Abstral

Name: Abstral

Before Using Abstral

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of fentanyl in children younger than 18 years of age for the Abstral®, Fentora®, Onsolis®, and Subsys® brands, and in children younger than 16 years of age for the Actiq® brand. Safety and efficacy have not been established in these age groups.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fentanyl in the elderly. However, elderly patients may be more sensitive to the effects of narcotic analgesics than younger adults and are more likely to have age-related lung or kidney problems, which may require caution and an adjustment in the dose for patients receiving fentanyl in order to avoid serious side effects.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Amifampridine
  • Mifepristone
  • Nalmefene
  • Naltrexone
  • Safinamide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acepromazine
  • Alefacept
  • Alfentanil
  • Almotriptan
  • Alprazolam
  • Amineptine
  • Amiodarone
  • Amisulpride
  • Amitriptyline
  • Amitriptylinoxide
  • Amobarbital
  • Amoxapine
  • Amphetamine
  • Anileridine
  • Aripiprazole
  • Asenapine
  • Baclofen
  • Benperidol
  • Benzphetamine
  • Blinatumomab
  • Boceprevir
  • Bromazepam
  • Bromopride
  • Brompheniramine
  • Buprenorphine
  • Buspirone
  • Butabarbital
  • Butorphanol
  • Carbamazepine
  • Carbinoxamine
  • Cariprazine
  • Carisoprodol
  • Carphenazine
  • Ceritinib
  • Chloral Hydrate
  • Chlordiazepoxide
  • Chlorpheniramine
  • Chlorpromazine
  • Chlorzoxazone
  • Citalopram
  • Clarithromycin
  • Clobazam
  • Clomipramine
  • Clonazepam
  • Clorazepate
  • Clozapine
  • Cobicistat
  • Cocaine
  • Codeine
  • Conivaptan
  • Cyclobenzaprine
  • Desipramine
  • Desmopressin
  • Desvenlafaxine
  • Dexmedetomidine
  • Dextroamphetamine
  • Dextromethorphan
  • Dezocine
  • Diazepam
  • Dibenzepin
  • Dichloralphenazone
  • Difenoxin
  • Dihydrocodeine
  • Diphenhydramine
  • Diphenoxylate
  • Dolasetron
  • Donepezil
  • Doxepin
  • Droperidol
  • Duloxetine
  • Eletriptan
  • Eluxadoline
  • Enflurane
  • Enzalutamide
  • Escitalopram
  • Estazolam
  • Eszopiclone
  • Ethchlorvynol
  • Ethopropazine
  • Ethylmorphine
  • Flibanserin
  • Fluoxetine
  • Fluphenazine
  • Flurazepam
  • Fluspirilene
  • Fluvoxamine
  • Fosphenytoin
  • Fospropofol
  • Frovatriptan
  • Furazolidone
  • Golimumab
  • Granisetron
  • Guselkumab
  • Halazepam
  • Haloperidol
  • Halothane
  • Hexobarbital
  • Hydrocodone
  • Hydromorphone
  • Hydroxytryptophan
  • Hydroxyzine
  • Idelalisib
  • Imipramine
  • Indinavir
  • Iproniazid
  • Isocarboxazid
  • Isoflurane
  • Itraconazole
  • Ketamine
  • Ketobemidone
  • Ketoconazole
  • Levomilnacipran
  • Levorphanol
  • Linezolid
  • Lisdexamfetamine
  • Lithium
  • Lofepramine
  • Lopinavir
  • Lorazepam
  • Lorcaserin
  • Loxapine
  • Lumacaftor
  • Meclizine
  • Melitracen
  • Melperone
  • Meperidine
  • Mephobarbital
  • Meprobamate
  • Meptazinol
