Fentanyl Lozenge

• It is used to ease pain.
• This medicine is not for mild pain or pain that only lasts a short time (like headaches, toothaches, or pain after surgery).

• Tell all of your health care providers that you take fentanyl lozenge. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Do not stop taking fentanyl lozenge all of a sudden without calling your doctor. You may have a greater risk of signs of withdrawal. If you need to stop this medicine, you will want to slowly stop it as ordered by your doctor.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Do not take fentanyl lozenge with other strong pain drugs or if you are using a pain patch without talking to your doctor first.
• Avoid grapefruit and grapefruit juice.
• This medicine may raise the chance of seizures in some people, including people who have had seizures in the past. Talk to your doctor to see if you have a greater chance of seizures while taking this medicine.
• If you are 65 or older, use fentanyl lozenge with care. You could have more side effects.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this medicine, call your doctor right away.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time fentanyl lozenge is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take fentanyl lozenge or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to fentanyl lozenge. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Table 3 includes clinically significant drug interactions with oral transmucosal fentanyl citrate.

Table 3: Clinically Significant Drug Interactions with Oral Transmucosal Fentanyl Citrate

Clinical Presentation

Acute overdose with oral transmucosal fentanyl citrate can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin,constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [see Clinical Pharmacology (12.2)].

Treatment of Overdose

In case of overdose, priorities are: removal of the oral transmucosal fentanyl citrate unit, if still in the mouth, the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support techniques.

The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to fentanyl overdose, administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to fentanyl overdose.

Because the duration of opioid reversal is expected to be less than the duration of action of fentanyl in oral transmucosal fentanyl citrate, carefully monitor the patient until spontaneous respiration is reliably re-established. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product’s prescribing information.

In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be begun with care and by titration with smaller than usual doses of the antagonist.

Oral transmucosal fentanyl citrate is supplied in six dosage strengths. Each unit is individually wrapped in a child-resistant, protective blister package. These blister packages are packed 30 per shelf carton for use when patients have been titrated to the appropriate dose.

Each dosage unit has a white to off-white color. Each individual solid drug matrix is marked with “FENTANYL” and the strength of the unit (“200 MCG”, “400 MCG”, “600 MCG”, “800 MCG”, “1200 MCG”, or “1600 MCG”). The dosage strength is also marked on the handle tag, the blister package and the carton. See blister package and carton for product information.

Note: Colors are a secondary aid in product identification. Please be sure to confirm the printed dosage before dispensing.

Store at 20° to 25°C (68° to 77°F) with excursions permitted between 15° and 30°C (59° to 86°F) until ready to use [see USP Controlled Room Temperature]. Protect oral transmucosal fentanyl citrate from freezing and moisture. Do not use if the blister package has been opened.

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Life-Threatening Respiratory Depression

Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting oral transmucosal fentanyl citrate or when the dosage is increased, and that it can occur even at recommended dosages [see Warnings and Precautions (5.1)]. Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop.

Accidental Ingestion

Physicians and dispensing pharmacists must specifically question patients or caregivers about the presence of children in the home (on a full time or visiting basis) and counsel them regarding the dangers to children from inadvertent exposure [see Warnings and Precautions (5.2)].

Inform patients that accidental ingestion, especially in children, may result in respiratory depression or death [see Warnings and Precautions (5.2)].

Instruct patients to take steps to store oral transmucosal fentanyl citrate securely and to dispose of unused oral transmucosal fentanyl citrate [see Warnings and Precautions (5.2, 5.7), Patient Counseling Information, Disposal of Used Oral Transmucosal Fentanyl Citrate Units].

Instruct patients and caregivers to keep both used and unused oral transmucosal fentanyl citrate out of the reach of children [see Warnings and Precautions (5.2)].

Inform patients and their caregivers that, in the event that a unit is not completely consumed, it must be properly disposed as soon as possible [see Warnings and Precautions (5.2), Patient Counseling Information, Disposal of Used Oral Transmucosal Fentanyl Citrate Units].

Oral Transmucosal Fentanyl Citrate Child Safety Kit

Provide patients and their caregivers who have children in the home or visiting with an oral transmucosal fentanyl citrate Child Safety Kit, which contains educational materials and safe interim storage containers to help patients store oral transmucosal fentanyl citrate and other medicines out of the reach of children. To obtain a supply of Child Safety Kits, healthcare professionals can call 1-800-223-1499.

Interactions with Benzodiazepines and Other CNS Depressants (including Alcohol)

Inform patients and caregivers that potentially fatal additive effects may occur if oral transmucosal fentanyl citrate is used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider [see Warnings and Precautions (5.4), Drug Interactions (7)].

