FENTANYL (Page 4 of 17)

2.9 Safe Reduction or Discontinuation of Fentanyl Transdermal System

Do not abruptly discontinue fentanyl transdermal system in patients who may be physically dependent on opioids. Rapid discontinuation of opioid analgesics in patients who are physically dependent on opioids has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide. Rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. Patients may also attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances.

When a decision has been made to decrease the dose or discontinue therapy in an opioid-dependent patient using fentanyl transdermal system, there are a variety of factors that should be considered, including the total daily dose of opioid (including fentanyl transdermal system) the patient has been using, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient. It is important to ensure ongoing care of the patient and to agree on an appropriate tapering schedule and follow-up plan so that patient and provider goals and expectations are clear and realistic. When opioid analgesics are being discontinued due to a suspected substance use disorder, evaluate and treat the patient, or refer for evaluation and treatment of the substance use disorder. Treatment should include evidence-based approaches, such as medication assisted treatment of opioid use disorder. Complex patients with comorbid pain and substance use disorders may benefit from referral to a specialist.

There are no standard opioid tapering schedules that are suitable for all patients. Good clinical practice dictates a patient-specific plan to taper the dose of the opioid gradually. For patients on fentanyl transdermal system who are physically opioid-dependent, initiate the taper by a small enough increment (e.g., no greater than 25% of the total daily dose) to avoid withdrawal symptoms, and proceed with dose-lowering at an interval of every 2 to 4 weeks. Patients who have been taking opioids for briefer periods of time may tolerate a more rapid taper.

It may be necessary to provide the patient with a lower dosage strength to accomplish a successful taper. Reassess the patient frequently to manage pain and withdrawal symptoms, should they emerge. Common withdrawal symptoms include restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. If withdrawal symptoms arise, it may be necessary to pause the taper for a period of time or raise the dose of the opioid analgesic to the previous dose, and then proceed with a slower taper. In addition, evaluate patients for any changes in mood, emergence of suicidal thoughts, or use of other substances.

When managing patients taking opioid analgesics, particularly those who have been treated for an extended period of time and/or with high doses for chronic pain, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper. A multimodal approach to pain management may optimize the treatment of chronic pain, as well as assist with the successful tapering of the opioid analgesic [see Warnings and Precautions (5.21), Drug Abuse and Dependence (9.3)].

3 DOSAGE FORMS AND STRENGTHS

Fentanyl Transdermal System is available as 12 mcg/hour*, 25 mcg/hour, 37.5 mcg/hour, 50 mcg/hour, 62.5 mcg/hour, 75 mcg/hour, 87.5 mcg/hour or 100 mcg/hour of fentanyl.

