Sumavel DosePro

Sumavel DosePro 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:

• Use only if a clear diagnosis of migraine or cluster headache has been established.
• If a patient has no response to the first migraine attack treated with Sumavel DosePro, reconsider the diagnosis of migraine before Sumavel DosePro is administered to treat any subsequent attacks.
• Sumavel DosePro is not indicated for the prevention of migraine attacks.

Dosage Forms And Strengths

Sumavel DosePro is a prefilled, single-dose, needle-free subcutaneous delivery system delivering 0.5 mL of sterile solution containing 4 mg or 6 mg sumatriptan (as the succinate salt).

Storage And Handling

Each Sumavel DosePro needle-free delivery system contains sumatriptan (base) in 0.5 mL, in a sterile, nonpyrogenic solution and is supplied as follows:

• Sumavel DosePro, 4 mg in a package of six prefilled, single-dose units (NDC 63481-229-06).
• Sumavel DosePro, 6 mg in a package of six prefilled, single-dose units (NDC 63481-367-06).

Store at 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F). Do not freeze.
Protect from light.

Manufactured by: Patheon UK, Limited, Swindon, United Kingdom. Revised: Sep 2015

Mechanism Of Action

Sumatriptan is the active component of Sumavel DosePro. Sumatriptan binds with high affinity to human cloned 5-HT1B/1D receptors. Sumatriptan presumably exerts its therapeutic effects in the treatment of migraine headache by binding to 5- HT1B/1D receptors located on intracranial blood vessels and sensory nerves of the trigeminal system.

Current theories proposed to explain the etiology of migraine headache suggest that symptoms are due to local cranial vasodilatation and/or to the release of sensory neuropeptides (including substance P and calcitonin gene-related peptide) through nerve endings in the trigeminal system. The therapeutic activity of sumatriptan for the treatment of migraine and cluster headaches is thought to be due to the agonist effects at the 5-HT1B/1D receptors on intracranial blood vessels (including the arterio-venous anastomoses) and sensory nerves of the trigeminal system, which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.

Pharmacodynamics

Blood Pressure: Significant elevation in blood pressure, including hypertensive crisis, has been reported in patients with and without a history of hypertension [see WARNINGS AND PRECAUTIONS].

Peripheral (Small) Arteries: In healthy volunteers (N = 18), a trial evaluating the effects of sumatriptan on peripheral (small vessel) arterial reactivity failed to detect a clinically significant increase in peripheral resistance.

Heart Rate: Transient increases in blood pressure observed in some subjects in clinical trials carried out during sumatriptan’s development as a treatment for migraine were not accompanied by any clinically significant changes in heart rate.

Pharmacokinetics

Sumavel DosePro is bioequivalent to sumatriptan needle-based injection via autoinjector at the thigh and abdomen administration sites. A sub-optimal dose may be delivered when administered to the arm and therefore, the arm is not recommended as a site of administration.

Pharmacokinetic parameters following a 6 mg subcutaneous dose of Sumavel DosePro into the thigh were determined in 32 subjects (males and females). The maximum serum concentration (C ) (mean ± standard deviation) was 71.9 ± 14.4 ng/mL; the time to peak concentration (T ) was 12 minutes after dosing (range, 4 to 20 minutes); and the terminal half-life was 103 ± 22 minutes.

Pharmacokinetic parameters following a 6 mg subcutaneous dose of Sumavel DosePro into the abdomen were determined in 35 subjects (males and females). The maximum serum concentration (C ) (mean ± standard deviation) was 78.6 ± 17.3 ng/mL; the time to peak concentration (T ) was 12 minutes after dosing (range, 6 to 20 minutes); and the terminal half-life was 102 ± 12 minutes.

The bioavailability of sumatriptan via subcutaneous site injection to 18 healthy male subjects was 97% ± 16% of that obtained following intravenous injection. Protein binding, determined by equilibrium dialysis over the concentration range of 10 to 1,000 ng/mL, is low, approximately 14% to 21%. The effect of sumatriptan on the protein binding of other drugs has not been evaluated.

