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.
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).
- Data on file, Reckitt Benckiser Pharmaceuticals Inc., Richmond, VA:
- 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?"
- 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.
- 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.
- 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.