Fentanyl (Actiq) is a strong pain medication used to treat breakthrough cancer pain in people who already take around-the-clock opioid pain medications. It can be used in people age 16 and older, but it requires special monitoring because of the risk of abuse, addiction, and overdose.
Breakthrough cancer pain in people 16 years and older
Fentanyl (Actiq) belongs to a group of pain medications, known as opioids. It works directly on opioid receptors in your brain to relieve pain.
Fentanyl (Actiq) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk factors: First 1 to 3 days of starting fentanyl (Actiq) | Dose changes | High doses | Switching between fentanyl-containing medications | Opioid-intolerance | Accidental overdose | Children | Age 65 years or older | Severe lung conditions | History of sleep apnea | Taking other medications that cause respiratory depression
Fentanyl (Actiq) can cause serious,
life-threatening slowed breathing (respiratory depression) and death, even at normal doses. Your risk is greatest during the first 24 to 72 hours of starting fentanyl (Actiq) and after your dose is raised. If you're opioid-intolerant, meaning you aren't taking opioids around-the-clock, don't take fentanyl (Actiq).
For your safety, use fentanyl (Actiq) exactly as prescribed by your healthcare provider, and don't adjust your dose or switch between products without discussing with your provider first. Fentanyl (Actiq) is NOT equal to other forms of fentanyl, such as the patch, tablets, or spray. Don't convert, switch, or substitute fentanyl (Actiq) with any other fentanyl-containing medications without proper guidance from your healthcare provider. Make sure to discuss your entire medical history with your provider, since some conditions put you at a higher risk for respiratory depression.
Accidental ingestion of even one dose, especially by children, can lead to severe breathing problems and death. Respiratory depression is a medical emergency that must be managed and treated right away. Alcohol and other medications, like benzodiazepines, sedatives, anxiety medications, and certain muscle relaxants, can slow down your breathing even more and you should avoid taking them together with fentanyl (Actiq). If you have shortness of breath, slowed breathing, tiredness or sleepiness during the day, anxiety, or confusion, call for emergency medical help right away.
Risk factors: Children | Using more fentanyl (Actiq) than prescribed
Overdose can happen at recommended doses of fentanyl (Actiq), or if it's accidentally taken by a child or a loved one. Accidental ingestion of even one dose in a child can cause overdose and death. It can also happen if you take higher doses or take the medication more often than prescribed. If you live in a home with children or if children frequently visit your home, store both used and unused medication in a secure place. For questions about proper storage or disposal of fentanyl (Actiq), refer to the medication guide that came with your medication or ask your pharmacist.
Symptoms of an overdose include slowed breathing, sleepiness, muscle weakness, small pupils, cold or clammy skin, slow heart rate, and unresponsiveness. If you, your child, or anyone around you accidentally overdoses on fentanyl (Actiq), get emergency medical help right away. If you're at a high risk for overdose, have a history of opioid overdose, or live with children or other family members at high risk, your provider might prescribe naloxone (Narcan). Naloxone (Narcan) can be used in emergency situations for fentanyl (Actiq) overdose. It's important for you and your caregiver to know how to use naloxone (Narcan) in case an accidental overdose happens. Even if you use naloxone (Narcan) for an overdose, you'll still have to call for emergency medical help because it's effects are temporary.
Using fentanyl (Actiq) with certain medications or suddenly stopping some medications can raise or lower levels of fentanyl (Actiq) in your body. For example, taking erythromycin (Ery-Tab), ketoconazole, or ritonavir (Norvir) raises fentanyl (Actiq) levels, leading to greater side effects, such as slowed breathing. Other medications like phenytoin (Dilantin), carbamazepine (Tegretol), or rifampin (Rifadin) can lower fentanyl (Actiq) levels in your body, leading to withdrawal symptoms or lessened pain relief. In these situations, your provider might need to adjust your medications or dosage. If you start or stop any medications, ask your pharmacist or healthcare provider if it's safe to continue using fentanyl (Actiq).