Addiction, Abuse, and Misuse

Inform patients that the use of oral transmucosal fentanyl citrate, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see Warnings and Precautions (5.6)]. Instruct patients not to share oral transmucosal fentanyl citrate with others and to take steps to protect oral transmucosal fentanyl citrate from theft or misuse.

Transmucosal Immediate-Release Fentanyl (TIRF) REMS

Advise patients of the following information pertaining to the TIRF REMS

• Inform outpatients that they must be enrolled in the TIRF REMS Access program before they can receive oral transmucosal fentanyl citrate.
• Allow patients the opportunity to ask questions and discuss any concerns regarding oral transmucosal fentanyl citrate or the TIRF REMS Access program.
• As required by the TIRF REMS Access program, review the contents of the oral transmucosal fentanyl citrate Medication Guide with every patient before initiating treatment with oral transmucosal fentanyl citrate.
• Advise the patient that oral transmucosal fentanyl citrate is available only from pharmacies that are enrolled in the TIRF REMS Access program, and provide them with the telephone number and website for information on how to obtain the drug.
• Advise the patient that only enrolled healthcare providers may prescribe oral transmucosal fentanyl citrate.
• Inform the patient that they must sign the Patient-Prescriber Agreement to acknowledge that they understand the risks of oral transmucosal fentanyl citrate.
• Advise patients that they may be requested to participate in a survey to evaluate the effectiveness of the TIRF REMS Access program [see Warnings and Precautions (5.7)].

Serotonin Syndrome

Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their physicians if they are taking, or plan to take serotonergic medications [see Warnings and Precautions (5.10), Drug Interactions (7)].

MAOI Interaction

Inform patients to avoid taking oral transmucosal fentanyl citrate while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking oral transmucosal fentanyl citrate [see Warnings and Precautions (5.10, 5.18); Drug Interactions (7)].

Adrenal Insufficiency

Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms [see Warnings and Precautions (5.11)].

Important Administration Instructions [see Dosage and Administration (2)]

• Instruct patients not to take oral transmucosal fentanyl citrate for acute pain, postoperative pain, pain from injuries, headache, migraine or any other short-term pain, even if they have taken other opioid analgesics for these conditions.
• Instruct patients on the meaning of opioid tolerance and that oral transmucosal fentanyl citrate is only to be used as a supplemental pain medication for patients with pain requiring around-the-clock opioids, who have developed tolerance to the opioid medication, and who need additional opioid treatment of breakthrough pain episodes.
• Instruct patients that, if they are not taking an opioid medication on a scheduled basis (around-the-clock), they should not take oral transmucosal fentanyl citrate.
• Instruct patients that, if the breakthrough pain episode is not relieved 15 minutes after finishing the oral transmucosal fentanyl citrate unit, they may take only one additional unit of oral transmucosal fentanyl citrate using the same strength for that episode. Thus, patients should take no more than two units of oral transmucosal fentanyl citrate for any breakthrough pain episode.
• Instruct patients that they MUST wait at least 4 hours before treating another episode of breakthrough pain with oral transmucosal fentanyl citrate.
• Instruct patients NOT to share oral transmucosal fentanyl citrate and that sharing oral transmucosal fentanyl citrate with anyone else could result in the other individual’s death due to overdose.
• Make patients aware that oral transmucosal fentanyl citrate contains fentanyl which is a strong pain medication similar to hydromorphone, methadone, morphine, oxycodone, and oxymorphone.
• Caution patients to talk to their doctor if breakthrough pain is not alleviated or worsens after taking oral transmucosal fentanyl citrate.
• Instruct patients to use oral transmucosal fentanyl citrate exactly as prescribed by their doctor and not to take oral transmucosal fentanyl citrate more often than prescribed.

Hypotension

Inform patients that oral transmucosal fentanyl citrate may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position) [see Warnings and Precautions (5.12)].

Anaphylaxis

Inform patients that anaphylaxis have been reported with ingredients contained in FENTORA®. Advise patients how to recognize such a reaction and when to seek medical attention [see Contraindications (4), Adverse Reactions (6)].

Pregnancy

Neonatal Opioid Withdrawal Syndrome

Inform patients that prolonged use of oral transmucosal fentanyl citrate during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated [see Warnings and Precautions (5.8), Use in Specific Populations (8.1)].

Embryo-Fetal Toxicity

Inform female patients of reproductive potential that oral transmucosal fentanyl citrate can cause fetal harm and to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations (8.1)].

Lactation

Advise nursing mothers to monitor infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Instruct nursing mothers to seek immediate medical care if they notice these signs [see Use in Specific Populations (8.2)].

Infertility

Inform patients that chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible [see Use in Specific Populations (8.3)].

Driving or Operating Heavy Machinery

Inform patients that oral transmucosal fentanyl citrate may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery. Advise patients not to perform such tasks until they know how they will react to the medication [see Warnings and Precautions (5.16)].

