Butrans® (buprenorphine) Transdermal System is indicated for the
management of moderate to severe chronic pain when a continuous,
around-the-clock opioid analgesic is needed for an extended period of time.
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.
One Butrans—7 Days
of Buprenorphine Delivery
Butrans is a Schedule III, single-entity opioid analgesic
Initiate treatment with Butrans 5 mcg/hour when Butrans is the patient’s first opioid analgesic
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
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ADMINISTRATION OF BUTRANS
Butrans is for transdermal use (on intact
skin) only. Each Butrans is intended to be
worn for 7 days
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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
Instruct patients to apply immediately after
removal from the individually sealed pouch
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
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removal, wait a minimum of 21 days
before reapplying to the same skin site
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
WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, and ACCIDENTAL EXPOSURE
Abuse Potential
Butrans contains buprenorphine, an opioid agonist and Schedule III controlled substance with an abuse liability
similar to other Schedule III opioids, legal or illicit [see Warnings and Precautions (5.1)]. Assess each patient’s
risk for opioid abuse or addiction prior to prescribing Butrans. The risk for opioid abuse is increased in patients
with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental
illness (eg, major depressive disorder). Routinely monitor all patients receiving Butrans for signs of misuse,
abuse, and addiction during treatment [see Drug Abuse and Dependence (9)].
Life-Threatening Respiratory Depression
Respiratory depression, including fatal cases, may occur with use of Butrans, even when the drug has been used
as recommended and not misused or abused [see Warnings and Precautions (5.2)]. Proper dosing and titration
are essential and Butrans should only be prescribed by healthcare professionals who are knowledgeable in the
use of potent opioids for the management of chronic pain. Monitor for respiratory depression, especially during
initiation of Butrans or following a dose increase.
Accidental Exposure
Accidental exposure to Butrans, especially in children, can result in a fatal overdose of buprenorphine [see
Warnings and Precautions (5.3)].
Parentheses refer to sections in the Full Prescribing Information.