FENTANYL PRESCRIPTION LIST AND INFORMATION

Fentanyl Discovery and Development

Fentanyl is an extremely potent narcotic analgesic (pain reliever) first discovered and synthesized by Dr. Paul Janssen in 1960. Initially introduced as a general anesthesic, fentanyl has since been developed into a variety of prescription medication formulations utilized for the treatment of severe and chronic painful conditions including breakthrough cancer pain. Fentanyl is considered a schedule II narcotic in the U.S., meaning that it has a very high potential for addiction or abuse. Fentanyl is also very dangerous if used improperly. For these reasons, I am going to write a brief article describing the proper use and potential side-effects of all of the currently available fentanyl-containing prescription products typically available for outpatient use.

The advice and information about fentanyl products contained in this article is intended to help patients and prescribers, but is not intended to replace your doctor's advice or the manufacturers dosing guidelines. In this article I will review the current prescribing information and common side-effects associated with the 6 currently available fentanyl prescription drugs for outpatient (home) use.

The 6 prescription fentanyl products reviewed below include:

  • Abstral
  • Actiq
  • Duragesic
  • Fentora
  • Lazanda
  • Onsolis

On Micrograms, a side note: Fentanyl doses are measured in "micrograms" (mcg). That's small! Most medicines are measured in milligrams (1 milligram = 1000mcg). Just for reference, a grain of sand is about 15mcg. So an "average" dose of fentanyl of, say 400mcg, has the equivalent of about 27 grains of sand of fentanyl. By way of comparison, an 800mg dose of ibuprofen contains about 53,333 grains of sand of ibuprofen. The point? Fentanyl is very potent!

1. ABSTRAL - fentanyl sublingual tablets

Abstral is a fentanyl tablet intended for the treatment of breakthrough cancer pain (BTcP). Abstral is a "sublingual" tablet, meaning it is intended to be placed under the tongue and dissolved. Abstral is rapidly absorbed and acheives maximum blood levels within 30-60 minutes. Abstral, manufactured by ProStrakan (a UK pharmaceutical company), received U.S. marketing approval in January 2011.

Abstral, like all fentanyl products, is intended ONLY for patients that are already accustomed to narcotic use (AKA "opioid tolerant" patients). This is because the extreme potency of fentanyl can cause fatal suppression of the central nervous system in patients not already tolerant to opioids.

Abstral is currently available in 6 strengths:

  • 100mcg
  • 200mcg
  • 300mcg
  • 400mcg
  • 600mcg
  • 800mcg

Several important things to remember about taking Abstral:

  • Abstral is for breakthrough cancer pain only. You must be taking a regular "around the clock" narcotic for pain (like morphine or oxycodone) while taking Abstral.
  • Because of the risks associated with rapidly released fentanyl, patients prescribed Abstral will need to be enrolled in a special program to ensure you understand the risks and how to use it safely (known as the REMS program).
  • Abstral is intended only for adults 18 years and older.
  • A single-tablet Abstral dose is taken for breakthrough pain. Another dose is typically allowed in 30 minutes if necessary. After 2 doses, another dose may not be used for 2 hours. Always keep Abstral in the blister-pack containers it comes in, until you need it.
  • Allow a tablet to completely dissolve under the tongue before drinking any water.

Possible Side Effects Include: Significant drowsiness, dizziness. Do not drive. Also, nausea, constipation, headache. If you experience difficulty breathing - contact your healthcare provider (or call 911) immediately.

2. ACTIQ - fentanyl lollipops

Fentanyl lollipops? That may sound rather bizarre, and they look nothing like candy lollipops, but the availability of fentanyl in this formulation was a great step forward in managing breakthrough cancer pain. Actiq was approved by the FDA in 1998 and is marketed by Cephalon pharmaceuticals. Actiq is available generically also.

Concerns have been raised by the apparently large proportion of prescriptions written for Actiq that are not for breakthrough cancer pain, considered "off label" prescribing.

