FENTANYL CITRATE- fentanyl citrate lozenge 
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Medication Guide

Oral Transmucosal Fentanyl Citrate (or׳ ǝl ● tranz mu-kō׳ s'l ● fĕn׳ tǝ-nĭl ● sĭt׳ rāt)
oral transmucosal lozenge, CII

IMPORTANT:
Do not use oral transmucosal fentanyl citrate 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 oral transmucosal fentanyl citrate in a safe place away from children.
Get emergency medical help right away if:

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

These are medical emergencies that can cause death. If possible, remove oral transmucosal fentanyl citrate from the mouth.

Oral transmucosal fentanyl citrate is:

  • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage breakthrough pain in adults (16 years of age and older) with cancer who are already routinely taking other opioid pain medicines around-the-clock for cancer pain. Oral transmucosal fentanyl citrate is started only after you have been taking other opioid pain medicines and your body has become used to them (you are opioid tolerant). Do not use oral transmucosal fentanyl citrate if you are not opioid tolerant.
  • An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Important information about oral transmucosal fentanyl citrate:

  • Get emergency help right away if you take too much oral transmucosal fentanyl citrate (overdose). When you first start taking oral transmucosal fentanyl citrate, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
  • Taking oral transmucosal fentanyl citrate with other medicines that may make you sleepy, such as other pain medicines, anti-depressants, sleeping pills, anti-anxiety medicines, antihistamines, or tranquilizers, or with alcohol or street drugs can cause severe drowsiness, confusion, breathing problems, coma, and death.
  • Never give anyone else your oral transmucosal fentanyl citrate. They could die from taking it. Selling or giving away oral transmucosal fentanyl citrate is against the law.
  • Store oral transmucosal fentanyl citrate securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.
  • If you stop taking your around-the-clock opioid pain medicine for your cancer pain, you must stop using oral transmucosal fentanyl citrate. You may no longer be opioid tolerant. Talk to your healthcare provider about how to treat your pain.
  • Oral transmucosal fentanyl citrate is available only through a program called the Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access program. To receive oral transmucosal fentanyl citrate, you must:
    • talk to your healthcare provider
    • understand the benefits and risks of oral transmucosal fentanyl citrate
    • agree to all of the instructions
    • sign the Patient-Prescriber Agreement form
  • Oral transmucosal fentanyl citrate is only available at pharmacies that are part of the TIRF REMS Access program. Your healthcare provider will let you know the pharmacy closest to your home where you can have your oral transmucosal fentanyl citrate prescription filled.
  • Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Do not take oral transmucosal fentanyl citrate if:

  • You are not opioid tolerant. Opioid tolerant means that you are already taking other opioid pain medicines around-the-clock for at least one week or longer for your cancer pain, and your body is used to these medicines.
  • You have severe asthma, trouble breathing, or other lung problems.
  • You have a bowel blockage or have narrowing of the stomach or intestines.
  • You are allergic to any of the ingredients in oral transmucosal fentanyl citrate. See the end of this Medication Guide for a complete list of ingredients in oral transmucosal fentanyl citrate.
  • You have short-term pain that you would expect to go away in a few days, such as:
    • pain after surgery
    • headache or migraine
    • dental pain

Before taking oral transmucosal fentanyl citrate, tell your healthcare provider if you have a history of:

  • troubled breathing or lung problems such as asthma, wheezing, or shortness of breath
  • mental problems [including major depression, schizophrenia or hallucinations (seeing or hearing things that are not there)]
  • head injury, seizures
  • problems urinating
  • slow heart rate or other heart problems
  • liver, kidney, thyroid problems
  • low blood pressure
  • pancreas or gallbladder problems
  • abuse of street or prescription drugs, alcohol addiction, or mental health problems
  • diabetes. Each oral transmucosal fentanyl citrate unit contains about ½ teaspoon (2 grams) of sugar.

Tell your healthcare provider if you are:

  • pregnant or planning to become pregnant. Prolonged use of oral transmucosal fentanyl citrate during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
  • breastfeeding. Oral transmucosal fentanyl citrate passes into breast milk and may harm your baby.
  • taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking oral transmucosal fentanyl citrate with certain other medicines can cause serious side effects that could lead to death.

