FENTANYL CITRATE- fentanyl citrate lozenge 
Teva Pharmaceuticals USA, Inc.

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MEDICATION GUIDE

Oral Transmucosal Fentanyl Citrate (OTFC)

(fentanyl citrate) oral transmucosal lozenge, CII

IMPORTANT:

Do not use Oral Transmucosal Fentanyl Citrate (OTFC) unless you are regularly using another opioid pain medicine around-the-clock for at least one week or longer for your cancer pain and your body is used to these medicines (this means that you are opioid tolerant). You can ask your healthcare provider if you are opioid tolerant.

Keep OTFC in a safe place away from children.

Get emergency medical help right away if:

  • a child takes OTFC. OTFC can cause an overdose and death in any child who uses it.
  • an adult who has not been prescribed OTFC uses it.
  • an adult who is not already taking opioids around-the-clock, uses OTFC.

These are medical emergencies that can cause death. If possible, remove OTFC from the mouth.

Oral Transmucosal Fentanyl Citrate (OTFC) is:

Important information about Oral Transmucosal Fentanyl Citrate (OTFC):

Do not take Oral Transmucosal Fentanyl Citrate (OTFC) if:

Before taking Oral Transmucosal Fentanyl Citrate (OTFC), tell your healthcare provider if you have a history of:

Tell your healthcare provider if you are:

When taking Oral Transmucosal Fentanyl Citrate (OTFC):

The possible side effects of Oral Transmucosal Fentanyl Citrate (OTFC):

Get emergency medical help if you have:

These are not all the possible side effects of OTFC. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov

How should I store Oral Transmucosal Fentanyl Citrate (OTFC)?

The OTFC Child Safety Kit contains important information on the safe storage and handling of OTFC.

The Child Safety Kit includes:

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Figure 1

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Figure 2

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Figure 3

How should I dispose of Oral Transmucosal Fentanyl Citrate (OTFC) units when they are no longer needed?

Disposing of OTFC units after use:

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

After you have finished the OTFC 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 OTFC unit after you have finished:

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Figure 4

Temporary Storage of Used OTFC Units:

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Figure 5

Disposing of Used OTFC Units from the Temporary Storage Bottle:

You must dispose of all used OTFC 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).

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Figure 6

2. Remove one OTFC unit from the temporary storage bottle. Hold the OTFC 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 OTFC 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 OTFC units, OTFC handles, or blister packages down the toilet.

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

1. Remove all OTFC from the locked storage space (See Figure 7).

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Figure 7

2. Remove one OTFC 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).

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Figure 8A Figure 8B
3. Hold OTFC 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).

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Figure 9A Figure 9B
4. Throw the handle away in a place that is out of the reach of children (See Figure 10).

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Figure 10

5. Repeat steps 1 through 4 for each OTFC unit.
6. Flush the toilet twice after the medicine ends from 5 OTFC units have been cut off (See Figure 11). Do not flush more than 5 OTFC units at a time.

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Figure 11

If you need help with disposal of OTFC, call Teva Pharmaceuticals at 1-888-483-8279, or call your local Drug Enforcement Agency (DEA) office.

General information about Oral Transmucosal Fentanyl Citrate (OTFC)

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

This Medication Guide summarizes the most important information about OTFC. If you would like more information, talk with your healthcare provider or pharmacist. You can ask your pharmacist or healthcare provider for information about OTFC 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 (OTFC)?

Active Ingredient: fentanyl citrate

Inactive Ingredients: sugar, citric acid, dibasic sodium phosphate, artificial berry flavor, magnesium stearate, modified food starch and confectioner’s sugar.

Patient Instructions for Use

Before you use OTFC, 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 OTFC the right way. Ask your healthcare provider or pharmacist if you have any questions about the right way to use OTFC.

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


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Figure 12

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Figure 13A Figure 13B

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Figure 14

1. Place the medicine end of the OTFC unit in your mouth between your cheeks and gums and actively suck on the medicine.
2. Move the medicine end of the OTFC unit around in your mouth, especially along the inside of your cheeks (See Figure 15).

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Figure 15

3. Twirl the handle often.
4. Finish the OTFC unit completely over 15 minutes to get the most relief. If you finish OTFC too quickly, you will swallow more of the medicine and get less relief.
5. Do not bite or chew OTFC. You will get less relief for your breakthrough cancer pain.

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Figure 16

See “How should I dispose of Oral Transmucosal Fentanyl Citrate (OTFC) units when they are no longer needed?” for proper disposal of OTFC.

Distributed by:

Teva Pharmaceuticals USA, Inc. call 1-888-483-8279
North Wales, PA 19454

Revised 10/2019

OTFMG-014
©2000-2019 Cephalon, Inc., a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd. All rights reserved.
Printed in USA

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

Revised: 10/2019
Teva Pharmaceuticals USA, Inc.