Actiq (sometimes referred to as Actiq "lozenges") is available in 6 "berry flavored" strengths:

  • 200mcg
  • 400mcg
  • 600mcg
  • 800mcg
  • 1200mcg
  • 1600mcg

About Using Actiq:

  • As with all fentanyl products, use ONLY if you are opioid tolerant (i.e. are currently taking other opioids for pain)
  • Actiq is only intended for adults age 16 and older
  • Patients prescribed Actiq will need to be enrolled in the safety "REMS" program to be sure they understand the risks of fentanyl
  • Actiq comes on a white stick and the end is placed between the lower cheek and gum and slowly sucked to release the medication. For best results, allow the medication to be released over 15 minutes.
  • Typically, if pain relief is not achieved 15 minutes AFTER finishing the Actiq dose, another dose may be adminisered. However, after the second dose, you must wait 4 hours to use the medication again.

Common side-effects include: Nausea, vomiting, dizziness, drowsiness, headache, constipation. Note: Breathing difficulty should be reported to a healthcare provider right away.

FDA Warning

The FDA recently issued a public warning about the importance of careful disposal of used Duragesic patches. There have been at least 10 cases in which young children have accidentally applied a "used" patch to themselves resulting in a fatal overdose. The recommended disposal method is to fold the sticky sides of the patch together and flush it down the toilet.

3. DURAGESIC - fentanyl transdermal patch

Originally approved by the FDA in January of 2005, Duragesic patches became the first form of fentanyl which patients could administer to themselves (i.e. a non-injectable form). Duragesic patches are different than every other prescription fentanyl preparation in three ways:

  1. Duragesic patches deliver fentanyl through a topical patch applied to the skin, changed every 72 hours.
  2. Duragesic patches are designed for slow-release maintenance pain control, not for immediate breakthrough pain.
  3. Duragesic is approved for more "general" pain relief, rather than simply being restricted to cancer-related pain. The official language used to describe its approved indication is "for management of persistent, moderate to severe, chronic pain" the requires (a) continuous around-the-clock opioid administration and (b) for pain that cannot be managed by other means.

Like other fentanyl preparations, Duragesic should only be used by patients already tolerant to opioids (i.e. patients who have been taking narcotic pain relievers already). Basically, if your body is not used to narcotics already, Duragesic is TOO strong for you. For practical purposes, we consider a patient "tolerant" if they have been taking at least 60mg of morphine daily, 30mg of oxycodone daily or 8mg of hydromorphone daily.

Duragesic patches are available in 5 strengths:

  • Duragesic 12mcg (actually delivers 12.5mcg/hour)
  • Duragesic 25mcg
  • Duragesic 50mcg
  • Duragesic 75mcg
  • Duragesic 100mcg

Using Duragesic Patches:

Duragesic patches should be applied to a clean, hairless (ideally), area of skin on the upper body such as the chest, back, flank or outer arm. The skin should be clean, dry and non-irritated or broken.

Duragesic patches should be removed from the pouch immediately before application to the skin. Be careful not to accidentally cut or tear the patch (such patches cannot be used). Press firmly onto the skin for at least 30 seconds. If necessary, first aid tape can be used to hold the patch in place.

Duragesic patches should remain in place for 72 hours. In some cases, patients will need to change the patch every 48 hours. After 72 hours the patch should be removed, folded in half (adhesive sides together), and disposed of in a toilet. A new patch should then be applied to a different location (to prevent skin irritation). It is okay for the patch to get wet (shower) but patients should avoid exposing the patch on the skin to excessive heat (e.g. heating pads).

Side Effects: Nausea, vomiting, constipation, drowsiness, dry mouth, sweating. Note: Difficulty breathing should be immediately reported to a health care practitioner.


4. FENTORA - fentanyl buccal tablet

Fentora is a fentanyl tablet which is intended to dissolve in the patient's mouth when placed between the upper gums and cheeck. Fentora is indicated for the management of breakthrough cancer pain in patients who are already opioid tolerant (i.e. already take other narcotics to manage chronic cancer pain). Fentora was approved for use in the U.S. by the FDA in September 2006 and is marketed by Cephalon pharmaceuticals (they also market Actiq).

Fentora tablets come in 6 different strengths:

  • 100mcg
  • 200mcg
  • 300mcg
  • 400mcg
  • 600mcg
  • 800mcg

How to use Fentora:

  • A Fentora tablet is removed from the blister pack and immediately placed between the gum and cheek beside your upper molar. Allow the tablet to slowly dissolve (without sucking or chewing). This usually takes 15-25 minutes.
  • If pain relief is not sufficient in 30 minutes a second dose may be administered. After this second dose, a patient may not use Fentora again for 4 hours.
  • Your Fentora dose may need to be slowly increased under the direction of your doctor to properly manage your pain.
  • Fentora contains no sugar and is unflavored.

