pharmacists

Pharmacist Resources

As a pharmacist, you play a significant role in determining the outcome of patients' opioid-dependence treatment. For instance, you come into contact with people who are just starting their treatment, and taking a supportive stance can have a powerful effect on patients' efforts toward recovery. In addition, physicians will look to you to partner closely with them throughout treatment so that patient outcomes can be optimized.

You also play an important role in making sure that patients are informed about their medication so that they use it correctly. This will help to optimize their outcomes as well as to minimize the potential for misuse, abuse, and diversion. A Risk Evaluation and Mitigation Strategy (REMS) that includes a Medication Guide is in place to help address these concerns. This plan includes guidelines and tools to help those involved with opioid-dependence treatment ensure the proper use of SUBOXONE Film. You can help by distributing the Medication Guide (containing important information about the product, including proper administration, potential adverse events, and other precautions) and discussing its contents with every patient who fills a SUBOXONE Film prescription. Open communications with physicians who prescribe SUBOXONE Film can help to ensure safe and effective use of the product.

By working together, we can make treatment with SUBOXONE Film as safe and effective as possible while protecting patients and the community.

Read about REMS

In addition, by providing your expertise in drug-drug interactions, pharmacokinetics, patient counseling, and interacting with trained physicians, you can contribute significantly to the success of patients' opioid-dependence treatment.

Pharmacists and patients can work together to achieve effective SUBOXONE Film treatment. You have an opportunity to experience the gratification that comes from helping friends and neighbors gain control of their opioid dependence and improve their lives.

Pharmacist Labeling Brochure
Includes information on properly and safely dispensing treatment for opioid dependence.

Patient Education Brochure
This brochure provides important information on SUBOXONE Film and how it provides an evolved patient experience. It also includes information on the Here to Help^® Program.

Medication Guide
This guide contains important information about the safe and proper use of SUBOXONE Film.

This site is sponsored by Reckitt Benckiser Pharmaceuticals Inc. and intended for residents of the United States.
SUBOXONE^® and Here to Help^® are registered trademarks of Reckitt Benckiser Healthcare (UK) Ltd.
SUBOXONE^® Film is manufactured for Reckitt Benckiser Pharmaceuticals Inc., Richmond, VA 23235 by MonoSol Rx LLC, Warren, NJ 07059
© 2012 Reckitt Benckiser Pharmaceuticals Inc.

Important Safety Information

SUBOXONE^® (buprenorphine and naloxone) Sublingual Film (CIII) is indicated for maintenance treatment of opioid dependence as part of a complete treatment plan to include counseling and psychosocial support. Treatment should be initiated under the direction of physicians qualified under the Drug Addiction Treatment Act.

SUBOXONE Sublingual Film should not be used by patients hypersensitive to buprenorphine or naloxone.

SUBOXONE Sublingual Film can be abused in a manner similar to other opioids, legal or illicit. Clinical monitoring appropriate to the patient's level of stability is essential.

Chronic use of buprenorphine can cause physical dependence. A sudden or rapid decrease in dose may result in an opioid withdrawal syndrome that is typically milder than seen with full agonists and may be delayed in onset.

SUBOXONE Sublingual Film can cause serious life-threatening respiratory depression and death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other central nervous system (CNS) depressants (ie, sedatives, tranquilizers, or alcohol). It is extremely dangerous to self-administer nonprescribed benzodiazepines or other CNS depressants while taking SUBOXONE Sublingual Film. Dose reduction of CNS depressants, SUBOXONE Sublingual Film, or both when both are being taken should be considered.

Liver function should be monitored before and during treatment.

Death has been reported in nontolerant, nondependent individuals, especially in the presence of CNS depressants.

Children who take SUBOXONE Sublingual Film can have severe, possibly fatal, respiratory depression. Emergency medical care is critical. Keep SUBOXONE Sublingual Film out of the sight and reach of children.

Intravenous misuse or taking SUBOXONE Sublingual Film before the effects of full-agonist opioids (eg, heroin, hydrocodone, methadone, morphine, oxycodone) have subsided is highly likely to cause opioid withdrawal symptoms.

Neonatal withdrawal has been reported. Use of SUBOXONE Sublingual Film in pregnant women or during breast-feeding should only be considered if the potential benefit justifies the potential risk. Caution should be exercised when driving vehicles or operating hazardous machinery, especially during dose adjustment.

Adverse events commonly observed with the sublingual administration of SUBOXONE Sublingual Film are numb mouth, sore tongue, redness of the mouth, headache, nausea, vomiting, sweating, constipation, signs and symptoms of withdrawal, insomnia, pain, swelling of the limbs, disturbance of attention, palpitations, and blurred vision.

Cytolytic hepatitis, jaundice, and allergic reactions, including anaphylactic shock, have been reported.

This is not a complete list of potential adverse events associated with SUBOXONE Sublingual Film. Please see full Prescribing Information for a complete list.

To report an adverse event associated with taking SUBOXONE Sublingual Film, please call 1-877-782-6966. You are encouraged to report adverse events of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full US prescribing information and Medication Guide for SUBOXONE sublingual film.

For more information about SUBOXONE^® (buprenorphine and naloxone) sublingual tablets (CIII), please see full US prescribing information and Medication Guide.

Pharmacist Resources

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