"Young children have died or become seriously ill from accidental exposure to a skin patch containing fentanyl, a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a Drug Safety Communication to warn pa"...
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DURAGESIC 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.
DOSAGE AND ADMINISTRATION
Proper Patient Selection
Assess patients for their clinical risks for opioid abuse or addiction prior to being prescribing DURAGESIC [see WARNINGS AND PRECAUTIONS].
Opioid tolerance to an opioid of comparable potency must be established before prescribing DURAGESIC [see WARNINGS AND PRECAUTIONS].
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.
Conversion to DURAGESIC in Opioid-Tolerant Patients
The recommended starting dose when converting from other opioids to DURAGESIC is intended to minimize the potential for overdosing patients with the first dose. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with DURAGESIC [see WARNINGS AND PRECAUTIONS].
In selecting an initial DURAGESIC dose, take the following factors into account:
- 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);
- the reliability of the relative potency estimates used to calculate the DURAGESIC dose needed (potency estimates may vary with the route of administration);
- the degree of opioid tolerance;
- the general condition and medical status of the patient.
To convert adult and pediatric patients from oral or parenteral opioids to DURAGESIC, use Table 1. Do not use Table 1 to convert from DURAGESIC to other therapies because this conversion to DURAGESIC is conservative and will overestimate the dose of the new agent.
TABLE 11: DOSE CONVERSION GUIDELINES
|Current Analgesic||Daily Dosage (mg/day)|
|Intramuscular or Intravenous morphine||10-22||23-37||38-52||53-67|
|Recommended||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.
1Table 1 should not be used to convert from DURAGESIC to other therapies because this conversion to DURAGESIC 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 Titration and Maintenance of Therapy].
Alternatively, for adult and pediatric patients taking opioids or doses not listed in Table 1, use the following methodology:
- Calculate the previous 24-hour analgesic requirement.
- 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 DURAGESIC dose. Use this table to find the calculated 24-hour morphine dose and the corresponding DURAGESIC dose. Initiate DURAGESIC 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.
- Do not use Table 2 to convert from DURAGESIC to other therapies because this conversion to DURAGESIC is conservative and will overestimate the dose of the new agent.
RECOMMENDED INITIAL DURAGESIC DOSE BASED UPON DAILY ORAL MORPHINE DOSE
|Oral 24-hour Morphine (mg/day)||DURAGESIC Dose (mcg/hour)|
|NOTE: In clinical trials, these ranges of daily oral morphine
doses were used as a basis for conversion to DURAGESIC.
1Table 2 should not be used to convert from DURAGESIC to other therapies because this conversion to DURAGESIC 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 Titration and Maintenance of Therapy].
For delivery rates in excess of 100 mcg/hour, multiple systems may be used.
Avoid the use of DURAGESIC in patients with severe hepatic impairment. In patients with mild to moderate hepatic impairment, start with one half of the usual dosage of DURAGESIC. Closely monitor for signs of sedation and respiratory depression, including at each dosage increase [see WARNINGS AND PRECAUTIONS, Use In Specific Populations and CLINICAL PHARMACOLOGY].
Avoid the use of DURAGESIC in patients with severe renal impairment. In patients with mild to moderate renal impairment, start with one half of the usual dosage of DURAGESIC. Closely monitor for signs of sedation and respiratory depression, including at each dosage increase [see WARNINGS AND PRECAUTIONS, Use In Specific Populations and CLINICAL PHARMACOLOGY].
Titration and Maintenance of Therapy
Once therapy is initiated, assess pain intensity and opioid adverse reactions frequently, especially respiratory depression [see WARNINGS AND PRECAUTIONS]. Routinely monitor all patients for signs of misuse, abuse and addiction [see WARNINGS AND PRECAUTIONS].
The initial DURAGESIC dose may be increased after 3 days based on the daily dose of supplemental opioid analgesics required by the patient on the second or third day of the initial application.
It may take up to 6 days for fentanyl levels to reach equilibrium on a new dose [see CLINICAL PHARMACOLOGY]. Therefore, evaluate patients for further titration after no less than two 3-day applications before any further increase in dosage is made.
Base dosage increments on the daily dosage of supplementary opioids, using the ratio of 45 mg/24 hours of oral morphine to a 12 mcg/hour increase in DURAGESIC dose.
The majority of patients are adequately maintained with DURAGESIC administered every 72 hours. Some patients may not achieve adequate analgesia using this dosing interval and may require systems to be applied at 48 hours rather than at 72 hours, only if adequate pain control cannot be achieved using a 72-hour regimen. An increase in the DURAGESIC dose should be evaluated before changing dosing intervals in order to maintain patients on a 72-hour regimen. Dosing intervals less than every 72 hours were not studied in children and adolescents and are not recommended.
Discontinuation of DURAGESIC
To convert patients to another opioid, remove DURAGESIC and titrate the dose of the new analgesic based upon the patient's report of pain until adequate analgesia has been attained. Upon system removal, 17 hours or more are required for a 50% decrease in serum fentanyl concentrations. Withdrawal symptoms are possible in some patients after conversion or dose adjustment [see WARNINGS AND PRECAUTIONS].