Constipation

Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention [see Adverse Reactions (6), Clinical Pharmacology (12.2)].

Dental Decay

Because each oral transmucosal fentanyl citrate unit contains approximately 2 grams of sugar (hydrated dextrates), frequent consumption may increase the risk of dental decay. The occurrence of dry mouth associated with the use of opioid medications (such as fentanyl) may add to this risk.

Post-marketing reports of dental decay have been received in patients taking oral transmucosal fentanyl citrate [see Adverse Reactions (6.2)]. In some of these patients, dental decay occurred despite reported routine oral hygiene. As dental decay in cancer patients may be multi-factorial, patients using oral transmucosal fentanyl citrate should consult their dentist to ensure appropriate oral hygiene.

Diabetic Patients

Advise diabetic patients that oral transmucosal fentanyl citrate contains approximately 2 grams of sugar per unit.

Disposal of Used Oral Transmucosal Fentanyl Citrate Units

Instruct patients on proper disposal of completely used and partially used oral transmucosal fentanyl citrate units as follows:

1.     After consumption of the unit is complete and the matrix is totally dissolved, throw away the handle in a trash container that is out of the reach of children.

2.     If any of the drug matrix remains on the handle, place the handle under hot running tap water until all of the drug matrix is dissolved, and then dispose of the handle in a place that is out of the reach of children.

3.     Dispose of handles in the child-resistant container (as described in steps 1 and 2) at least once a day.

If the patient does not entirely consume the unit and the remaining drug cannot be immediately dissolved under hot running water, the patient or caregiver must temporarily store the oral transmucosal fentanyl citrate unit in the specially provided child-resistant container out of the reach of children until proper disposal is possible.

Disposal of Unopened Oral Transmucosal Fentanyl Citrate Units When No Longer Needed

Patients and members of their household must be advised to dispose of any unopened units remaining from a prescription as soon as they are no longer needed.

To dispose of the unused oral transmucosal fentanyl citrate units:

• Remove the oral transmucosal fentanyl citrate unit from its blister package using scissors, and hold the oral transmucosal fentanyl citrate by its handle over the toilet bowl.
• Using wire-cutting pliers cut off the drug matrix end so that it falls into the toilet.
• Dispose of the handle in a place that is out of the reach of children.
• Repeat steps 1, 2, and 3 for each oral transmucosal fentanyl citrate unit. Flush the toilet twice after 5 units have been cut and deposited into the toilet.

Do not flush the entire oral transmucosal fentanyl citrate units, oral transmucosal fentanyl citrate handles, blister packages, or cartons down the toilet. Dispose of the handle where children cannot reach it.

Detailed instructions for the proper storage, administration, disposal, and important instructions for managing an overdose of oral transmucosal fentanyl citrate are provided in the oral transmucosal fentanyl citrate Medication Guide. Encourage patients to read this information in its entirety and give them an opportunity to have their questions answered.

In the event that a caregiver requires additional assistance in disposing of excess unusable units that remain in the home after a patient has expired, instruct them to call the toll-free number for Mallinckrodt Inc. (1-800-778-7898) or seek assistance from their local DEA office.

Fentora is a registered trademark of Cima Labs, Inc.

Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company.

© 2017 Mallinckrodt.

Manufactured by:
Mallinckrodt Inc.
Hazelwood, MO 63042 USA

Issued 03/2017             
1230000

Mallinckrodt™
Pharmaceuticals

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 Mallinckrodt Inc., 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:
Mallinckrodt Inc.
Hazelwood, MO 63042 USA

Revised 03/2017

1110000                

Mallinckrodt™                                                                      

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

Mallinckrodt

NDC 0406-9212-30

30 Units

Only for patients already taking opioids (narcotics) such as fentanyl or morphine.

Oral Transmucosal Fentanyl Citrate

CII

equivalent to 1200 mcg fentanyl base
Warning: May be habit forming.

Pharmacist: Dispense with Medication Guide

WARNING: Keep out of the reach of children.
Accidental ingestion of this medicine by a child could be harmful or fatal.
Read enclosed oral transmucosal fentanyl citrate Medication Guide for important warnings and directions.

Mallinckrodt

NDC 0406-9216-30

30 Units

Only for patients already taking opioids (narcotics) such as fentanyl or morphine.

Oral Transmucosal Fentanyl Citrate

CII

equivalent to 1600 mcg fentanyl base
Warning: May be habit forming.

Pharmacist: Dispense with Medication Guide

WARNING: Keep out of the reach of children.
Accidental ingestion of this medicine by a child could be harmful or fatal.
Read enclosed oral transmucosal fentanyl citrate Medication Guide for important warnings and directions.