Zembrace SymTouch injection

Name: Zembrace SymTouch injection

What is Zembrace SymTouch (sumatriptan injection)?

Sumatriptan is a headache medicine that narrows blood vessels around the brain. Sumatriptan also reduces substances in the body that can trigger headache pain, nausea, sensitivity to light and sound, and other migraine symptoms.

Sumatriptan is used to treat migraine headaches and cluster headaches in adults. Sumatriptan will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

Sumatriptan should not be used to treat a common tension headache or a headache that causes loss of movement on one side of your body. Use this medicine only if your condition has been confirmed by a doctor as migraine headaches.

Sumatriptan may also be used for purposes not listed in this medication guide.

What should I discuss with my health care provider before using Zembrace SymTouch (sumatriptan injection)?

You should not use this medicine if you are allergic to sumatriptan, or if you have:

  • coronary artery disease, angina (chest pain), blood circulation problems, lack of blood supply to the heart;

  • a heart disorder called Wolff-Parkinson-White syndrome;

  • a history of heart disease, heart attack, or stroke, including "mini-stroke";

  • untreated or or uncontrolled high blood pressure;

  • severe liver disease;

  • circulation problems affecting your intestines; or

  • a headache that seems different from your usual migraine headaches.

Do not use sumatriptan if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

To make sure sumatriptan is safe for you, tell your doctor if you have:

  • liver or kidney disease;

  • epilepsy or other seizure disorder;

  • high blood pressure, a heart rhythm disorder; or

  • risk factors for coronary artery disease (such as diabetes, menopause, smoking, being overweight, having high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).

Sumatriptan can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medicine.

It is not known whether sumatriptan will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine. Your name may need to be listed on a sumatriptan pregnancy registry.

Sumatriptan can pass into breast milk and may harm a nursing baby. Do not breast-feed within 12 hours after using a sumatriptan injection. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

Sumatriptan injection is not approved for use by anyone younger than 18 years old.

How should I use Zembrace SymTouch (sumatriptan injection)?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Overuse of migraine headache medicine can actually make your headaches worse.

Sumatriptan is injected under the skin. You may be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and syringes.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Use sumatriptan as soon as you notice headache symptoms, or after an attack has already begun.

Your blood pressure will need to be checked often.

Sumatriptan injection comes in a vial (bottle), an auto-injector or prefilled cartridge to be loaded into an auto-injector syringe, or in a needle-free injector device. Each vial, cartridge, or needle-free device is for one use only.

After using an injection: If your headache does not completely go away after the injection, call your doctor before using a second sumatriptan injection. If your headache goes away and then comes back, you may use a second injection if it has been at least one (1) hour since your first injection. Do not use more than two (2) injections in 24 hours. If your symptoms do not improve, contact your doctor before using any more injections.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Store at room temperature away from moisture, heat, and light. Throw away any unused medicine after the expiration date on the label has passed.

What should I avoid while using Zembrace SymTouch (sumatriptan injection)?

Do not use sumatriptan within 24 hours before or after using another migraine headache medicine, including:

  • sumatriptan tablets or nasal spray, almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, zolmitriptan; or

  • ergot medicine such as dihydroergotamine, ergotamine, ergonovine, or methylergonovine.

Sumatriptan may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

For Healthcare Professionals

Applies to sumatriptan: nasal capsule, nasal spray, oral tablet, subcutaneous kit, subcutaneous solution, transdermal film extended release

General

The more commonly observed adverse reactions have included those of pressure sensation, flushing, tingling, dizziness/vertigo, warm/hot sensation, burning sensation, flushing, and numbness; formulation specific events including injection site reactions, application site pain, and nasal discomfort have been reported.[Ref]

Cardiovascular

Life-threatening disturbances of cardiac rhythm, such as ventricular tachycardia and ventricular fibrillation leading to death, and rare reports of acute myocardial infarction, have been reported within a few hours after administration of 5-HT1 agonists.

Chest discomfort is usually noncardiac in origin. A survey of 453 migraine patients found chest symptoms occurred in up to 58% of patients in at least some attacks and in up to 42% of patients in all attacks.

One study of 735 consecutive migraine patients reported that chest symptoms are frequent, but rarely important adverse effects of (primarily subcutaneous) sumatriptan (the active ingredient contained in Zembrace SymTouch) The risk of chest symptoms was reported to be patient dependent and not related, even opposite, to cardiovascular disease. This report contradicts the hypothesis that chest symptoms after sumatriptan are caused by cardiac ischemia.

