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SUBOXONE Film Dosing Guidance

Dosing for SUBOXONE Film is determined by an individual's need and is based on the effective management of cravings and withdrawal symptoms. Appropriate dosing ranges differ from patient to patient, but the general dosing range should be between 4 mg and 24 mg a day.

SUBOXONE Film is indicated for maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. Under the Drug Addiction Treatment Act (DATA), prescription use of this product in the treatment of opioid dependence is limited to physicians who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription.

NOTE: The following instructions are for guidance only and do not replace clinical decisions by the prescriber. Individual patient needs may vary.

Phases of Opioid-Dependence Treatment

Induction

  • Patients must be in moderate withdraval (eg, COWS*>12), and appropriate lab tests performed
  • Induct in-office to reach clinical response as rapidly as possible
    – Target dose is 12 mg to 16 mg buprenorphine by Day 2
    – A buprenorphine-only medication is preferred for induction
  • Evaluate and discuss counseling
  • Provide patients with a SUBOXONE® Film or Tablet prescription for nonsupervised use, and after-hours office contact information

Medication-assisted Treatment
Stabilization              &              Maintenance

  • Beginning stage of maintenance
  • Continue to assess withdrawal
    symptoms to determine
    appropriate dosage
  • – Recommended target dose
    is between 12 mg and
    16 mg/day
  • Patients may need frequent
    visits during the first few weeks
  • Continue counseling and
    relapse prevention
  • Manage triggers/stressors
  • Length of treatment varies
    by patient
  • Conduct appropriate lab
    evaluations to support
    effective treatment

Continued Maintenance

  • Maintain patient on
    clinically effective dose in conjunction with
    counseling
  •  

Medical Taper

  • Decision by patient and
    treatment team
  • Slow taper is recommended
  • Patients at risk of relapse
    during taper should be
    restabilized
  • Recommend continued
    counselling during and after medical taper

* Clinical Opiate Withdrawal Scale.

The safety and effectiveness of SUBOXONE Film in daily doses over 24 mg have not been established.

The decision to taper the dose of SUBOXONE Film should be made as part of a comprehensive treatment plan. Both gradual and abrupt discontinuation have been used, but no controlled trials have been undertaken to determine the best method of dose taper at the end of treatment.


Learn about REMS and the
Appropriate Use Checklist




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up to $50 a month

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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
© 2013 Reckitt Benckiser Pharmaceuticals Inc.

Indication:

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.

Important Safety Information:

SUBOXONE Sublingual Film should not be used by patients hypersensitive to buprenorphine or naloxone, as serious adverse reactions, including anaphylactic shock, have been reported.

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 oral hypoesthesia, glossodynia, oral mucosal erythema, headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema.

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.

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Dear Healthcare Professional:

We would like to personally inform you about an important medication update regarding SUBOXONE® Tablets (buprenorphine and naloxone) Sublingual (CIII). Reckitt Benckiser Pharmaceuticals Inc. will discontinue the sale of SUBOXONE Tablets and cease distribution as of March 18, 2013 in the United States. SUBOXONE Film (buprenorphine and naloxone) Sublingual (CIII) is still available and will remain on the market.

Reckitt Benckiser Pharmaceuticals formally announced in September 2012 that the company is voluntarily discontinuing SUBOXONE Tablets after receiving an analysis based on U.S. Poison Control Centers data that found consistently and significantly higher rates of accidental pediatric exposure with SUBOXONE Tablets than seen with SUBOXONE Film. The different rates of pediatric exposure are not related to the active ingredient found in both SUBOXONE Tablets and SUBOXONE Film.

Reckitt Benckiser Pharmaceuticals recognizes that many of your patients have relied on SUBOXONE Tablets to manage their opioid dependence over the years and encourage you to please contact your patients currently taking SUBOXONE Tablets to immediately transition them to the same active ingredient with SUBOXONE Film to minimize any risk to the continuity of their treatment. It's important to remember that SUBOXONE Tablets and SUBOXONE Film are clinically interchangeable. The transition from SUBOXONE Tablets to SUBOXONE Film does not require that your patients go through induction again, but there are some differences in how your patients will need to take SUBOXONE Film. In addition to the 2 mg and 8 mg dosage strengths, SUBOXONE Film is now available in 4 mg and 12 mg dosage strengths.

