Sumatriptan Injection

Sumavel DosePro contains sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure:

The empirical formula is C12H21N3O2S•C4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate is a white to off-white powder that is readily soluble in water and in saline.

Sumatriptan solution is a clear, colorless to pale yellow, sterile, nonpyrogenic solution for subcutaneous delivery. Each 0.5 mL of Sumavel DosePro 8 mg/mL solution contains 4 mg of sumatriptan (base) as the succinate salt and 3.8 mg of sodium chloride, USP in Water for Injection, USP. Each 0.5 mL of Sumavel DosePro 12 mg/mL solution contains 6 mg of sumatriptan (base) as the succinate salt and 3.5 mg of sodium chloride, USP, in water for injection, USP. The pH range of both solutions is approximately 4.2 to 5.3. The osmolality of both solutions is 291 mOsmol.

Sumavel DosePro is a pre-filled, single-use, disposable, needle-free subcutaneous delivery system delivering sterile sumatriptan injection. Sumavel DosePro consists of the following components: a gray plastic handle and snap-off tip, a lavender (4 mg) or green (6 mg) lever, and a glass medication chamber that is pre-filled with 4 mg or 6 mg per 0.5 mL sumatriptan injection. Utilizing pressure from a compressed nitrogen gas source in the handle, Sumavel DosePro delivers the medication by pushing it through a small, precise hole in the glass medication chamber. The resulting stream of medication is propelled through the skin and is delivered subcutaneously without a needle, following a biphasic pressure profile.

Included as part of the "PRECAUTIONS" section

Sumavel® DosePro®
(SUE-muh-vell DOSE-pro)
(sumatriptan) Injection

Read this Patient Information before you start using Sumavel DosePro and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

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 is Sumavel DosePro?

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 any of the following medicines in the last 24 hours:
• almotriptan (AXERT®)
• eletriptan (RELPAX®)
• frovatriptan (FROVA®)
• naratriptan (AMERGE®)
• rizatriptan (MAXALT®, MAXALT-MLT®)
• ergotamines (CAFERGOT®, ERGOMAR®, MIGERGOT®)
• dihydroergotamine (D.H.E. 45®, MIGRANAL®)
Ask your healthcare provider if you are not sure if your medicine is listed above.
• are allergic to sumatriptan or any of the ingredients in Sumavel DosePro. See the end of this leaflet for a complete list of ingredients in Sumavel DosePro.

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, including if you:

• have high blood pressure
• have high cholesterol
• have diabetes
• smoke
• are overweight
• have heart problems or family history of heart problems or stroke
• have liver problems
• have had epilepsy or seizures
• are not using effective birth control
• become pregnant while taking Sumavel DosePro
• are breastfeeding or plan to breastfeed. Sumavel DosePro passes into your breast milk and may harm your baby. Talk with your healthcare provider about the best way to feed your baby if you take Sumavel DosePro.

Tell your healthcare provider 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.

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

• selective serotonin reuptake inhibitors (SSRIs)
• serotonin norepinephrine reuptake inhibitors (SNRIs)
• tricyclic antidepressants (TCAs)
• monoamine oxidase inhibitors (MAOIs)

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

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

How should I take Sumavel DosePro?

• See the Instructions for Use at the end of this leaflet for complete information on how to use Sumavel DosePro.
• Certain people should take their first dose of Sumavel DosePro in their healthcare provider's office or in another medical setting. Ask your healthcare provider if you should take your first dose in a medical setting.
• Use Sumavel DosePro exactly as your healthcare provider tells you to use it.
• Before you try to inject Sumavel DosePro yourself, a healthcare provider should teach you how to use the Sumavel DosePro Needle-free Delivery System.
• Your healthcare provider may change your dose. Do not change your dose without first talking to your healthcare provider.
• You should use Sumavel DosePro as soon as the symptoms of your headache start, but it may be given at any time during a migraine attack.
• If you did not get any relief after the first dose, do not give a second dose without first talking with your healthcare provider.
• You may use a second dose of Sumavel DosePro or 1 dose of another sumatriptan medicine separated by at least 1 hour, but not sooner, if your headache came back after your first dose.
• Do not use more than 2 doses of 6 mg or 3 doses of 4 mg Sumavel DosePro in a 24-hour period.
• If you use too much Sumavel DosePro, call your healthcare provider or go to the nearest hospital emergency room right away.
• You should write down when you have headaches and when you take Sumavel DosePro so you can talk with your healthcare provider about how Sumavel DosePro is working for you.

