Proper Use of This Medicine

Transmucosal fentanyl contains a medicine in an amount which can be fatal to a child . Patients and their caregivers should keep transmucosal fentanyl out of the reach of children and discard open units properly.

Transmucosal fentanyl comes with patient instructions. Read them carefully before using the product.

How to use transmucosal fentanyl:
• Keep medication in sealed pouch until ready to use.
• The foil package should be opened with scissors immediately prior to product use.
• Place the medicine in mouth between the cheek and lower gum, occasionally moving the medicine from one side to the other using the handle.
• The medicine should be sucked, not chewed.
• Suck the medicine over a 15-minute period.

Dosing—The dose of transmucosal fentanyl will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of transmucosal fentanyl. If your dose is different, do not change it unless your doctor tells you to do so.

The number of units that you use will depend on the strength of the medicine. Also, the number of doses you use each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using transmucosal fentanyl .

• For oral transmucosal dosage form :
  • For cancer pain:
    • Adults—The initial dose to treat episodes of breakthrough cancer pain in patients who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain is 200 micrograms.
      Redosing may start 15 minutes after the previous dose has been completed (30 minutes after the start of the previous dose). Patients should not use more than 2 units per episode of breakthrough pain. Patients should record their use over several episodes of breakthrough cancer pain and review their experience with their physicians to determine if a dosage adjustment is warranted.
    • Children—Use and dose must be determined by the doctor.

Missed dose—If your medical doctor has ordered you to use this medicine according to a regular schedule and you miss a dose, use it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses .

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.
• Do not use if the foil pouch has been opened.
• A temporary storage bottle is provided as part of the Actiq ^{[reg ]} Welcome Kit. This container is to be used by patients or their caregivers in the event that a partially consumed unit cannot be disposed of promptly. If additional assistance is required, refer to 1-800-615-0187.