"Young children have died or become seriously ill from accidental exposure to a skin patch containing fentanyl, a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a Drug Safety Communication to warn pa"...
BUTRANS is indicated for the management of pain severe enough to require daily, around-the clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Limitations of Use
- Because of the risks of addiction, abuse and misuse with opioids, even at recommended doses, and because of the greater risk of overdose and death with extended-release opioid formulations, reserve BUTRANS for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
- BUTRANS is not indicated as an as-needed (prn) analgesic
DOSAGE AND ADMINISTRATION
BUTRANS should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.
BUTRANS doses of 7.5, 10, 15, and 20 mcg/hour are for opioid-experienced patients only.
Initiate the dosing regimen for each patient individually; taking into account the patient's prior analgesic treatment experience and risk factors for addiction, abuse, and misuse [see WARNINGS AND PRECAUTIONS]. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with BUTRANS [see WARNINGS AND PRECAUTIONS].
BUTRANS is for transdermal use (on intact skin) only. Each BUTRANS patch is intended to be worn for 7 days.
Instruct patients not to use BUTRANS if the pouch seal is broken or the patch is cut, damaged, or changed in any way and not to cut BUTRANS.
Use of BUTRANS as the First Opioid Analgesic
Initiate treatment with BUTRANS with a 5 mcg/hour patch.
Conversion from Other Opioids to BUTRANS
Discontinue all other around-the-clock opioid drugs when BUTRANS therapy is initiated.
There is a potential for buprenorphine to precipitate withdrawal in patients who are already on opioids.
Prior Total Daily Dose of Opioid Less than 30 mg of Oral Morphine Equivalents per Day: Initiate treatment with BUTRANS 5 mcg/hour at the next dosing interval (see Table 1 below, middle column).
Prior Total Daily Dose of Opioid Between 30 mg to 80 mg of Oral Morphine Equivalents per Day: Taper the patient's current around-the-clock opioids for up to 7 days to no more than 30 mg of morphine or equivalent per day before beginning treatment with BUTRANS. Then initiate treatment with BUTRANS 10 mcg/hour at the next dosing interval (see Table 1 below, right column). Patients may use short-acting analgesics as needed until analgesic efficacy with BUTRANS is attained.
Prior Total Daily Dose of Opioid Greater than 80 mg of Oral Morphine Equivalents per Day: BUTRANS 20 mcg/hour may not provide adequate analgesia for patients requiring greater than 80 mg/day oral morphine equivalents. Consider the use of an alternate analgesic.
Table 1: Initial BUTRANS Dose
|Previous Opioid Analgesic Daily Dose (Oral Morphine Equivalent)||< 30 mg||30-80 mg|
|Recommended BUTRANS Starting Dose||5 mcg/hour||10 mcg/hour|
Conversion from Methadone to BUTRANS
Close monitoring is of particular importance when converting from methadone to other opioid agonists. The ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure. Methadone has a long half-life and can accumulate in the plasma.
Titration And Maintenance Of Therapy
Individually titrate BUTRANS to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving BUTRANS to assess the maintenance of pain control and the relative incidence of adverse reactions, and monitor for the development of addiction, abuse, or misuse. Frequent communication is important among the prescriber, other members of healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. During chronic therapy, periodically reassess the continued need for opioid analgesics.
The minimum BUTRANS titration interval is 72 hours, based on the pharmacokinetic profile and time to reach steady state levels [see CLINICAL PHARMACOLOGY].
The maximum BUTRANS dose is 20 mcg/hour. Do not exceed a dose of one 20 mcg/hour BUTRANS system due to the risk of QTc interval prolongation. In a clinical trial, BUTRANS 40 mcg/hour (given as two BUTRANS 20 mcg/hour systems) resulted in prolongation of the QTc interval [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].
If the level of pain increases, attempt to identify the source of increased pain, while adjusting the BUTRANS dose to decrease the level of pain. Because steady-state plasma concentrations are achieved within 72 hours, BUTRANS dosage may be adjusted every 3 days. Dose adjustments may be made in 5 mcg/hour, 7.5 mcg/hr, or 10 mcg/hour increments by using no more than two patches of the 5 mcg/hour, or 7.5 mcg/hr, or 10 mcg/hour system(s). The total dose from both patches should not exceed 20 mcg/hour. For the use of two patches, patients should be instructed to remove their current patch, and apply the two new patches at the same time, adjacent to one another at a different application site [see Administration].
Patients who experience breakthrough pain may require dosage adjustment increase of BUTRANS, or may need rescue medication with an appropriate dose of an immediate-release analgesic. If the level of pain increases after dose stabilization, attempt to identify the source of increased pain before increasing the BUTRANS dose.
