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Fentanyl Transmucosal

(fent-uh-nil trans-mew-ko-sul)

Trade/other name(s): Actiq, Fentora, Lazanda, Onsolis, Abstral, fentanyl lozenge or troche, fentanyl lollipop,

Why would this drug be used?

Fentanyl transmucosal is used for long-term pain that is moderate to severe. Because it acts quickly and its effects last a short time, this drug is mainly used for "breakthrough" pain. To manage severe chronic pain, two medicines are usually needed. One is a long-acting medicine that is taken on a regular schedule to provide ongoing pain relief. The second medicine is used for any pain that "breaks through" this long-acting pain medicine. Fentanyl transmucosal is one of the second types of pain medicine, also known as a "rescue" drug for managing pain that is not controlled by the long-acting pain medicine.

Before starting fentanyl, the patient must have already gotten used to taking opioid pain medicines such as morphine, hydromorphone, or oxycodone, and have taken them every day for at least a week.

How does this drug work?

Transmucosal fentanyl is an opioid pain reliever much like morphine. The pain relief is quick (starting within 5 minutes), because it is absorbed directly through the mucous membranes in the mouth. Patients typically feel its maximum effect within 25-30 minutes. Transmucosal fentanyl binds to opioid receptors in the brain and central nervous system. This reduces the perception of pain, as well as the emotional response to pain.

One form of transmucosal fentanyl looks like a flat tablet attached to a handle. This type is placed between the lower gum and the lining of the cheek (mucosa), where it is sucked until it is completely melted away.

Another form of transmucosal fentanyl looks like a small tablet, but you do not swallow it. It is placed between the cheek and gum and kept there until it melts away.

Another type is a tablet you put under your tongue and let melt.

A fourth form is a small thin film that sticks to the inside of the cheek. It melts away as it is absorbed through the cheek.

With all these forms, much of the drug is absorbed directly into the blood from the cheek and gum. Part of it melts into the saliva and is swallowed, and some of that is absorbed into the blood later. But this drug is not absorbed as well from the stomach as it is from the mucous membranes of the mouth.

Before taking this medicine

Tell your doctor…

  • If you are allergic to anything, including medicines, dyes, additives, or foods.
  • Exactly how much of which pain medicines you have been taking, and how much they relieved your pain. This will help the doctor decide what starting dose of fentanyl you should get.
  • If you have any medical conditions such as kidney disease, liver disease (including hepatitis), low thyroid function, or Addison's disease (low adrenal function). These conditions may require that your medicine dose, regimen, or timing be changed.
  • If you have had abdominal pain or any disorder with slowed or blocked intestines, such as paralytic ileus. Fentanyl can worsen this problem.
  • If you have trouble urinating, narrow urethra, or if you have an enlarged prostate. Fentanyl can make it harder to urinate.
  • If you have ever had a seizure, head injury, or if you have had problems with pressure, infection, or a tumor in your head or brain. Fentanyl can raise your risk of seizures.
  • If you have low blood pressure, slow heart rate, or other heart problem . Fentanyl can worsen this.
  • If you have asthma, emphysema, chronic bronchitis, sleep apnea, or other breathing problem. Fentanyl can make it worse.
  • If you have gallstones, gallbladder disease, or pancreatitis. Fentanyl can sometimes worsen these problems.
  • If you have taken monoamine oxidase inhibitors within the past 2 weeks (see drug interactions section, below.) Fentanyl can cause coma, slow or shallow breathing, low blood pressure, excitability, seizures, or shock.
  • If you drink alcohol or take any medicine that can affect your brain or nervous system. These may worsen the side effects of fentanyl or cause other problems.
  • If you have trouble with addiction, alcohol, or drug abuse now or have had one in the past. Fentanyl can be habit forming, especially for those who have had problems before.
  • If you have serious mental illness such as schizophrenia or bipolar disorder. You may have more problems when you try to stop fentanyl.
  • If any family members have or have had an addiction or drug problem. Fentanyl is sometimes stolen by or for those who have become addicted to it or similar drugs.
  • If you are pregnant, trying to get pregnant, or if there is any chance of pregnancy. There may be an increased risk of harm to the fetus if a woman takes this drug during pregnancy, especially later in pregnancy.
  • If you are breast-feeding. The drug passes into breast milk and can harm the baby.
  • About any other prescription or over-the-counter medicines you are taking, including vitamins and herbs. In fact, keeping a written list of each of these medicines (including the doses of each and when you take them) with you in case of emergency may help prevent complications if you get sick.