  • Mesoridazine
  • Metaxalone
  • Methadone
  • Methamphetamine
  • Methdilazine
  • Methocarbamol
  • Methohexital
  • Methotrimeprazine
  • Methylene Blue
  • Midazolam
  • Milnacipran
  • Mirtazapine
  • Mitotane
  • Moclobemide
  • Molindone
  • Moricizine
  • Morphine
  • Morphine Sulfate Liposome
  • Nalbuphine
  • Naratriptan
  • Nefazodone
  • Nelfinavir
  • Netupitant
  • Nialamide
  • Nicardipine
  • Nicomorphine
  • Nifedipine
  • Nitrazepam
  • Nitrous Oxide
  • Nortriptyline
  • Olanzapine
  • Ondansetron
  • Opipramol
  • Opium
  • Opium Alkaloids
  • Orphenadrine
  • Oxazepam
  • Oxycodone
  • Oxymorphone
  • Palonosetron
  • Papaveretum
  • Paregoric
  • Paroxetine
  • Pazopanib
  • Pentazocine
  • Pentobarbital
  • Perampanel
  • Perazine
  • Periciazine
  • Perphenazine
  • Phenelzine
  • Phenobarbital
  • Phenytoin
  • Pimozide
  • Piperacetazine
  • Pipotiazine
  • Piritramide
  • Pitolisant
  • Posaconazole
  • Prazepam
  • Primidone
  • Procarbazine
  • Prochlorperazine
  • Promazine
  • Promethazine
  • Propofol
  • Protriptyline
  • Quazepam
  • Quetiapine
  • Ramelteon
  • Ranolazine
  • Rasagiline
  • Remifentanil
  • Remoxipride
  • Ribociclib
  • Rifampin
  • Ritonavir
  • Rizatriptan
  • Saquinavir
  • Secobarbital
  • Secukinumab
  • Selegiline
  • Sertindole
  • Sertraline
  • Sibutramine
  • Sodium Oxybate
  • St John's Wort
  • Sufentanil
  • Sulpiride
  • Sumatriptan
  • Suvorexant
  • Tapentadol
  • Telaprevir
  • Telithromycin
  • Temazepam
  • Thiethylperazine
  • Thiopental
  • Thiopropazate
  • Thioridazine
  • Tianeptine
  • Tilidine
  • Tizanidine
  • Tolonium Chloride
  • Topiramate
  • Tramadol
  • Tranylcypromine
  • Trazodone
  • Triazolam
  • Trifluoperazine
  • Trifluperidol
  • Triflupromazine
  • Trimeprazine
  • Trimipramine
  • Tryptophan
  • Venlafaxine
  • Vilazodone
  • Voriconazole
  • Vortioxetine
  • Zaleplon
  • Ziprasidone
  • Zolmitriptan
  • Zolpidem
  • Zopiclone
  • Zotepine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Ethanol
  • Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcohol abuse, or history of or
  • Brain tumor, history of or
  • Breathing problems (eg, asthma, apnea) or
  • Chronic obstructive pulmonary disease (COPD) or
  • Cor pulmonale (serious heart condition) or
  • Depression, history of or
  • Drug dependence, especially narcotic abuse, history of or
  • Head injury, history of or
  • Mental health problems, history of—Use with caution. May cause side effects to become worse.
  • Bradyarrhythmia (slow heart rhythm) or
  • Hypotension (low blood pressure) or
  • Pancreatitis (inflammation of the pancreas)—Use with caution. May make these conditions worse.
  • Diabetes—Use the Actiq® brand with caution. There are 2 grams of sugar in each unit.
  • Kidney disease or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Stomach or bowel blockage (including paralytic ileus), known or suspected—Should not be used in patients with these conditions.

