Zecuity

Zecuity is a prescription medication used to treat migraine headaches once they have already started. Zecuity belongs to a group of drugs called serotonin receptor agonists, which are also known as "triptans". These work to relieve migraine headache pain by narrowing blood vessels in and around the brain.

This medication comes in a skin patch form and is applied at the onset of a migraine headache. It should not be applied more than twice per 24 hour period. 

Common side effects of Zecuity include application site pain, itching, and discoloration.

Zecuity can also cause dizziness and/or drowsiness. Do not drive or operate heavy machinery until you know how Zecuity affects you.

Zecuity is a prescription medication used to stop migraine headaches in adults, with or without a preceding aura, after they've already started.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Zecuity. See the “Zecuity Precautions” section.

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.

This is not a complete list of Zecuity side effects. Ask your doctor or pharmacist for more information.

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

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• selective serotonin reuptake inhibitors (SSRIs) such as escitalopram (Lexapro), sertraline (Zoloft), citalopram (Celexa), paroxetine (Paxil), fluoxetine (Prozac, Sarafem), and fluvoxamine (Luvox)
• serotonin norepinephrine reuptake inhibitors (SNRIs) such as duloxetine (Cymbalta) and venlafaxine (Effexor)
• monoamine oxidase inhibitors (MAOIs) such as tranylcypromine (Parnate), phenelzine (Nardil), selegiline (Eldepryl, Zelapar), isocarboxazid (Marplan), and rasagiline (Azilect)
• other ergot-containing medications such as dihydroergotamine (D.H.E. 45, MIGRANAL) or methysergide
• other triptans such as eletriptan (Relpax), almotriptan (Axert), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), and zolmitriptan (Zomig)

This is not a complete list of Zecuity drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Zecuity including the following:

• Risk of injury during magnetic resonance imaging (MRI) procedure. Zecuity contains metal parts and must be removed before an MRI procedure.
• Allergic contact dermatitis. Use of Zecuity may lead to allergic contact dermatitis (ACD). Consult with your physician about your risk for developing ACD and if you have ever had any serious allergic skin reactions in the past before starting treatment with Zecuity.
• 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 one or both legs or feet
• Heart attack and other heart problems. Zecuity is not for people with abnormal heart rhythms or risk factors for heart disease or strokes unless a heart exam is done and shows no problems. You have a higher risk for heart disease and strokes if you:
  • have high blood pressure
  • have high cholesterol levels
  • smoke
  • are overweight
  • have diabetes
  • have a family history of heart disease
  • are a female who has gone through menopause
  • are a male over age 40

Stop taking 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 heavy pressure, squeezing, or fullness
• 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

• Increase in blood pressure. Significant elevations in blood pressure have been reported on rare occasions in patients treated with medications similar to Zecuity, including people without a history of high blood pressure. Consult with your physician if you have a history of high blood pressure.
• Anaphylactic allergic reactions. Severe allergic reactions have occurred in patients receiving Zecuity. Such reactions can be life threatening or fatal. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens. Inform your physician if you have ever had an anaphylactic allergic reaction before starting treatment with Zecuity.
• Medication overuse headaches. Overuse of Zecuity may lead to exacerbation of headaches, also known as medication overuse headaches. Medication overuse headaches may appear as migraine-like daily headaches or as a marked increase in frequency of migraine attacks. Always use Zecuity exactly as prescribed.
• Serotonin syndrome. Serotonin syndrome is a serious and life-threatening problem that can occur in people taking Zecuity, especially if Zecuity is used with anti-depressant medicines called selective serotonin reuptake inhibitors (SSRIs) or selective norepinephrine reuptake inhibitors (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) or agitation
• fast heartbeat
• changes in blood pressure
• high body temperature
• tight muscles
• trouble walking
• nausea, vomiting, or diarrhea

• Seizures. Seizures have occurred in people taking Zecuity who have never had seizures before. Talk with your healthcare provider about your risk for having seizures while you take Zecuity.

