SUBOXONE film Key Benefits

SUBOXONE Film Key Benefits

There is no generic equivalent for SUBOXONE Film, an essential component of the treatment of opioid dependence for a growing number of healthcare providers and their patients. SUBOXONE Film provides a patient-preferred experience and comes in unit-dose, child-resistant packaging and a formulation that is intended to discourage misuse and abuse.

Make sure the medication you chose is dispensed as you intended by writing DAW (Dispense as Written) or BMN (Brand Medically Necessary) on each SUBOXONE Film prescription.*

* Requirements to protect your choices vary by state. Please consult your Reckitt Benckiser Clinical Liaison if you have questions.

There is no substitute for SUBOXONE Film

SUBOXONE Film

SUBOXONE^® Tablet

Indicated for maintenance treatment of opioid dependence

Should be used as part of a complete treatment plan to include counseling and psychosocial support

Patient-preferred experience

To enhance patient satisfaction

Patient-preferred taste, dissolve time, and portabiliy^†1

Unit-dose, child-resistant packaging

Pouches achieved a high level of child resistance (F=2)^‡§1
Unit-dose packaging to reduce the risk of multidose exposure²

Formulation is intended to discourage misuse and abuse

Film form makes it difficult to crush into a powder and abuse

Unrestricted access to additional patient support

24/7 access to HereToHelpProgram.com keeps patient support within reach
Care Coordinators who can be reached at 866-973-HERE (4373) can refer patients to counseling and resources

Copay card program

$0 copay for the rest of 2012 (up to $50 a month)^||

† Results from a questionnaire collected at discharge of a 13-week, multicenter, open-label safety trial.

‡ Pediatric exposure to SUBOXONE in any form or quantity may be dangerous.

§ According to the Consumer Product Safety Commission current protocol for child-resistant effectiveness. During testing, 4 children out of 100 were able to open 2 or more pouches before instruction. 7 children were successful after instruction. This represents 89% child-resistant effectiveness. Instruction increased the ability of children to open pouches. Instruct patients not to open pouches in front of children and to destroy unused medication appropriately.

|| This card reduces out-of-pocket expenses up to $50 off each of eligible third-party prescriptions (up to a maximum of 10 in 2012). Each prescription filled must be for a minimum of 14 SUBOXONE sublingual films. Patients will be responsible for any remaining out-of-pocket fees. Savings on each prescription filled cannot exceed amount of copay.

¶ Savings on each prescription filled cannot exceed the amount of the patient copay. Patients may take advantage of only one savings offer from Reckitt Benckiser Pharmaceuticals Inc. at any one time. For full details regarding this offer, including rules and restrictions, visit www.suboxone.com

Comparable Efficacy and Safety

Provides comparable efficacy and safety to the SUBOXONE Tablet formulation—Clinical interchangeability established in an open-label, randomized clinical trial in patients maintained on the tablet formulation¹

A dose adjustment may be needed for patients switching from SUBOXONE Tablet to SUBOXONE Film due to potential individual variability in bioavailability

Adheres firmly and dissolves quickly²—Dissolves more quickly than SUBOXONE Tablet formulation and adheres firmly to the oral mucosa

The mechanism of action is the same as for SUBOXONE Tablet formulation¹

Helps reduce illicit opioid use and increase treatment retention by suppressing opioid withdrawal symptoms and reducing cravings

Once-daily dosing due to long duration of effect¹

References

SUBOXONE Sublingual Film [package insert]. Richmond, VA: Reckitt Benckiser Pharmaceuticals Inc; August 2010.

Data on file, Reckitt Benckiser Pharmaceuticals Inc., Richmond, VA.

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.

There is no substitute for SUBOXONE Film
	SUBOXONE Film	SUBOXONE^® Tablet
Indicated for maintenance treatment of opioid dependence Should be used as part of a complete treatment plan to include counseling and psychosocial support
Patient-preferred experience To enhance patient satisfaction Patient-preferred taste, dissolve time, and portabiliy^†1
Unit-dose, child-resistant packaging Pouches achieved a high level of child resistance (F=2)^‡§1 Unit-dose packaging to reduce the risk of multidose exposure²
Formulation is intended to discourage misuse and abuse Film form makes it difficult to crush into a powder and abuse
Unrestricted access to additional patient support 24/7 access to HereToHelpProgram.com keeps patient support within reach Care Coordinators who can be reached at 866-973-HERE (4373) can refer patients to counseling and resources
Copay card program $0 copay for the rest of 2012 (up to $50 a month)^\|\|