Indication
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.

Selected Safety Information
SUBOXONE Sublingual Film should not be used by patients hypersensitive to buprenorphine or naloxone, as serious adverse reactions, including anaphylactic shock, have been reported.

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.

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.

Please see the important safety information below.

We remain committed to supporting you with updated information and resources to ensure you have the tools you need to educate and transition your patients to SUBOXONE Film. Contact your Clinical Liaison with any questions you may have or call our medical information unit at 877-782-6966 for more information. Visit this website often to receive updated information as it becomes available.

We thank you for your continued support of Reckitt Benckiser Pharmaceuticals as we uphold our commitment to patients and the safety of the public.

Please see full Prescribing Information and Medication Guide for SUBOXONE Film.

For more about SUBOXONE Tablet, please see full Prescribing Information and Medication Guide.


Sincerely,

Rolley E. Johnson, PharmD

Rolley E. Johnson, PharmD
Vice President, Treatment and Health Policy
Reckitt Benckiser Pharmaceuticals Inc.

Tim Baxtor, MD

Tim Baxter, MD
Global Medical Director
Reckitt Benckiser Pharmaceuticals Inc.

Please see the important safety information below.


Indication:

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.

Important Safety Information:

SUBOXONE Sublingual Film should not be used by patients hypersensitive to buprenorphine or naloxone, as serious adverse reactions, including anaphylactic shock, have been reported.

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 oral hypoesthesia, glossodynia, oral mucosal erythema, headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema.

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 Prescribing Information and Medication Guide for SUBOXONE Film.

For more about SUBOXONE Tablet, please see full Prescribing Information and Medication Guide.

Cancel
Questions and answers about the discontinuation of SUBOXONE® (buprenorphine and naloxone) sublingual tablet (CIII)

UPDATED January 10, 2013: Reckitt Benckiser Pharmaceuticals Inc. will be discontinuing the distribution of SUBOXONE® Tablets on March 18, 2013. Please discuss your treatment options with your physician, who should have received communications about this change in September 2012, along with patient educational resources to help with the transition.

Why are SUBOXONE Tablets being discontinued?

Reckitt Benckiser Pharmaceuticals Inc. has decided to discontinue SUBOXONE Tablets because of strong evidence that the tablet form of SUBOXONE is linked to significantly higher rates of pediatric exposure (when a child takes the medicine accidentally) as compared with the lower rates of pediatric exposure linked to SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII). SUBOXONE Film will remain available. The different rates of pediatric exposure are not related to the active ingredient found in both SUBOXONE Tablets and SUBOXONE Film.

I don't have children at home. Why should pediatric exposure affect my treatment?

Pediatric exposure to SUBOXONE in any form or quantity can be dangerous. Unit-dose, child-resistant packaging is an important measure of protection against pediatric exposure, because it limits a child's ability to get the medication and it also limits the amount that can be taken at one time. Whether or not you have children at home, there is always the possibility that a child could access and take your medication, especially if it looks appealing.

I am doing well on SUBOXONE Tablets. Will I have a similar treatment experience with SUBOXONE Film?

SUBOXONE Film has the same active ingredient as SUBOXONE Tablets, and the two products are clinically interchangeable in treating opioid dependence. That means for most people, the dose will stay the same and produce the same effect. However, some people may require a dose adjustment. SUBOXONE Film is a more recent form of the medication, designed to provide important safeguards and an improved treatment experience for patients.1 Your doctor will guide your transition plan and make sure that you receive the appropriate dosage to manage your symptoms.

How do I switch from SUBOXONE Tablets to SUBOXONE Film?

Many patients have successfully switched from SUBOXONE Tablets to SUBOXONE Film. Because every patient is different, your doctor will work with you to individualize your treatment. If you do notice a difference in the effect for you, make sure you let your doctor know right away so that he or she can make the appropriate dosing decision for your situation. Do not change your prescribed dose without consulting your physician. You will not need to repeat induction when you transition to SUBOXONE Film.