Risk factors: Age 65 years or older | Alcohol use | Taking other medications that make you less alert | High doses
Using fentanyl (Actiq) with alcohol or other medications, like benzodiazepines, sleep medications, antipsychotics, muscle relaxers, or other opioids, can slow down brain activity and lead to severe sleepiness, slowed breathing, coma, and even death. If you currently take or start taking any of these medications, work with your healthcare provider to take the lowest dose for the shortest amount of time. Because of the risk of excessive drowsiness, make sure you know how this medication affects you before driving a car or doing activities that require concentration. For your safety, let your provider know if you have a history of substance abuse. Call for emergency medical help right away if you experience severe sleepiness, dizziness, low heart rate, slowed breathing, muscle weakness, headache, slurred speech, blurred vision, or confusion.
Risk factors: Personal or family history of substance or alcohol abuse | History of mental health conditions | Using more fentanyl (Actiq) than prescribed | Long-term use of fentanyl (Actiq) | Improper storage or disposal of fentanyl (Actiq)
Using fentanyl (Actiq) can lead to abuse, misuse (using it for reasons other than prescribed), or addiction, even if you use it at the recommended dose. This can cause serious problems, such as overdose and death. Your risk is greater if you have a history of substance or alcohol abuse or mental health conditions, such as depression. To lower this risk, your healthcare provider will prescribe the lowest amount of fentanyl (Actiq) that's necessary for you for the shortest period of time possible. It's also important to properly store and dispose of used and unused medication to prevent it from coming into contact with anyone else.
Because of the risk of abuse, misuse, addiction, and overdose, the U.S. Food and Drug Administration (FDA) requires this medication to be under a restricted program called the Transmucosal Immediate Release Fentanyl Risk Evaluation and Mitigation Strategy (TIRF REMS). This means that fentanyl (Actiq) is only available at certified pharmacies, and healthcare providers must complete special training before prescribing this medication. Under this program, your provider or pharmacist is required to provide you with a medication guide and talk to you about the proper use, serious risks, and appropriate storage and disposal of this medication in order to keep you and your loved ones safe. It's important that you read the medication guide every time to familiarize yourself with safe use of this medication. To learn more about the TIRF REMS program or for a list of certified pharmacies, visit the website or call 1-866-822-1483.
Risk factors: Long-term use of fentanyl (Actiq) during pregnancy
Long-term use of fentanyl (Actiq) during pregnancy can cause your unborn baby to become dependent on opioids the same way that you can. Once your baby is born, they can experience withdrawal symptoms just like if you were to stop the medication suddenly. Withdrawal symptoms in your newborn can include high-pitched crying, poor feeding and sucking behavior, trembling, irritability, abnormal sleep patterns, and seizures. This condition is called neonatal opioid withdrawal syndrome and can be life-threatening if not recognized and treated in time. Let your healthcare provider know if you've used fentanyl (Actiq) during pregnancy or if you notice these symptoms in your baby.
Risk factors: Using fentanyl (Actiq) with serotonergic medications
Using fentanyl (Actiq) with other medications that raise serotonin levels in your brain, known as serotonergic medications, can cause a life-threatening condition called serotonin syndrome. Some examples of serotonergic medications include fluoxetine (Prozac), duloxetine (Cymbalta), amitriptyline (Elavil), sumatriptan (Imitrex), monoamine oxidase inhibitors (MAOIs), and trazodone (Desyrel). Serotonin syndrome generally occurs within a few hours or a few days of combining these medications, but might occur later. Let your healthcare provider or pharmacist know if you start a new medication to make sure it's safe to combine with fentanyl (Actiq). Call for emergency medical help right away and stop using fentanyl (Actiq) if you experience nausea, vomiting, diarrhea, fever, agitation, hallucinations (seeing things that aren't there), shivering, restlessness, sweating, fast heart rate, or stiff muscles.
