sumatriptan iontophoretic transdermal system

• Sumatriptan iontophoretic transdermal system (Zecuity) is anti-migraine drug that is delivered through the skin or transdermally. It is a serotonin (5HT) 1b/1d receptor agonist that is used for the acute treatment of migraine headaches in adults.
• Zecuity contains the drug, sumatriptan, which has been previously available as tablets, injections, and nasal spray. As the exact cause of migraine headaches remains unclear, the mechanism by which sumatriptan helps to this type of headache is not well understood. However, it is thought that sumatriptan helps to alleviate migraine pain by decreasing the dilation of blood vessels in the brain and inhibiting the release of inflammatory chemicals in the brain. This drug is designed to deliver sumatriptan through the skin with application of a battery operated device on the upper arm or thigh of the patient.
• This drug was approved by the FDA in January, 2013.
• Zecuity is the brand name for sumatriptan iontophoretic transdermal system available in the US.
• Zecuity is not available in generic form. You need a prescription for this drug.

• Zecuity is used for the acute treatment of migraine headaches with or without aura in adults. It should not be used to prevent migraine headaches, and should be reserved for use in patients previously diagnosed with migraines.

The most common side effects include of this headache drug:

• Pain
• Tingling
• Itching
• Warmth
• Discomfort or change in the skin color at the application site

Rare but serious side effects include:

• Injury during a magnetic resonance imaging (MRI) procedure because Zecuity contains metal parts.
• Allergic skin reactions (allergic contact dermatitis)
• Changes in the color or sensations in your fingers or toes (Raynaud's phenomenon)
• Stomach or intestinal problems (gastrointestinal ischemia and infarction events, peripheral vasospastic reactions)
• Problems with blood circulation to your legs or feet
• Medication overuse headache
• Serotonin syndrome
• Increases in blood pressure
• Chest pain( Prinzmetal's angina)
• Heart attack
• Abnormal heartbeats
• Stroke
• Blindness
• Vision loss
• Seizures
• Serious allergic reactions

• The patch delivers sumatriptan, a commonly used medication for migraine through a transdermal system in which the drug is absorbed through the skin.
• Each patch delivers 6.5 mg of medication over four hours by using a low electrical current (iontophoresis) and is powered by two coin cell lithium batteries.
• Patients may use up to 2 patches in 24 hours, and the second patch should not be used any sooner than 2 hours after the activation of the 1st. Patients should only use four patches per month.
• Patches can be applied to the upper arm or thigh of the patient.
• The patches are about 8 inches long and 4 inches wide and are to be worn only on unbroken skin and to an area relatively free of hair.
• Once applied the patch must be activated by pushing a button to turn on the device within 15 minutes.
• A red light indicates that the patch is on and is delivering medication to the patient.
• The red light turns off when dosing is complete and patients may then remove the patch.
• Used patches must be folded and discarded in accordance with state and local regulations as patches contain lithium-manganese dioxide.

Zecuity should not be used in combination or within 24 hours of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide). Concomitant use has been reported to cause prolonged or additive vasospastic reactions.

Use of this drug with medications that increase serotonin levels may increase the risk of serotonin syndrome, a rare but serious disorder that may cause symptoms such as:

• Mental status changes (agitation, confusion, and hallucinations)
• Sweating
• High blood pressure
• Diarrhea
• Fever
• Tremor
• Breathing difficulties

Therefore, co-administration with the following classes of antidepressants is not recommended.

• Selective serotonin reuptake inhibitors (SSRIs)
• Serotonin norepinephrine reuptake inhibitors (SNRIs)
• Tricyclic antidepressants (TCAs)
• Monoamine oxidase (MOA) inhibitors

A class of antidepressants called monoamine oxidase inhibitors or MOAIs doubles blood levels of Zecuity. Due to the risk of side effects, use of this drug with MOAIs is contraindicated. Examples of MOAIs include:

• tranylcypromine (Parnate)
• phenelzine (Nardil)
• selegiline (Eldepryl, Carbex, Zelapar)

• Use of this drug has not been adequately evaluated in pregnant women. Due to the lack of conclusive safety data, this drug should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Sumatriptan iontophoretic transdermal system is classified as FDA pregnancy risk category C (risk not ruled out).
• It is not known if this drug is excreted in breast milk following transdermal administration. Due to the lack of safety data, use in nursing mothers should be avoided if possible.

What preparations of Zecuity are available?

• This drug is available as an iontophoretic transdermal system that uses a mild electrical current to deliver the drug sumatriptan through the skin. Upon application, it delivers 6.5 mg of sumatriptan over 4 hours.

How should I keep Zecuity stored?

• This drug should be stored at room temperature, between 15 C to 30 C (59 F to 86 F).