Ionsys
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"Nov. 1, 2012 -- Two more drugs made by the New England Compounding Center (NECC) are crawling with various kinds of bacteria, FDA tests reveal.
The NECC is the Massachusetts compounding pharmacy whose drugs are the likely source of th"...
Ionsys
Please Note: This Brand Name drug is no longer available in the US.(Generic versions may still be available.)
Ionsys Side Effects Center
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Ionsys in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: 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:
- weak, shallow breathing;
- severe weakness, feeling light-headed or fainting;
- cold, clammy skin; or
- pale skin, easy bruising or bleeding.
Less serious side effects may include:
- nausea, vomiting, stomach pain, constipation, gas;
- dizziness, drowsiness, anxiety, sleep problems (insomnia);
- muscle stiffness, back pain;
- itching, blistering, redness, or swelling where the patch or device was worn; or
- 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.
Read the entire detailed patient monograph for Ionsys (Fentanyl Iontophoretic Transdermal System) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Ionsys FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
In controlled and uncontrolled studies, the safety of IONSYS™ 40 mcg was evaluated in a total of 2114 patients with acute postoperative pain requiring opioid analgesia.
The most common adverse events ( ≥ 2%) in the placebo-controlled studies, regardless of relationship to study medication, are listed in Table 5.
Table 5 Adverse Events with Incidence ≥ 2% in Placebo-controlled
Studies 1, 2, and 3 (N=791; 24 Hour Duration), Regardless of Relationship to
Study Medication
| Adverse Event | IONSYS™ (n=475) |
Placebo (n=316) |
| Body as a Whole | ||
| Headache | 9% | 7% |
| Fever | 9% | 10% |
| Back Pain | 2% | 3% |
| Cardiovascular | ||
| Hypotension | 2% | < 1% |
| Digestive* | ||
| Nausea | 39% | 22% |
| Vomiting | 12% | 6% |
| Hemic and Lymphatic | ||
| Anemia | 3% | < 1% |
| Nervous system | ||
| Insomnia | 3% | 5% |
| Dizziness | 3% | 1% |
| Skin system | ||
| Application site reaction- Erythema | 14% | 2% |
| Pruritus | 6% | < 1% |
| Urogenital | ||
| Urinary retention | 3% | < 1% |
| * NOTE: Patients reported as having "Nausea and vomiting" are included in "Nausea" and "Vomiting" in Table 5. | ||
Adverse Events Reported in All Studies in Patients Treated With IONSYS™ (40 mcg/dose: n= 2114 including 3 Placebo-Controlled Trials and 4 Active Comparator Trials vs. IV PCA morphine)
The most common ( > 10%) adverse events reported regardless of relationship to IONSYS™ use were nausea, vomiting, application site reaction-erythema, fever, and headache. Other adverse events reported for IONSYS™ were:
Body as a whole: abdominal pain**, back pain**, extremity pain**, pain**, injection site reaction*, chills*, internal postoperative bleeding*, chest pain*, infection*, injection site edema*, injection site pain*, immune system disorder*, abdomen enlarged*, asthenia*, neck pain*, abscess*, and hypothermia*, Cardiovascular System: hypotension**, tachycardia**, hypertension**, syncope*, postural hypotension*, pulmonary embolus*, atrial fibrillation*, bradycardia*, migraine*, myocardial infarct*, vasodilation*, hemorrhage*, deep thrombophlebitis*, bigeminy*, and arrhythmia*, Digestive System: constipation**, flatulence**, dyspepsia**, ileus**, gastrointestinal disorder*, dry mouth*, diarrhea*, and gastrointestinal hemorrhage*, Hemic and Lymphatic System: anemia**, and leukocytosis*, and Metabolic and Nutritional System: hypokalemia**, peripheral edema*, hypomagnesemia*, hypocalcemia*, hyponatremia*, hyperglycemia*, healing abnormal*, hypoglycemia*, hypophosphatemia*, edema*, and dehydration*, Musculoskeletal System: leg cramps* and myalgia*, Nervous System: dizziness**, insomnia**, anxiety**, hypertonia**, somnolence**, confusion*, paresthesia*, hypesthesia*, nervousness*, agitation*, abnormal dreams*, and tremor*, Respiratory System: hypoxia**, pharyngitis**, hypoventilation*, dyspnea*, apnea*, cough increased*, lung disorder*, asthma*, hiccup*, pneumonia*, atelectasis*, upper respiratory tract infection*, rhinitis*, sinusitis*, and hyperventilation*, Skin System: pruritus**, application site reaction (ASR)-itching**, ASR-vesicles**, ASR-edema**, ASR-other**, sweating**, wound site oozing/bleeding**, wound site inflammation/erythema*, rash*, ASR-dry and flaky*, ASR-papules/pustules*, vesiculobullous rash*, ASR-pain*, ASR-burning*, Special Senses: abnormal vision-blurred vision*, and ear pain*, Urogenital System: urinary retention**, urination impaired*, oliguria*, urogenital disorder*, hematuria*, urinary tract infection*, urinary urgency*, and dysuria*.
The level of current (62 microA/cm2) provided by IONSYS™ is generally imperceptible to the patient.
Scheduled observation of the skin approximately 24 hours after system removal was included in several studies. Some redness at the skin sites was observed in approximately 60% of patients at this observation. The skin findings included erythema, edema, and papules. The majority of these events were categorized as mild. Two patients were noted to have hyperpigmentation lasting 2-3 weeks at the application site. Three patients from another study noted a rectangular mark at the application site, which persisted for up to 3 months after study completion.
Drug Abuse And Dependence
Controlled Substance
IONSYS™ contains fentanyl, a Schedule II controlled substance.
Abuse
IONSYS™ contains a high concentration of a potent Schedule II controlled opioid agonist, fentanyl. Schedule II opioid substances, which include fentanyl, morphine, oxycodone, oxymorphone, hydromorphone, and methadone, have the highest potential for abuse. These drugs also have a risk of fatal overdose due to respiratory depression. Fentanyl can be abused and is subject to criminal diversion. The high drug content and concentrated formulation of fentanyl in IONSYS™ may be a particular target for abuse and diversion and may add to the risk of adverse outcomes from abuse. After the maximum dosage administration, a significant amount of fentanyl remains in the device.
Access to abusable drugs such as IONSYS™ presents a risk for abuse and diversion in the health care community. Implementation of effective accounting procedures in addition to routine procedures for handling controlled substances may minimize these risks.
Dependence
Tolerance and physical and psychological dependence may develop upon repeated administration of opioids. latrogenic addiction following opioid administration is relatively rare. Physicians should not let concerns of physical dependence deter them from using adequate amounts of opioids in the management of acute post-operative pain when such use is indicated.
(** indicates 1 to < 10%, * indicates between 0.1 to < 1%).
Read the entire FDA prescribing information for Ionsys (Fentanyl Iontophoretic Transdermal System) »
Additional Ionsys Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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