Risk factors: Using opioids for greater than 1 month | History of low cortisol levels
Using opioids like fentanyl (Actiq), especially for longer than 1 month, can lead to low levels of cortisol hormone (adrenal insufficiency). Cortisol helps control your mood, stress, blood pressure, and blood sugar levels. If you have symptoms such as nausea, vomiting, loss of appetite, tiredness, weakness, or dizziness, let your healthcare provider know so that tests can be performed. If your cortisol levels are too low, your provider will treat you with corticosteroids and you might slowly be weaned off of fentanyl (Actiq) or switched to another medication if necessary.
Risk factors: Age 65 years or older | Taking other medications that lower blood pressure | Dehydration | History of low blood pressure | Taking certain antipsychotics | Starting fentanyl (Actiq) | Dose adjustments | History of slow heart rate | Heart problems
Fentanyl (Actiq) can cause severe low blood pressure, including a drop in blood pressure when you stand from a sitting or lying position. This can lead to dizziness and fainting. Your risk is greater if you take medications for high blood pressure or if you take certain antipsychotics, known as phenothiazines. Be careful as you stand up after sitting for an extended period of time and make sure to sit back down if you feel faint or dizzy. The chances of low blood pressure are higher when you first start using fentanyl (Actiq) or with dose changes. Fentanyl (Actiq) can also cause slowed heart rate. Make sure to let your provider know if you have a history of heart problems, like abnormal heart rate (arrhythmias). If dizziness or lightheadedness doesn't go away, talk to your healthcare provider.
Risk factors: History of seizures | Taking other medications or having health conditions that raise your risk of seizures
Fentanyl (Actiq) can raise your risk of seizures if you have a history of seizures. If your seizures have worsened or become harder to control after starting fentanyl (Actiq), let your healthcare provider know right away.
Source:Â DailyMed
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Black, tarry stools
blurred vision
confusion
convulsions
decreased urine
difficult or labored breathing
dizziness
fainting
fever or chills
increased thirst
irregular heartbeat
lightheadedness
loss of appetite
lower back or side pain
mood changes
muscle pain or cramps
nausea or vomiting
nervousness
numbness or tingling in the hands, feet, or lips
painful or difficult urination
pale skin
pounding in the ears
rapid breathing
sunken eyes
swelling of the hands, ankles, feet, or lower legs
tightness in the chest
troubled breathing with exertion
ulcers, sores, or white spots in the mouth
unusual bleeding or bruising
unusual tiredness or weakness
wrinkled skin
Less common
Abdominal or stomach pain
change in walking and balance
clumsiness or unsteadiness
decreased awareness or responsiveness
decreased frequency of urination
headache
muscle twitching or jerking
pounding in the ears
rhythmic movement of the muscles
seeing, hearing, or feeling things that are not there
seizures
severe constipation
severe sleepiness
shakiness in the legs, arms, hands, or feet
slow or fast heartbeat
thinking abnormalities
trembling or shaking of the hands or feet
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
Extremely shallow or slow breathing
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Back pain
difficulty having a bowel movement (stool)
difficulty with moving
discouragement
feeling sad or empty
irritability
lack or loss of strength
loss of interest or pleasure
muscle stiffness
pain in the joints
sleepiness or unusual drowsiness
tiredness
trouble concentrating
trouble sleeping
Less common
Changes in vision
excessive muscle tone
feeling of constant movement of self or surroundings
feeling of warmth or heat
flushing or redness of the skin, especially on the face and neck
irritation, pain, or sores at the site of application
itching skin
muscle tension or tightness
rash
sensation of spinning
sweating
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Available as a lower-cost generic medication
Available in multiple dosage strengths
Works within 15 minutes to relieve breakthrough cancer pain
Good alternative if you have trouble swallowing pills
Can only be used if you already take opioids around-the-clock (opioid-tolerant)
Can become habit-forming and lead to abuse, misuse, addiction, and overdose
Has undesirable side effects, such as constipation, headache, and dizziness
Not for short-term pain, such as dental pain or pain after surgery
Can't be used in children younger than 16 years old
Before using fentanyl (Actiq), make sure to read the medication guide that comes with the medication to familiarize yourself with how to take it and dispose of it safely.
