FENTANYL TRANSDERMAL SYSTEM

FENTANYL TRANSDERMAL SYSTEM- fentanyl patch, extended release
Lake Erie Medical DBA Quality Care Products LLC

WARNING: ABUSE POTENTIAL, RESPIRATORY DEPRESSION AND DEATH, ACCIDENTAL EXPOSURE, CYTOCHROME P450 3A4 INTERACTION, AND EXPOSURE TO HEAT

Abuse Potential

Fentanyl transdermal system contains fentanyl, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics. Fentanyl transdermal system can be abused in a manner similar to other opioid agonists, legal or illicit. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Assess patients for their clinical risks for opioid abuse or addiction prior to prescribing fentanyl transdermal system and then routinely monitor all patients for signs of misuse, abuse and addiction during treatment [see Warnings and Precautions (5.1) and Drug Abuse and Dependence (9)].

Respiratory Depression and Death

Respiratory depression and death may occur with use of fentanyl transdermal system, even when fentanyl transdermal system has been used as recommended and not misused or abused. Proper dosing and titration are essential and fentanyl transdermal system should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Fentanyl transdermal system is contraindicated for use in conditions in which the risk of life-threatening respiratory depression is significantly increased, including use as an as-needed analgesic, use in non-opioid tolerant patients, acute pain, and postoperative pain. Monitor for respiratory depression, especially during the first two applications following initiation of dosing, or following an increase in dosage [see Contraindications (4) and Warnings and Precautions (5.2)].

Accidental Exposure

Death and other serious medical problems have occurred when children and adults were accidentally exposed to fentanyl transdermal system. Advise patients about strict adherence to the recommended handling and disposal instructions in order to prevent accidental exposure [see Dosage and Administration (2.3) (2.4) and Warnings and Precautions (5.3)].

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. Monitor patients receiving fentanyl transdermal system and any CYP3A4 inhibitor [see Warnings and Precautions (5.8), and Clinical Pharmacology (12.3)].

Exposure To Heat

The fentanyl transdermal system application site and surrounding area must not be exposed 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. Exposure to heat may increase fentanyl absorption and there have been reports of overdose and death as a result of exposure to heat (5.9). 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 (5.10).

1 INDICATIONS AND USAGE

Fentanyl transdermal system is a transdermal formulation of fentanyl indicated for the management of persistent, moderate to severe chronic pain in opioid-tolerant patients 2 years of age and older when a continuous, around-the-clock opioid analgesic is required for an extended period of time, and the patient cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids.

Patients considered opioid-tolerant are those who are taking 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 for a week or longer.

2 DOSAGE AND ADMINISTRATION

2.1 Proper Patient Selection

Abuse Potential

Assess patients for their clinical risks for opioid abuse or addiction prior to being prescribing fentanyl transdermal system [see Warnings and Precautions (5.1)].

Opioid Tolerance

Opioid tolerance to an opioid of comparable potency must be established before prescribing fentanyl transdermal system [see Warnings and Precautions (5.2)].

Patients considered opioid-tolerant are those who are taking 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 for a week or longer.

2.2 Dosing

Conversion to Fentanyl Transdermal System in Opioid-Tolerant Patients

The recommended starting dose when converting from other opioids to fentanyl transdermal system is intended to minimize the potential for overdosing patients with the first dose. Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with fentanyl transdermal system [see Warnings and Precautions (5.2)].

In selecting an initial fentanyl transdermal system dose, take the following factors into account:

1. the daily dose, potency, and characteristics of the opioid the patient has been taking previously (e.g., whether it is a pure agonist or mixed agonist-antagonist);

2. the reliability of the relative potency estimates used to calculate the fentanyl transdermal system dose needed (potency estimates may vary with the route of administration);

3. the degree of opioid tolerance;

4. the general condition and medical status of the patient.

To convert adult and pediatric patients from oral or parenteral opioids to fentanyl transdermal system, use Table 1. Do not use Table 1 to convert from fentanyl transdermal system to other therapies because this conversion to fentanyl transdermal system is conservative and will overestimate the dose of the new agent.