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 are the possible side effects of Sumavel DosePro?

Sumavel DosePro may cause serious side effects, including:

• See "What is the most important information I should know about Sumavel DosePro?"
• 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. You may report side effects to the FDA at 1-800-FDA-1088.

How should I store Sumavel DosePro Injection?

• Store Sumavel DosePro between 68°F to 77°F (20°C to 25°C).
• Do not freeze.
• Protect from light.

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

General information about the safe and effective use of 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 you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Sumavel DosePro. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Sumavel DosePro that is written for healthcare professionals.

For more information, go to www.SumavelDosePro.com or call Endo Pharmaceuticals at 1-800-462-3636

What are the ingredients in Sumavel DosePro Injection?

Active ingredient: sumatriptan succinate

Inactive ingredients: sodium chloride, water for injection

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

• coronary heart disease, angina (chest pain), blood circulation problems, lack of blood supply to the heart;
• a history of heart disease, heart attack, or stroke, including "mini-stroke";
• severe or uncontrolled high blood pressure;
• severe liver disease;
• ischemic bowel disease; or
• a headache that seems different from your usual migraine headaches.

Do not use sumatriptan if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days.

To make sure you can safely use sumatriptan, tell your doctor if you have any of these other conditions:

• liver disease;
• kidney disease;
• epilepsy or other seizure disorder;
• high blood pressure, a heart rhythm disorder; or
• coronary heart disease (or risk factors 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).

FDA pregnancy category C. 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 medication.

Your name may need to be listed on a sumatriptan pregnancy registry when you start using this medication.

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.

This medicine should not be given to anyone under 18 or over 65 years of age.

Since sumatriptan is used as needed, it does not have a daily dosing schedule. Call your doctor promptly if your symptoms do not improve after using sumatriptan.

After using a sumatriptan injection, you must wait one (1) hour before using a second injection. Do not use more than two (2) injections in 24 hours.

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.

Usual Adult Dose for Migraine:

Use only after a clear diagnosis of migraine has been established

Oral:
Initial dose: 25 mg, 50 mg, or 100 mg orally, once
-If some response to first dose occurs, a second dose may be administered at least 2 hours after first dose if needed
-Oral doses of 50 and 100 mg may provide greater relief than 25 mg; however, a 100 mg dose may not provide greater effect than a 50 mg dose
Maximum dose: 200 mg per 24 hours

Subcutaneous:
Initial dose: 1 to 6 mg subcutaneously, once
-If some response to first dose occurs, a second dose may be administered at least 1 hour after first dose if needed.
Maximum dose: 12 mg per 24 hours

Intranasal:
Nasal spray: Initial dose: 5 mg, 10 mg, or 20 mg into one nostril, once
-Administer the 5 and 20 mg doses as a single spray in 1 nostril; the 10 mg dose may be administered as 5 mg into each nostril
-If some response to first dose occurs, a second dose may be administered at least 2 hours after first dose if needed
Maximum dose: 40 mg per 24 hours

Nasal capsule/powder: Initial dose: 11 mg into each nostril via Xsail (R) breath-powered delivery device once
-If symptoms have not resolved in 2 hours, or return after transient improvement a second dose may be administered at least 2 hours after the first dose
Maximum dose: 2 doses (44 mg/4 nosepieces) per 24 hours

Comments:
-Treatment should be started at the first sign of a migraine headache, or associated symptoms such as nausea, vomiting, or photophobia; this drug should not be used for migraine prophylaxis.
-Higher doses may have a greater effect, but also carry a greater risk of adverse reactions.
-The safety of treating an average of more than 4 headaches in a 30 day period has not been established.

