Important Safety Information about SUMAVEL® DosePro®

What is SUMAVEL® DosePro® used for?

SUMAVEL® DosePro® is a prescription medicine used to treat acute migraine headaches with or without aura and acute cluster headaches in adults who have been diagnosed with migraine or cluster headaches.
SUMAVEL® DosePro® is not used to treat other types of headaches such as hemiplegic (that make you unable to move on one side of your body) or basilar (rare form of migraine with aura) migraines.
SUMAVEL® DosePro® is not used to prevent or decrease the number of migraine or cluster headaches you have.
It is not known if SUMAVEL® DosePro® is safe and effective in children under 18 years of age.

Who should not take SUMAVEL® DosePro®?
Do not take SUMAVEL® DosePro® 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
  • 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 other prescription migraine medications in the last 24 hours, including other triptans, ergotamines or ergotamine-type medicines. Ask your healthcare provider if you are not sure if your medicine is listed above.

What should I tell my healthcare provider before taking SUMAVEL® DosePro®?

Before you take SUMAVEL® DosePro®, tell your healthcare provider about all of your medical conditions, and about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Using SUMAVEL® DosePro® with certain other medicines can affect each other, causing serious side effects.

What should I avoid while taking SUMAVEL® DosePro®?

SUMAVEL® DosePro® 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.

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

SUMAVEL® DosePro® can cause serious side effects, including:

Heart attack and other heart problems. Heart problems may lead to death. Stop taking SUMAVEL® DosePro® 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
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • 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

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

What are the possible side effects of SUMAVEL® DosePro®?

SUMAVEL® DosePro® may cause serious side effects, including:

  • stroke
  • 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
  • medication overuse headaches. Some people who use too many SUMAVEL® DosePro® injections may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with SUMAVEL® DosePro®.
  • serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using SUMAVEL® DosePro®, especially if SUMAVEL® DosePro® 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 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
  • seizures. Seizures have happened in people taking SUMAVEL® DosePro® who have never had seizures before. Talk with your healthcare provider about your chance of having seizures while you take SUMAVEL® DosePro®.

The most common side effects of SUMAVEL® DosePro® include:

  • pain or redness at your injection site
  • 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 SUMAVEL® DosePro®. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects.

INDICATION and Usage

SUMAVEL® DosePro® (sumatriptan injection) is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache.

Limitations of Use:

IMPORTANT SAFETY INFORMATION about SUMAVEL® DosePro®

 

What is SUMAVEL® DosePro® used for?

SUMAVEL® DosePro® is a prescription medicine used to treat acute migraine headaches with or without aura and acute cluster headaches in adults who have been diagnosed with migraine or cluster headaches.
SUMAVEL® DosePro® is not used to treat other types of headaches such as hemiplegic (that make you unable to move on one side of your body) or basilar (rare form of migraine with aura) migraines.
SUMAVEL® DosePro® is not used to prevent or decrease the number of migraine or cluster headaches you have.
It is not known if SUMAVEL® DosePro® is safe and effective in children under 18 years of age.

Who should not take SUMAVEL® DosePro®?
Do not take SUMAVEL® DosePro® 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
  • 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 other prescription migraine medications in the last 24 hours, including other triptans, ergotamines or ergotamine-type medicines. Ask your healthcare provider if you are not sure if your medicine is listed above.
  • taken other prescription migraine medications in the last 24 hours, including other triptans, ergotamines or ergotamine-type medicines. Ask your healthcare provider if you are not sure if your medicine is listed above.

What should I tell my healthcare provider before taking SUMAVEL® DosePro®?

Before you take SUMAVEL® DosePro®, tell your healthcare provider about all of your medical conditions, and about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Using SUMAVEL® DosePro® with certain other medicines can affect each other, causing serious side effects.

What should I avoid while taking SUMAVEL® DosePro®?

SUMAVEL® DosePro® 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.

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

SUMAVEL® DosePro® can cause serious side effects, including:

Heart attack and other heart problems. Heart problems may lead to death. Stop taking SUMAVEL® DosePro® 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
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • 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

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

What are the possible side effects of SUMAVEL® DosePro®?

SUMAVEL® DosePro® may cause serious side effects, including:

  • stroke
  • 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
  • medication overuse headaches. Some people who use too many SUMAVEL® DosePro® injections may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with SUMAVEL® DosePro®.
  • serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using SUMAVEL® DosePro®, especially if SUMAVEL® DosePro® 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 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
  • seizures. Seizures have happened in people taking SUMAVEL® DosePro® who have never had seizures before. Talk with your healthcare provider about your chance of having seizures while you take SUMAVEL® DosePro®.

The most common side effects of SUMAVEL® DosePro® include:

  • pain or redness at your injection site
  • 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 SUMAVEL® DosePro®. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects.

 

Intended for U.S. Residents Only.

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Rx Only

SUMAVEL is a registered trademark of
Endo Ventures Bermuda LTD.
DosePro is a registered trademark of Zogenix, Inc.
Distributed by Endo Pharmaceuticals Inc.
Manufactured for Endo ventures LTD (Ireland)
Manufactured by Zogenix, Inc.
© 2014 Endo Pharmaceuticals Inc.
All Rights Reserved. Malvern, PA 19355
Privacy/Legal SD-03314/September 2014
www.Sumaveldosepro.com 1-800-462-ENDO (3636)

Rx Only
Sumavel is a registered trademark of Endo Ventures Bermuda LTD.
DosePro is a registered trademark of Zogenix, Inc.
Distributed by Endo Pharmaceuticals Inc.
Manufactured for Endo Ventures LTD (Ireland).
Manufactured by Zogenix, Inc.
© 2014 Endo Pharmaceuticals Inc. All Rights Reserved. Malvern, PA 19355
Privacy/Legal SD-03314/September 2014 www.Sumaveldosepro.com 1-800-462-ENDO (3636)

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