TABLE 1*: DOSE CONVERSION GUIDELINES

Current Analgesic

Daily Dosage (mg/day)

Oral morphine

60-134

135-224

225-314

315-404

Intramuscular or Intravenous morphine

10-22

23-37

38-52

53-67

Oral oxycodone

30-67

67.5-112

112.5-157

157.5-202

Intramuscular or Intravenous oxycodone

15-33

33.1-56

56.1-78

78.1-101

Oral codeine

150-447

448-747

748-1047

1048-1347

Oral hydromorphone

8-17

17.1-28

28.1-39

39.1-51

Intravenous hydromorphone hydromorphone

1.5-3.4

3.5-5.6

5.7-7.9

8-10

Intramuscular meperidine

75-165

166-278

279-390

391-503

Oral methadone

20-44

45-74

75-104

105-134

Intramuscular methadone

10-22

23-37

38-52

53-67

Recommended Fentanyl Transdermal System Dose

25 mcg/hour

50 mcg/hour

75 mcg/hour

100 mcg/hour

Alternatively, for adult and pediatric patients taking opioids or doses not listed in Table 1 , use the conversion methodology outlined above with Table 2.

* Table 1 should not be used to convert from fentanyl transdermal system to other therapies because this conversion to fentanyl transdermal system is conservative. Use of Table 1 for conversion to other analgesic therapies can overestimate the dose of the new agent. Overdosage of the new analgesic agent is possible [see Dosage and Administration (2.3)].

Alternatively, for adult and pediatric patients taking opioids or doses not listed in Table 1 , use the following methodology:

1. Calculate the previous 24-hour analgesic requirement.

2. Convert this amount to the equianalgesic oral morphine dose using a reliable reference.

Refer to Table 2 for the range of 24-hour oral morphine doses that are recommended for conversion to each fentanyl transdermal system dose. Use this table to find the calculated 24‑hour morphine dose and the corresponding fentanyl transdermal system dose. Initiate fentanyl transdermal system treatment using the recommended dose and titrate patients upwards (no more frequently than 3 days after the initial dose and every 6 days thereafter) until analgesic efficacy is attained.

3. Do not use Table 2 to convert from fentanyl transdermal system to other therapies because this conversion to fentanyl transdermal system is conservative and will overestimate the dose of the new agent.

TABLE 2*: RECOMMENDED INITIAL FENTANYL TRANSDERMAL SYSTEM DOSE BASED UPON DAILY ORAL MORPHINE DOSE

Oral 24-hour

Morphine

(mg/day)

Fentanyl Transdermal System

Dose

(mcg/hour)

60-134

25

135-224

50

225-314

75

315-404

100

405-494

125

495-584

150

585-674

175

675-764

200

765-854

225

855-944

250

945-1034

275

1035-1124

300

NOTE: In clinical trials, these ranges of daily oral morphine doses were used as a basis for conversion to fentanyl transdermal system.

* Table 2 should not be used to convert from fentanyl transdermal system to other therapies because this conversion to fentanyl transdermal system is conservative. Use of Table 2 for conversion to other analgesic therapies can overestimate the dose of the new agent. Overdosage of the new analgesic agent is possible [see Dosage and Administration (2.3)].

For delivery rates in excess of 100 mcg/hour, multiple systems may be used.

Hepatic Impairment

Avoid the use of fentanyl transdermal system in patients with severe hepatic impairment. In patients with mild to moderate hepatic impairment, start with one half of the usual dosage of fentanyl transdermal system. Closely monitor for signs of sedation and respiratory depression, including at each dosage increase [see Warnings and Precautions (5.12), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

Renal Impairment

Avoid the use of fentanyl transdermal system in patients with severe renal impairment. In patients with mild to moderate renal impairment, start with one half of the usual dosage of fentanyl transdermal system. Closely monitor for signs of sedation and respiratory depression, including at each dosage increase [see Warnings and Precautions (5.13), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

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