If OVERDOSE is suspected

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.

How should this medicine be used?

Fentanyl comes as a lozenge on a handle (Actiq), a sublingual (underneath the tongue) tablet (Abstral), a film (Onsolis), and a buccal (between the gum and cheek) tablet (Fentora) to dissolve in the mouth. Fentanyl is used as needed to treat breakthrough pain but not more often than four times a day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

Your doctor will probably start you on a low dose of fentanyl and gradually increase your dose until you find the dose that will relieve your breakthrough pain. If you still have pain 30 minutes after using fentanyl films (Onsolis), your doctor may tell you to use another pain medication to relieve that pain, and may increase your dose of fentanyl films (Onsolis) to treat your next episode of pain . Talk to your doctor about how well the medication is working and whether you are experiencing any side effects so that your doctor can decide whether your dose should be adjusted.

Do not use fentanyl more than four times a day. Call your doctor if you experience more than four episodes of breakthrough pain per day. Your doctor may need to adjust the dose of your other pain medication(s) to better control your pain.

Fentanyl may be habit forming. Use fentanyl exactly as directed. Do not use a larger dose of fentanyl, use the medication more often, or use it for a longer period of time than prescribed by your doctor.

Do not stop using fentanyl without talking to your doctor. Your doctor may decrease your dose gradually. If you suddenly stop using fentanyl, you may experience unpleasant withdrawal symptoms.

To use fentanyl lozenges (Actiq), follow these steps:

  1. Check the blister package and the handle of the lozenge to make sure the lozenge contains the dose of medication you have been prescribed.
  2. Use scissors to cut open the blister package and remove the lozenge. Do not open the blister package until you are ready to use the medication.
  3. Place the lozenge in your mouth, between your cheek and gum. Actively suck on the lozenge, but do not chew or bite it. Move the lozenge around in your mouth, from one side to the other, using the handle. Twirl the handle often.
  4. Do not eat or drink anything while the lozenge is in your mouth.
  5. Finish the lozenge in about 15 minutes.
  6. If you begin to feel dizzy, very sleepy, or nauseated before you have finished the lozenge, remove it from your mouth. Dispose of it immediately as described below or put it in the temporary storage bottle for later disposal.
  7. If you finish the entire lozenge, throw the handle away in a garbage can that is out of the reach of children. If you did not finish the entire lozenge, hold the handle under hot running water to dissolve all the medication, and then throw the handle away in a garbage can that is out of the reach of children and pets.

To use fentanyl buccal tablets (Fentora), follow these steps:

  1. Separate one blister unit from the blister card by tearing along the perforations. Peel back the foil to open the blister unit. Do not try to push the tablet through the foil. Do not open the blister unit until you are ready to use the tablet.
  2. Place the tablet in your mouth above one of your upper back teeth between your cheek and your gum.
  3. Leave the tablet in place until it dissolves completely. You may notice a gentle bubbling feeling between your cheek and gum as the tablet dissolves. It may take 14 to 25 minutes for the tablet to dissolve. Do not split, chew, bite, or suck the tablet.
  4. If any of the tablet is left in your mouth after 30 minutes, swallow it with a drink of water.
  5. If you begin to feel dizzy, very sleepy, or nauseated before the tablet dissolves, rinse your mouth with water and spit the remaining pieces of tablet into the sink or toilet. Flush the toilet or rinse the sink to wash away the tablet pieces.

To use fentanyl sublingual tablets (Abstral), follow these steps:

  1. Take a sip of water to moisten your mouth if it is dry. Spit out or swallow the water. Make sure your hands are dry before handling the tablet.
  2. Separate one blister unit from the blister card by tearing along the perforations. Peel back the foil to open the blister unit. Do not try to push the tablet through the foil. Do not open the blister unit until you are ready to use the tablet.
  3. Place the tablet under your tongue as far back as you can. If more than 1 tablet is needed for your dose, spread them around on the floor of your mouth under your tongue.
  4. Leave the tablet in place until it dissolves completely. Do not suck, chew, or swallow the tablet.
  5. Do not eat or drink anything until the tablet is completely dissolved and you no longer feel it in your mouth.

To use fentanyl films (Onsolis), follow these steps:

  1. Use scissors to cut along the arrows of the foil package to open it. Separate the layers of the foil package and remove the film. Do not open the foil package until you are ready to use the medication. Do not cut or tear the film.
  2. Use your tongue to wet the inside of your cheek, or if needed, rinse your mouth with water to wet the area where you will place the film.
  3. Hold the film on a clean, dry finger, with the pink side facing up. Place the film in your mouth, with the pink side against the inside of your moistened cheek. With your finger, press the film against your cheek for 5 seconds. Then remove your finger and the film will stick to the inside of your cheek. If more than one film is needed for your dose, do not put the films on top of each other. You may place the films on either side of your mouth.
  4. Leave the film in place until it dissolves completely. The film will release a minty flavor as it dissolves. It may take 15 to 30 minutes for the film to dissolve. Do not chew or swallow the film. Do not touch or move the film while it dissolves.
  5. You may drink liquids after 5 minutes, but do not eat anything until the film dissolves completely.

