Fentanyl – Novaplus

Fentanyl – Novaplus Manufacturers

• Watson Laboratories, Inc.
  

  ×

  Fentanyl – Novaplus | Watson Laboratories, Inc.

  

  ---

  2.1 Proper Patient Selection

  Abuse Potential
  Assess patients for their clinical risks for opioid abuse or addiction prior to 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 24-72 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:

  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 fentanyl transdermal system 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 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 11: 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  Oral codeine  150-447        Oral hydromorphone  8-17  17.1-28 28.1-39  39.1-51  Intravenous 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    ↓  ↓ ↓ ↓  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.

  1 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:

  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 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. 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 21: 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.

  1 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)].

  2.3 Titration and Maintenance of Therapy

  Once therapy is initiated, assess pain intensity and opioid adverse reactions frequently, especially respiratory depression [see Warnings and Precautions (5.2)]. Routinely monitor all patients for signs of misuse, abuse and addiction [see Warnings and Precautions (5.1)].

  The initial fentanyl transdermal system 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 (12.3)]. 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 fentanyl transdermal system dose.

  The majority of patients are adequately maintained with fentanyl transdermal system 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 fentanyl transdermal system 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 Fentanyl Transdermal System
  To convert patients to another opioid, remove fentanyl transdermal system 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 (5.15)].

  Do not use Tables 1 and 2 to convert from fentanyl transdermal system to other therapies to avoid overestimating the dose of the new agent potentially resulting in overdose of the new analgesic and death.

  When discontinuing fentanyl transdermal system 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 (5.15)]. It is not known at what dose level fentanyl transdermal system may be discontinued without producing the signs and symptoms of opioid withdrawal.

  2.4 Administration of Fentanyl Transdermal System

  Fentanyl transdermal system patches are for transdermal use, only.

  Proper handling of fentanyl transdermal system is advised in order to prevent adverse reactions, including death, associated with accidental secondary exposure to fentanyl transdermal system [see Warnings and Precautions (5.3)].

  Application and Handling Instructions

  Patients should apply fentanyl transdermal system 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 fentanyl transdermal system 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 fentanyl transdermal system immediately upon removal from the sealed package. The patch must not be altered (e.g., cut) in any way prior to application. fentanyl transdermal system 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 fentanyl transdermal system 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 fentanyl transdermal system 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 fentanyl transdermal system) should wash their hands immediately with soap and water after applying fentanyl transdermal system. Contact with unwashed or unclothed application sites can result in secondary exposure to fentanyl transdermal system and should be avoided. Examples of accidental exposure include transfer of a fentanyl transdermal system 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 fentanyl transdermal system was not prescribed.

  Avoidance of Heat
  Instruct patients to avoid exposing 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, while wearing the system [see Warnings and Precautions (5.9)].

  2.5 Disposal Instructions

  Proper disposal of fentanyl transdermal system is advised in order to prevent adverse reactions, including death, associated with accidental secondary exposure to fentanyl transdermal system [see Warnings and Precautions (5.3)].

  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.

  Close
  No Recall

  More Info