Another study of 125 patients concluded that panic-like symptoms may explain the chest pain and related side effects after sumatriptan administration in patients with high levels of anxiety.[Ref]

Common (1% to 10%): Chest pain/tightness/pressure and/or heaviness, flushing, neck/throat/jaw pain/tightness/pressure, transient increases in blood pressure (arising soon after treatment)
Uncommon (0.1% to 1%): Bradycardia, hypertension, hypotension, palpitations, pulsating sensations, tachycardia, various transient ECG changes (nonspecific ST or T-wave changes, prolongation of PR or QTc intervals, sinus arrhythmia, nonsustained ventricular premature beats, isolated junctional ectopic beats, atrial ectopic beats, delayed activation of the right ventricle)
Rare (less than 0.1%): Abnormal pulse, arrhythmia, pallor, Raynaud's phenomenon, vasodilation
Frequency not reported: Abdominal aortic aneurysm, angina, atherosclerosis, cerebrovascular lesion, coronary artery vasospasm, edema, heart block, peripheral cyanosis, phlebitis, thrombosis, transient myocardial ischemia
Postmarketing reports: Cyanosis, hypotension, myocardial infarction, palpitations[Ref]

Nervous system

Very common (10% or more): Dizziness (10%), abnormal taste (20%; nasal powder)
Common (1% to 10%): Bad/unusual taste, drowsiness/sedation, dystonia, headache, hypoesthesia, paraesthesia (all types), tremor
Uncommon (0.1% to 1%): Syncope
Rare (less than 0.1%): Difficulties in concentration, disturbances of smell, dysarthria, dysesthesia, hyperesthesia, monoplegia/diplegia, myoclonia, transient hemiplegia
Frequency not reported: Bradylogia, cerebral ischemia, cerebrovascular lesion, cluster headache, convulsions, facial paralysis, incoordination, increased alertness, memory disturbance, migraine, motor dysfunction, neuralgia, nystagmus, paralysis, radiculopathy, raised intracranial pressure, seizures, speech disturbance
Postmarketing reports: Central nervous system vasculitis, cerebellar infarction, cerebrovascular accident, subarachnoid hemorrhage, serotonin syndrome, temporal arteritis[Ref]

Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred with 5-HT1 treatment; some have resulted in fatalities. One case of sumatriptan-induced cortical stroke has been reported in a patient with sagittal sinus thrombosis. In some cases, it appears possible that the cerebrovascular events were primary, and the 5-HT1 agonist administered in the belief that presenting symptoms were due to migraine when they were not. Patients with migraine may also be at an increased risk of certain cerebrovascular events such as stroke, hemorrhage, and transient ischemic attacks.

Medication overuse headache may present as migraine-like headaches or as a marked increase in frequency of migraine attacks.

Serotonin syndrome is characterized by mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). The onset of symptoms generally occurs within minutes to hours of receiving a new or a greater dose of a serotoninergic medications.

Seizures have been reported in patients with either a history of seizures or concurrent conditions predisposing to seizures and also in patients where no such predisposing factors are apparent.[Ref]

Gastrointestinal

Common (1% to 10%): Abdominal discomfort, dysphagia, nausea and/or vomiting
Uncommon (0.1% to 1%): Diarrhea, gastroesophageal reflux
Rare (less than 0.1%): Flatulence/eructation, gallstones, peptic ulcer, retching
Frequency not reported: Abdominal distention, colitis, constipation, dental pain, disorder of mouth and tongue (e.g., burning of tongue, numbness of tongue, dry mouth), dyspeptic symptoms, feelings of gastrointestinal pressure, gastritis, gastroenteritis, gastrointestinal bleeding, gastrointestinal pain, hematemesis, hypersalivation, hyposalivation, intestinal obstruction, ischemic colitis, melena, oral itching and irritation, pancreatitis, salivary gland swelling, swallowing disorders[Ref]

It is unclear whether the nausea and vomiting is related to sumatriptan therapy or to the underlying condition.

One report has suggested that "throat tightness" and chest pain associated with sumatriptan may sometimes be attributable to changes in esophageal motility.[Ref]

Other

Very common (10% or more): Atypical sensations such as tingling, warm or hot sensations, vertigo
Common (1% to 10%): Atypical sensations such as burning sensation, chills, facial pain, fatigue, feeling of pressure, feeling strange, jaw discomfort, malaise, neck pain/stiffness, numbness, pain and other pressure sensations, pain where the location is specified, prickling sensations, stinging sensations, sensation of lightness, tight feeling in head, tightness or heaviness, weakness
Rare (less than 0.1%): Fever, intoxication, simultaneous hot and cold sensations, swelling of the extremities, tickling sensations
Frequency not reported: Abortion, contusions, ear infection, ear, nose, and throat hemorrhage, external otitis, feeling of fullness in the ear(s), hearing disturbances, hearing loss, Meniere's disease, otalgia, overdose, photophobia, sensitivity to noise, swelling of face, tinnitus
Postmarketing reports: Deafness[Ref]

Dermatologic

Very common (10% or more): Application site pain (26%; transdermal patch)
Common (1% to 10%): Sweating, allergic contact dermatitis and application site paresthesia/pruritus/warmth/discomfort/irritation/site discoloration (transdermal patch)
Uncommon (0.1% to 1%): Eruptions, erythema, pruritus, skin rashes
Rare (less than 0.1%): Skin tenderness
Frequency not reported: Dry/scaly skin, eczema, hematoma, hyperhidrosis, seborrheic dermatitis, skin nodules, tightness of skin, wrinkling of skin
Postmarketing reports: Allergic vasculitis, angioedema, exacerbation of sunburn, photosensitivity, urticaria, burns scars, severe redness, pain, skin discoloration, blistering and cracked skin with the iontophoretic transdermal system[Ref]

