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Zecuity

PATIENT INFORMATION

ZECUITY®
(zeh-CUE-eh-tee)
(sumatriptan succinate) Iontophoretic Transdermal System (TDS) for topical use

Read this Patient Information before you start using ZECUITY and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about ZECUITY?

ZECUITY can cause serious side effects, including:

Heart attack and other heart problems. Heart problems may lead to death.

Stop using ZECUITY and get emergency medical help right away if you have any of the following symptoms of a heart attack:

  • discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
  • chest pain or chest discomfort that feels like an uncomfortable heavy pressure, squeezing, fullness, or pain
  • pain or discomfort in your arms, back, neck, jaw, or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

ZECUITY is not for people with risk factors for heart disease unless a heart exam is done and shows no problem. You have a higher risk for heart disease if you:

What is ZECUITY?

ZECUITY is a prescription medicine used for the acute treatment of migraine headaches with or without aura in adults. ZECUITY comes in an iontophoretic transdermal system (TDS) that uses a mild electrical current to deliver the medicine sumatriptan through your skin.

ZECUITY is used for people who have been told by a healthcare provider that they have migraine headaches.

ZECUITY is not used to prevent or decrease the number of migraine headaches you have.

It is not known if ZECUITY is safe and effective in children under 18 years of age.

Who should not use ZECUITY?

Do not use ZECUITY if you have:

  • heart problems or a history of heart problems
  • had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation
  • narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
  • uncontrolled high blood pressure
  • hemiplegic migraines or basilar migraines. If you are not sure if you have these types of migraines, ask your healthcare provider
  • taken any of the following medicines in the last 24 hours:
    • almotriptan (AXERT®)
    • eletriptan (RELPAX®)
    • frovatriptan (FROVA®)
    • naratriptan (AMERGE®)
    • rizatriptan (MAXALT®, MAXALT-MLT®)
    • sumatriptan and naproxen (TREXIMET®)
    • ergotamines (CAFERGOT®, ERGOMAR®, MIGERGOT®)
    • dihydroergotamine (D.H.E. 45®, MIGRANAL®)

Ask your healthcare provider if you are not sure if your medicine is listed above.

  • severe liver problems
  • an allergy to sumatriptan, the medicine in ZECUITY, or any of the components in ZECUITY TDS. See the end of this leaflet for a complete list of ingredients in ZECUITY.

What should I tell my healthcare provider before using ZECUITY?

Before you use ZECUITY, tell your healthcare provider about all of your medical conditions, including if you:

  • have high blood pressure
  • have high cholesterol
  • have diabetes
  • smoke
  • are overweight
  • are a female who has gone through menopause
  • have heart problems or family history of heart problems or stroke
  • have liver problems
  • have had epilepsy or seizures
  • are not using effective birth control
  • have or have had any side effects caused by the use of electrical devices. Talk to your healthcare provider if you are not sure if you have a medical electronic device or sensitivities to electrical devices.
  • are pregnant or plan to become pregnant. It is not known if ZECUITY will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if the medicine in ZECUITY passes into your breast milk. You and your healthcare provider should decide if you will use ZECUITY or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Using ZECUITY with certain other medicines can affect each other, causing serious side effects.

Especially tell your healthcare provider if you take antidepressant medicines called:

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

How should I use ZECUITY?

  • Read the Instructions for Use in the package that comes with your ZECUITY TDS for information about the right way to use ZECUITY TDS.
  • Certain people should apply their first dose of ZECUITY in their healthcare provider's office or in another medical setting. Ask your healthcare provider if you should use your first dose in a medical setting.
  • ZECUITY is for use on the skin only.
  • Use ZECUITY exactly as your healthcare provider tells you to.
  • Apply 1 ZECUITY to your upper arm or thigh.
  • Do not apply ZECUITY to other areas of your body. Talk to your healthcare provider if you are not sure where to apply ZECUITY.
  • If your headache comes back or you only get some relief from your headache, you may apply a second ZECUITY to your other arm or thigh, no sooner than 2 hours after the activation of the previously applied ZECUITY.
  • Do not apply more than 2 ZECUITY in 24 hours.
  • If you use too much ZECUITY, call your healthcare provider or go to the nearest hospital emergency room right away.
  • It is not known if using more than 4 ZECUITY in 1 month is safe.

What should I avoid while using ZECUITY?

  • Do not bathe, shower, or swim while wearing ZECUITY.
  • ZECUITY can cause dizziness, weakness, or drowsiness. If you have these symptoms, do not drive a car, use machinery, or do anything where you need to be alert.
  • You should remove ZECUITY before you have a Magnetic Resonance Imaging (MRI) procedure.