Side Effects:

Nausea, vomiting, dizziness, confusion. Call your doctor if you experience difficulty breathing or experience excessive drowsiness as this may mean the dose it too high for you.



5. LAZANDA - fentanyl nasal spray

The latest addition to the fentanyl family of prescription drugs is a nasal spray called Lazanda. Approved by the FDA in June 2011, Lanzanda is a product of Archimedes Pharma. Lazanda is indicated for the relief of breakthrough cancer pain in adult patients age 18 and older. As with other forms of fentanyl, Lazanda may only be used by patients already tolerant to opioids. Prescribers, patients and pharmacies must be enrolled in the manufacturers REMS program to ensure they are trained and qualified to properly instruct patients to safely use Lazanda. The pharmacy will enroll patients who present a prescription for the first time.

Lazanda is the only fentanyl nasal spray available, and currently comes in 2 strengths:

  • 100mcg/dose
  • 400mcg/dose

Each glass bottle of Lazanda contains just 8 doses (after priming). A box of Lazanda contains either 1 bottle or 4 bottles. All patients should begin with the 100mcg dose/spray.

How To Use Lazanda:

  • Lazanda nasal spray must be "primed" before the first use. You will do this by spraying Lazanda into the supplied pouch until a "green" solid line appears in the counter window.
  • Administer Lazanda by inserting the tip into 1 nostril, holding the other nostril closed, and give 1 spray of the bottle. NEVER use more than 1 spray unless instructed to do so by your doctor. After your dose, you must wait 2 hours to administer another dose.
  • Lazanda must be discarded if (1) it has been 5 days since you last used it or (2) it has been 14 days since initial priming.

Side Effects:

Potential side effects with Lazanda are similar to all of the other rapidly released fentanyl products and includes: Vomiting, nausea, constipation and drowsiness. Difficulty breathing should be immediately reported to a health care professional.




6. ONSOLIS - fentanyl buccal film

The FDA approved this unique dosage form of fentanyl in July of 2009. Onsolis, manufactured by MEDA pharmaceuticals, is an orally dissolving film containing fentanyl intended only for breakthrough cancer pain in patients 18 years of age or older. As with other fast-acting fentanyl products, Onsolis may only be used by patients already tolerant to opioids and also (like others) requires enrollment in their REMS program to prescribe, dispense and receive this drug. The REMS program for Onsolis is called "Focus" and this program will arrange for the direct delivery of this medication to the patient from a specialty pharmacy.

Onsolis is available in 5 different strengths:

  • 200mcg
  • 400mcg
  • 600mcg
  • 800mcg
  • 1200mcg

How to use Onsolis:

Onsolis is used by wetting the inside of your cheek (with your tongue, or with a rinse of water). Carefully place 1 Onsolis film inside your mouth and press against the moistened cheek for 5 seconds. Onsolis will slowly dissolve in 15-30 minutes. Do not use more than 1 dose per episode of breakthrough pain, and do not repeat dosages sooner than 2 hours (max of 4 doses per day).

Side Effects: Nausea, vomiting, dizziness, dehydration and drowsiness. Difficulty breathing should be immediately reported to a health care professional.


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Comments 9 comments

Marvin Story 5 years ago

I suffered what i can only imagine is kind of a cancer pain that generated in the pon section and mylem sheath of my brain. it has left me with this undescibable pain that literarately make me sick to my stomach from the intense pain about 4-5 times a week violent sickness in which i become totally confused kind of out of my mind and ive been like this for around 15 yrs now with very to little help. I get doctors who don't believe me ones who give me 3 tylenol and call them in the morning but none that will step out on alimb and say this is something we know little about but he's trying to tell us. What i had is called Lock in Syndrome it's a terrible thing to have to go threw andlive with and it even harder when no one takes the initative and studies what it is what it causes and what you can do to make the person comfortable. I hate to saay it but doctors are so afraid of there licenses that it takes away more of there ability to treat than it does for them to help so it leaves us with a buch of qualified paper holders and that's the damn truth. Sure weve had our bad apples but when its justified and they can prove it they still are to afraid of the consiquences so people like you and i live out an existence not to be confused with a life and keep going to these paper holders to sit down and tell you theres nothing they can do about it. Im about at the end of my rope as far as that goes and the next one that tells me that i think i'm going to break his nose and tell him theres nothing i can do about it.


pharmacist profile image

pharmacist 5 years ago from Whitinsville, MA Author

Dear Marvin,

I hear you. And I'm sorry. What you have discovered is what many have discovered, that there are many ways our healthcare system can be improved. You are doing the right things in asking questions and seeking answers. In some ways, you have to be your own physician, do the research, look for clues, make connections with others in similar situations. Research, study, be the expert. I know that doesn't solve anything, but it is the reality of where you are at. I sincerely hope you can find some answers and get some help. Best wishes.


