Before taking Abstral, tell your healthcare provider if you:
- are allergic to fentanyl or any other medications
- 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
- are pregnant or breastfeeding
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Abstral can cause life-threatening breathing problems which can lead to death.
Do not take Abstral if you are not opioid tolerant. If you stop taking your around-the-clock opioid pain medicine for your cancer pain, you must stop taking Abstral. You may no longer be opioid tolerant. Talk to your healthcare provider about how to treat your pain.
Do not switch from Abstral to other medicines that contain fentanyl without talking with your healthcare provider. The amount of fentanyl in a dose of Abstral is not the same as the amount of fentanyl in other medicines that contain fentanyl. Your healthcare provider will prescribe a starting dose of Abstral that may be different than other fentanyl containing medicines you may have been taking.
Do not take Abstral for short-term pain that you would expect to go away in a few days, such as:
- pain after surgery
- headache or migraine
- dental pain
Never give Abstral to anyone else, even if they have the same symptoms you have. It may harm them or even cause death.
Abstral is a federally controlled substance (CII) because it is a strong opioid (narcotic) pain medicine that can be misused by people who abuse prescription medicines or street drugs.
- Prevent theft, misuse or abuse. Keep Abstral in a safe place to protect it from being stolen. Abstral can be a target for people who abuse opioid (narcotic) medicines or street drugs.
- Selling or giving away this medicine is against the law.
Do not take Abstral if you are allergic to any of the ingredients in Abstral. See “Forms of Medication” section for a list of ingredients.
Abstral is available only through a program called the TIRF (Transmucosal Immediate-Release Fentanyl) 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
How to store Abstral:
- 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, between 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.
How to dispose of unopened Abstral tablets when they are no longer needed:
- Dispose of any unopened Abstral units remaining from a prescription as soon as you no longer need them:
- remove the tablets from the blister cards and flush them down the toilet.
- Do not flush the Abstral blister cards, units or cartons down the toilet.
- If you need help with disposal of Abstral, call ProStrakan, Inc., at 1-888-227-8725 or call your local Drug Enforcement Agency (DEA) office.
Grapefruit and grapefruit juice may interact with Abstral and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.
Abstral (generic: fentanyl) is a prescription medication used to treat breakthrough pain in adults with cancer who are already taking other opioid pain medicines around-the-clock for cancer pain. Abstral belongs to a group of drugs called opioids that work by binding to opioid receptors within the central nervous system to relieve pain.
This medication comes in tablet form to be taken underneath the tongue (sublingual) where it is dissolved. Do not eat or drink anything until the tablet dissolves.
Common side effects of Abstral include constipation, nausea, sleepiness, and headache. Do not drive or operate heavy machinery until you know how Abstral affects you.
Active Ingredient: fentanyl citrate
Inactive Ingredients: croscarmellose sodium, magnesium stearate, mannitol, and silicified microcrystalline cellulose.
Symptoms of overdose may include:
- trouble breathing
- drowsiness with slowed breathing
- shallow breathing (little chest movement with breathing)
- feeling faint, very dizzy, confused, or other unusual symptoms
These symptoms may lead to serious problems or death if not treated right away. Call your healthcare provider or get emergency medical help right away.
All patients receive the same Abstral starting dose of 100 mcg. Even patients switching from other fentanyl containing products to Abstral must start with the 100 mcg dose.
- Continue to treat breakthrough pain with this dose if this amount adequately relieves your pain.
- If, after 30 minutes, adequate pain relief is not achieved, an additional 100 mcg dose can be taken.
- No more than two doses of Abstral may be used to treat an episode of breakthrough pain.
- Patients must wait at least 2 hours before treating another episode of breakthrough pain with Abstral.
If the 100 mcg dose is not effective for treating your breakthrough pain, your healthcare provider will gradually increase your dose following a process called “dose titration”. The dose is increased by 100 mcg until you reach a 400 mcg dose. If this dose does not adequately relieve your breakthrough pain, the next dose is 600 mcg, and then 800 mcg if necessary.
Abstral can cause serious side effects, including:
- Breathing problems that can become life-threatening. See “Drug Precautions” section.
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.
- Decreased blood pressure. This can make you feel dizzy or lightheaded if you get up too fast from sitting or lying down.
- 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.
- 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.
The most common side effects of Abstral are:
- nausea
- sleepiness
- headache
Constipation (not often enough or hard bowel movements) is a very common side effect of pain medicines (opioids) including Abstral and is unlikely to go away without treatment. Talk to your healthcare provider about dietary changes, and the use of laxatives (medicines to treat constipation) and stool softeners to prevent or treat constipation while taking Abstral.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Abstral. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about your side effects. You may report side effects to FDA at 1-800-FDA-1088.
WARNINGS: RISK OF RESPIRATORY DEPRESSION, MEDICATION ERRORS, ABUSE POTENTIAL
RESPIRATORY DEPRESSION
Fatal respiratory depression has occurred in patients treated with immediate-release transmucosal fentanyl, including following use in opioid non-tolerant patients and improper dosing. The substitution of Abstral for any other fentanyl product may result in fatal overdose.