What are the possible side effects of ZECUITY?

See “What is the most important information I should know about ZECUITY?”

ZECUITY may cause serious side effects including:

  • injury during a Magnetic Resonance Imaging (MRI). The ZECUITY TDS contains metal parts and must be removed before an MRI.
  • allergic contact dermatitis (ACD). Some people have had a serious skin reaction called allergic contact dermatitis (ACD) where ZECUITY is applied. Symptoms of ACD include:
    • itching, redness, or irritation of skin
    • blistering or peeling of your skin
    • warmth or tenderness of skin
    • blisters that ooze, drain, or crust over
      You should stop using ZECUITY and call your healthcare provider if you have any of the symptoms of ACD. If you have or have had ACD while using ZECUITY and need to take sumatriptan by mouth or injection, your first dose of sumatriptan should be given in your healthcare provider's office or in another medical setting.
  • changes in color or sensation in your fingers and toes (Raynaud's syndrome)
  • stomach and intestinal problems (gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and colonic ischemic events include:
    • sudden or severe stomach pain
    • stomach pain after meals
    • weight loss
    • nausea or vomiting
    • constipation or diarrhea
    • bloody diarrhea
    • fever
  • problems with blood circulation to your legs and feet (peripheral vascular ischemia). Symptoms of peripheral vascular ischemia include:
    • cramping and pain in your legs or hips
    • feeling of heaviness or tightness in your leg muscles
    • burning or aching pain in your feet or toes while resting
    • numbness, tingling, or weakness in your legs
    • cold feeling or color changes in 1 or both legs or feet
  • medication overuse headaches. Some people who use too many ZECUITY may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with sumatriptan.
  • serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using ZECUITY, especially if ZECUITY is used with anti-depressant medicines called SSRIs or SNRIs.

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

Call your healthcare provider right away if you have any of the following symptoms of serotonin syndrome:

    • mental changes such as seeing things that are not there (hallucinations), agitation, or coma
    • fast heartbeat
    • changes in blood pressure
    • high body temperature
    • tight muscles
    • trouble walking
    • nausea, vomiting, or diarrhea
  • increases in blood pressure. You should not use ZECUITY if you have uncontrolled high blood pressure.
  • serious allergic reactions. Get medical help right away if you have any of these symptoms of a serious allergic reaction:
    • swelling of your face, lips, mouth, or tongue
    • trouble breathing
    • wheezing
    • severe itching
    • skin rash, redness, or swelling
    • dizziness or fainting
    • fast heartbeat or pounding in your chest (tachycardia)
    • sweating
  • seizures. Seizures have happened in people taking sumatriptan who have never had seizures before. Talk with your healthcare provider about your chance of having seizures while you take ZECUITY.

The most common side effects of ZECUITY include pain, tingling, itching, warmth, discomfort or a change in the skin color at the application site of ZECUITY.

Most people have some skin redness after removal of ZECUITY. This redness will usually go away in 24 hours.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of ZECUITY. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ZECUITY?

  • Store ZECUITY at room temperature between 68°F to 77°F (20°C to 25°C).
  • Do not store ZECUITY in the refrigerator or freezer.

Keep ZECUITY and all medicines out of the reach of children.

General information about the safe and effective use of ZECUITY

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ZECUITY for a condition for which it was not prescribed. Do not give ZECUITY to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about ZECUITY. If you would like more information, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information about ZECUITY that is written for healthcare professionals.

For more information, go to www.ZECUITY.com or call 1-855-ZECUITY.

What are the ingredients in ZECUITY?

Active ingredient: sumatriptan succinate

Inactive ingredients:

  • Sumatriptan Reservoir Card and pad: purified water, basic butylated methacrylate copolymer (polyamine), lauric acid, adipic acid, methylparaben, and non-woven viscose pad.
  • Salt Reservoir Card and pad: purified water, hydroxypropylcellulose, sodium chloride, methylparaben, and non-woven viscose pad.
  • Iontophoretic device: medical grade adhesive fabric, foam and plastic dome containing an activation button, coin cell lithium batteries, and electronics.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Instructions for Use

ZECUITY
(zeh-CUE-eh-tee)
(sumatriptan succinate) Iontophoretic Transdermal System (TDS) For topical use

Read this Patient Instructions for Use before using your ZECUITY and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment.

Your ZECUITY Transdermal System (TDS): See Figure A

Figure A

ZECUITY Transdermal System - Illustration

Preparation

ZECUITY is a single-use Transdermal System (TDS) or patch.

