Zecuity™ (sumatriptan iontophoretic transdermal system)
Zecuity is no longer on the market as a treatment for migraine.
Zecuity™ is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for the acute treatment of migraine, with or without aura, in adults who have a clear migraine diagnosis. It is administered by a transdermal system (TDS). It uses a mild electrical current to deliver the medicine sumatriptan through your skin. A patch is applied to a clean and dry area of skin on the upper arm or thigh. Zecuity works quickly and is intended to reduce acute migraine symptoms. It is not intended as a prophylactic therapy to prevent the onset of migraine.
Overuse of acute migraine drugs can cause medication overuse headaches. Overuse is considered using more than 4 TDS patches per month. Symptoms of overuse may need to be treated and detoxification from migraine medications may be required. Zecuity is excreted in the urine.
What are the ingredients in Zecuity?
The active ingredient in Zecuity is sumatriptan.
How does Zecuity work?
Zecuity is believed to work by binding with 5-HT1B/1D receptors on blood vessels in the brain. It narrows the blood vessels (constriction) around the brain. The effect is to reduce inflammatory substances in the body that can trigger head pain, nausea, sensitivity to light and sound, and other migraine symptoms.
What are the possible side effects of Zecuity?
Many clinical trials evaluated the safety and efficacy of Zecuity. The most common side effects experienced by those taking Zecuity include:
- Application-site reactions including redness in the area under the transdermal patch (usually disappears within 24 hours)
- Tingling or numbness in fingers or toes
- Flushing (warm red skin or face)
- Discomfort or stiffness in the neck
- Feeling weak, drowsy, or tired
This is not an exhaustive list of all potential side effects of Zecuity. For more information, consult your doctor or healthcare provider. If you notice any new or worsening side effects when taking Zecuity, contact your doctor or healthcare provider immediately.
Things to note about Zecuity
The Zecuity TDS method for sumatriptan administration is by iontophoresis, a process of transdermal drug delivery that uses an electric voltage gradient on the skin. Before starting Zecuity talk with your doctor if you:
- Have a history of hypersensitivity to sumatriptan or electrical devices
- Have a history of coronary artery disease (CAD), angina or heart attacks
- Have a history of Wolff-Parkinson-White syndrome or arrhythmias, or conduction pathway disorders
- Have a history of stroke or transient ischemic attack (TIA)
- Have a history of hemiplegic or basilar migraine which may be at increased stroke risk
- Have peripheral vascular disease (circulation in the extremities)
- Have ischemic bowel disease
- Have a history of uncontrolled hypertension
- Have taken a ergot-containing medication or another triptan within the 24 hours prior to migraine
- Have taken a MAO-A inhibitor within 2 weeks prior to migraine
- Take anti-depressant medicines including selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), or tricyclic antidepressants (TCAs)
- Have severe hepatic (liver) impairment
- Are pregnant or planning to get pregnant, as there is limited information on the use of Zecuity in pregnancy. It should be used only if the potential benefit of Zecuity therapy exceeds risk to the fetus.
Individuals with the above conditions should be monitored closely while taking Zecuity.
If there is no response to the first migraine attack treated with Zecuity, a physician should reconsider the migraine diagnosis prior to using the medication in any subsequent attacks.
A cardiovascular evaluation should be performed on patients who have never taken a triptan medication, but who have multiple cardiovascular risk factors (e.g. increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) before starting Zecuity. For those with a cardiac history, the first use should be administered in a medically supervised setting, and an electrocardiogram (ECG) should be performed immediately following the dosing.
The Zecuity system is composed of an iontophoretic device and a drug reservoir card. The reservoir card contains 2 non-woven pads and 2 different gel formulations. One is a sumatriptan succinate formulation, and the other a sodium salt formulation. The device consists of medical grade adhesive fabric and foam, and a plastic dome that contains an activation button, batteries, and electronics. Sumatriptan and salt pads are contained in individual reservoirs. A foil strip that is removed prior to placing the pads onto the device seals each reservoir. For Zecuity to work, the pads must completely cover the electrodes.
Zecuity delivers 6.5 mg of sumatriptan over a 4-hour period. The recommended dose is 1 TDS patch. A maximum dose of 2 patches can be applied in a 24-hour period. Each dose must be separated by at least 2 hours. It should only be applied to the abdomen or the thigh in an area that is relatively free of hair, is without scars, tattoos, abrasions, or other skin conditions. Zecuity should not get wet; no one should bathe, swim or shower while wearing the TDS patch. Zecuity should not be applied to other areas of the body, and the patch should not be cut. Zecuity TDS should not be applied to a previous application site until the area remains erythema-(superficial reddening or irritation of the skin)-free for at least 3 days.
Once adhered to the skin, an activation button must be pushed, and a red light-emitting diode (LED) will illuminate. Zecuity must be applied and activated within 15 minutes of assembling the system. When dosing is completed, the system stops operating, and the activation light turns off, signaling that it is ready to be removed. Once dosing is complete, the system cannot be reactivated.
A healthcare professional should review the proper technique for assembling and applying Zecuity. Because the system contains lithium manganese dioxide batteries, it should be disposed of carefully in accordance with state and local regulations.
For additional details, read the full prescribing information of Zecuity.
- ZECUITY prescribing information available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202278s000lbl.pdf Accessed 4/30/18.