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Fentanyl transdermal system, CII 75 mcg/hr

INDICATIONS AND USAGE 

Fentanyl Transdermal System (CII) is indicated for the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. 

Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid.

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve fentanyl 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.

IMPORTANT RISK INFORMATION

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING  RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; AND EXPOSURE TO HEAT

Addiction, Abuse, and Misuse

Fentanyl 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 fentanyl transdermal system, and monitor all patients regularly for the development of these behaviors or conditions.

Life-Threatening Respiratory Depression 

Serious, life-threatening, or fatal respiratory depression may occur with use of fentanyl transdermal system, even when used as recommended. Monitor for respiratory depression, especially during initiation of fentanyl transdermal system or following a dose increase. Because of the risk of respiratory depression, fentanyl transdermal system is contraindicated for use as an as-needed analgesic, in non-opioid tolerant patients, in acute pain, and in postoperative pain.

Accidental Exposure

Deaths due to a fatal overdose of fentanyl have occurred when children and adults were accidentally exposed to fentanyl transdermal system. Strict adherence to the recommended handling and disposal instructions is of the utmost importance to prevent accidental exposure.

Neonatal Opioid Withdrawal Syndrome

Prolonged use of fentanyl 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.

Cytochrome P450 3A4 Interaction

The concomitant use of fentanyl transdermal system with all cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations , which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in fentanyl plasma concentration. Monitor patients receiving fentanyl transdermal system and any CYP3A4 inhibitor or inducer.

Exposure To Heat

Exposure of the fentanyl transdermal system application site and surrounding area to direct external heat sources, such as heating pads or electric blankets , heat or tanning lamps, sunbathing, hot baths, saunas, hot tubs, and heated water beds may increase fentanyl absorption and has resulted in fatal overdose of fentanyl and death. Patients wearing fentanyl transdermal systems who develop fever or increased core body temperature due to strenuous exertion are also at risk for increased fentanyl exposure and may require an adjustment in the dose of fentanyl transdermal system to avoid overdose and death.

CONTRAINDICATIONS

  • Fentanyl transdermal system is contraindicated in:
    • patients who are not opioid tolerant.
    • the management of acute, intermittent,or mild pain.
    • 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).patients with significant respiratory compromise, especially if adequate monitoring and resuscitative equipment are not readily available.
    • patients with acute or severe bronchial asthma.
    • patients who have or are suspected of having paralytic ileus.
    • patients with known hypersensitivity to fentanyl or any components of the transdermal system. Severe hypersensitivity reactions, including anaphylaxis have been observed with fentanyl transdermal system. 

    WARNINGS AND PRECAUTIONS

    • Fentanyl is a Schedule II controlled substance. As an opioid, fentanyl transdermal system exposes users to the risks of addiction, abuse, and misuse. As 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.
    • While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of the fentanyl transdermal system, the risk is greatest during the initiation of therapy, or following a dose increase. Overestimating the fentanyl transdermal system dose when converting patients from another opioid product can result in fatal overdose with the first dose. Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients. In patients with chronic obstructive pulmonary disease or cor pulmonale, and patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression, fentanyl transdermal system may decrease respiratory drive to the point of apnea, particularly when initiating therapy, even at usual therapeutic doses.  
    • A considerable amount of active fentanyl remains in fentanyl transdermal system even after use as directed. Death and other serious medical problems have occurred when children and adults were accidentally exposed to fentanyl transdermal system.
    • Hypotension, profound sedation, coma, respiratory depression, and death may result if fentanyl transdermal is used concomitantly with alcohol or other central nervous system (CNS) depressants (e.g., sedatives, anxiolytics, hypnotics, neuroleptics, other opioids).
    • Patients with brain tumors or those with evidence of increased intracranial pressure, impaired consciousness, or coma may be particularly susceptible to the intracranial effects of CO2 retention. Fentanyl transdermal system may reduce respiratory drive and CO2 retention can further increase intracranial pressure. Opioids may  obscure the clinical course of patients with head injury.
    • Fentanyl transdermal system may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is an increased risk in patients whose ability to maintain blood pressure has already been compromised.
    • The concomitant use of fentanyl transdermal system with CYP3A4 inhibitors may result in an increase in fentanyl plasma concentrations. CYP450 inducers may induce the metabolism of fentanyl and, therefore may cause a decrease in fentanyl plasma concentrations. 
    • Exposure to heat may increase fentanyl absorption and there have been reports of overdose and death.
    • Serum fentanyl concentrations could theoretically increase by approximately one-third with a core body temperature of 40°C (104°F). due to temperature-dependent increases in fentanyl released from the system and increased skin permeability. 
    • Fentanyl transdermal system may cause bradycardia. Avoid use of fentanyl transdermal system in patients with severe hepatic or renal impairment.
    • Fentanyl transdermal system may cause spasm of the sphincter of Oddi.
    • The use of mixed agonist/antagonist (i.e. pentazocine, nalbuphine, and butorphanol) or partial agonist (buprenorphine) analgesics in patients who have received or are receiving a course of therapy with an opioid agonist analgesic, including fentanyl transdermal system may reduce the analgesic effect and/or may precipitate withdrawal symptoms. 
    • Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of the fentanyl transdermal system.

    ADVERSE REACTIONS

    • Serious adverse events may include respiratory depression, bradycardia, anaphylactic reactions, convulsions, hypotension or hypertension.
    • Common adverse reactions reported include nausea, vomiting, somnolence, dizziness, insomnia, constipation, hyperhidrosis, fatigue, and feeling cold.

    USE IN SPECIFIC POPULATIONS

    • Pregnancy: Opioids cross the placenta and may produce respiratory depression in neonates. Prolonged use of fentanyl transdermal system during pregnancy can result in withdrawal syndrome in the neonate, which can be life threatening.
    • The safety and effectiveness of fentanyl transdermal system in children under 2 years of age have not been established. 
    • Breastfeeding: Fentanyl is excreted in human milk and is not recommended in nursing women.

     

      Description Rectangular transparent patch
      Dosage Strength 75 mcg/hr
      Compares To DURAGESIC® 75 mcg/hr
      Identification Code Rectangular transparent unit comprising a protective liner and four functional layers. Color coded on patch, carton and blister package as 75 mcg/hr in Blue color

      Order Information

      NDC # Package Size Case Quantity
      0406-9075-76 5 24

      For additional information on Fentanyl transdermal system, CII 75 mcg/hr, call Customer Service at 1.800.325.8888 or Medical Information at 1.800.778.7898.

      DURAGESIC is a registered trademark of Johnson & Johnson.