Interactions with other drugs

The following drugs can also cause fentanyl to build up in the body, raising the risk of serious side effects or even overdose. If you need one of these medicines while you are taking fentanyl, your doctor may be able to adjust your fentanyl dose:

  • antidepressant drugs nefazodone (Serzone), fluvoxamine (Luvox), fluoxetine (Prozac, Serafem)
  • antibiotics erythromycin, clarithromycin, and similar drugs
  • anti-fungal antibiotics such as ketoconazole and itraconazole
  • the anti-nausea drug aprepitant
  • certain blood pressure medicines such as diltiazem and verapamil
  • HIV drugs such as indinavir, ritonavir, amprenavir, fosamprenavir, and nelfinavir

Do not start these medicines while on fentanyl without talking with the prescribing doctor(s) about all of the medicines you take, including fentanyl.

Antidepressants of the older MAO inhibitor type such as phenelzine (Nardil), tranylcypromine (Parnate), isocarboxazid (Marplan), or selegiline (Emsam) may cause coma, slow or shallow breathing, low blood pressure, excitability, seizures, or shock if fentanyl is given within 2 weeks of the last MAO inhibitor dose.

Medicines or substances that slow down the brain or nervous system, such as these, can cause worse side effects if taken with fentanyl:

  • anti-anxiety drugs (tranquilizers or sedatives)
  • sleeping pills
  • muscle relaxers
  • barbiturates
  • anti-seizure medicines
  • other opioid drugs
  • anesthetics
  • antidepressants (tricyclic type) such as amitriptyline, desipramine, doxepin, imipramine, nortriptyline
  • anti-psychotic drugs
  • certain anti-nausea medicines
  • certain antihistamines (those that cause sleepiness)
  • alcohol

Some of these drugs can cause slowed breathing, low blood pressure, extreme sleepiness, coma, or even death if taken with fentanyl.

Naltrexone will keep fentanyl from working or stop it from working.

Buprenorphine (Subutex, Suboxone), butorphanol (Stadol), nalbuphine (Nubain), or pentazocine (Talwin, Talacen) may decrease the effects of fentanyl or stop its action altogether. This can cause withdrawal symptoms if you have taken the fentanyl for some time.

The anti-seizure drugs carbamazepine and phenytoin can make the body get rid of fentanyl faster, as can the TB drugs rifampin and rifabutin, and the herb St. John's wort. They can make fentanyl less effective in controlling pain, although doses can be adjusted if you are taking the medicines regularly. If you are on one of these medicines when you start taking fentanyl, talk to your doctor before you stop them. You may need less fentanyl after you stop the drug.

If you are using decongestant nasal spray to help with a runny or stuffy nose, nasal fentanyl (Lazanda) may not work as well for you.

Check with your doctor, nurse, or pharmacist about whether other medicines, vitamins, herbs, and supplements can cause problems with this medicine.

Do not start or stop any medicines while on fentanyl without talking with the prescribing doctor(s) about all of the medicines you take, including fentanyl.

Interactions with foods

Certain foods, such as grapefruit or grapefruit juice, may raise the level of this drug in your body. This can worsen any bad effects the drug may have on you and may increase its action in a harmful way. Check with your doctor, nurse, or pharmacist about whether other foods may be a problem

Tell all the doctors, dentists, nurses, and pharmacists you visit that you are taking this drug.

How is this drug taken or given?

It is important that you keep taking your regular pain control medicine that your doctor has prescribed. This medicine is typically given as a stopgap for when the main pain medicine doesn't work to control your pain.

For the tablet with the handle (Actiq): Just before you plan to use it, remove the transmucosal fentanyl from its child-resistant blister pack using scissors. Place the drug in your mouth between the cheek and the lower gum, and suck the medicine from the handle over 15 minutes. Move it from one side of the mouth to the other along the cheek, twirling the handle often. Do not chew or swallow the medicine, as less of it will be absorbed. It is OK to drink water or fluids before taking your medicine, but do not eat or drink while taking your medicine.

If you feel relief before the 15 minutes is over, or if you feel very dizzy or not well, remove the lozenge from your mouth. The remaining drug should be removed from the handle by running hot water over it, and the handle discarded right away, out of the reach of children or pets.

For the tablet or lozenge (Fentora): Just before you are going to use it, carefully peel the foil from the plastic of the blister pack. Place the tablet near the back of your mouth, between the upper cheek and gum. Leave the tablet in place until it dissolves. This takes about 14 to 25 minutes. You must wait at least 4 hours before your next dose unless your doctor instructs you differently.

Transmucosal fentanyl is sold in different strengths, which come in different color packages to identify the strength of the lozenge. Store this medicine where it cannot be reached by children, pets, or others. Protect from freezing and moisture.

