BUPRENORPHINE- buprenorphine patch, extended release
Teva Pharmaceuticals USA, Inc.
WARNING: ADDICTION, ABUSE, and MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Addiction, Abuse, and Misuse
Buprenorphine transdermal system exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing buprenorphine transdermal system, and monitor all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1) and Overdosage (10)].
Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS): To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products [see Warnings and Precautions (5.2)]. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to
- complete a REMS-compliant education program,
- counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products,
- emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and
- consider other tools to improve patient, household, and community safety.
L ife-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of buprenorphine transdermal system. Monitor for respiratory depression, especially during initiation of buprenorphine transdermal system or following a dose increase. Misuse or abuse of buprenorphine transdermal system by chewing, swallowing, snorting or injecting buprenorphine extracted from the transdermal system will result in the uncontrolled delivery of buprenorphine and pose a significant risk of overdose and death [see Warnings and Precautions (5.3)].
Accidental exposure to even one dose of buprenorphine transdermal system, especially in children, can result in a fatal overdose of buprenorphine [see Warnings and Precautions (5.3)].
Neonatal Opioid Withdrawal Syndrome
P rolonged use of buprenorphine transdermal system during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions (5.4)].
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see Warnings and Precautions (5.5), Drug Interactions (7)].
- Reserve concomitant prescribing of buprenorphine transdermal system and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
- L i m it dosages and durations to the minimum required.
- Follow patients for signs and symptoms of respiratory depression and sedation.
Buprenorphine transdermal system 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.
L imitations 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 [see Warnings and Precautions (5.1)] , reserve buprenorphine transdermal system 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.
- Buprenorphine transdermal system is not indicated as an as-needed (prn) analgesic
Buprenorphine transdermal system should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.
Buprenorphine transdermal system doses of 7.5 mcg/hour, 10 mcg/hour, 15 mcg/hour, and 20 mcg/hour are only for use in patients who are opioid experienced and in whom tolerance to an opioid of comparable potency has been established. Patients who are opioid-experienced are those receiving, for one week or longer, daily opioid doses up to 80 mg/day of oral morphine or an equianalgesic dose of another opioid.
- Use the lowest effective dosage for the shortest duration consistent with individual patient’s treatment goals [see Warnings and Precautions (5)].
- Initiate the dosing regimen for each patient individually, taking into account the patient’s severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1)].
- Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dosage increases with buprenorphine transdermal system [see Warnings and Precautions (5.3)].
- Instruct patients not to use buprenorphine transdermal system if the pouch seal is broken or the patch is cut, damaged, or changed in any way and not to cut buprenorphine transdermal system.
- Instruct patients to avoid exposing buprenorphine transdermal system to external heat sources, hot water, or prolonged direct sunlight [see Warnings and Precautions (5.15)].
Buprenorphine transdermal system is for transdermal use (on intact skin) only. Each buprenorphine transdermal system patch is intended to be worn for 7 days.
Use of Buprenorphine Transdermal System as the First Opioid Analgesic (opioid-naive patients)
Initiate treatment with buprenorphine transdermal system with a 5 mcg/hour patch.
C onversion from Other Opioids to Buprenorphine Transdermal System
Discontinue all other around-the-clock opioid drugs when buprenorphine transdermal system 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 buprenorphine transdermal system 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 buprenorphine transdermal system. Then initiate treatment with buprenorphine transdermal system 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 buprenorphine transdermal system is attained.
Prior Total Daily Dose of Opioid Greater than 80 mg of Oral Morphine Equivalents per Day:
Buprenorphine transdermal system 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.
Previous Opioid Analgesic
30 mg to 80 mg
(Oral Morphine Equivalent)
Recommended Buprenorphine Transdermal System Starting Dose
C onversion from Methadone to Buprenorphine Transdermal System
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.
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