Burns and scars have been reported on the skin where the transdermal iontophoretic transdermal system has been worn. These reports describe severe redness, pain, skin discoloration, blistering, and cracked skin. On June 13, 2016, the manufacturer of the patch suspended sales and distribution of the patch to investigate the cause of these reports.[Ref]

Endocrine

Frequency not reported: Elevated thyrotropin stimulating hormone (TSH) levels, endocrine cysts, lumps, and masses, hypothyroidism[Ref]

Genitourinary

Rare (less than 0.1%): Dysmenorrhea, dysuria
Frequency not reported: Abnormal menstrual cycle, bladder inflammation, breast swelling, breast tenderness, cysts, disorder of breasts, endometriosis, galactorrhea, hematuria, increased urination, inflammation of fallopian tubes, intermenstrual bleeding, lumps, masses of breasts, menstruation symptoms, micturition disorders, nipple discharge, urethritis, urinary infections[Ref]

Hematologic

Frequency not reported: Anemia, lymphadenopathy
Postmarketing reports: Hemolytic anemia, pancytopenia, thrombocytopenia[Ref]

Hepatic

Uncommon (0.1% to 1%): Minor disturbances in liver function tests[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions ranging from cutaneous hypersensitivity to anaphylaxis[Ref]

Immunologic

Rare (less than 0.1%): Influenza
Frequency not reported: Herpes[Ref]

Local

Very common (10% or more): Injection site reaction
Common (1% to 10%): Burning sensation (nasal administration)
Frequency not reported: Injection site stinging/burning, swelling, erythema, bruising, and bleeding
Postmarketing reports:
-Following subcutaneous administration: Contusion, induration, lipoatrophy, lipohypertrophy, pain, redness, stinging, subcutaneous bleeding, swelling[Ref]

Local irritative symptoms were reported in clinical trials with sumatriptan nasal spray in approximately 5% of patients, and were severe in about 1% of cases. Symptoms were noted as being transient and generally resolved in less than 2 hours.[Ref]

Metabolic

Uncommon (0.1% to 1%): Thirst
Rare (less than 0.1%): Dehydration, hunger, polydipsia, reduced appetite
Frequency not reported: Fluid disturbances, fluid retention, hyperglycemia, hypoglycemia, weight gain, weight loss[Ref]

Musculoskeletal

Common (1% to 10%): Muscle cramps, myalgia
Uncommon (0.1% to 1%): Joint disturbances (pain, stiffness, swelling, ache)
Rare (less than 0.1%): Backache, muscle stiffness, muscle tiredness, need to flex calf muscles
Frequency not reported: Acquired musculoskeletal deformity, arthralgia, arthritis, articular rheumatitis, difficulty in walking, intervertebral disc disorder, muscle atrophy, muscle tightness and rigidity, musculoskeletal inflammation, rigidity, tetany, twitching[Ref]

Ocular

Loss of vision included reports of permanent defects. Causality has not been established as visual disorders may occur during a migraine attack itself.[Ref]

Common (1% to 10%): Vision alterations
Uncommon (0.1% to 1%): Irritation of the eye, lacrimation, photophobia
Frequency not reported: Accommodation disorders, blindness, conjunctivitis, diplopia. disorders of sclera, low vision, eye edema and swelling, eye hemorrhage, eye itching, eye pain, external ocular muscle disorders, flickering, keratitis, mydriasis, scotoma, visual disturbances
Postmarketing reports: Ischaemic optic neuropathy, retinal artery occlusion, retinal vein thrombosis[Ref]

Oncologic

Frequency not reported: Neoplasm of pituitary, primary malignant breast neoplasm[Ref]

Psychiatric

Common (1% to 10%): Anxiety
Uncommon (0.1% to 1%): Agitation, euphoria, mental confusion, relaxation
Rare (less than 0.1%): Depression, globus hystericus, hysteria, sleep disturbance
Frequency not reported: Aggressiveness, apathy, depressive disorders, detachment, disturbance of emotions, drug abuse, hallucinations, neurotic disorders, personality change, phobia, psychomotor disorders, stress, suicide[Ref]

Renal

Rare (less than 0.1%): Renal calculus
Postmarketing reports: Acute renal failure[Ref]

Respiratory

The consequences of repeated and prolonged use of the nasal spray on nasal and/or respiratory mucosa have not been established.[Ref]

Very common (10% or more): Nasal discomfort (up to 11%; nasal powder)
Common (1% to 10%): Bronchospasm, disorder/discomfort of nasal cavity/sinuses (nasal administration, subcutaneous administration), dyspnea, throat discomfort (nasal administration); rhinitis (nasal administration), rhinorrhea (nasal administration)
Rare (less than 0.1%): Diseases of the lower respiratory tract, hiccoughs, yawning
Frequency not reported: Allergic rhinitis, asthma, breathing disorder, bronchitis, cough, nasal inflammation, sinusitis, upper respiratory tract inflammation, voice disturbances
Postmarketing reports: Shortness of breath (as part of hypersensitivity reaction)[Ref]

Some side effects of Zembrace SymTouch may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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