Medication Guide

How should I store oral transmucosal fentanyl citrate?

• Always keep oral transmucosal fentanyl citrate in a safe place away from children and from anyone for whom it has not been prescribed. Protect oral transmucosal fentanyl citrate from theft.

  • You can use the oral transmucosal fentanyl citrate Child Safety Kit to help you store oral transmucosal fentanyl citrate and your other medicines out of the reach of children. It is very important that you use the items in the oral transmucosal fentanyl citrate Child Safety Kit to help protect the children in your home or visiting your home.
  • If you were not offered a Child Safety Kit when you received your medicine, call Mallinckrodt Pharmaceutical Child Safety Kit Request Line at 1-800-223-1499 to request one.

  The oral transmucosal fentanyl citrate Child Safety Kit contains important information on the safe storage and handling of oral transmucosal fentanyl citrate.

  The Child Safety Kit includes:

  • A child-resistant lock that you use to secure the storage space where you keep oral transmucosal fentanyl citrate (See Figure 1).

  Figure 1

  • A portable locking pouch for you to keep a small supply of oral transmucosal fentanyl citrate nearby. The rest of your oral transmucosal fentanyl citrate must be kept in a locked storage space.

    • Keep this pouch secured with its lock and keep it out of the reach and sight of children (See Figure 2).

    Figure 2

    • A child-resistant temporary storage bottle (See Figure 3).

    Figure 3

    • Store oral transmucosal fentanyl citrate at room temperature, 59°F to 86°F (15°C to 30°C) until ready to use.

    • Do not freeze oral transmucosal fentanyl citrate.

    • Keep oral transmucosal fentanyl citrate in the original sealed child-resistant blister package.  Do not open the blister package until you are ready to use oral transmucosal fentanyl citrate.

    • Keep oral transmucosal fentanyl citrate dry.

      How should I dispose of oral transmucosal fentanyl citrate units when they are no longer needed?

      Disposing of oral transmucosal fentanyl citrate units after use:

      Partially used oral transmucosal fentanyl citrate units may contain enough medicine to be harmful or fatal to a child or other adults who have not been prescribed oral transmucosal fentanyl citrate. You must properly dispose of the oral transmucosal fentanyl citrate handle right away after use even if there is little or no medicine left on it.

      After you have finished the oral transmucosal fentanyl citrate unit and the medicine is totally gone, throw the handle away in a place that is out of the reach of children.

      If any medicine remains on the used oral transmucosal fentanyl citrate unit after you have finished:

    • Place the used oral transmucosal fentanyl citrate unit under hot running water until the medicine is gone, and then throw the handle away out of the reach of children and pets (See Figure 4).

    Figure 4

    Temporary Storage of Used Oral Transmucosal Fentanyl Citrate Units:

    • If you did not finish the entire oral transmucosal fentanyl citrate unit and you cannot dissolve the medicine under hot running water right away, put the used oral transmucosal fentanyl citrate unit in the temporary storage bottle that you received in the oral transmucosal fentanyl citrate Child Safety Kit. Place the oral transmucosal fentanyl citrate unit into the bottle and secure the cap. Never leave unused or partially used oral transmucosal fentanyl citrate units where children or pets can get to them (See Figure 5).

    Figure 5

    Disposing of Used Oral Transmucosal Fentanyl Citrate Units from the Temporary Storage Bottle:

    You must dispose of all used oral transmucosal fentanyl citrate units in the temporary storage bottle at least one time each day, as follows:

    1. To open the temporary storage bottle, push down on the cap until you are able to twist the cap to the left to remove it (See Figure 6).

    Figure 6

    2. Remove one oral transmucosal fentanyl citrate unit from the temporary storage bottle. Hold the oral transmucosal fentanyl citrate by its handle over the toilet bowl.

    3. Using wire-cutting pliers, cut the medicine end off so that it falls into the toilet.

    4. Throw the handle away in a place that is out of the reach of children.

    5. Repeat these 3 steps for each oral transmucosal fentanyl citrate handle that is in the storage bottle. There should not be more than 4 handles in the temporary storage bottle for 1 day.

    6. Flush the toilet twice.

    Do not flush entire unused oral transmucosal fentanyl citrate units, oral transmucosal fentanyl citrate handles, or blister packages down the toilet.

    Disposing of unopened oral transmucosal fentanyl citrate units: Dispose of any unopened oral transmucosal fentanyl citrate units remaining from a prescription as soon as they are no longer needed, as follows: 

    1. Remove all oral transmucosal fentanyl citrate from the locked storage space (See Figure 7).

    Figure 7

    2. Remove one oral transmucosal fentanyl citrate unit from its blister package by using scissors to cut off the marked end and then peel back the blister backing (See Figures 8A and 8B).

     Figure 8A

    Figure 8B

    3. Hold oral transmucosal fentanyl citrate by its handle over the toilet bowl. Use wire-cutting pliers to cut the medicine end off so that it falls into the toilet (See Figures 9A and 9B).

