Abstral

Name: Abstral

What do I need to tell my doctor BEFORE I take Abstral?

  • If you have an allergy to Abstral or any part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon dioxide in the blood; or stomach or bowel block or narrowing.
  • If you have any of these health problems: Kidney disease or liver disease.
  • If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking Abstral within 14 days of those drugs can cause very bad high blood pressure.
  • If you are taking any of these drugs: Linezolid or methylene blue.
  • If you are taking any of these drugs: Buprenorphine, butorphanol, nalbuphine, or pentazocine.
  • If you are breast-feeding. Do not breast-feed while you take this medicine.

This is not a list of all drugs or health problems that interact with Abstral (fentanyl sublingual tablet).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

How do I store and/or throw out Abstral?

  • Store at room temperature. Do not freeze.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Follow the information that comes with this medicine for throwing out doses that are not needed. Check with your pharmacist if you have questions about how to throw out Abstral.

Consumer Information Use and Disclaimer

  • 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 this medicine is refilled. If you have any questions about Abstral, 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 this medicine 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 Abstral. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. 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 Abstral.

Review Date: October 4, 2017

What special precautions should I follow?

Before using fentanyl,

  • tell your doctor and pharmacist if you are allergic to fentanyl patches, injection, nasal spray, tablets, lozenges, or films; any other medications; or any of the ingredients in fentanyl tablets, lozenges, or films. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following medications: antihistamines; barbiturates such as phenobarbital; buprenorphine (Buprenex, Subutex, in Suboxone); butorphanol (Stadol); carbamazepine (Carbatrol, Epitol, Tegretol); efavirenz (Sustiva, in Atripla); modafinil (Provigil); nalbuphine (Nubain); naloxone (Evzio, Narcan); nevirapine (Viramune); oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos); oxcarbazepine (Trileptal); pentazocine (Talwin); phenytoin (Dilantin, Phenytek); pioglitazone (Actos, in Actoplus Met, in Duetact); rifabutin (Mycobutin); and rifampin (Rifadin, Rimactane, in Rifamate, in Rifater). Also tell your doctor or pharmacist if you are taking any of the following medications or if you have stopped taking them within the past two weeks: monoamine oxidase (MAO) inhibitors including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor what herbal products you are taking, especially St. John's wort.
  • tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol or uses or has ever used street drugs or excessive amounts of prescription medications. Also tell your doctor if you have or have ever had a head injury, a brain tumor, a stroke, or any other condition that caused high pressure inside your skull; seizures; slowed heartbeat or other heart problems; low blood pressure; mental problems such as depression, schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions), or hallucinations (seeing things or hearing voices that do not exist); breathing problems such as asthma and chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema); or kidney or liver disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using fentanyl, call your doctor.
  • you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of taking fentanyl.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are using fentanyl.
  • you should know that fentanyl may make you drowsy or dizzy. Do not drive a car or operate machinery until you know how this medication affects you.
  • you should know that fentanyl may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start using fentanyl. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
  • if you have diabetes, you should know that each fentanyl lozenge (Actiq) contains about 2 grams of sugar.
  • if you will be using the lozenges (Actiq), talk to your dentist about the best way to care for your teeth during your treatment. The lozenges contain sugar and may cause tooth decay and other dental problems.
  • you should know that fentanyl may cause constipation. Talk to your doctor about changing your diet and using other medications to treat or prevent constipation.

Indications

ABSTRAL (fentanyl) sublingual tablets are indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking around-theclock medicine consisting of at least 60 mg of oral morphine daily, or at least 25 mcg of transdermal fentanyl/hour, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or at least 25 mg oral oxymorphone daily, or an equianalgesic dose of another opioid medication daily for a week or longer. Patients must remain on around-the-clock opioids when taking ABSTRAL.

ABSTRAL is contraindicated for patients who are not already tolerant to opioids because life-threatening respiratory depression and death could result at any dose in patients not on a chronic regimen of opioids. For this reason, ABSTRAL is contraindicated in the management of acute or postoperative pain, including headache/migraine, dental pain, or use in the emergency room.

ABSTRAL is intended to be prescribed only by healthcare professionals who are knowledgeable of, and skilled in, the use of Schedule II opioids to treat cancer pain.

Limitations of Use

As a part of the TIRF REMS Access program, ABSTRAL may be dispensed only to outpatients enrolled in the program [see WARNINGS AND PRECAUTIONS]. For inpatient administration of ABSTRAL (e.g., hospitals, hospices, and long-term care facilities that prescribe for inpatient use), patient and prescriber enrollment is not required.

Uses of Abstral

Abstral is a prescription medication used to manage breakthrough pain in adults with cancer (18 years of age and older) who are already routinely taking other opioid pain medicines around-the-clock for cancer pain.

Abstral 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 Abstral if you are not opioid tolerant.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Abstral Interactions

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

  • Antihistamines
  • Barbiturates such as phenobarbital (Luminal)
  • Buprenorphine (Buprenex, Subutex, in Suboxone)
  • Butorphanol (Stadol)
  • Carbamazepine (Carbatrol, Epitol, Tegretol)
  • Efavirenz (in Atripla, Sustiva)
  • Modafinil (Provigil)
  • Nalbuphine (Nubain)
  • Nalmefene (Revex)
  • Naloxone (Narcan)
  • Nevirapine (Viramune)
  • Oral steroids such as dexamethasone (Decadron, Dexpak), methylprednisolone (Medrol), and prednisone
  • Oxcarbazepine (Trileptal)
  • Other pain medications
  • Pentazocine (Talwin)
  • Phenytoin (Dilantin, Phenytek)
  • Pioglitazone (Actos, in Actoplus Met, in Duetact)
  • Rifabutin (Mycobutin)
  • Rifampin (Rifadin, Rimactane, in Rifamate, in Rifater)
  • Sedatives, sleeping pills, or tranquilizers

Also tell your doctor or pharmacist if you are taking any of the following medications or if you have stopped taking them within the past two weeks: monoamine oxidase (MAO) inhibitors including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate).

This is not a complete list of Abstral drug interactions. Ask your doctor or pharmacist for more information.

Abstral Food Interactions

Grapefruit and grapefruit juice may interact with Abstral and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

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.

Other Interactions

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
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