Due to the risk of respiratory depression, Abstral is contraindicated in the management of acute or postoperative pain including headache/migraine and in opioid non-tolerant patients.
Abstral must be kept out of reach of children.
The concomitant use of Abstral with CYP3A4 inhibitors may result in an increase in fentanyl plasma concentrations, and may cause potentially fatal respiratory depression.
MEDICATION ERRORS
Substantial differences exist in the pharmacokinetic profile of Abstral compared to other fentanyl products that result in clinically important differences in the extent of absorption of fentanyl that could result in fatal overdose.
- When prescribing, do not convert patients on a mcg per mcg basis from any other fentanyl products to Abstral.
- When dispensing, do not substitute an Abstral prescription for other fentanyl products.
ABUSE POTENTIAL
Abstral contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. Abstral can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Abstral in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion.
Because of the risk for misuse, abuse, addiction, and overdose, Abstral is available only through a restricted program, required by the Food and Drug Administration, called a Risk Evaluation and Mitigation Strategy (REMS). Under the TIRF (Transmucosal Immediate Release Fentanyl) REMS Access program, outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors must enroll in the program. Further information is available atwww.TIRFREMSAccess.com or by calling1-866-822-1483.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take:
- indinavir (Crixivan)
- nelfinavir (Viracept)
- ritonavir (Norvir)
- clarithromycin (Biaxin)
- itraconazole (Sporanox)
- ketoconazole (Nizoral)
- nefazodone (Serzone)
- saquinavir (Fortovase, Invirase)
- telithromycin (Ketek)
- aprepitant (Emend)
- diltiazem (Cardizem, Cartia, Dilacor XR, Taztia, Tiazac)
- erythromycin (EES, Ery-C, Ery-tab, Erythrocin, PCE Dispertab, Pediamycin)
- fluconazole (Diflucan)
- grapefruit juice
- verapamil (Calan, Covera-HS, Isoptin SR, Verelan)
- cimetidine (Tagamet)
- barbiturates
- carbamazepine (Carbatrol, Epitol, Equetro, Tegretol)
- efavirenz (Sustiva)
- glucocorticoids
- modafinil (Provigil)
- nevirapine (Viramune)
- oxcarbazepine (Trileptal)
- phenobarbital (Donnatal, Luminal)
- phenytoin (Dilantin)
- pioglitazone (Actos)
- rifabutin (Mycobutin)
- rifampin (Rifadin)
- St. John’s wort
Some medicines may cause serious or life-threatening side effects when taken with Abstral. Sometimes, the doses of certain medicines and Abstral may need to be changed if used together.
- Do not take any medicine while using Abstral until you have talked to your healthcare provider. Your healthcare provider will tell you if it is safe to take other medicines while you are using Abstral.
- Be very careful about taking other medicines that may make you sleepy, such as other pain medicines, anti-depressants, sleeping pills, anti-anxiety medicines, antihistamines, or tranquilizers.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
Tell your healthcare provider if you are pregnant or plan to become pregnant. Abstral may cause serious harm to your unborn baby.
Abstral is a prescription medicine used to treat breakthrough pain in adults with cancer who are already receiving around-the-clock opioid pain medications.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Before you can begin to take Abstral:
- Your healthcare provider will explain the TIRF REMS Access program to you.
- You will sign the TIRF REMS Access program Patient-Prescriber Agreement form.
- Abstral 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 Abstral prescription filled.
Taking Abstral:
- Take Abstral exactly as prescribed. Do not take Abstral more often than prescribed.
- Place the Abstral tablet on the floor of your mouth, under your tongue, as far back as you can. If more than 1 tablet is required, spread them around the floor of your mouth under your tongue.
- Let the tablet dissolve completely.
- Do not suck, chew or swallow the tablet.
- You should not drink or eat anything until the tablet has completely dissolved under your tongue and you can no longer feel it in your mouth.
How often can you take Abstral:
- You must not use more than 2 doses of Abstral for each episode of breakthrough cancer pain:
- Take 1 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 1 more dose of Abstral as instructed by your healthcare provider.
- If your breakthrough pain does not get better after the second dose of Abstral, call your healthcare provider for instructions. Do not take another dose of Abstral at this time.
- Wait at least 2 hours before treating a new episode of breakthrough cancer pain with Abstral:
- If you only need to take 1 dose of Abstral for an episode of breakthrough pain, you must wait 2 hours from the time of that dose to take a dose of Abstral for a new episode of breakthrough pain
- If you need to take 2 doses of Abstral for an episode of breakthrough pain, you must wait 2 hours after the second dose to take a dose of Abstral for a new episode of breakthrough pain.
- 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.
- If you take too much Abstral or overdose, you or your caregiver should call for emergency medical help or have someone take you to the nearest hospital emergency room right away.
What to avoid while taking Abstral:
- Do not drive, operate heavy machinery, or do other dangerous activities until you know how Abstral affects you. Abstral can make you sleepy. Ask your healthcare provider when it is okay to do these activities.
- Do not drink alcohol while using Abstral. It can increase your chance of getting dangerous side effects.
Tell your healthcare provider if you 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.