"March 11, 2014 - The U.S. Food and Drug Administration allowed marketing of the first device as a preventative treatment for migraine headaches. This is also the first transcutaneous electrical nerve stimulation (TENS) device specifically "...
Limitations of Use
- Use only if a clear diagnosis of migraine has been established.
- If a patient has no response to the first migraine attack treated with ZECUITY reconsider the diagnosis of migraine before ZECUITY is administered to treat any subsequent attacks.
- ZECUITY is not intended for the prevention of migraine attacks.
DOSAGE AND ADMINISTRATION
ZECUITY is for transdermal use only and is designed for patient self-administration to the upper arm or thigh (see Figure 1). ZECUITY should not be applied to other areas of the body. ZECUITY should not be cut.
The maximum recommended single dose is one ZECUITY iontophoretic transdermal system (TDS). No more than two ZECUITY TDS should be used in any 24 hour period, and the second ZECUITY TDS should be applied no sooner than 2 hours after activation of the first ZECUITY TDS. There is no evidence of benefit for the use of a second ZECUITY TDS to treat headache recurrence or incomplete headache relief during a migraine attack.
ZECUITY should be applied to dry intact, non-irritated skin on the upper arm or thigh on a site that is relatively hair free and is without scars, tattoos, abrasions, or other skin conditions (i.e., generalized skin irritation or disease including eczema, psoriasis, melanoma, contact dermatitis). ZECUITY should not be applied to a previous application site until the site remains erythema free for at least 3 days.
Figure 1: Applied Transdermal System
ZECUITY delivers 6.5 mg of sumatriptan over 4 hours. Once applied, the activation button must be pushed, and the red light emitting diode (LED) will turn on. ZECUITY TDS must be applied and activated within 15 minutes of initiation of assembly. When dosing is completed, the system stops operating and the activation light turns off, signaling that the system can be removed. Once dosing is completed, the system cannot be reactivated. If the light turns off before 4 hours, dosing has stopped and ZECUITY can be removed. If headache relief is incomplete, a second ZECUITY TDS can be applied to a different site. [see PATIENT INFORMATION].
The ZECUITY TDS should remain in place for 4 hours or until the red LED light goes off. The iontophoretic device can be secured with medical tape if needed.
The safety of using more than 4 ZECUITY in one month has not been established.
ZECUITY is for single use only. After use, the TDS should be folded so the adhesive side sticks to itself and safely discarded away from children and pets. ZECUITY contains lithium-manganese dioxide batteries; it should be disposed in accordance with state and local regulations.
Dosage Forms And Strengths
Iontophoretic transdermal system: 6.5 mg over 4 hours.
Storage And Handling
ZECUITY contains 86 mg sumatriptan that delivers 6.5 mg of sumatriptan over 4 hours.
After use, fold used system so the adhesive side sticks to itself and safely discard away from children and pets. ZECUITY contains lithium-manganese dioxide batteries; dispose in accordance with state and local regulations.
Store at room temperature, between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F). Do not store in the refrigerator or freezer.
ZECUITY is packaged individually in a sealed pouch. ZECUITY is supplied in cartons of 4 systems, NDC 51759-101-04.
NuPathe Inc., 7 Great Valley Parkway, Suite 300, Malvern, PA 19355. Approved: March 2014
Last reviewed on RxList: 4/3/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Zecuity 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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