Ionsys contains fentanyl, a narcotic (opioid) pain medicine.
Ionsys is used only in a hospital to treat acute pain after surgery.
Ionsys may be used for other purposes not listed in this medication guide.
Important information
Ionsys is used only while you are in a hospital. You will not be allowed to use the device at home. Do not leave the hospital with a device on your skin. Do not use Ionsys unless you are already being treated with a similar opioid (narcotic) pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant. Fentanyl may be habit-forming and should be used only by the person it was prescribed for. Ionsys should never be shared with another person, especially someone who has a history of drug abuse or addiction.
Avoid drinking alcohol, or using other medicines that make you sleepy (such as cold medicine, other pain medication, muscle relaxers, and medicine for depression or anxiety) while using Ionsys. They can add to extreme drowsiness or breathing problems caused by fentanyl.
The Ionsys transdermal device may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the device before undergoing such a test.
Before using Ionsys
Do not use Ionsys unless you are already being treated with a similar opioid (narcotic) pain medicine and your body is tolerant to it. Opioid medicines include morphine (Kadian, MS Contin, Oramorph, and others), oxycodone (OxyContin), and hydromorphone (Dilaudid). Talk with your doctor if you are not sure you are opioid-tolerant.
Before you receive Ionsys, tell your doctor if you are allergic to fentanyl or any other medications, or if you have:
If you have any of these conditions, you may need a dose adjustment or special tests to safely use Ionsys.
FDA pregnancy category C. Ionsys may be harmful to an unborn baby, and could cause addiction or withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Fentanyl may also cause addiction and withdrawal symptoms in a nursing infant. Do not use Ionsys without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medicine. Ionsys may be habit-forming and should be used only by the person it was prescribed for. Ionsys should never be shared with another person, especially someone who has a history of drug abuse or addiction.
See also: Pregnancy and breastfeeding warnings (in more detail)
How is Ionsys used?
Ionsys is used only while you are in a hospital. You will not be allowed to use Ionsys at home. Do not leave the hospital with a device on your skin.
If the skin must be washed before the Ionsys transdermal device is applied, use clear water only. Allow the skin to dry completely before applying the medicine.
Do not use soaps, oils, lotions, alcohol, or other chemicals on the skin where you will apply the Ionsys transdermal device. These substances could increase the amount of fentanyl that your skin absorbs, possibly causing harmful effects.
The Ionsys device will be applied where you can reach it, such as your chest or the outer side of your upper arm. The device is worn for 24 hours or until the device has delivered 80 doses of fentanyl.
To release the medicine from the Ionsys device, press the dosing button twice. The device will sound a beep when the dose starts, and a red light will come on for 10 minutes while the dose is delivered. The light will also flash between doses to let your caregivers know how many doses are left in the device. Tell your care provider if the Ionsys device comes loose or falls off.
The device will allow you to give yourself up to 6 doses per hour. Do not allow others to press the dosing button for you.
The Ionsys transdermal device may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the device before undergoing such a test.
What happens if I miss a dose?
Since Ionsys is applied by a healthcare professional in a hospital setting, it is not likely that you will miss a dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A fentanyl overdose can be fatal.
Overdose symptoms may include slow breathing, extreme weakness or dizziness, pinpoint pupils, cold and clammy skin, or fainting.
What should I avoid?
Ionsys is for use only on the skin. Avoid touching the gel inside a device with your fingers. Do not allow the medicine to come into contact with your eyes, nose, mouth, or lips. If it does, rinse with water. Do not use soap or other chemicals. Fentanyl can cause side effects that may impair your thinking or reactions. Be careful if you do anything that requires you to be awake and alert. Avoid drinking alcohol, which can increase dizziness or drowsiness.
Ionsys side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Ionsys: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Tell your caregivers right away if you have any of these serious side effects:
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weak, shallow breathing;
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severe weakness, feeling light-headed or fainting;
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cold, clammy skin; or
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pale skin, easy bruising or bleeding.
Less serious Ionsys side effects may include:
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nausea, vomiting, stomach pain, constipation, gas;
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dizziness, drowsiness, anxiety, sleep problems (insomnia);
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muscle stiffness, back pain;
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itching, blistering, redness, or swelling where the device was worn; or
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increased sweating, urinating less than usual.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
What other drugs will affect Ionsys?
Before using Ionsys tell your doctor if you regularly use other medicines that make you sleepy (such as cold medicine, other pain medicine, muscle relaxers, and medicine for depression or anxiety). They can add to extreme drowsiness or breathing problems caused by fentanyl.
Tell your doctor about all other medicines you use, especially:
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carbamazepine (Tegretol, Carbatrol);
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phenytoin (Dilantin);
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diltiazem (Cartia, Cardizem);
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St. John"s wort;
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rifampin (Rifater, Rifamate, Rimactane);
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an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), or telithromycin (Ketek);
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antifungal medication such as itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), miconazole (Oravig), or voriconazole (Vfend); or
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HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir, Kaletra).
This list is not complete and other drugs may interact with Ionsys. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