Daniel 4 years ago

I just had to write and tell my own story. I am 29 from indiana. Ive been healthy most of my life,until the summer of 2011. I had broken my hand in the spring. Had it casted the whole nine yards. My hand kept having unbearable pain in it,it felt like it was unfire even though it looked normal. Id get small scrpits of vicodin or percs here and there from different dctorts cuz they had no clue why I was in so much pain. I was accussed of drug seeking maney times yet in the er id see guys with a hurt tooth get a shot of morphine and you could clearly tell they were fakeing it. But yet I got nothing and told me it was all in my head. I was about to admit myself to rehab when I finally found a doctor who beleaved me and accually told me I know your pain is real it isn't in your head. He went on to tell me I have rsd aka complex regional pain syndrome. Its a rare nerve disease that's as painfull as cancer. Its like cancer as there is no cure for it and it can spread ultimitly it can make you wheeled chair bound it just wont kill you. You have good days and bad days. The cold and rain and snow can make the pain worse. I guess my point here is there are drug seekers who a lot of times get what they want and there are people out there who truly need these meds and have to really fight to get them. Im on a 100mcg fentanyl patch, 4mg of hydromorphine that I take 4times a day and 5-325 of oxycodone that I can take every 6hrs for breakthrew pain as needed. I have a wonderful doctor who is treating my rsd the best way she can plus I go to the cleveland clinic. The diffrence from a addict and a non addict is a addict takes the meds for the high and more then they are supposed to. A non addict takes there meds as they are supposed to and don't look forward to feeling foggy. I tell my wife everyday I wish they would find a cure or a drug that works just as well as the narcotic drugs do. My heart goes out to the people who truly are in pain and need the meds but are being denied by docs who feel they are drug seeking. And I pray for the fakers who make it bad for the people who really need the meds. I pray for your familys that have to bury you from overdoses.


pharmacist profile image

pharmacist 4 years ago from Whitinsville, MA Author

Daniel,

Thanks for sharing your story.


william 4 years ago

why do i have to wait 1-3 days for the insurace to get a prior authoraization before i can get my fentanyl patches filled? I have had my leg amputeated and the dr said i had gangrene which was not true and now he said i have diabetes which is not true, I have had blood work done and they all come back with my glucose level being normal. i am seeking a good attorney to sue the dr who cut off my leg.. why do i have to wait for my ptches to be filled while i am in pain?


pharmacist profile image

pharmacist 4 years ago from Whitinsville, MA Author

William,

Try putting a call in directly to your insurance company, using the 1-800 number on your card. They should be able to explain their process. I'm very sorry for the trouble you are having.


Amanda 3 years ago

Daniel, I read your post and I feel the same way. I am 29 and from Indiana as well. I broke 4 bones in my left foot in Jan of this year. It was casted as well. Long story short I was diagnosed with RSD or the new term is CRPS. It has now spread through both legs and into my lower back. I had a spinal cord stimulator installed but, it doesn't work for me.

I am having the same trouble with my pain doctor on giving me medicine to help with the intense pain, burning, etc. I have been stuck in wheelchair for 3 months now.

I am looking to change doctors.

Can I ask who the doctor you see is? Where they are located?

Thanks,

Amanda


Chris 3 years ago

I completely understand the jerks who accuse us of drug seeking... I live in Utah and finally found an amazing pain clinic. I'm a multiple brain tumor survivor and still deal with all the pain, nausea, dizziness, and vomiting. I was told many of the same things prior to finding my doctor. I am enraged that doctors are so ignorant and could care less about our pain. I will help anyone in the area in need of a good pain specialist.


Gt 20 months ago

I was wondering Why some pharmasist sometimes prescribe hydrocodone for a script written for percoset I heard of this and it's illegal right

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