For the tablet (Abstral): When you are ready to take your medicine, be sure your hands are dry. But your mouth should be wet, so if it feels dry, take a sip of water. Peel back the foil (pushing the tablet through the foil will damage it) and remove the tablet, then put it as far back under your tongue as you can. If your dose is 2 or more tablets, spread them out under your tongue. Let them melt away without chewing or sucking on them. Don’t eat or drink until the tablets are dissolved completely.

If your breakthrough pain does not get better within 30 minutes after taking the first dose of Abstral, you can take one more dose. If your breakthrough pain does not get better after the second dose, call your doctor. Do not take another dose for breakthrough pain for at least 2 hours..

For the film (Onsolis): Use scissors to open the foil package when you are ready to use it. Your hands should be clean and dry before you open the pack. Be sure that the inside of your mouth is wet, then place the film between the cheek and gum with the pink side next to the cheek. Press it there for a few seconds. The film will stick and slowly dissolve within 15 to 30 minutes. Do not eat, move, or touch the film while it is dissolving. You must wait at least 2 hours before your next dose. If the drug does not relieve your pain, tell your doctor.

If your doctor tells you to use more than one film at a time, they should not be placed on top of each other. The films should be placed on both sides of the mouth.

For the nasal spray (Lazanda): Follow the instructions to prime the bottle when you are ready to use the drug for the first time. After the green line appears, put your index and middle fingers on the finger grips, insert the nozzle about ½ inch into your nostril and press the bottom of the bottle to get one spray. (You may not feel the medicine going in your nose; this is normal.) Do not take another dose for at least 2 hours.

Storage and disposal of fentanyl

Store this medicine where it cannot be reached by children, pets, or others. Protect from freezing and moisture.

Do not share the drug with others, as it can be abused. It can also cause death even in adults who are not used to fentanyl and other opioid drugs.

Remove unused fentanyl from its package and flush the film or tablets down the toilet as soon as possible. The fentanyl with the handle can be dissolved off the stick by running water over it in the sink. For nasal fentanyl, follow the instructions to empty the bottle, put the bottle in the special plastic pouch that comes with it, then seal and discard the pouch where children and pets can’t get to it.

Precautions

If you have never taken opioid pain relievers before, be sure your doctor or nurse knows that before you start using transmucosal fentanyl. Only people who have taken opioid pain medicines regularly should switch to transmucosal fentanyl. It is important that your doctor know exactly what medicines you were taking before starting fentanyl. Keep a record of the times and names of pain relievers you are taking so that you can show it to your doctor or nurse. This will help your doctor to choose the best dose of fentanyl for you.

This medicine can cause drowsiness and lightheadedness. Do not drive, operate machinery, or perform other activities that require alertness until you know how you react to this medicine.

Fentanyl can make you feel dizzy or faint, and increase your risk of falling. Be careful getting up, changing position, or walking. Start slowly and hold onto something or someone to keep you steady. If you feel lightheaded or dizzy, it may help to lie down. It is best to have a responsible adult with you for the first few days after starting the morphine and after any increase in dose, until you know how you will respond to it.

Since fentanyl affects the central nervous system, do not take other drugs or substances that slow down the brain or nervous system such as alcohol, sedatives, muscle relaxers, and sleeping pills unless your doctor tells you to do so.

Call your doctor right away if you have trouble breathing, get short of breath, get confused, feel very drowsy, or start seeing or hearing things that aren't there. These may be signs your dose is too high, or you could have gotten an accidental overdose of the medicine.

Tell your doctor or nurse right away if you have trouble passing your urine, trouble walking, vision problems, fainting, trouble swallowing, or other problems.

If you are having any kind of surgery or medical procedure, be sure to tell the doctor or dentist in charge that you are using this medicine.

Constipation is a very common side effect of taking opioid pain medicines. While you're taking fentanyl, you should take medicines such as stool softeners, bulk-forming agents, and/or laxatives as needed to have regular (daily) bowel movements. Talk to your nurse or doctor about this when you first start this medicine. Drink plenty of fluids throughout the day, and try to eat foods high in fiber such as whole grains, bran, fruits, and vegetables. Call your doctor or nurse right away if you have not moved your bowels in 2 days.

Most cancer pain can be controlled. Keep your doctor or nurse informed about how well your pain medicines are working and any side effects you are having. Your cancer team may need to adjust your medicines several times before they find the medicines that work best for you. When the transmucosal fentanyl is first started, your doctor may only prescribe 6 doses or so. It can take awhile to decide on the best fentanyl dose for you.

Usually, transmucosal fentanyl is given to control breakthrough pain that is not controlled by a longer-acting pain medicine. Do not take more of the transmucosal fentanyl or take it more often than the doctor directs. If you do, it could increase your chance of overdose and serious side effects.

