Sumavel DosePro

Generic Name: sumatriptan
Date of Approval: July 15, 2009
Company: Zogenix, Inc.

Treatment for: Migraine; Cluster Headache

FDA Approves Sumavel DosePro

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The U.S. Food and Drug Administration (FDA) has approved Sumavel DosePro (sumatriptan injection) needle-free delivery system to treat acute migraine, with or without aura, and cluster headache. Sumavel DosePro is a first-of-its-kind needle-free delivery system for subcutaneous sumatriptan, a treatment that provides migraine relief within 10 minutes for some patients.

The FDA approval of Sumavel DosePro is based on extensive efficacy and safety data from original filings for needle-based sumatriptan injection (Imitrex), in addition to clinical studies conducted by Zogenix on bioequivalence, usability and safety specific to the Sumavel DosePro combination drug/needle-free delivery system.

About Sumavel DosePro

Sumavel DosePro (sumatriptan injection) needle-free delivery system is indicated for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache episodes.

Sumavel DosePro should only be used where a clear diagnosis of migraine or cluster headache has been established. Sumavel DosePro is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine and should not be administered intravenously. For a given attack, if a patient does not respond to the first dose of Sumavel DosePro, the diagnosis of migraine or cluster headache should be reconsidered before administration of a second dose.

Important Safety Information

Sumavel DosePro is contraindicated in patients with ischemic heart disease or those with symptoms consistent with ischemic heart disease. It should not be administered to patients with cerebrovascular syndromes, peripheral vascular disease or in patients with uncontrolled hypertension. Very rarely, serious cardiac adverse events have been reported when taking sumatriptan, including patients with no findings of cardiovascular disease. Considering the extent of use of sumatriptan in patients with migraine, the incidence of these events is extremely low.

Sumavel DosePro should not be used within 24 hours of other ergotamine-containing or ergot-type medications or other 5-HT1 agonists and is not generally recommended for use with selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors SNRIs or MAO inhibitors. Sumavel DosePro should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The most common adverse events observed in controlled clinical trials with sumatriptan injection were injection site reactions, atypical sensations (such as feelings of tingling, warm/hot sensations), dizziness and flushing. Most side effects lasted for only a short time. In clinical trials comparing the safety and tolerability of Sumavel DosePro to sumatriptan injection, most injection site reactions resolved spontaneously, with no apparent difference between Sumavel DosePro and sumatriptan needle injection.

About DosePro technology

The DosePro technology is an easy-to-use, pre-filled drug delivery system designed to enable self-administration of single doses of liquid drug formulations, subcutaneously, without a needle. The DosePro technology has undergone more than ten years of design, process engineering, clinical evaluation and development work. DosePro is protected by more than 80 patents, issued and applied for, worldwide. Approximately 9,000 injections have been delivered in clinical trials in healthy volunteers using the DosePro needle-free drug delivery system.

Sumavel DosePro Patient Information

Read the Patient Information that comes with Sumavel DosePro before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or treatment. You and your doctor should talk about Sumavel DosePro when you start taking it and at regular checkups.

What is the most important information I should know about Sumavel DosePro?

In very rare cases, patients taking triptans, such as Sumavel DosePro, may experience serious side effects, including heart attacks. Call your doctor right away if you have:

• severe chest pain
• shortness of breath

Sumavel DosePro 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" is a serious and life-threatening problem that can happen with Sumavel DosePro, especially if used with anti-depressant medicines called selective serotonin reuptake inhibitors (SSRIs) or selective norepinephrine reuptake inhibitors (SNRIs). Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Call your doctor if you have any of these symptoms of serotonin syndrome:

• mental changes (hallucinations, agitation, coma)
• fast heartbeat
• changes in blood pressure
• high body temperature
• tight muscles
• trouble walking
• nausea, vomiting, diarrhea

What is Sumavel DosePro?

Sumavel DosePro is a prescription medicine given with a needle-free delivery system to treat people who have been diagnosed with migraine or cluster headaches.

Sumavel DosePro is not used to prevent or lessen the number of migraine or cluster headache attacks you have.

Sumavel DosePro is not used to treat other types of headaches.

It is not known if Sumavel DosePro is safe or effective in people younger than 18 years of age.

Who should not take Sumavel DosePro?

Do not take Sumavel DosePro if you have:

• narrowing of blood vessels to the legs, arms, stomach or kidney (peripheral vascular disease)
• heart disease or a history of heart disease
• uncontrolled high blood pressure
• migraines that cause temporary paralysis (unable to move) on one side of your body or basilar migraine. If you are not sure about this, ask your doctor.
• 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)
  • sumatriptan (Imitrex)
  • sumatriptan and naproxen (Treximet)
  • ergotamines like Bellergal-S, Cafergot, Ergomar
  • dihydroergotamine (D.H.E. 45) or (Migranal)
  • are allergic to sumatriptan.
• expired medication

What should I tell my doctor before taking Sumavel DosePro?

Before taking Sumavel DosePro, tell your doctor about all of your medical conditions, including if you:

• have high cholesterol
• have diabetes
• smoke
• are overweight
• have gone through menopause
• have heart disease or a family history of heart disease or stroke
• are pregnant or plan to become pregnant. It is not known if Sumavel DosePro will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
• are breast feeding or plan to breast feed. Sumavel DosePro passes into your breast milk and may harm your baby. Talk to your doctor about the best way to feed your baby if you take Sumavel DosePro.
• are not using effective birth control
• have had epilepsy or seizures

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

Using Sumavel DosePro with certain other medicines can affect each other causing serious side effects.

Especially tell your doctor if you take anti-depressant medicines called:

• selective serotonin reuptake inhibitors (SSRIs)
• serotonin norepinephrine reuptake inhibitors (SNRIs)
• Monoamine Oxidase Inhibitors (MAO-A)

Ask your doctor or pharmacist for a list of these medicines if you are not sure.