    Figure 9A

    Figure 9B

    4. Throw the handle away in a place that is out of the reach of children (See Figure 10).

    Figure 10

    5. Repeat steps 1 through 4 for each oral transmucosal fentanyl citrate unit.

    6. Flush the toilet twice after the medicine ends from 5 oral transmucosal fentanyl citrate units have been cut off (See Figure 11). Do not flush more than 5 oral transmucosal fentanyl citrate units at a time.

    Figure 11

    • Do not flush entire unused oral transmucosal fentanyl citrate units, oral transmucosal fentanyl citrate handles, or blister packages down the toilet.

    If you need help with the disposal of oral transmucosal fentanyl citrate, call SpecGx LLC, Product Monitoring at
    1-800-778-7898, or call your local Drug Enforcement Agency (DEA) office.

    General information about oral transmucosal fentanyl citrate

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Use oral transmucosal fentanyl citrate only for the purpose for which it was prescribed. Do not give oral transmucosal fentanyl citrate to other people, even if they have the same symptoms you have. Oral transmucosal fentanyl citrate can harm other people and even cause death. Sharing oral transmucosal fentanyl citrate is against the law.

    This Medication Guide summarizes the most important information about oral transmucosal fentanyl citrate. If you would like more information, talk with your healthcare provider or pharmacist. You can ask your pharmacist or healthcare provider for information about oral transmucosal fentanyl citrate that is written for healthcare professionals. For more information about the TIRF REMS Access program, go to www.TIRFREMSAccess.com or call 1-866-822-1483.

    What are the ingredients of oral transmucosal fentanyl citrate?

    Active Ingredient:  fentanyl citrate

    Inactive Ingredients: Raspberry flavor, citric acid, confectioners sugar, dextrates, magnesium stearate, dibasic sodium phosphate, modified food starch, ethanol, water, purified shellac, propylene glycol, FD&C blue no. 1, ammonium hydroxide.

    Patient Instructions for Use

    Before you use oral transmucosal fentanyl citrate, it is important that you read the Medication Guide and these Patient Instructions for Use.  Be sure that you read, understand, and follow these Patient Instructions for Use so that you use oral transmucosal fentanyl citrate the right way. Ask your healthcare provider or pharmacist if you have any questions about the right way to use oral transmucosal fentanyl citrate.

    When you get an episode of breakthrough cancer pain, use the dose of oral transmucosal fentanyl citrate prescribed by your healthcare provider as follows:

    • You may drink some water before using oral transmucosal fentanyl citrate but you should not drink or eat anything while using oral transmucosal fentanyl citrate.

    • Each unit of oral transmucosal fentanyl citrate is sealed in its own blister package (See Figure 12). Do not open the blister package until you are ready to use oral transmucosal fentanyl citrate.

    Figure 12

    • When you are ready to use oral transmucosal fentanyl citrate, cut open the package using scissors. Peel back the blister backing, and remove the oral transmucosal fentanyl citrate unit (See Figures 13A and 13B). The end of the unit printed with “FENTANYL” and the strength number of the unit (“200MCG”, “400MCG”, “600MCG”, “800MCG”, “1200MCG”, or “1600MCG”) is the medicine end that is to be placed in your mouth. Hold the oral transmucosal fentanyl citrate unit by the handle (See Figure 14).

    Figure 13A

    Figure 13B

    Figure 14

    1. Place the medicine end of the oral transmucosal fentanyl citrate unit in your mouth between your cheeks and gums and actively suck on the medicine.

    2. Move the medicine end of the oral transmucosal fentanyl citrate unit around in your mouth, especially along the inside of your cheeks (See Figure 15).

    Figure 15

    3. Twirl the handle often.

    4. Finish the oral transmucosal fentanyl citrate unit completely over 15 minutes to get the most relief. If you finish oral transmucosal fentanyl citrate too quickly, you will swallow more of the medicine and get less relief.

    5. Do not bite or chew oral transmucosal fentanyl citrate. You will get less relief for your breakthrough cancer pain.

    • If you cannot finish all of the medicine on the oral transmucosal fentanyl citrate unit and cannot dissolve the medicine under hot tap water right away, immediately put the oral transmucosal fentanyl citrate unit in the temporary storage bottle for safe keeping (See Figure 16).

      • Place the oral transmucosal fentanyl citrate unit into the bottle and secure the cap. You must properly dispose of the oral transmucosal fentanyl citrate unit as soon as you can.       

    Figure 16

    See “How should I dispose of oral transmucosal fentanyl citrate units when they are no longer needed?” for proper disposal of oral transmucosal fentanyl citrate.

    Manufactured by:
    SpecGx LLC
    Webster Groves, MO 63119 USA 

    Revised 03/2021
    1110000

    Mallinckrodt™

    This Medication Guide has been approved by the U.S. Food and Drug Administration.