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Actiq (Fentanyl Citrate Oral Transmucosal) - Summary

 
 



BOX WARNING

PHYSICIANS AND OTHER HEALTHCARE PROVIDERS MUST BECOME FAMILIAR WITH THE IMPORTANT WARNINGS IN THIS LABEL.

Actiq is indicated only for the management of breakthrough cancer pain in patients with malignancies 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 at least 60 mg morphine/day, 50 mcg transdermal fentanyl/hour, or an equianalgesic dose of another opioid for a week or longer.

Because life-threatening hypoventilation could occur at any dose in patients not taking chronic opiates, Actiq is contraindicated in the management of acute or postoperative pain. This product must not be used in opioid non-tolerant patients.

Actiq is intended to be used only in the care of cancer patients and only by oncologists and pain specialists who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.

Patients and their caregivers must be instructed that Actiq contains a medicine in an amount which can be fatal to a child. Patients and their caregivers must be instructed to keep all units out of the reach of children and to discard opened units properly. (See Information for Patients and Their Caregivers for disposal instructions.)

WARNING:

May be habit forming

 

ACTIQ SUMMARY

Actiq (oral transmucosal fentanyl citrate) is a solid formulation of fentanyl citrate, a potent opioid analgesic, intended for oral transmucosal administration. Actiq is formulated as a white to off-white solid drug matrix on a handle that is radiopaque and is fracture resistant (ABS plastic) under normal conditions when used as directed.

Actiq is indicated only for the management of breakthrough cancer pain in patients with malignancies 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 at least 60 mg morphine/day, 50 mcg transdermal fentanyl/hour, or an equianalgesic dose of another opioid for a week or longer.

Because life-threatening hypoventilation could occur at any dose in patients not taking chronic opiates, Actiq is contraindicated in the management of acute or postoperative pain. This product must not be used in opioid non-tolerant patients.

Actiq is intended to be used only in the care of cancer patients and only by oncologists and pain specialists who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.

Actiq should be individually titrated to a dose that provides adequate analgesia and minimizes side effects. If signs of excessive opioid effects appear before the unit is consumed, the dosage unit should be removed from the patient's mouth immediately, disposed of properly, and subsequent doses should be decreased (see DOSAGE AND ADMINISTRATION).

Patients and their caregivers must be instructed that Actiq contains a medicine in an amount that can be fatal to a child. Patients and their caregivers must be instructed to keep all units out of the reach of children and to discard opened units properly in a secured container.


See all Actiq indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Actiq (Fentanyl Oral Transmucosal)

Post-op pain affects sleep, extends hospital stay
Source: Arthritis / Rheumatology News From Medical News Today [2014.09.26]
Pain can make it difficult for some patients to get a good night's rest while recovering in the hospital following certain surgical procedures, often resulting in longer hospital stays, according to...

DEA Makes Vicodin, Some Other Pain Meds Harder to Get
Source: MedPageToday.com - medical news plus CME for physicians [2014.09.26]
(MedPage Today) -- The agency is ratcheting up the restrictions on opioid painkillers another notch.

U.S. Pledges Millions to Study Ways to Ease Soldiers' Pain
Source: MedicineNet Alternative Medicine Specialty [2014.09.26]
Title: U.S. Pledges Millions to Study Ways to Ease Soldiers' Pain
Category: Health News
Created: 9/25/2014 12:36:00 PM
Last Editorial Review: 9/26/2014 12:00:00 AM

Common Painkillers Tied to Blood Clot Risk, Study Suggests
Source: MedicineNet Allergy Specialty [2014.09.25]
Title: Common Painkillers Tied to Blood Clot Risk, Study Suggests
Category: Health News
Created: 9/24/2014 7:36:00 PM
Last Editorial Review: 9/25/2014 12:00:00 AM

'Polyherbacy' a Common Challenge in Pain Patients
Source: Medscape NeurologyHeadlines [2014.09.23]
With chronic pain patients the leading drivers of the multi-billion-dollar dietary supplement industry, clinicians are put to the test to place things in perspective.
Medscape Medical News

more news >>

Published Studies Related to Actiq (Fentanyl Oral Transmucosal)

Fentanyl pectin nasal spray: in breakthrough pain in opioid-tolerant adults with cancer. [2011.06.01]
Fentanyl pectin nasal spray (PecFent(R)) uses a novel pectin-based delivery system that turns from an aqueous solution into a gel when applied to mucosal surfaces... Fentanyl pectin nasal spray 100-800 mug was generally well tolerated and was not associated with nasal tolerability problems.