  • Remove ZECUITY by folding and tearing from the notch at the corner of the clear pouch. See Figure B
    • ZECUITY TDS should not be cut.
    • Do not use ZECUITY TDS if the clear pouch is torn or damaged.

Figure B

Remove ZECUITY by folding and tearing from the notch at the corner of the clear pouch - Illustration

  • Choose an application site: See Figure C

Figure C

Choose an application site - Illustration

Choose an application site on your upper arm or thigh. Do not apply ZECUITY to any other body parts.

Choose an area of skin that is dry, clean and relatively hair free.

Do not apply ZECUITY over skin that is red or irritated. Skin should be free of redness and irritation for at least 3 days prior to application.

Do not apply ZECUITY over scars, tattoos, scratches, burns, abrasions, or broken skin.

Step 1 - Pull Tabs

To apply the ZECUITY TDS you must pull the 2 foil tabs. These tabs are marked on the package as Step 1a and Step 1b. See Figure D

  • Place ZECUITY on a flat surface with the foil packets facing up.
  • While holding the package, pull both foil tabs out, 1 at a time, and throw the foil tabs away in the trash.

Note: You must apply and activate ZECUITY within 15 minutes of completing Step 1.

Figure D

Tabs are marked on the package as Step 1a and Step 1b - Illustration

Step 2 - Rub Foil Packets

ZECUITY has 2 foil packets that each contain a white medication pad that must be properly attached to the ZECUITY TDS before use.

  • To transfer and attach the medication pads to the ZECUITY TDS use 2 fingers and firmly press and rub each foil packet, tracing the green arrow 3 times around. See Figure E

Figure E

Rub Foil Packets - Illustration

Step 3 - Unfold and Lift Open

Unfold the orange flap, marked as Step 3 on the bottom of the packet and lift open the package. See Figure F

Figure F

Unfold and Lift Open - Illustration

Step 4 - Peel Pads and Check

  • Slowly peel the first part of the ZECUITY TDS back from the silver liner. If the medication pad is not attached, lay the ZECUITY TDS down on a hard surface and repeat Steps 2 and 3. See Figure G

Figure G

Peel Pads and Check - Illustration

After checking to make sure that both white medication pads are securely attached, peel the ZECUITY TDS completely away from liner. See Figure H

  • The ZECUITY TDS will not work properly if both medication pads are not attached.
  • There may be gel left in the reservoirs after the ZECUITY TDS is peeled back from the silver liner.

Figure H

Peel the ZECUITY TDS - Illustration

Step 5 - Apply and Activate

Apply ZECUITY to your upper arm or thigh and activate it by pressing the button to turn it on. The button will blink and then turn solid red as it releases the medicine.

See Figure I

  • If the light does not turn solid red or goes off within the first 10 minutes of application this means no medicine is being delivered. The TDS should be gently removed and thrown away. See “How to safely remove and throw away ZECUITY TDS” for instructions. You can immediately apply a new TDS to a different application site.
  • Wear the TDS for 4 hours or until the red light goes off.
  • If the red light turns off before 4 hours, the TDS has stopped delivering your medicine and should be gently removed and thrown away. See “How to safely remove and throw away ZECUITY TDS” for instructions. If you still have migraine pain, another ZECUITY TDS can be applied to a different application site.

Figure I

Apply and Activate - Illustration

Important Information about using ZECUITY TDS:

  • You may feel slight tingling or a mild burning sensation within 30 seconds of activating the ZECUITY TDS after pressing the button.
  • If ZECUITY begins to peel off, the ZECUITY TDS may be taped downwith medical tape.
  • You must keep ZECUITY dry. Do not bathe, shower, or swim while wearing ZECUITY.
  • Do not have a Magnetic Resonance Imaging (MRI) while wearing ZECUITY.
  • Remove ZECUITY if you have a painful burning sensation during use.

How to safely remove and throw away ZECUITY TDS:

  • Slowly remove ZECUITY to minimize skin irritation. Gently clean the area with mild soap and water to remove any medicine that might be left on the skin.
  • ZECUITY TDS contains lithium-manganese dioxide batteries. Talk to your pharmacist or healthcare provider about how to follow state and local regulations when throwing away ZECUITY.
  • After use, fold your used ZECUITY TDS so the adhesive side sticks to itself and safely throw it away.
  • Keep ZECUITY out of the reach of children and pets.

How should I store ZECUITY?

  • Store ZECUITY TDS at room temperature between 68°F to 77°F (20°C to 25°C).
  • Do not store ZECUITY in the refrigerator or freezer.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 4/3/2014
This monograph has been modified to include the generic and brand name in many instances.

A A A

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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