When taking oral transmucosal fentanyl citrate:

  • Do not change your dose. Take oral transmucosal fentanyl citrate exactly as prescribed by your healthcare provider.
  • Your healthcare provider will change the dose until you and your healthcare provider find the right dose for you.
  • See the detailed Patient Instructions for Use at the end of this Medication Guide for information about how to use oral transmucosal fentanyl citrate.
  • Finish the unit completely in 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.
  • Do not bite or chew. You will get less relief for your breakthrough cancer pain.
  • 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.
  • You must not use more than 2 units of oral transmucosal fentanyl citrate during each episode of breakthrough cancer pain:
    • Use 1 unit for an episode of breakthrough cancer pain. Finish the unit over 15 minutes.
    • If your breakthrough cancer pain is not relieved 15 minutes after you finished the oral transmucosal fentanyl citrate unit, use only 1 more unit of oral transmucosal fentanyl citrate at this time.
    • If your breakthrough pain does not get better after the second unit of oral transmucosal fentanyl citrate, call your healthcare provider for instructions. Do not use another unit of oral transmucosal fentanyl citrate at this time.
  • Wait at least 4 hours before treating a new episode of breakthrough cancer pain with oral transmucosal fentanyl citrate.
  • It is important for you to keep taking your around-the-clock opioid pain medicine.
  • Talk to your healthcare provider if your dose of oral transmucosal fentanyl citrate does not relieve your breakthrough cancer pain. Your healthcare provider will decide if your dose of oral transmucosal fentanyl citrate needs to be changed.
  • Talk to your healthcare provider if you have more than 4 episodes of breakthrough cancer pain per day. The dose of your around-the-clock opioid pain medicine may need to be adjusted.
  • If you begin to feel dizzy, sick to your stomach, or very sleepy before oral transmucosal fentanyl citrate is completely dissolved, remove oral transmucosal fentanyl citrate from your mouth.
  • Do not stop taking oral transmucosal fentanyl citrate without talking to your healthcare provider. You could become sick with uncomfortable withdrawal symptoms because your body has become used to these medicines. Physical dependency is not the same as drug addiction.
  • After you stop taking, or when oral transmucosal fentanyl citrate is no longer needed, 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.
  • Dispose of expired, unwanted, or unused oral transmucosal fentanyl citrate by following the “How should I dispose of oral transmucosal fentanyl citrate units when they are no longer needed?” sections of this Medication Guide below. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.
  • DO NOT Drive or operate heavy machinery, until you know how oral transmucosal fentanyl citrate affects you. Oral transmucosal fentanyl citrate can make you sleepy, dizzy, or lightheaded.
  • DO NOT Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with oral transmucosal fentanyl citrate may cause you to overdose and die.
  • DO NOT Switch from oral transmucosal fentanyl citrate to other medicines that contain fentanyl without talking to your healthcare provider. The amount of fentanyl in a dose of oral transmucosal fentanyl citrate is not the same as the amount of fentanyl in other medicines that contain fentanyl. Your healthcare provider will prescribe a starting dose of oral transmucosal fentanyl citrate that may be different than other fentanyl containing medicines you may have been taking.

The possible side effects of oral transmucosal fentanyl citrate:

  • constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain, weakness, anxiety, depression, rash, trouble sleeping. Call your healthcare provider if you have any of these symptoms and they are severe.
  • Decreased blood pressure. This can make you feel dizzy or lightheaded if you get up too fast from sitting or lying down.
  • Oral transmucosal fentanyl citrate contains sugar. Cavities and tooth decay can happen in people taking oral transmucosal fentanyl citrate. When taking oral transmucosal fentanyl citrate, you should talk to your dentist about proper care of your teeth.

Get emergency medical help if you have:

  • trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.
  • These symptoms can be a sign that you have used too much oral transmucosal fentanyl citrate or the dose is too high for you. These symptoms may lead to serious problems or death if not treated right away. If you have any of these symptoms, do not use any more oral transmucosal fentanyl citrate until you have talked to your healthcare provider.

These are not all the possible side effects of oral transmucosal fentanyl citrate. 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?

Revised: 6/2020
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