"Nov. 2, 2012 -- Safety steps taken in the wake of the fungal meningitis outbreak have worsened drug shortages, raising questions about whether the U.S. must choose between the safety and the availability of crucial medicines.
Limitations of Use
BUTRANS is not for use:
- As an as-needed (prn) analgesic
- For pain that is mild or not expected to persist for an extended period of time
- For acute pain
- For postoperative pain unless the patient is already receiving chronic opioid therapy prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time
DOSAGE AND ADMINISTRATION
Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with BUTRANS [see WARNINGS AND PRECAUTIONS]. Overestimating the BUTRANS dose when converting patients from another opioid medication can result in fatal overdose with the first dose [see OVERDOSAGE].
Consider the following factors when selecting an initial dose of BUTRANS:
- Total daily dose, potency, and any prior opioid the patient has been taking previously;
- Reliability of the relative potency estimate used to calculate the equivalent dose of buprenorphine needed (Note: potency estimates may vary with the route of administration);
- Patient's degree of opioid experience and opioid tolerance;
- General condition and medical status of the patient;
- Concurrent medication;
- Type and severity of the patient's pain.
BUTRANS is for transdermal use (on intact skin) only. Each BUTRANS 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.
BUTRANS as the First Opioid Analgesic
Initiate treatment with BUTRANS 5 mcg/hour.
Conversion from Other Opioids to BUTRANS
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.
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. 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
|Current Opioid Analgesic||Current Daily Dose|
|Oral Morphine Equivalent||< 30 mg||30-80 mg|
|Recommended BUTRANS Starting Dose||5 mcg/hour||10 mcg/hour|
Titration and Maintenance of Therapy
Individually titrate BUTRANS to a dose that provides adequate analgesia and minimizes adverse reactions. 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 approximated within 72 hours, BUTRANS dosage adjustments may be done every 3 days. Patients who experience breakthrough pain may require dosage adjustment or rescue medication with an appropriate dose of an immediate-release opioid or non-opioid medication.
If signs of excessive opioid-related adverse reactions are observed, the current patch may be removed or next dose 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.
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.
If problems with adhesion of BUTRANS occur, the edges may be taped with first aid tape.
If BUTRANS falls off during the 7 days dosing interval, dispose of the transdermal system properly and place a new BUTRANS on at a different skin site.
When changing the system, instruct patients to remove BUTRANS, fold it over on itself, and flush it down the toilet. Alternatively, BUTRANS can be sealed in the Patch-Disposal Unit provided and then disposed of in the trash. Never throw BUTRANS away in the trash without sealing it in the Patch-Disposal Unit.
See the Instructions for Use for step-by-step instructions for applying BUTRANS.
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.
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 three strengths:
- BUTRANS 5 mcg/hour Transdermal System (dimensions: 45 mm by 45 mm)
- BUTRANS 10 mcg/hour Transdermal System (dimensions: 45 mm by 68 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 NDC 59011-750-04
BUTRANS 10 mcg/hour Transdermal System, 4-count carton NDC 59011-751-04
BUTRANS 20 mcg/hour Transdermal System, 4-count carton NDC 59011-752-04
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 Therapie-Systeme AG, Andernach, Germany. Revised July 2012.
Last reviewed on RxList: 7/19/2012
This monograph has been modified to include the generic and brand name in many instances.
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