How should I take Sumavel DosePro?

• Use Sumavel DosePro exactly as your doctor tells you to
• Read the detailed Patient Instructions for Use at the end of this leaflet.
• Deliver Sumavel DosePro into your stomach area (abdomen), or thigh
• Do NOT deliver Sumavel DosePro into the arm or other body parts.
• Do NOT deliver Sumavel DosePro to a vein or a muscle
• Do not deliver Sumavel DosePro within 2 inches of your belly button (navel).
• Do not deliver more than two doses of Sumavel DosePro in a 24-hour period.
• You may deliver a second dose at least one hour after your first dose if your migraine or cluster headache symptoms come back.
• If you do not feel better after your first dose, do not deliver a second dose for the same attack without talking to your doctor.

What are the possible side effects of Sumavel DosePro?

Sumavel DosePro can cause serious side effects including death. See "What is the most important information I should know about Sumavel DosePro?"

Serious side effects include:

• heart attack
• fast heartbeat
• increase in blood pressure
• stroke
• changes in mental status (agitation, hallucinations, coma)
• changes in color or sensation to your fingers and toes (Raynaud’s syndrome)
• gastrointestinal ischemic events
• peripheral vascular ischemia and colonic ischemia

Get medical help right away, if you have:

• severe tightness, pain, pressure or heaviness in your chest, throat, neck, or jaw
• shortness of breath or wheezing
• sudden or severe stomach pain
• hives (itchy bumps), swelling of your tongue, mouth, or throat
• problems seeing
• unusual weakness or numbness
• nausea or vomiting
• bloody diarrhea
• stomach pain
• high temperature
• unusual sweating

The most common side effects of Sumavel DosePro include:

• bleeding, swelling, redness, bruising and pain at the delivery site
• tingling or numbness in your fingers or toes
• dizziness
• warm, hot, burning feeling to your face (flushing)
• feeling of heaviness or pressure
• discomfort or tightness in the in chest, neck, throat, nose, or jaw
• feeling weak, drowsy, or tired
• feeling strange
• muscle pain

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Sumavel DosePro. For more information, ask your doctor or pharmacist.

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

How should I store Sumavel DosePro?

• Store Sumavel DosePro between 59°F to 86°F (15°C to 30°C).
• Do not freeze.

Keep Sumavel DosePro and all medicines out of the reach of children.

General information about Sumavel DosePro

Medicines are sometimes prescribed for purposes other than those listed in patient information leaflets. Do not use Sumavel DosePro for a condition for which it was not prescribed. Do not give Sumavel DosePro to other people, even if they have the same symptoms that you have. It may harm them. This patient information leaflet summarizes the most important information about Sumavel DosePro. If you would like more information about Sumavel DosePro, talk to your doctor. You can ask your doctor or pharmacist for information about Sumavel DosePro that is written for health professionals.

For more information, go to www.SumavelDosePro.com or call 1-866-ZOGENIX.

What are the Ingredients in Sumavel DosePro?

Active ingredient: sumatriptan

Inactive ingredients: sodium chloride

Patient Instructions for Use

Read these Patient Instructions for Use which come with Sumavel DosePro before you start using it and each time you get a refill. Follow these instructions each time you use Sumavel DosePro. Before you use Sumavel DosePro for the first time, make sure your healthcare provider shows you the right way to use it.

A. Check your device:

The snap-off tip should sit firmly on the end of the clear medication chamber. Do not use Sumavel DosePro if the snap-off tip is tilted or broken off. The medicine inside Sumavel DosePro should be clear and colorless or pale yellow. Do not use Sumavel DosePro if the medicine looks dark-colored or cloudy. The expiration date is printed on both the Sumavel DosePro label and carton. Do not use Sumavel DosePro if the medicine is expired.

B. Choose a delivery site:

Select a delivery site such as your stomach area (abdomen) or your thigh. Do not deliver Sumavel DosePro in the arm. Your skin should be clean, and dry, and free of clothing. Do not deliver through your clothes. Do not deliver into scars or moles, or within 2 inches of your belly button (navel). Do not deliver into the same spot. Change delivery sites with each use.

1. Snap: Firmly hold the handle of Sumavel DosePro in one hand. With the other hand, use your fingers to grip the top and bottom of the snap-off tip, where the finger grips are located. To break off the snap-off tip, firmly snap it off in a downward motion. You may need to use some force. You do not need to twist or pull the snap-off tip; doing so will not work.
2. Flip: In this step, you will learn how to prepare Sumavel DosePro for delivery of the medicine. Firmly press the green lever all the way down (away from the clear plastic end), until it clicks and locks into the handle. You may feel some resistance – this is normal. Once you have flipped the lever, do not touch the end of the clear medication chamber. Keep the medication chamber pointed away from your face or eyes.
3. Press: In this step, you will learn how to deliver the medicine. Deliver the dose exactly as shown to you by your healthcare provider. Pinch about 2 inches of the skin of your stomach (abdomen) or thigh to create a firm section of skin. Place Sumavel DosePro straight out from the delivery site with the end of the clear medication chamber against your skin. Do not hold Sumavel DosePro at an angle to your skin. During the next step, you will hear a loud burst of air. Do not be alarmed – this indicates that the medicine has been delivered. Steadily press Sumavel DosePro straight down against your skin until you hear and feel a burst of air. There is no button to push. After you hear the burst of air (whoosh), the medicine has been delivered and you can remove Sumavel DosePro from your skin. Let go of your pinched skin after the medicine has been delivered.

After removing Sumavel DosePro from your skin, gently wipe the delivery site with a cotton ball or gauze.

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