Use: For the acute treatment of migraine with or without aura.

Usual Adult Dose for Cluster Headache:

Subcutaneous injection:
Initial dose: 6 mg subcutaneously, once. If symptoms recur, the dose may be repeated if at least 1 hour has elapsed since the first dose.
Maximum dose: 12 mg per 24 hours

Comments:
-Treatment should be started at the first sign of cluster headache, or associated symptoms such as nausea, vomiting, or photophobia. This drug should not be used prophylactically.
-The safety of treating an average of more than 4 headaches in a 30 day period has not been established.

Use: For the acute treatment of cluster headache.

Using sumatriptan while you are using certain other medicines can cause high levels of serotonin to build up in your body, a condition called "serotonin syndrome," which can be fatal. Tell your doctor if you also use:

• medicine to treat depression;

• medicine to treat a psychiatric disorder;

• a narcotic (opioid) medication; or

• medicine to prevent nausea and vomiting.

This list is not complete. Other drugs may interact with sumatriptan, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Coronary vasospasm was observed after intravenous administration of Sumatriptan Injection [see Contraindications (4)]. Overdoses would be expected from animal data (dogs at 0.1 g/kg, rats at 2 g/kg) to possibly cause convulsions, tremor, inactivity, erythema of the extremities, reduced respiratory rate, cyanosis, ataxia, mydriasis, injection site reactions (desquamation, hair loss, and scab formation), and paralysis.

The elimination half-life of sumatriptan is about 2 hours [see Clinical Pharmacology (12.3)]; therefore, monitoring of patients after overdose with Sumatriptan Injection should continue for at least 10 hours or while symptoms or signs persist.

It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of sumatriptan.

Sumatriptan (soo'' ma trip' tan)
Injection USP

Read this Patient Information before you start taking sumatriptan and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

What is the most important information I should know about sumatriptan?

Sumatriptan can cause serious side effects, including:

Heart attack and other heart problems. Heart problems may lead to death.

Stop taking sumatriptan 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

Sumatriptan 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 is Sumatriptan?

Sumatriptan Injection 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.

Sumatriptan 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.

Sumatriptan is not used to prevent or decrease the number of migraine or cluster headaches you have.

It is not known if sumatriptan is safe and effective in children under 18 years of age.

Who should not take sumatriptan?

Do not take sumatriptan if you have:

• heart problems or a history of heart problems
• narrowing of blood vessels to your legs, arms, stomach, or kidneys (peripheral vascular disease)
• uncontrolled high blood pressure
• severe liver problems
• 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 any of the following medicines in the last 24 hours:
  • almotriptan (AXERT®)
  • eletriptan (RELPAX®)
  • frovatriptan (FROVA®)
  • naratriptan (AMERGE®)
  • rizatriptan (MAXALT®, MAXALT-MLT®)
  • sumatriptan and naproxen (TREXIMET®)
  • ergotamines (CAFERGOT®, ERGOMAR®, MIGERGOT®)
  • dihydroergotamine (D.H.E. 45®, MIGRANAL®)

Ask your healthcare provider if you are not sure if your medicine is listed above.

•  an allergy to sumatriptan or any of the ingredients in Sumatriptan Injection. See the end of this leaflet for a complete list of ingredients in Sumatriptan Injection.

What should I tell my healthcare provider before taking sumatriptan?

Before you take sumatriptan, tell your healthcare provider about all of your medical conditions, including if you:

• have high blood pressure
• have high cholesterol
• have diabetes
• smoke
• are overweight
• have heart problems or family history of heart problems or stroke
• have kidney problems
• have liver problems
• have had epilepsy or seizures
• are not using effective birth control
• become pregnant while taking sumatriptan
• are breastfeeding or plan to breastfeed. Sumatriptan passes into your breast milk and may harm your baby. Talk with your healthcare provider about the best way to feed your baby if you take sumatriptan.

