TM Owner Upsher-Smith Laboratories, LLC
Zembrace SymTouch 3mg/0.5mL Injection
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Indications & Clinical Uses
- Zembrace SymTouch 3mg/0.5mL is a single-dose, prefilled autoinjector containing sumatriptan (as sumatriptan succinate), a triptan (5-HT1 agonist) migraine medicine.
- It is approved in the US for the acute treatment of migraine with or without aura in adults.
- It treats an attack that has already started; it is not for preventing migraines, and a clear migraine diagnosis should be made before use.
- Each device gives one 3 mg dose by subcutaneous (under the skin) injection, which patients can self-administer after training.
- Do not confuse this 3 mg product with other sumatriptan injections made in a 6 mg strength, because doses are not interchangeable without prescriber advice.
- The current US label is held by Upsher-Smith Laboratories (an earlier label named Promius Pharma).
- The label carries no boxed warning.
Side Effects
- In trials of sumatriptan injection, the most common side effects (about 5% or more, and more frequent than with placebo) were injection site reactions, unusual sensations, tingling, dizziness or vertigo, feelings of warmth or heat, burning, flushing, and feelings of heaviness or pressure.
- In the Zembrace SymTouch trial, injection site reactions occurred in about 30% of people versus 13% with placebo.
- Serious but less common reactions include heart attack or angina, irregular heartbeat, stroke, restricted blood flow in the gut or limbs (vasospasm), raised blood pressure, serotonin syndrome, seizures, severe allergic reactions and medication overuse headache.
- The label has no boxed warning.
- Seek emergency help straight away for chest, throat, neck or jaw pain or tightness, or any sign of a stroke.
Precautions & Warnings
- Zembrace SymTouch must not be used with ischaemic coronary artery disease or coronary vasospasm, Wolff-Parkinson-White syndrome or other cardiac accessory pathway disorders, a history of stroke or TIA, hemiplegic or basilar migraine, peripheral vascular disease, ischaemic bowel disease, uncontrolled high blood pressure, severe liver impairment, or known allergy to sumatriptan.
- Inject under the skin only.
- The usual dose is 3 mg, repeated no sooner than 1 hour later if needed, up to a maximum of 12 mg in 24 hours.
- Frequent use can cause medication overuse headache.
- Animal data suggest possible fetal harm; registry data on 626 first-trimester exposures showed 4.2% major birth defects, similar to the general population.
- Sumatriptan passes into breast milk, and the label advises avoiding breastfeeding for 12 hours after an injection.
- Store at 20°C to 25°C, protected from light; do not freeze.
Avoid Interactions
- Increase risk or effect: MAO-A inhibitors are contraindicated during and within 2 weeks of use because they roughly double sumatriptan exposure.
- SSRI, SNRI and tricyclic antidepressants and MAO inhibitors can cause serotonin syndrome when combined with sumatriptan.
- Ergot-containing medicines and other 5-HT1 agonists (other triptans) add to blood-vessel constriction and must not be used within 24 hours of Zembrace SymTouch.
- Reduce efficacy: the label lists no medicines that reduce the effect of sumatriptan.
- Tell your prescriber and pharmacist about all prescription and over-the-counter medicines, herbal products and supplements before using this autoinjector.
References
Frequently Asked Questions
Zembrace SymTouch (sumatriptan) 3 mg is an autoinjector that treats acute migraine attacks, with or without aura, in adults. You use it once a migraine has started. It is not for preventing migraines or treating other types of headache. Each autoinjector delivers one 3 mg dose.
Zembrace SymTouch (sumatriptan) is injected under the skin as a single 3 mg dose when a migraine starts. If needed, you can repeat a dose after at least 1 hour, up to a maximum of 12 mg in 24 hours. It is for subcutaneous use only.
Zembrace SymTouch commonly causes injection site reactions, tingling, dizziness, warm or burning sensations, flushing, and feelings of heaviness or pressure. Get emergency help for chest, throat, neck or jaw pain or tightness, or signs of a stroke, as these can signal a heart or brain problem. The label has no boxed warning.
Do not use Zembrace SymTouch (sumatriptan) within 24 hours of ergot medicines or other triptans, or within 2 weeks of an MAO-A inhibitor. Antidepressants such as SSRIs and SNRIs can cause serotonin syndrome, so tell your prescriber about every medicine you take.
Store Zembrace SymTouch (sumatriptan) autoinjectors at 20°C to 25°C, with short excursions to 15°C to 30°C allowed. Keep them in the carton to protect them from light, and do not freeze them or expose them to high heat. Discuss any device that has been frozen or overheated with your pharmacist.
Animal data suggest the sumatriptan in Zembrace SymTouch may harm an unborn baby, though registry data on 626 first-trimester exposures showed a birth defect rate (4.2%) similar to the general population. Sumatriptan passes into breast milk, so the label advises avoiding breastfeeding for 12 hours after an injection.
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