In vitro studies with human microsomes suggest that sumatriptan is metabolized by MAO, predominantly the A isoenzyme. Most of a radiolabeled dose of sumatriptan excreted in the urine is the major metabolite indole acetic acid (IAA) or the IAA glucuronide, both of which are inactive.

After a single 6 mg subcutaneous dose, 22% ± 4% was excreted in the urine as unchanged sumatriptan and 38% ± 7% as the IAA metabolite.

Special Populations

Age: The pharmacokinetics of sumatriptan in the elderly (mean age: 72 years, 2 males and 4 females) and in subjects with migraine (mean age: 38 years, 25 males and 155 females) were similar to that in healthy male subjects (mean age: 30 years).

Renal Impairment: The effect of renal impairment on the pharmacokinetics of sumatriptan has not been examined.

Hepatic Impairment: The effect of mild to moderate hepatic disease on the pharmacokinetics of subcutaneously administered sumatriptan has been evaluated. There were no significant differences in the pharmacokinetics of subcutaneously administered sumatriptan in moderately hepatically impaired subjects compared with healthy controls. The pharmacokinetics of subcutaneously administered sumatriptan in patients with severe hepatic impairment has not been studied. The use of Sumavel DosePro in this population is not recommended [see Use In Specific Populations].

Race: The systemic clearance and Cmax of sumatriptan were similar in Black (n = 34) and Caucasian (n = 38) healthy male subjects.

Drug Interaction Studies

Monoamine Oxidase-A Inhibitors: In a trial of 14 healthy females, pretreatment with an MAO-A inhibitor decreased the clearance of sumatriptan, resulting in a 2-fold increase in the area under the sumatriptan plasma concentration-time curve (AUC), corresponding to a 40% increase in elimination half-life.

Clinical Studies

In controlled clinical trials enrolling more than 1,000 subjects during migraine attacks who were experiencing moderate or severe pain and 1 or more of the symptoms enumerated in Table 3, onset of relief began as early as 10 minutes following a 6 mg sumatriptan injection. Lower doses of sumatriptan injection may also prove effective, although the proportion of subjects obtaining adequate relief was decreased and the latency to that relief is greater with lower doses. In one wellcontrolled study, 6 different doses of sumatriptan injection (n = 30 each group) were compared with placebo (n = 62), in a single-attack, parallel-group design, the dose response relationship was found to be as shown in Table 2.

Table 2. Proportion of Subjects with Migraine Relief and Incidence of Adverse Events by Time and by Sumatriptan Dose

In 2 randomized, placebo-controlled clinical trials of sumatriptan injection 6 mg in 1,104 subjects with moderate or severe migraine pain, the onset of relief was less than 10 minutes. Headache relief, as defined by a reduction in pain from severe or moderately severe to mild or no headache, was achieved in 70% of the subjects within 1 hour of a single 6 mg subcutaneous dose of sumatriptan injection. Approximately 82% and 65% of subjects treated with sumatriptan 6 mg had headache relief and were pain free within 2 hours, respectively.

Table 3 shows the 1- and 2-hour efficacy results for sumatriptan injection 6 mg.

Table 3. Proportion of Subjects with Pain Relief and Relief of Migraine Symptoms After 1 and 2 Hours of Treatment

Subcutaneous sumatriptan also relieved photophobia, phonophobia (sound sensitivity), nausea, and vomiting associated with migraine attacks. The efficacy of sumatriptan injection was unaffected by whether or not the migraine was associated with aura, duration of attack, gender or age of the subject, or concomitant use of common migraine prophylactic drugs (e.g., betablockers).