Pharmacokinetics and relative bioavailability of fentanyl pectin nasal spray 100 - 800 microg in healthy volunteers. [2010.12]
CONCLUSIONS: FPNS has a shorter tmax, higher Cmax and greater bioavailability than OTFC and is well tolerated. The dose proportionality of Cmax and AUC0-1 was demonstrated. It is concluded that the pharmacokinetic profile of FPNS suggests this product is suitable for clinical investigation in breakthrough pain in cancer patients.

Pharmacokinetic comparisons of three nasal fentanyl formulations; pectin, chitosan and chitosan-poloxamer 188. [2010.02]
CONCLUSIONS: All nasal formulations demonstrated significantly increased systemic exposure and reduced times to peak plasma values compared with OTFC. The FPNS formulation exhibited the most favorable nasal and general tolerability profiles. It appears suitable for further investigation in breakthrough cancer pain management.

Oral transmucosal fentanyl citrate: a novel analgesic agent for use in retinal photocoagulation. [2009.11]
PURPOSE: To evaluate the analgesic effect of 200 microg oral transmucosal fentanyl citrate during peripheral retinal scatter photocoagulation and to determine the side effect profile... CONCLUSION: OTFC at a dosage of 200 microg is an effective and convenient analgesic for use in peripheral retinal scatter photocoagulation. We found this agent to be well tolerated in the outpatient setting. However, a larger study would be required to ascertain safety across a larger population of opiate-naive patients.

A randomized clinical trial of oral transmucosal fentanyl citrate versus intravenous morphine sulfate for initial control of pain in children with extremity injuries. [2007.08]
BACKGROUND: Extremity injury is a common condition that requires pain management in an emergency department. In pediatric patients, the most frequently used method of pain control is intravenous (IV) morphine sulfate. Oral transmucosal fentanyl citrate (OTFC) is a potential alternative to morphine, which may obviate the need to place an IV before addressing pain. OBJECTIVE: To compare OTFC with IV morphine for sedation and analgesia during initial evaluation of children with deformity of an extremity and suspected fracture... CONCLUSIONS: The use of OTFC can provide improved pain control when compared with IV morphine. The pain reduction starts 30 minutes after initiation of medication, and the effect is seen as far as 75 minutes after the initiation of analgesic medication. The study size was too small to make any statements concerning adverse effects; thus, further studies with larger sample sizes are needed to determine the use of OTFC.

more studies >>

Clinical Trials Related to Actiq (Fentanyl Oral Transmucosal)

Staccato® Fentanyl Pharmacokinetics in Healthy Volunteers [Completed]
The Phase I clinical trial in approximately 50 healthy volunteers will be conducted at a single clinical center in two stages. Stage 1 is an open-label, cross-over comparison of a single dose of Staccato Fentanyl and an equivalent dose of intravenous (IV) fentanyl. Stage 2 is a randomized, doubleblind, placebo-controlled dose escalation of Staccato Fentanyl, evaluating multiple doses of fentanyl. The three primary aims of the Phase I clinical trial are to evaluate the pharmacokinetics (PK) and absolute bioavailability for Fentanyl, compare the Staccato Fentanyl PK profile to the IV fentanyl PK profile, and examine the tolerability and safety of Staccato Fentanyl in a non-opioid-tolerant, healthy volunteer population.

Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl [Completed]
CONTEXT AND OBJECTIVE: Controversies exist regarding the site of action of Fentanyl after epidural injection. The objective of this investigation was to compare the analgesic effect of epidural and intravenous Fentanyl for lower limb orthopedic surgeries.

DESIGN AND SETTING: A randomized and double-blind study was performed in Hospital Săo Paulo.

METHODS: 29 patients were divided into two groups. During the postoperative period, in the presence of pain, group 1 (n = 14) patients received 5 mL of a 100 mcg Fentanyl solution in saline without preservative by the epidural route and 2 mL saline intravenously. Group 2 (n = 15) patients received 5 mL saline by the epidural route and 2 mL (100 mcg) Fentanyl intravenously. Analgesic supplementation consisted of 40 mg intravenous Tenoxicam and 5 mL epidural 0. 25% bupivacaine (if pain relief was not achieved with Tenoxicam). Pain intensity was evaluated by numerical scale and plasma concentrations of Fentanyl were measured simultaneously.

