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IONSYS™ should only be used for the treatment of hospitalized patients. Treatment with IONSYS™ should be discontinued before patients are discharged from the hospital.
Treatment with fentanyl, the active component of IONSYS ™ , may result in potentially life-threatening respiratory depression and death. To avoid potential overdosing, only the patient should activate IONSYS™ dosing.
Inappropriate use of IONSYS™, leading to ingestion or contact with mucous membranes or unintended exposure to the fentanyl hydrogel could lead to the absorption of a potentially fatal dose of fentanyl. Therefore, the hydrogels should not come into contact with fingers or mouth.
IONSYS™ contains fentanyl, a potent opioid agonist and Schedule II controlled substance with high potential for abuse similar to hydromorphone, methadone, morphine, and oxycodone. Fentanyl can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing IONSYS™ in situations where the Health Care Professional is concerned about an increased risk of misuse, abuse, or diversion. After the maximum dosage administration, a significant amount of fentanyl remains in the device.
IONSYS™ should always be kept out of reach of children.
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IONSYS SUMMARY
IONSYS™ (fentanyl iontophoretic transdermal system)
40 mcg*/activation
IONSYS™ (fentanyl iontophoretic transdermal system) is a patient-controlled iontophoretic transdermal system providing on-demand systemic delivery of fentanyl, an opioid agonist, for up to 24 hours or a maximum of 80 doses, whichever comes first.
IONSYS™ is indicated for the short-term management of acute postoperative pain in adult patients requiring opioid analgesia during hospitalization. Patients should be titrated to an acceptable level of analgesia before initiating treatment with IONSYS™. IONSYS™ is not intended for home use and is, therefore, inappropriate for use in patients once they have been discharged from the hospital. It is not recommended for patients under the age of 18 years (see WARNINGS and PRECAUTIONS).
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NEWS HIGHLIGHTS
Published Studies Related to Ionsys (Fentanyl Transdermal)
Six- versus 12-h conversion method from intravenous to transdermal fentanyl in chronic cancer pain: a randomized study. [2011.05]
PURPOSE: The objective of the present prospective study was to compare the safety and efficacy of a 12-h method to a 6-h method in chronic cancer pain management... CONCLUSIONS: Excellent safety profile and sustained efficacy are shown for the 6-h conversion method.
Pharmacokinetic/pharmacodynamic relationships of transdermal buprenorphine and fentanyl in experimental human pain models. [2011.04]
Pharmacokinetic/pharmacodynamic (PK/PD) modelling can be used to characterize the relationship between dose regimen of opioids, plasma concentration and effect of opioids, which in turn can lead to more rational treatment regimens of pain. The aim of this study was to investigate the concentration-effect relationship for transdermal buprenorphine and fentanyl in experimentally induced pain...
Bioequivalence and safety of a novel fentanyl transdermal matrix system compared with a transdermal reservoir system. [2011.03]
CONCLUSIONS: The transdermal fentanyl matrix system adhered well, was well tolerated, and produced systemic exposures of fentanyl that were bioequivalent to the reservoir system.
Six- versus 12-h conversion method from intravenous to transdermal fentanyl in
chronic cancer pain: a randomized study. [2011]
and efficacy of a 12-h method to a 6-h method in chronic cancer pain management... CONCLUSIONS: Excellent safety profile and sustained efficacy are shown for the
The post-operative analgesic effects of epidurally administered morphine and transdermal fentanyl patch after ovariohysterectomy in dogs. [2010.11]
OBJECTIVE: To investigate the analgesic and side effects of epidural morphine or a fentanyl patch after ovariohysterectomy in dogs... CONCLUSION AND CLINICAL RELEVANCE: Epidurally administered morphine provided better analgesia and caused fewer adverse effects than the fentanyl patch after ovariohysterectomy in dogs.
Clinical Trials Related to Ionsys (Fentanyl Transdermal)
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 São 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.
A Study to Assess the Safety, Dose Conversion, and Dose Individualization of Duragesic® (Fentanyl Transdermal Patch) in the Treatment of Children With Chronic Pain Requiring Narcotic Pain Relief Therapy [Completed]
The objective of this study is to assess the safety of treatment with Duragesic® (a
transdermal patch delivering the narcotic pain-reliever fentanyl) in doses of 12. 5, 25, 50,
75 and 100 micrograms/hour in pediatric subjects requiring narcotic pain relief therapy.
Particular attention is paid to appropriate dose conversion to Duragesic® therapy from the
subject's current narcotic pain relief therapy, and to the parameters for increasing the
Duragesic® dose to achieve analgesic effectiveness. Pharmacokinetics (fentanyl levels in the
bloodstream during treatment) will also be assessed.
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Page last updated: 2013-02-10
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