Ionsys - Fentanyl

What is Ionsys - Fentanyl used for?

Ionsys is a transdermal system used for the management of moderate to severe pain after surgery in hospitalized adult patients. It contains the active substance fentanyl.

How is Ionsys - Fentanyl used?

Ionsys can only be used in a hospital environment. Treatment should be administered under the supervision of a physician experienced in the treatment of opioids such as fentanyl. Because of the potential for fentanyl abuse, the physician must assess whether the patient has a history of substance abuse before giving Ionsys, in which case he should closely monitor the patient.

The Ionsys transdermal system delivers the active ingredient, fentanyl, through the skin. The doctor or nurse must apply the transdermal system to the patient's skin, chest or upper arm. When he feels pain, the patient uses a button placed on the Ionsys system to initiate the release of a dose of fentanyl (40 micrograms). Ionsys can be used up to 6 times per hour, but up to a maximum of 80 doses over a 24-hour period. The system stops working 24 hours after the first dose is released or after 80 doses have been administered, depending on which event occurs first. Ionsys must be removed by a doctor or nurse before the patient is discharged from the hospital. For more information, see the package leaflet.

How does Ionsys - Fentanyl work?

Ionsys contains the active substance fentanyl, which is a powerful opioid pain reliever. It is a well-known substance, used for many years for pain control. When the patient activates Ionsys, a dose of fentanyl enters the skin through the blood stream. Once in the blood, fentanyl acts on receptors in the brain and spinal cord, alleviating pain.

What benefit has Ionsys - Fentanyl shown during the studies?

Ionsys has been shown to be effective in controlling post-operative pain in seven main studies, involving a total of 3 300 patients. In three of these studies, Ionsys was compared with a placebo (a dummy treatment). The percentage of patients who discontinued therapy because the pain was not sufficiently controlled was lower in the group treated with Ionsys (between 8% and 27% of patients) than in the group treated with placebo (between 40% and 57%).

The other four studies compared Ionsys with morphine given by intravenous injection and recorded the number of patients who judged pain relief to be "good" or "excellent". These studies have shown that Ionsys is as effective as morphine in pain management.

All the studies described above were carried out with a different delivery device, which was recalled from the market in 2008 due to a system design defect. In the new system the defect was corrected.

What is the risk associated with Ionsys - Fentanyl?

The most common side effects with Ionsys (which may affect more than 1 in 10 people) are nausea, vomiting and erythema (redness) at the site of application. These effects are generally mild or moderate. The most serious side effects are hypotension (decrease in blood pressure) and apnea (pause of breathing) and patients must be carefully monitored for their onset. For the full list of all side effects reported with Ionsys, see the package leaflet.

Ionsys should not be used in patients with severe respiratory depression (breathing problems) or suffering from a rare condition known as cystic fibrosis. For the full list of limitations, see the package leaflet.

Why has Ionsys - Fentanyl been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Ionsys's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP is of the opinion that Ionsys is effective in the management of post-operative pain and that administration for an alternative route compared to the injection could be beneficial for patients. The safety profile is acceptable and is similar to that of intravenous morphine.

What measures are being taken to ensure the safe and effective use of Ionsys - Fentanyl?

A risk management plan has been developed to ensure that Ionsys is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ionsys, including the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company that markets Ionsys will provide all health professionals who may be using Ionsys with informational materials containing information on how to calculate the dose.