The efficacy of sumatriptan injection in the acute treatment of cluster headache was demonstrated in 2 randomized, doubleblind, placebo-controlled, 2-period crossover trials. Subjects aged 21 to 65 years were enrolled and were instructed to treat a moderate to very severe headache within 10 minutes of onset. Headache relief was defined as a reduction in headache severity to mild or no pain. In both trials, the proportion of individuals gaining relief at 10 or 15 minutes was significantly greater among subjects receiving 6 mg of sumatriptan injection compared with those who received placebo (see Table 4).

Table 4. Proportion of Subjects with Cluster Headache Relief by Time

An estimate of the cumulative probability of a subject with a cluster headache obtaining relief after being treated with either sumatriptan or placebo is presented in Figure 1.

Figure 1. Time to Relief of Cluster Headache from Time of Injectiona

aThe figure uses Kaplan-Meier (product limit) Survivorship Plot. Subjects taking rescue medication were censored at 15 minutes.

The plot was constructed with data from subjects who either experienced relief or did not require (request) rescue medication within a period of 2 hours following treatment. As a consequence, the data in the plot are derived from only a subset of the 258 headaches treated (rescue medication was required in 52 of the 127 placebo-treated headaches and 18 of the 131 headaches treated with sumatriptan injection).

Other data suggest that treatment with sumatriptan injection is not associated with an increase in early recurrence of headache and has little effect on the incidence of later-occurring headaches (i.e., those occurring after 2, but before 18 or 24 hours).

Sumavel DosePro is part of the drug class:

• Selective serotonin

Sumatriptan may cause serious side effects. See “Drug Precautions”.

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 take/use too much sumatriptan may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with sumatriptan.

The most common side effects of sumatriptan tablets include:

• tingling or numbness in your fingers or toes
• dizziness
• warm, hot, burning feeling to your face (flushing)
• feeling weak, drowsy, or tired

The most common side effects of sumatriptan nasal spray include:

• dizziness
• warm, hot, burning feeling to your face (flushing)
• discomfort of your neck, throat, or nose
• unusual or bad taste in your mouth
• feeling weak, drowsy, or tired
• sensitivity to loud noises

The most common side effects of sumatriptan injection include:

• injection site reactions such as redness, pain, or swelling
• 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.

• Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.
• 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.
• Take sumatriptan exactly as your healthcare provider tells you to take it.Do not take more or less of it or take it more often than prescribed by your doctor.
• Your healthcare provider may change your dose. Do not change your dose without first talking to your healthcare provider.

Sumatriptan tablets:

• Take sumatriptan tablets with water or other liquids.
• If you do not get any relief after your first sumatriptan tablet, do not take a second tablet without first talking with your healthcare provider.
• If your headache comes back or you only get some relief from your headache, you can take a second tablet 2 hours after the first tablet.
• Do not take more than a total of 200 mg of sumatriptan tablets in a 24‑hour period.
• Some people who take too many sumatriptan tablets may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with sumatriptan.

Sumatriptan nasal spray:

Before using sumatriptan nasal spray, read the "Instructions for Use" at the end of the Patient Information leaflet that comes with the medicine.

• Certain people should take their first dose of sumatriptan nasal spray 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 nasal spray 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.
• If you do not get any relief after your first nasal spray, do not use a second nasal spray without first talking with your healthcare provider.
• If your headache comes back after the first nasal spray or you only get some relief from your headache, you can use a second nasal spray 2 hours after the first nasal spray.
• Do not take more than a total of 40 mg of sumatriptan nasal spray in a 24‑hour period.
• It is not known how using sumatriptan nasal spray for a long time affects the nose and throat.
• Some people who use too much sumatriptan Nasal Spray may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with sumatriptan nasal spray.

Sumatriptan injection:

Imitrex Injection comes in an autoinjection device so that you can self-inject this medication into your thigh or deltoid area (shoulder joint). Your doctor or pharmacist should show you how to load the injector and administer the medication.

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 migraine start, but it may be given at any time during an attack. You may give a second injection if your migraine symptoms come back.