The 12 mcg/hour* (system size 3.13 cm2) transdermal system consists of a translucent rectangular patch with rounded corners, printed with “Fentanyl 12 mcg/hr” and diagonal stripes in blue ink, on a removable release liner. The patch is overlaid and underlaid with additional release liners, and is contained in a square pouch. The pouch is labeled with the lot number and expiration date.
The 25 mcg/hour (system size 6.25 cm2) transdermal system consists of a translucent rectangular patch with rounded corners, printed with “Fentanyl 25 mcg/hr” and diagonal stripes in blue ink, on a removable release liner. The patch is overlaid and underlaid with additional release liners, and is contained in a square pouch. The pouch is labeled with the lot number and expiration date.
The 37.5 mcg/hour (system size 9.38 cm2) transdermal system consists of a translucent rectangular patch with rounded corners, printed with “Fentanyl 37.5 mcg/hr” and diagonal stripes in blue ink, on a removable release liner. The patch is overlaid and underlaid with additional release liners, and is contained in a square pouch. The pouch is labeled with the lot number and expiration date.
The 50 mcg/hour (system size 12.5 cm2) transdermal system consists of a translucent rectangular patch with rounded corners, printed with “Fentanyl 50 mcg/hr” and diagonal stripes in blue ink, on a removable release liner. The patch is overlaid and underlaid with additional release liners, and is contained in a square pouch. The pouch is labeled with the lot number and expiration date.
The 62.5 mcg/hour (system size 15.63 cm2) transdermal system consists of a translucent rectangular patch with rounded corners, printed with “Fentanyl 62.5 mcg/hr” and diagonal stripes in blue ink, on a removable release liner. The patch is overlaid and underlaid with additional release liners, and is contained in a square pouch. The pouch is labeled with the lot number and expiration date.
The 75 mcg/hour (system size 18.75 cm2) transdermal system consists of a translucent rectangular patch with rounded corners, printed with “Fentanyl 75 mcg/hr” and diagonal stripes in blue ink, on a removable release liner. The patch is overlaid and underlaid with additional release liners, and is contained in a square pouch. The pouch is labeled with the lot number and expiration date.
The 87.5 mcg/hour (system size 21.88 cm2) transdermal system consists of a translucent rectangular patch with rounded corners, printed with “Fentanyl 87.5 mcg/hr” and diagonal stripes in blue ink, on a removable release liner. The patch is overlaid and underlaid with additional release liners, and is contained in a square pouch. The pouch is labeled with the lot number and expiration date.
The 100 mcg/hour (system size 25 cm2) transdermal system consists of a translucent rectangular patch with rounded corners, printed with “Fentanyl 100 mcg/hr” and diagonal stripes in blue ink, on a removable release liner. The patch is overlaid and underlaid with additional release liners, and is contained in a square pouch. The pouch is labeled with the lot number and expiration date.

*This lowest strength is designated as 12 mcg/hour (however, the actual strength is 12.5 mcg/hour) to distinguish it from a possible 125 mcg/hour dosage that could be prescribed by using multiple transdermal systems.

4 CONTRAINDICATIONS

Fentanyl transdermal system is contraindicated in:

patients who are not opioid-tolerant.
the management of acute or intermittent pain, or in patients who require opioid analgesia for a short period of time.
the management of post-operative pain, including use after out-patient or day surgeries, (e.g., tonsillectomies).
the management of mild pain.
patients with significant respiratory depression [see Warnings and Precautions (5.12)].
in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.12)].
in patients with known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.19)].
in patients with hypersensitivity to fentanyl (e.g., anaphylaxis) or any components of the transdermal system [see Adverse Reactions (6.2)].

5 WARNINGS AND PRECAUTIONS

5.1 Addiction, Abuse, and Misuse

Fentanyl transdermal system contains fentanyl, an opioid agonist and a Schedule II controlled substance. As an opioid, fentanyl transdermal system exposes users to the risks of addiction, abuse, and misuse. Because modified-release products such as fentanyl transdermal system deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of fentanyl present [see Drug Abuse and Dependence (9)].

Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed fentanyl transdermal system. Addiction can occur at recommended doses and if the drug is misused or abused.

Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing fentanyl transdermal system, and reassess all patients receiving fentanyl transdermal system for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as fentanyl transdermal system, but use in such patients necessitates intensive counseling about the risks and proper use of fentanyl transdermal system along with frequent reevaluation for signs of addiction, abuse, and misuse. Consider prescribing naloxone for the emergency treatment of opioid overdose [see Dosage and Administration (2.2), Warnings and Precautions (5.2)].

Abuse or misuse of fentanyl transdermal system by placing it in the mouth, chewing it, swallowing it, or using it in ways other than indicated may cause choking, overdose, and death [see Overdosage (10)].

Opioids are sought for nonmedical use and are subject to diversion from legitimate prescribed use. Consider these risks when prescribing or dispensing fentanyl transdermal system. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on careful storage of the drug during the course of treatment and proper disposal of unused drug. Contact local state professional licensing board or state-controlled substances authority for information on how to prevent and detect abuse or diversion of this product.

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