Study of the Effect of Clinical Procedures on Drug Delivery of Mylan Fentanyl Transdermal System 25 µg/hr and Duragesic® 25 µg/hr [Terminated]
The objective of this study was to investigate the effect of clinical procedures on the drug delivery of Fentanyl Transdermal Systems, 25 mcg/h manufactured for Mylan Pharmaceuticals Inc. by Mylan Technologies Inc., and Duragesic, 25 mcg/h manufactured for Janssen Pharmaceutica by ALZA Corporation.

Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal System [Completed]
The objective of this study was to investigate the effect of three different types of occlusive overlays on the drug delivery of Fentanyl Transdermal Systems, 25 mcg/h manufactured for Mylan Pharmaceuticals Inc. by Mylan Technologies Inc., and Duragesic, 25 mcg/h manufactured for Janssen Pharmaceutica by ALZA Corporation. The acute irritation of each type of overlay worn with each fentanyl treatment was also assessed after patch removal.

Evaluate the Efficacy and Safety of ACTIQ in Patients With Cancer and Breakthrough Pain [Completed]
The primary objective of the study is to determine whether a test titration regimen of ACTIQ treatment will reduce the number of inadequately managed episodes of breakthrough pain for an individual patient by attaining a successful dose of ACTIQ treatment more quickly. The successful ACTIQ dose provides a satisfactory combination of efficacy and tolerability after a single administration, as assessed by the patient.

more trials >>

Reports of Suspected Actiq (Fentanyl Oral Transmucosal) Side Effects

OFF Label USE (78)Drug Prescribing Error (43)Pain (40)Dental Caries (24)Malaise (17)Vomiting (16)Drug Dependence (16)Nausea (15)Withdrawal Syndrome (14)Tooth Disorder (14)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 1 ratings/reviews, Actiq has an overall score of 1. The effectiveness score is 10 and the side effect score is 4. The scores are on ten point scale: 10 - best, 1 - worst.
 

Actiq review by 40 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   chronic pain
Dosage & duration:   1200 mg x 8 a day taken 2 years for the period of 2 years
Other conditions:   Interstitial Cystitis, Fibromyalgia
Other drugs taken:   Cymbalta, Oxycontin
  
Reported Results
Benefits:   Without question, Actiq is an extremely effective drug if you are in chronic severe pain and have no responsibilities. Actiq relaxes the body and the brain becomes numb and able to handle ongoing pain effectively. It is fast acting in the subcutaneous, "lollipop" form and within minutes you are comfortable. The flavor is also quite pleasant.
Side effects:   Actiq, when taken as directed, induces a feeling of numbness. and slurred speech is common. Thinking becomes confused and it is not unusual to fall asleep in mid-sentence. Actiq slows breathing and causes extreme tiredness. Actiq are highly addictive and it is literally impossible to stop taking them without a medical detoxification. Actiq delivered in subcutaneous form causes the teeth to rot after extended use of more than 6 months.
Comments:   Actiq should only be taken by individuals who are in severe, chronic pain where tolerance to the drug will not become problematic. It needs to be closely monitored and locked away out of reach of children or any adult who may have problems with addiction. My chronic pain condition was followed by a Pain Center at a reputable hospital. The use of opioids were used only after all other treatments for my condition had failed. Unfortunately, once Actiq was introduced to me, my medical problems worsened, although my pain was under control. I was unable to function responsibly, began dealing with symptoms of withdrawal whenever I didn't take it, which at times became worse than my actual pain and discomfort. I became more of a patient to my family and on a side note, at age 40 lost 4 molars due to the ingredients present in the "lollipops" I was taking. I had no choice but to be hospitalized for an inpatient medical detox in order to safely get this horrible drug out of my body. Fortunately my husband and I were fortunate enought to have the money to go through this detox program. I have no memory of 2 years of my life, thanks to an ignorant, negligent doctor and the drug, Actiq. Believe it or not, my painful conditions are now completely under control now, and I am able to care for my husband and children, and work! After my experience with Actiq I no longer believe in the use of pharmaceutical products as a whole, and owe my good health to diet, exercise and several natural supplements. I have never felt better in my life!

See all Actiq reviews / ratings >>

Page last updated: 2014-09-26

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