Do not take Zecuity if you have:

• heart problems or a history of strokes, heart and/or heart rhythm problems
• narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
• uncontrolled high blood pressure
• severe liver problems
• ischemic bowel disease
• hemiplegic migraines or basilar migraines. If you are not sure if you have these types of migraines, ask your healthcare provider.
• had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation
• 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)
• an allergy to Zecuity or any of the ingredients in Zecuity. 

Zecuity can also cause dizziness and/or drowsiness. Do not drive or operate heavy machinery until you know how Zecuity affects you.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Zecuity there are no specific foods that you must exclude from your diet when receiving Zecuity.

Before you take Zecuity, tell your healthcare provider about all of your medical conditions, including if you:

• are allergic to Zecuity or to any of its ingredients
• have high blood pressure
• have high cholesterol
• have diabetes
• smoke
• are overweight
• are a female who has gone through menopause
• have heart disease or a family history of heart disease or stroke
• have liver problems
• have a history of strokes and/or abnormal heart rhythms
• have ischemic bowel disease
• have had epilepsy or seizures
• have ever had an allergic skin reaction to a medication product or food
• are not using effective birth control
• are pregnant or plan to become pregnant
• become pregnant while taking sumatriptan
• are breastfeeding or plan to breastfeed

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

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Zecuity falls into category C. No well-controlled studies have been done in humans. Zecuity should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed.

It is not known if Zecuity crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Zecuity.

Take Zecuity exactly as prescribed.

• Zecuity comes in a skin patch form and is applied at the onset of a migraine headache.
• 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 a 24 hour period.
• 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.
• Upon removal of Zecuity, most patients experience some skin redness under the patch, which usually disappears within 24 hours.

Apply and use Zecuity exactly as prescribed by your physician. You may refer to the following section for additional information:

Choosing an application site: 

• 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.

Applying Zecuity:

1. Remove Zecuity from its packaging by folding and tearing from the notch at the corner of the clear pouch. Zecuity should not be cut. Do not use Zecuity if the clear pouch is torn or damaged.
2. To apply the Zecuity you must pull the 2 foil tabs. 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. You must apply and activate Zecuity within 15 minutes of completing this step. 
3. Zecuity has 2 foil packets that each contain a white medication pad that must be properly attached to the Zecuity before use. To transfer and attach the medication pads to the Zecuity use 2 fingers and firmly press and rub each foil packet, tracing the green arrow 3 times around. 
4. Unfold the orange flap and lift open the package. Slowly peel the first part of the Zecuity back from the silver liner. After checking to make sure that both white medication pads are securely attached, peel the Zecuity completely away from liner. The Zecuity will not work properly if both medication pads are not attached.
5. 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. If the light does not turn solid red or goes off within the first 15 minutes of application this means no medicine is being delivered. (If this does occur, then the system should be gently removed and thrown away. You can immediately apply a new system to a different application site.)
6. Wear the patch for 4 hours or until the red light goes off. If the red light turns off before 4 hours, the patch has stopped delivering your medicine and should be gently removed and thrown away. 
7. If you still have migraine pain, another Zecuity can be applied to a different application site
8. You may feel a slight tingling or a mild burning sensation within 30 seconds of activating the Zecuity after pressing the button.
9. If Zecuity begins to peel off, the patch may be taped down with medical tape.

Removal of Zecuity:

• 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 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 so the adhesive side sticks to itself and safely throw it away.

• Keep Zecuity out of the reach of children and pets.     

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your age

The recommended dose of Zecuity to stop migraine headaches in adults, with or without a preceding aura, after they've already started is one patch applied to the skin at the onset of a migraine headache and worn for at least four hours.

If you apply too much Zecuity, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store at room temperature, between 20°C to 25°C (68°F to 77°F)
• Do not store this medication in the refrigerator or freezer.
• After use, fold used patch 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
• Keep this and all medicines out of the reach of children