Like SUBOXONE Tablets, SUBOXONE Film is taken under the tongue, once daily. Your doctor will show you how to take SUBOXONE Film, including written instructions. You can also see the "how to take SUBOXONE Film" video here.

Will I have to go through induction (withdrawal) again?

No. If you are taking SUBOXONE Tablets for maintenance treatment of opioid dependence, you will not need to repeat induction when switching to SUBOXONE Film.

Do I need to get a new prescription? Can I use my SUBOXONE Tablet prescription to get SUBOXONE Film at the pharmacy?

You will need a new prescription for SUBOXONE Film, since it cannot be dispensed at the pharmacy with a SUBOXONE Tablet prescription. You should continue with your current treatment until you are able to make an appointment with your doctor to discuss a transition plan.

Is my doctor prepared to help me switch from SUBOXONE Tablets to SUBOXONE Film?

Your doctor knows about the discontinuation of SUBOXONE Tablets and has the resources to help you make a successful transition.

Does SUBOXONE Film cost the same as SUBOXONE Tablets?

SUBOXONE Film is covered by the majority of insurance plans, Medicare, and Medicaid. You may also be eligible for a copay savings program that results in a $0 copay for many patients. You can download details (including restrictions) and a savings card at suboxone.com. You can also get a copay savings card at your doctor's office.

How is SUBOXONE Film different from SUBOXONE Tablets?

SUBOXONE Film contains the same active ingredient as SUBOXONE Tablets, but is not dispensed in a multidose bottle. SUBOXONE Film doses are individually packaged to help reduce the risk of pediatric exposure (accidental ingestion by a child).1d It is also patient-preferred,1a with improved dissolve time,1b taste,1c and portability.1d Patients taking SUBOXONE Film also have access to the additional support of the free Here to Help® Program.

Please see Important Safety Information below.


Indication:

SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) is a prescription medicine used for maintenance treatment of opioid dependence as part of a complete treatment plan to include counseling and behavioral therapy.

Important Safety Information:

Do not take SUBOXONE® (buprenorphine and naloxone) Sublingual Film if you are allergic to buprenorphine or naloxone as serious negative effects, including anaphylactic shock, have been reported.

SUBOXONE Sublingual Film can be abused in a manner similar to other opioids, legal or illicit.

SUBOXONE Sublingual Film contains buprenorphine, an opioid that can cause physical dependence with chronic use. Physical dependence is not the same as addiction. Your doctor can tell you more about the difference between physical dependence and drug addiction. Do not stop taking SUBOXONE Sublingual Film suddenly without talking to your doctor. You could become sick with uncomfortable withdrawal symptoms because your body has become used to this medicine.

SUBOXONE Sublingual Film can cause serious life-threatening breathing problems, overdose and death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other medications that act on the nervous system (ie, sedatives, tranquilizers, or alcohol). It is extremely dangerous to take nonprescribed benzodiazepines or other medications that act on the nervous system while taking SUBOXONE Sublingual Film.

You should not drink alcohol while taking SUBOXONE, as this can lead to loss of consciousness or even death.

Death has been reported in those who are not opioid dependent.

Your doctor may monitor liver function before and during treatment.

Keep SUBOXONE Sublingual Film out of the sight and reach of children. Accidental or deliberate ingestion of SUBOXONE Sublingual Film by a child can cause severe breathing problems and death.

Do not take SUBOXONE Sublingual Film before the effects of other opioids (eg, heroin, hydrocodone, methadone, morphine, oxycodone) have subsided as you may experience withdrawal symptoms.

Injecting SUBOXONE may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problem, and cravings.

Before taking SUBOXONE, tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking SUBOXONE, alert your doctor immediately as there may be significant risks to you and your baby; your baby may have symptoms of withdrawal at birth. If you are pregnant or become pregnant while taking SUBOXONE, you should report it using the contact information provided below.*

Before taking SUBOXONE, talk to your doctor if you are breast-feeding or plan to breast-feed. SUBOXONE can pass into your milk and may harm the baby. Talk to your doctor about the best way to feed your baby if you take SUBOXONE. Breast-feeding is not recommended while taking SUBOXONE.

Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how SUBOXONE affects you. Buprenorphine in SUBOXONE can cause drowsiness and slow reaction times during dose adjustment periods.

Common side effects of SUBOXONE Sublingual Film include nausea, vomiting, drug withdrawal syndrome, headache, sweating, numb mouth, constipation, painful tongue, redness of the mouth, intoxication (feeling lightheaded or drunk), disturbance in attention, irregular heartbeat, decrease in sleep, blurred vision, back pain, fainting, dizziness, and sleepiness.

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

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

Comparisons are between SUBOXONE® (buprenorphine and naloxone) sublingual tablets (CIII) and SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII).

References:

  1. Data on file, Reckitt Benckiser Pharmaceuticals Inc., Richmond, VA:
  1. Patient preferred: Clinical trial participants preferred SUBOXONE Film over the SUBOXONE Tablet. Results from a questionnaire collected at discharge of a 13-week, multicenter, open-label safety trial. Patients were asked, "Based on your previous experience with SUBOXONE Tablets and your current experience with SUBOXONE Film, which product do you prefer?"
  2. Dissolve time: The time required for both SUBOXONE Film and SUBOXONE Tablet dissolution is dependent on saliva quantity and is subject to individual variation, and dose and strength taken. Mean dissolution time for all doses tested (8 mg, 2 mg) was between 5 and 6.6 minutes for SUBOXONE Film and between 7 and 12.4 minutes for the SUBOXONE Tablet.
  3. Taste: In a patient questionnaire, more than 71% of patients who have tried SUBOXONE Film rated the taste as neutral or better on a 10-point scale. Results from a questionnaire collected at discharge of a 13-week, multicenter, open-label safety trial. Patients were asked, "Please give this product (SUBOXONE Film) a score which shows how you would rate the flavor." 10=extremely pleasant and 1=extremely unpleasant.
  4. Portability: Because each unit of SUBOXONE Film is individually packaged in a compact, child-resistant pouch, it's easy to carry with you. Remember to keep this medication out of the sight and reach of children, and take your prescription label along with you. If a child takes the medication, seek emergency care immediately.

SUBOXONE® and Here to Help® are registered trademarks of Reckitt Benckiser Healthcare (UK) Ltd.

Please see full Product Information and Medication Guide for SUBOXONE Film.

For more about SUBOXONE Tablet, please see full Product Information and Medication Guide.

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Questions and answers about the discontinuation of SUBOXONE® (buprenorphine and naloxone) sublingual tablet (CIII)

Why are SUBOXONE Tablets being voluntarily discontinued by Reckitt Benckiser Pharmaceuticals Inc.?

Reckitt Benckiser Pharmaceuticals Inc. received an analysis based on data from the US Poison Control Centers on September 15, 2012 that found consistently and significantly higher rates (7.8 – 8.5 times greater, depending on the study period) of accidental pediatric exposure with SUBOXONE Tablets as compared with SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII). In the interest of public health, Reckitt Benckiser Pharmaceuticals Inc. decided to inform the US Food and Drug Administration (FDA) that it will discontinue the supply of SUBOXONE Tablets in a manner that ensures patients will have time to transition to SUBOXONE Film.

When will SUBOXONE Tablets cease being available? UPDATED January 10, 2013

Reckitt Benckiser Pharmaceuticals Inc. made the decision to notify the FDA on September 18, 2012, regarding the company's plan to discontinue the supply of SUBOXONE Tablets and in accordance with that plan, will be discontinuing the distribution of SUBOXONE® Tablets in the United States on March 18, 2013.

To minimize any risk of impacting patient continuity of treatment, Reckitt Benckiser Pharmaceuticals Inc. has created patient educational resources to help with transitioning to Film. Please talk with your Clinical Liaison for these and other helpful resources for you and your patients.

As you help your patients transition to SUBOXONE Film, be sure to write DAW (dispense as written) or BMN (brand medically necessary) on your script so that the pharmacist dispenses the product appropriately. Please visit suboxone.com for updates.

Are there data related to the ingredient in the medication that should cause concern?