If your symptoms do not get better after the first injection, do not give a second injection for the same attack without first talking with your healthcare provider. Do not give more than two 6-mg doses in any 24-hour period. Allow at least 1 hour between each dose.

If you take 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.

The following adverse reactions are discussed in more detail in other sections of the labeling:

• Myocardial ischemia, myocardial infarction, and Prinzmetal’s angina [see Warnings and Precautions (5.1)]
• Arrhythmias [see Warnings and Precautions (5.2)]
• Chest, throat, neck, and/or jaw pain/tightness/pressure [see Warnings and Precautions (5.3)]
• Cerebrovascular events [see Warnings and Precautions (5.4)]
• Other vasospasm reactions [see Warnings and Precautions (5.5)]
• Medication overuse headache [see Warnings and Precautions (5.6)]
• Serotonin syndrome [see Warnings and Precautions (5.7)]
• Increase in blood pressure [see Warnings and Precautions (5.8)]
• Hypersensitivity reactions [see Contraindications (4) and Warnings and Precautions (5.9)]
• Seizures [see Warnings and Precautions (5.10)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Migraine Headache: Table 1 lists adverse reactions that occurred in 2 US placebo-controlled clinical trials in migraine subjects [see Clinical Studies (14.1)] following either a single 6 mg dose of sumatriptan injection or placebo. Only reactions that occurred at a frequency of 2% or more in groups treated with sumatriptan injection 6 mg and that occurred at a frequency greater than the placebo group are included in Table 1.

The incidence of adverse reactions in controlled clinical trials was not affected by gender or age of the subjects. There were insufficient data to assess the impact of race on the incidence of adverse reactions.

Cluster Headache: In the controlled clinical trials assessing the efficacy of sumatriptan injection as a treatment for cluster headache [see Clinical Studies (14.2)], no new significant adverse reactions were detected that had not already been identified in trials of sumatriptan in subjects with migraine.

Overall, the frequency of adverse reactions reported in the trials of cluster headache was generally lower than in the migraine trials. Exceptions include reports of paresthesia (5% sumatriptan, 0% placebo), nausea and vomiting (4% sumatriptan, 0% placebo), and bronchospasm (1% sumatriptan, 0% placebo).

7.1 Ergot-Containing Drugs

Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and Sumavel Dosepro within 24 hours of each other is contraindicated.

7.2 Monoamine Oxidase-A Inhibitors

MAO-A inhibitors increase systemic exposure by 2-fold. Therefore, the use of Sumavel Dosepro in patients receiving MAO-A inhibitors is contraindicated [see Clinical Pharmacology (12.3)].

7.3 Other 5-HT1 Agonists

Because their vasospastic effects may be additive, co-administration of Sumavel Dosepro and other 5-HT1 agonists (e.g., triptans) within 24 hours of each other is contraindicated.

7.4 Selective Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors and Serotonin Syndrome

Cases of serotonin syndrome have been reported during co-administration of triptans and SSRIs, or SNRIs, SNRIs, TCAs, and MAO inhibitors [see Warnings and Precautions (5.7)].

The elimination half-life of sumatriptan is about 2 hours [see Clinical Pharmacology (12.3)], and therefore monitoring of patients after overdose with subcutaneous sumatriptan 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.

See FDA-approved patient labeling.

Risk of Myocardial Ischemia and/or Infarction, Prinzmetal’s Angina, Other Vasospasm-Related Events, Arrhythmias and Cerebrovascular Events
Inform patients that Sumavel Dosepro may cause serious cardiovascular side effects such as myocardial infarction or stroke. Although serious cardiovascular events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, irregular heartbeat, significant rise in blood pressure, weakness, and slurring of speech and should ask for medical advice when observing any indicative sign or symptoms. Patients should be apprised of the importance of this follow-up [see Warnings and Precautions (5.1, 5.2, 5.4, 5.5, 5.8)].