What other information should I know?

Keep all appointments with your doctor.

Do not let anyone else use your medication, even if he or she has the same symptoms that you have. Selling or giving away this medication may cause severe harm or death to others and is against the law.

This prescription is not refillable. Be sure to schedule appointments with your doctor on a regular basis so that you do not run out of medication.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand names

  • Abstral®
  • Actiq®
  • Fentora®
  • Onsolis®

Abstral Overview

Abstral is a prescription medication used to manage breakthrough pain in adults with cancer who are already routinely taking other opioid pain medicines around-the-clock for cancer pain.

Abstral belongs to a group of drugs called opioid agonists or narcotic pain medications. These work by changing the way the brain and nervous system respond to pain. Take one dose for an episode of breakthrough cancer pain. If your breakthrough pain does not get better within 30 minutes after taking the first dose of Abstral, you can take one more dose as instructed by your healthcare provider.

This medication comes as a small tablet that is placed on the floor of the mouth under your tongue (sublingual) and allowed to dissolve.

Common side effects of Abstral include nausea, feeling tired, headache, and constipation.

Abstral can also drowsiness, and dizziness. Do not drive or operate heavy machinery until you know how Abstral affects you.

Abstral Drug Class

Abstral is part of the drug class:

  • Opioid anesthetics

Abstral Precautions

Serious side effects have been reported with Abstral, including the following:

  1. Breathing problems that can become life-threatening. See "What is the most important information I should know about Abstral?"
    • Call your healthcare provider or get emergency medical help right away if you:
      • have trouble breathing
      • have drowsiness with slowed breathing
      • have shallow breathing (little chest movement with breathing)
      • feel faint, very dizzy, confused, or have other unusual symptoms

      These symptoms can be a sign that you have taken too much Abstral 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 take any more Abstral until you have talked to your healthcare provider.

  2. Decreased blood pressure. This can make you feel dizzy or lightheaded if you get up too fast from sitting or lying down.
  3. Physical dependence. Do not stop taking Abstral or any other opioid, 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.
  4. A chance of abuse or addiction. This chance is higher if you are or have ever been addicted to or abused other medicines, street drugs, or alcohol, or if you have a history of mental health problems.

Abstral can cause drowsiness, dizziness, and blurred vision. Do not drive or operate heavy machinery until you know how Abstral affects you.

Do not drink alcohol while using Abstral. It can increase your chance of getting dangerous side effects.

Abstral is available only through a program called the TIRF (Transmucosal Immediate-ReleaseFentanyl) REMS (Risk Evaluation and Mitigation Strategy) Access program. To receive Abstral, you must:

  • talk to your healthcare provider
  • understand the benefits and risks of Abstral
  • agree to all of the instructions
  • sign the Patient-Prescriber Agreement form

Do not take Abstral if you:

  • are allergic to Abstral or to any of its ingredients
  • have not been taking other opioid pain medicines
  • hare treating short-term pain that you would expect to go away in a few days, such as pain after surgery, headache or migraine, and dental pain

Abstral and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed.

Abstral has been detected in human breast milk. Do not use Abstral in women who are nursing. 

Abstral Usage

Take Abstral exactly as prescribed.

This medication comes as a small tablet that is placed on the floor of the mouth under your tongue (sublingual) and allowed to dissolve.

Place Abstral (fentanyl) sublingual tablets on the floor of the mouth directly under the tongue immediately after removal from the blister pack. Do not chew, suck, or swallow Abstral tablets. Allow Abstral tablets to completely dissolve in the sublingual cavity. Do not eat or drink anything until the tablet is completely dissolved. If you have a dry mouth, use water to moisten the buccal mucosa before taking Abstral.

You must not take more than 2 doses of Abstral for each episode of breakthrough cancer pain.

You must wait two hours before treating a new episode of breakthrough pain with Abstral. 

It is important for you to keep taking your around-the-clock opioid pain medicine while taking Abstral.

Talk to your healthcare provider if your dose of Abstral does not relieve your breakthrough cancer pain. Your healthcare provider will decide if your dose of Abstral 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.

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