Abstral

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 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.

• Galena BioPharma, Inc.

• ProStrakan, Inc.

Serious side effects have been reported with Abstral. See the “Abstral Precautions” section.

Common side effects of Abstral include the following:

• nausea
• sleepiness
• headache
• dry mouth
• sweating
• drowsiness
• constipation
• stomach pain

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

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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.

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

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

Before taking Abstral, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Abstral or to any of its ingredients
• have trouble breathing or lung problems such as asthma, wheezing, or shortness of breath
• have or had a head injury or brain problem
• have liver or kidney problems
• have seizures
• have a slow heart rate or other heart problems
• have low blood pressure
• have mental health problems including major depression, schizophrenia or hallucinations (seeing or hearing things that are not there)
• have a past or present drinking problem (alcoholism), or a family history of drinking problems
• have a past or present drug abuse problem or addiction problem, or a family history of a drug abuse problem or addiction problem
• have any other medical conditions
• have more than 4 episodes of breakthrough cancer pain per day.
• are pregnant or plan to become pregnant. Abstral may cause serious harm to your unborn baby.
• are breastfeeding or plan to breastfeed. Abstral can pass into your breast milk. It can cause serious harm to your baby. You should not use Abstral while breastfeeding.

Tell your doctor if your dose of Abstral does not relieve your breakthrough cancer pain.

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

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Abstral falls into category C. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

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. 

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.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• how you respond to this medication
• your weight
• your age

The recommended dose/dose range of Abstral (fentanyl sublingual tablet) for the treatment of breakthrough cancer pain is 100 mcg to 800 mcg. 

Abstral is only indicated for patients who are opioid tolerant, meaning they have been taking opioid pain medications for at least one week.

The dose of Abstral is titrated based on your response to the medication and the dose may be repeated in 2 hours if additional pain relief is needed.

No more than 2 doses should be taken for each episode of breakthrough pain and no more than 4 episodes of pain should be treated with Abstral in one day.

If you take too much Abstral, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Always keep Abstral in a safe place away from children and from anyone for whom it has not been prescribed. Protect Abstral from theft.
• Store Abstral at room temperature, 59°F to 86°F (15°C to 30°C) until ready to use.
• Keep Abstral in the original blister unit. Do not remove Abstral tablets from their blister packaging for storage in a temporary container, such as a pillbox.
• Keep this and all medicines out of the reach of children.