If unacceptable opioid-related adverse reactions are observed, the subsequent doses may be reduced. Adjust the dose to obtain an appropriate balance between the management of pain and opioid-related adverse reactions.
Cessation Of Therapy
When the patient no longer requires therapy with BUTRANS, use a gradual downward titration of the dose every 7 days to prevent signs and symptoms of withdrawal in the physically dependent patient; consider introduction of an appropriate immediate-release opioid medication. Do not abruptly discontinue BUTRANS.
Patients With Hepatic Impairment
BUTRANS has not been evaluated in patients with severe hepatic impairment. As BUTRANS is only intended for 7-day application, consider use of an alternate analgesic that may permit more flexibility with the dosing in patients with severe hepatic impairment [see WARNINGS AND PRECAUTIONS, Use In Specific Populations, and CLINICAL PHARMACOLOGY].
Administration Of BUTRANS
Instruct patients to apply immediately after removal from the individually sealed pouch. Instruct patients not to use BUTRANS if the pouch seal is broken or the patch is cut, damaged, or changed in any way. See the Instructions for Use for step-by-step instructions for applying BUTRANS.
Apply BUTRANS to the upper outer arm, upper chest, upper back or the side of the chest. These 4 sites (each present on both sides of the body) provide 8 possible application sites. Rotate BUTRANS among the 8 described skin sites. After BUTRANS removal, wait a minimum of 21 days before reapplying to the same skin site [see CLINICAL PHARMACOLOGY].
Apply BUTRANS to a hairless or nearly hairless skin site. If none are available, the hair at the site should be clipped, not shaven. Do not apply BUTRANS to irritated skin. If the application site must be cleaned, clean the site with water only. Do not use soaps, alcohol, oils, lotions, or abrasive devices. Allow the skin to dry before applying BUTRANS.
Incidental exposure of the BUTRANS patch to water, such as while bathing or showering is acceptable based on experience during clinical studies.
If problems with adhesion of BUTRANS occur, the edges may be taped with first aid tape. If problems with lack of adhesion continue, the patch may be covered with waterproof or semipermeable adhesive dressings suitable for 7 days of wear.
If BUTRANS falls off during the 7-day dosing interval, dispose of the transdermal system properly and place a new BUTRANS patch on at a different skin site.
When changing the system, instruct patients to remove BUTRANS and dispose of it properly [see Disposal Instructions].
If the buprenorphine-containing adhesive matrix accidentally contacts the skin, instruct patients or caregivers to wash the area with water and not to use soap, alcohol, or other solvents to remove the adhesive because they may enhance the absorption of the drug.
Patients should refer to the Instructions for Use for proper disposal of BUTRANS. Dispose of used and unused patches by following the instructions on the Patch-Disposal Unit that is packaged with the BUTRANS patches.
Alternatively, patients can dispose of used patches by folding the adhesive side of the patch to itself, then flushing the patch down the toilet immediately upon removal. Unused patches should be removed from their pouches, the protective liners removed, the patches folded so that the adhesive side of the patch adheres to itself, and immediately flushed down the toilet.
Patients should dispose of any patches remaining from a prescription as soon as they are no longer needed.
Dosage Forms And Strengths
BUTRANS is a rectangular or square, beige-colored system consisting of a protective liner and functional layers. BUTRANS is available in five strengths:
- BUTRANS 5 mcg/hour Transdermal System (dimensions: 45 mm by 45 mm)
- BUTRANS 7.5 mcg/hour Transdermal System (dimensions: 58 mm by 45 mm)
- BUTRANS 10 mcg/hour Transdermal System (dimensions: 45 mm by 68 mm)
- BUTRANS 15 mcg/hour Transdermal System (dimensions: 59 mm by 72 mm)
- BUTRANS 20 mcg/hour Transdermal System (dimensions: 72 mm by 72 mm)
Storage And Handling
BUTRANS (buprenorphine) Transdermal System is supplied in cartons containing 4 individually-packaged systems and a pouch containing 4 Patch-Disposal Units.
BUTRANS 5 mcg/hour Transdermal System, 4-count carton
BUTRANS 7.5 mcg/hour Transdermal System, 4-count carton
BUTRANS 10 mcg/hour Transdermal System, 4-count carton
BUTRANS 15 mcg/hour Transdermal System, 4-count carton
BUTRANS 20 mcg/hour Transdermal System, 4-count carton
Store at 25°C (77°F); excursions permitted between 15°C - 30°C (59°F - 86°F).
Distributed by: Purdue Pharma L.P., Stamford, CT 06901-3431. Manufactured by: LTS Lohmann Therapy Systems Corp., West Caldwell, NJ 07006. Revised: June 2014
Last reviewed on RxList: 7/17/2014
This monograph has been modified to include the generic and brand name in many instances.
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