Don't eat or drink anything while using fentanyl (Actiq). If you have a dry mouth or feel thirsty, drink water before using the medication. Avoid biting or chewing on the medication because this might lessen pain relief. Fentanyl (Actiq) will provide the greatest pain relief if it's absorbed on the inside of your mouth, through your cheeks.
Don't open the blister package until you're ready to use fentanyl (Actiq). Use scissors to cut the blister package, peel open the backing, and remove the lozenge. The medication end that goes into your mouth will be printed with "Actiq" and the dosage strength.
Hold the handle with your fingertips and place the medication end into your mouth, between your cheek and gum. Make sure to suck on the medication and move it around in your mouth, especially along the inside of your cheeks, as this allows the medication to get absorbed into your body. Do this for 15 minutes to get the most pain relief. If you finish the medication too quickly, you'll swallow most of it and not get your desired pain relief.
Fentanyl (Actiq) contains 2 grams of sugar per lozenge, so it's important to brush your teeth and take proper care of your teeth while using this medication. Visit your dentist regularly because of the risk of cavities and tooth decay while using fentanyl (Actiq). It's also important to note the sugar content if you have diabetes or if you're on a low-sugar diet.
A common side effect of fentanyl (Actiq) is constipation. If you experience severe constipation, speak to your provider or pharmacist for treatment options that are safe for you.
Fentanyl (Actiq) can cause excessive sleepiness, dizziness, and lightheadedness. Don't drive or use any heavy machinery until you know how the medication affects you.
Talk to your pharmacist or healthcare provider about naloxone (Narcan), which is a medication that can be used in emergency situations for accidental overdose of fentanyl (Actiq). Make sure to tell your family and close friends where you keep your naloxone (Narcan) in the event of an emergency. Symptoms of an overdose include slowed breathing, sleepiness, muscle weakness, small pupils, cold or clammy skin, or unresponsiveness. If you use naloxone (Narcan) for an overdose situation, you should still call for emergency medical help because its effects are temporary.
If you no longer need to take fentanyl (Actiq), dissolve remaining used medication in hot water or put it in the temporary storage bottle. Flush it down the toilet at least once a day, along with any unwanted unused medication.
Use scissors to remove unused fentanyl (Actiq) from the blister package and hold the medication handle over the toilet. Use pliers to cut off the medication end and make sure it falls into the toilet. After cutting 5 lozenges into the toilet, flush the toilet two times. Don't flush more than 5 lozenges at one time, and don't flush the handle or blister package as this can clog your toilet. Ask your pharmacist or call your local Drug Enforcement Agency (DEA) office if you have additional questions about proper disposal of fentanyl (Actiq).
Store fentanyl (Actiq) at room temperature in a secure and dry place, out of reach from children, pets, and visitors at all times. Your medication should come with a Child Safety Kit and a child-resistant lock, where you can safely store your medication. If you don't have a kit, call 1-888-534-3119 to request one.
Fentanyl (Actiq) has a risk of life-threatening overdose, especially in children. If your child or someone you know accidentally takes fentanyl (Actiq), get emergency medical help right away.
Your provider will work with you to prescribe the right dose of fentanyl (Actiq) for your individual needs. It's recommended to use the lowest dose possible for the shortest duration of time to manage your pain.
The typical starting dose is one lozenge (200 mcg) placed in your mouth between your cheek and lower gum for 15 minutes. If your pain isn't relieved 15 minutes after using the first lozenge, you can use a second lozenge. Don't use more than 2 lozenges for any single episode of breakthrough pain.
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.
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.
Not taking around-the-clock opioids (opioid non-tolerance)
Serious, life-threatening slowed breathing (respiratory depression)
Short-term pain, such as headache or migraine, dental pain, or pain after surgery
Severe asthma
Stomach or intestinal blockage (paralytic ileus)
Breakthrough cancer pain in people 16 years and older
Breakthrough cancer pain in adults 18 years and older
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