Do not use Tables 1 and 2 to convert from DURAGESIC to other therapies to avoid overestimating the dose of the new agent potentially resulting in overdose of the new analgesic and death.
When discontinuing DURAGESIC and not converting to another opioid, use a gradual downward titration, such as halving the dose every 6 days, in order to reduce the possibility of withdrawal symptoms [see WARNINGS AND PRECAUTIONS]. It is not known at what dose level DURAGESIC may be discontinued without producing the signs and symptoms of opioid withdrawal.
Administration of DURAGESIC
DURAGESIC patches are for transdermal use, only.
Proper handling of DURAGESIC is advised in order to prevent adverse reactions, including death, associated with accidental secondary exposure to DURAGESIC [see WARNINGS AND PRECAUTIONS].
Application and Handling Instructions
- Patients should apply DURAGESIC to intact, non-irritated, and non-irradiated skin on a flat surface such as the chest, back, flank, or upper arm. In young children and persons with cognitive impairment, adhesion should be monitored and the upper back is the preferred location to minimize the potential of inappropriate patch removal. Hair at the application site may be clipped (not shaved) prior to system application. If the site of DURAGESIC application must be cleansed prior to application of the patch, do so with clear water. Do not use soaps, oils, lotions, alcohol, or any other agents that might irritate the skin or alter its characteristics. Allow the skin to dry completely prior to patch application.
- Patients should apply DURAGESIC immediately upon removal from the sealed package. The patch must not be altered (e.g., cut) in any way prior to application. DURAGESIC should not be used if the pouch seal is broken or if the patch is cut or damaged.
- The transdermal system is pressed firmly in place with the palm of the hand for 30 seconds, making sure the contact is complete, especially around the edges.
- Each DURAGESIC patch may be worn continuously for 72 hours. The next patch is applied to a different skin site after removal of the previous transdermal system.
- If problems with adhesion of the DURAGESIC patch occur, the edges of the patch may be taped with first aid tape. If problems with adhesion persist, the patch may be overlayed with a transparent adhesive film dressing.
- If the patch falls off before 72 hours, dispose of it by folding in half and flushing down the toilet. A new patch may be applied to a different skin site.
- Patients (or caregivers who apply DURAGESIC) should wash their hands immediately with soap and water after applying DURAGESIC.
- Contact with unwashed or unclothed application sites can result in secondary exposure to DURAGESIC and should be avoided. Examples of accidental exposure include transfer of a DURAGESIC patch from an adult's body to a child while hugging, sharing the same bed as the patient, accidental sitting on a patch and possible accidental exposure of a caregiver's skin to the medication in the patch while applying or removing the patch.
- Instruct patients, family members, and caregivers to keep patches in a secure location out of the reach of children and of others for whom DURAGESIC was not prescribed.
Avoidance of Heat
Instruct patients to avoid exposing the DURAGESIC 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, while wearing the system [see WARNINGS AND PRECAUTIONS].
Proper disposal of DURAGESIC is advised in order to prevent adverse reactions, including death, associated with accidental secondary exposure to DURAGESIC [see WARNINGS AND PRECAUTIONS].
Patients should dispose of used patches by folding the adhesive side of the patch to itself, then flush the patch down the toilet immediately upon removal.
Patients should dispose of any patches remaining from a prescription as soon as they are no longer needed. Unused patches should be removed from their pouches, fold so that the adhesive side of the patch adheres to itself, and flush down the toilet.
Dosage Forms And Strengths
DURAGESIC is available as:
- DURAGESIC 12 mcg/hour* Transdermal System (system size 5.25 cm²).
- DURAGESIC 25 mcg/hour Transdermal System (system size 10.5 cm²).
- DURAGESIC 50 mcg/hour Transdermal System (system size 21 cm²).
- DURAGESIC 75 mcg/hour Transdermal System (system size 31.5 cm²).
- DURAGESIC 100 mcg/hour Transdermal System (system size 42 cm²).
*This lowest dosage is designated as 12 mcg/hour (however, the actual dosage is 12.5 mcg/hour) to distinguish it from a 125 mcg/h dosage that could be prescribed by multiple patches.
Storage And Handling
DURAGESIC (fentanyl transdermal system) is supplied in cartons containing 5 individually packaged systems. See chart for information regarding individual systems.
|DURAGESIC Dose (mcg/h)||System Size (cm²)||Fentanyl Content (mg)||NDC Number|
|*This lowest dosage is designated as 12 mcg/h (however, the actual dosage is 12.5 mcg/h) to distinguish it from a 125 mcg/h dosage that could be prescribed by using multiple patches.|
Store in original unopened pouch. Store up to 25°C (77°F); excursions permitted to 15 -30°C (59 -86°F).
Manufactured by: ALZA Corporation, Vacaville, CA 95688. Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, NJ 08560. Sep 2013.
Last reviewed on RxList: 10/29/2013
This monograph has been modified to include the generic and brand name in many instances.
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