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

Sumatriptan and certain other medicines can affect each other, causing serious side effects.

Especially tell your healthcare provider if you take antidepressant medicines called:

• selective serotonin reuptake inhibitors (SSRIs)
• serotonin norepinephrine reuptake inhibitors (SNRIs)
• tricyclic antidepressants (TCAs)
• monoamine oxidase inhibitors (MAOIs)

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

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

How should I take sumatriptan?

• Certain people should take their first dose of sumatriptan in their healthcare provider’s office or in another medical setting. Ask your healthcare provider if you should take your first dose in a medical setting.
• Use sumatriptan exactly as your healthcare provider tells you to use it.
• Your healthcare provider may change your dose. Do not change your dose without first talking with your healthcare provider.
• For adults, the usual dose is a single injection given just below the skin.
• You should give an injection as soon as the symptoms of your headache start, but it may be given at any time during a migraine or cluster headache attack.
• If you did not get any relief after the first injection, do not give a second injection without first talking with your healthcare provider.
• If your headache comes back or you only get some relief after your first injection, you can take a second injection 1 hour after the first injection, but not sooner.
• Do not take more than 12 mg in a 24-hour period.
• If you use too much sumatriptan, call your healthcare provider or go to the nearest hospital emergency room right away.
• You should write down when you have headaches and when you take sumatriptan so you can talk with your healthcare provider about how sumatriptan is working for you.

What should I avoid while taking sumatriptan?

Sumatriptan 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 are the possible side effects of sumatriptan?

Sumatriptan may cause serious side effects. See “What is the most important information I should know about sumatriptan?”

These serious side effects include:

• 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
• hives (itchy bumps); swelling of your tongue, mouth, or throat
• medication overuse headaches. Some people who use too many Sumatriptan Injections may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with sumatriptan.
• serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using sumatriptan, especially if sumatriptan 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 sumatriptan who have never had seizures before. Talk with your healthcare provider about your chance of having seizures while you take sumatriptan.

The most common side effects of Sumatriptan Injection 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 sumatriptan. For more information, ask your healthcare provider 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 Sumatriptan Injection?

• Store Sumatriptan Injection between 36°F to 86°F (2°C to 30°C).
• Store your medicine away from light.
• Keep your medicine in the packaging provided with it.

Keep sumatriptan and all medicines out of the reach of children.

General information about the safe and effective use of sumatriptan

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use sumatriptan for a condition for which it was not prescribed. Do not give sumatriptan to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about sumatriptan. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about sumatriptan that is written for healthcare professionals.

For more information, call 1-866-850-2876.

What are the ingredients in Sumatriptan Injection?

Active ingredient: sumatriptan succinate

Inactive ingredients: sodium chloride, water for injection

AXERT® is the registered trademark of Almirall AG.

RELPAX® is the registered trademark of Pfizer Inc.

FROVA® is the registered trademark of Vernalis Development Limited.

AMERGE® and TREXIMET® are the registered trademarks of GlaxoSmithKline LLC.

MAXALT® and MAXALT-MLT® are the registered trademarks of Merck Sharp & Dohme Corp.

CAFERGOT® is the registered trademark of Novartis Pharmaceuticals Corporation.

ERGOMAR® is the registered trademark of Rosedale Therapeutics, LLC.

MIGERGOT®is the registered trademark of G&W Laboratories, Inc.

D.H.E. 45® and MIGRANAL® are the registered trademarks of Valeant Pharmaceuticals North America.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Manufactured for: AuroMedics Pharma LLC
                              6 Wheeling Road
                              Dayton, NJ 08810

Manufactured by: Aurobindo Pharma Limited
                             IDA, Pashamylaram – 502307
                             India

NOVAPLUS is a registered trademark of Vizient Inc.

Revised: June 2016