No. The different rates of pediatric exposure are not related to the active ingredient found in both SUBOXONE Tablets and SUBOXONE Film. These medications continue to provide the same clinical effectiveness and safety as reported in the respective package inserts. Since 2003, more than 3 million Americans have been treated for opioid dependence with buprenorphine and naloxone combination products.

Your patients can be assured that they can continue their tablet medication until they can transition to the film formulation under your medical supervision.

How will my patients learn about this change?

Reckitt Benckiser Pharmaceuticals Inc. will issue press releases, update information on suboxone.com, and provide healthcare professionals with informational brochures to help educate patients about the change and to encourage patients to work with you and your staff on a product transition plan. Your Reckitt Benckiser Pharmaceuticals Inc. Clinical Liaison will be able to offer resources and support, or you may call the Medical Information Unit at 1-877-782-6966. Visit suboxone.com often for updated information.

Is insurance coverage for SUBOXONE Film similar to that for SUBOXONE Tablets?

SUBOXONE Film is covered by the majority of insurance plans across the nation, and Medicare and Medicaid. Additionally, many patients can access a savings program at suboxone.com or at your office. This program helps reduce out-of-pocket costs for their medication. Click here for details.

What are important communications that should be shared with patients to aid in their transition?

Since SUBOXONE Film became available in September, 2010, a large majority of SUBOXONE Tablet patients have successfully been transitioned to SUBOXONE Film. Reassuring patients that the active ingredient is the same in the two formulations, and that they are clinically interchangeable, will help patients understand that their treatment will be continued and not changed to a completely different medication. Some patients express concern about having the management of their opioid dependence symptoms destabilized; letting them know that the transition is to a different formulation, and not a different medication, may help allay concerns.

In addition, patients should know that they will not need to go through induction again to successfully transition from one formulation to the other. As you begin transitioning your patients from SUBOXONE Tablet to SUBOXONE Film, you should start them on the same dosage. As with any transition, dosage adjustments may be necessary. While Tablet and Film are clinically interchangeable, Film has greater relative bioavailability compared with SUBOXONE Tablet. Because of this, it is recommended to monitor patients.

How can I learn more or have other questions addressed?

Reckitt Benckiser Pharmaceuticals Inc. recognizes that many patients currently rely on SUBOXONE Tablets to manage their opioid dependence, and that they may be concerned about the discontinuation of this formulation. We are committed to supporting you and your patients through this transition. To have any further questions answered, watch for updates on suboxone.com, speak with your Clinical Liaison, or call the Medical Information Unit at 1-877-782-6966.

Please see Important Safety Information below.


Indication:

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.

Important Safety Information:

SUBOXONE Sublingual Film should not be used by patients hypersensitive to buprenorphine or naloxone, as serious adverse reactions, including anaphylactic shock, have been reported.

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 oral hypoesthesia, glossodynia, oral mucosal erythema, headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema.

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 Film.

For more about SUBOXONE Tablet, please see full US prescribing information and Medication Guide.

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Find SUBOXONE Film Formulary Coverage
  •  
  •  
  •  
  SUBOXONE Film Co-pay/Coinsurance
Kaiser Permanente Not Covered T2: $25-75
Anthem Not Covered/ST N/A

Formulary data are provided by Fingertip Formulary® and are current as of April 18, 2014. Because formularies do change and many health plans offer more than one formulary, please check with the health plan directly to confirm coverage for individual patients.

PA=prior authorization; QL=quantity limits; ST=step therapy; OR=other restrictions; N/A=data not available

1. Tier status varies by age.
2. Tier status varies by strength.
3. QL does not apply to all strengths/formulations.
4. State Medicaid non-preferred product.

© 2014 Fingertip Formulary. All Rights Reserved.

*Insured lives are intended to show size of population and not imply disease or appropriate patients for treatment with SUBOXONE Film.

Indication:

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.

Important Safety Information:

SUBOXONE Sublingual Film should not be used by patients hypersensitive to buprenorphine or naloxone, as serious adverse reactions, including anaphylactic shock, have been reported.

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 oral hypoesthesia, glossodynia, oral mucosal erythema, headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema.

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 Prescribing Information and Medication Guide for SUBOXONE Film.

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

SBF-0261-r2Mar2014

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