If you do not get pain relief after using one transmucosal fentanyl dose after 15 to 30 minutes, talk with your doctor or nurse about using a second one. If you decide to try a second one, wait at least 15 minutes (or as long as the doctor tells you) after you finished the first one before starting the second. If you continue to need 2 doses to relieve your pain, talk with your doctor about increasing your pain medicine dosage.

Transmucosal fentanyl is an effective and safe drug when used correctly. However, it can be dangerous, and the following safety points should be remembered.

    This drug is only for people who have been taking opioid pain medicines regularly, and have some tolerance to this type of medicine. Otherwise, it can cause breathing problems (slow breathing or breathing may stop).

    The drug should be kept in a locked cabinet so that it cannot be reached by children, pets, or others, as it may cause death even in adults.

    When your dose is changed or the drug is stopped, safely dispose of any unused medicine. To do this with the table that has the handle, cut open one dose at a time using scissors. Hold over the toilet while the tablet part is cut off its handle with wire-cutting pliers, allowing the medicine to drop into the toilet. Flush the toilet twice after discarding 5 medicines in this way. Repeat until all drugs are disposed. Discard the handles in the trash, out of the reach of children and pets. To dispose of unused lozenges or film, open and drop each dose into the toilet. After all the medicine is in the toilet, flush it twice. For nasal fentanyl, follow the package instructions to empty the bottle, put the bottle in the special plastic pouch that comes with it, then seal and discard the pouch where children and pets can’t get to it.

    Keep the medicine away from the eyes, skin or other mucous membranes when it's not in your mouth or nose. Wash your hands after discarding any unused medicine.

    Call your nurse or doctor if you find you have to take the drug more than 4 times a day to control your pain. The dose may need to be increased, and your doctor or nurse will tell you how to do this.

Talk to your doctor or nurse about using the smallest effective dose to reduce side effects and the development of tolerance and physical dependence. Tolerance means that larger doses are needed to get the same pain relief. Physical dependence means that the body goes into withdrawal if drug is suddenly stopped. Both happen normally when strong (opioid) medicines are taken over several weeks to treat chronic pain. But this is different from addiction, which starts when the drug is taken for pleasure rather than pain relief. Tell your doctor or nurse if you still have pain even though you are taking the medicine as directed. Do not adjust your dose without talking to your doctor or nurse.

Do not stop taking this medicine without talking to your doctor or nurse. When no longer needed, this medicine should be stopped gradually with the help of your doctor. If it is stopped too quickly or the dose reduced too much, you can have withdrawal symptoms such as restlessness, irritability, anxiety, runny nose, watering eyes, yawning, sweating, chills, gooseflesh, aches, nausea, vomiting, poor appetite, high blood pressure, fast heartbeat, and fast breathing.

This drug is a controlled substance, and may be habit forming. Do not allow others to take your medicine. A person who has taken fentanyl for some time often needs large doses for pain relief, while the same amount could quickly kill someone else.

If you think you or someone else may have taken an overdose of fentanyl, get emergency help right away. Symptoms of fentanyl overdose may include extreme drowsiness, slow heart beat, slow or irregular breathing, cold clammy skin, or coma. Fentanyl overdose may cause the heart or breathing to stop.

Some of these drugs require that you sign up with a special program in order to get the drug. Check with your doctor about this. Pharmacies may not be able to fill these prescriptions, so you will want to call ahead. Some drugs may be delivered by courier rather than picked up at the drugstore.

Possible side effects

You will probably not have most of the following side effects, but if you have any talk to your doctor or nurse. They can help you understand the side effects and cope with them.

Common

  • sleepiness*
  • dizziness*
  • constipation*
  • nausea

Less common

  • trouble walking*
  • slow shallow breathing, or trouble breathing*
  • vomiting (more at higher doses)
  • low blood pressure which can cause dizziness when sitting up or standing*
  • confusion*
  • mood changes, such as euphoria (happiness), depression, irritability
  • nervousness
  • trouble sleeping
  • headache
  • fever
  • feeling tired
  • changes in vision
  • flushing
  • increased sensation

Rare

  • muscle aches
  • sore throat
  • cough
  • loss of appetite
  • swelling of feet
  • diarrhea
  • itching
  • rash
  • headache
  • hallucinations (seeing or hearing things that aren't there)*
  • dehydration
  • stomach upset
  • death from overdose

*See "Precautions" section for more detailed information.

There are some other side effects not listed above that can also occur in some patients. Tell your doctor or nurse if you develop these or any other problems.

FDA approval

Yes – first approved in 1998.

Disclaimer: This information does not cover all possible uses, actions, precautions, side effects, or interactions. It is not intended as medical advice, and should not be relied upon as a substitute for talking with your doctor, who is familiar with your medical needs.


Last Medical Review: 11/06/2009
Last Revised: 07/13/2011