Zembrace SymTouch

Zembrace SymTouch is a prescription medicine used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine. Zembrace SymTouch is used to treat migraine headaches once they have started. Zembrace SymTouch belongs to a group of drugs called serotonin receptor agonists or "triptans", which relieve pain by narrowing blood vessels around the brain.

This medication comes in an injectable form to be injected under the skin and is taken at the first sign of a migraine headache.

Common side effects of Zembrace SymTouch include tingling or numbness in fingers or toes, weakness, tiredness. Zembrace SymTouch can cause drowsiness. Do not drive a car or operate machinery if you have these symptoms.

Zembrace SymTouch is a prescription medication used to treat migraine headaches once they have started, with or without aura.

Zembrace SymTouch is also used to treat cluster headaches in adults.

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

Zembrace SymTouch may cause serious side effects. See “Drug Precautions”.

These serious side effects include:

• 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
• hives (itchy bumps); swelling of your tongue, mouth, or throat
• medication overuse headaches. Some people who take/use too much Zembrace SymTouch may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with Zembrace SymTouch.
• seratonin syndrome. Seratonin syndrome is a rare but serious problem that can happen in people using Zembrace SymTouch, especially if Zembrace SymTouch is used with anti-depressant medicines called SSRIs or SNRIs. Call your healthcare provider right away if you have any of the following symptoms of seratonin 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
• seizures. Seizures have happened in people taking Zembrace SymTouch who have never had seizures before. Talk to your healthcare provider about your chance of having a seizure while uo take Zembrace SymTouch. 

The most common side effects of Zembrace SymTouch include:

• injection site reactions such as redness, pain, or swelling
• tingling or numbness in your fingers or toes
• dizziness
• warm, hot, burning feeling to your face (flushing)
• discomfort or stiffness in your neck
• feeling weak, drowsy, or tired

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 Zembrace SymTouch. For more information, ask your healthcare provider or pharmacist.

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

Zembrace SymTouch and other medicines may affect each other, causing side effects.

Especially tell your healthcare provider 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 sumatriptan (Imitrex, Treximet), eletriptan (Relpax), almotriptan (Axert), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), and zolmitriptan (Zomig)

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.

Zembrace SymTouch can cause serious side effects, including:

Heart attack and other heart problems. Heart problems may lead to death. Stop taking Zembrace SymTouch 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

Zembrace SymTouch 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:

• 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

Serotonin syndrome. Serotonin syndrome is a serious and life-threatening problem that can happen in people taking Zembrace SymTouch, especially if Zembrace SymTouch 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), agitation, or coma
• fast heartbeat
• changes in blood pressure
• high body temperature
• tight muscles
• trouble walking
• nausea, vomiting, or diarrhea

Medication overuse headaches. Some people who take/use too much Zembrace SymTouch may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with Zembrace SymTouch.

Seizures. Seizures have happened in people taking Zembrace SymTouch who have never had seizures before. Talk with your healthcare provider about your chance of having seizures while you take Zembrace SymTouch.

Do not take Zembrace SymTouch if you have:

• heart problems or a history of heart problems
• narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
• uncontrolled high blood pressure
• severe liver problems
• 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 Zembrace SymTouch or any of the ingredients in Zembrace SymTouch. 

Zembrace SymTouch 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.

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 Zembrace SymTouch there are no specific foods that you must exclude from your diet when receiving Zembrace SymTouch.

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

• are allergic to Zembrace SymTouch
• 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 had epilepsy or seizures
• 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.

Zembrace SymTouch falls into category C.  In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Zembrace SymTouch may pass into your breast milk and may harm your baby. Talk with your healthcare provider about the best way to feed your baby if you take Zembrace SymTouch.

Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

If your headache comes back after the first dose, ask your doctor if you can administer another dose. 

• Certain people should take their first dose of Zembrace SymTouch in their healthcare provider’s office or in another medical setting. Ask your healthcare provider if you should take your first dose in a medical setting.
• Take Zembrace SymTouch exactly as your healthcare provider tells you to take it. Do not take more or less of it or take it more often than prescribed by your doctor.
• Your healthcare provider may change your dose. Do not change your dose without first talking to your healthcare provider.

Zembrace SymTouch comes in an autoinjection device so that you can self-inject this medication under the skin of your thigh or deltoid area. Your doctor or pharmacist should show you how to load the injector and administer the medication.

For adults, the usual dose is a single injection given just below the skin. You should give an injection as soon as the symptoms of your migraine start, but it may be given at any time during an attack. You may give a second injection if your migraine symptoms come back.

Do not take more than a total of 12 mg in a 24-hour period. For example, you may give one 3mg injection four times a day, at least 1 hour apart.

If you take too much Zembrace SymTouch, call your healthcare provider or go to the nearest hospital emergency room right away.

You should write down when you have headaches and when you take Zembrace SymTouch so you can talk with your healthcare provider about how Zembrace SymTouch is working for you.

Take Zembrace SymTouch exactly as prescribed. Follow the directions on your prescription label carefully.

The maximum recommended dose in adults of Zembrace SymTouch injection is 3 mg injected subcutaneously (under the skin). The maximum recommended dose that may be given in 24 hours is four 3 mg injections separated by at least one hour.

If you have taken more Zembrace SymTouch than has been prescribed for you, contact either your doctor, hospital emergency department, or your local Poison Control Center.

• Store between 68° and 77°F (20° and 25°C).
• Store your medicine away from light. 
• Keep your medicine in the packaging or carrying case provided with it. 
• Keep Zembrace SymTouch and all medicines out of the reach of children.