Anaphylactic/Anaphylactoid Reactions
Inform patients that anaphylactic/anaphylactoid reactions have occurred in patients receiving Sumavel Dosepro. Such reactions can be life threatening or fatal. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens [see Warnings and Precautions (5.9)].

Serotonin Syndrome
Patients should be cautioned about the risk of serotonin syndrome with the use of Sumavel Dosepro or other triptans, particularly during combined use with SSRIs, SNRIs, TCAs, and MAO inhibitors [see Warnings and Precautions (5.7) and Drug Interactions (7.4)].

Medication Overuse Headache
Inform patients that use of acute migraine drugs for 10 or more days per month may lead to an exacerbation of headache and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary) [see Warnings and Precautions (5.6)].

Pregnancy
Inform patients that Sumavel Dosepro should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus [see Use in Specific Populations (8.1)].

Nursing Mothers
Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations (8.3)].

Ability to Perform Complex Tasks
Since migraines or treatment with Sumavel Dosepro may cause somnolence and dizziness, instruct patients to evaluate their ability to perform complex tasks during migraine attacks and after administration of Sumavel Dosepro.

How to Use Sumavel Dosepro
Importance of Training
Patients who are to self-administer Sumavel Dosepro in medically unsupervised situations should receive instruction on the proper use of Sumavel Dosepro from the physician or healthcare professional prior to administering for the first time.

Advise patients that they will hear a click and feel a burst of air. Inform the patients that they will feel the dose being delivered. Instruct patients not to use a device if the tip of the device is tilted or broken off upon removal from packaging [see Instructions for Use].

Choosing Administration Sites
Sumavel Dosepro delivers the medication to the subcutaneous space in a manner similar to a subcutaneous injection. Since delivery is to be given subcutaneously, patients should be instructed to use administration sites on the abdomen or the thigh with adequate subcutaneous thickness to accommodate penetration of the drug into the subcutaneous space. Administration should not be made within 2 inches of the navel. Instruct patients not to administer Sumavel Dosepro to the arms or other areas of the body. Inform patients that Sumavel Dosepro is for subcutaneous use only and is not designed for intramuscular or intravenous use.

Distributed by:
Endo Pharmaceuticals Inc.
Malvern, PA 19355

Manufactured by:
Patheon UK, Limited
Swindon, United Kingdom

Sumavel® is a registered trademark of Endo Ventures Bermuda Limited.

DosePro® is a registered trademark of Zogenix, Inc.

©2016 Endo Pharmaceuticals Inc. All rights reserved.

Revised 06/2016

PATIENT INFORMATION
Sumavel® DosePro® (SUE-muh-vell DOSE-pro)
(sumatriptan injection) for subcutaneous use
Needle-free Delivery System

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
• smoke
• have diabetes
• have high cholesterol levels
• are overweight
• 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.

Do not take Sumavel Dosepro:

• 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®)
  • naratriptan (AMERGE®)
  • dihydroergotamine (D.H.E. 45®, MIGRANAL®)
  • eletriptan (RELPAX®)
  • rizatriptan (MAXALT®, MAXALT-MLT®)
  • ergotamines (CAFERGOT®, ERGOMAR®, MIGERGOT®)
  • frovatriptan (FROVA®)

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.

Before taking 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?

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
  • weight loss
  • constipation or diarrhea
  • fever
  • stomach pain after meals
  • nausea or vomiting
  • bloody diarrhea
• 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

These are not all the possible side effects of Sumavel Dosepro.  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 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 a Patient Information leaflet. 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. You can ask your pharmacist or healthcare provider for information about Sumavel Dosepro that is written for health professionals.

What are the ingredients in Sumavel Dosepro?

Active ingredient: sumatriptan succinate

Inactive ingredients: sodium chloride, water for injection

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

SIE 90030

Instructions for Use
Sumavel® DosePro® (SUE-muh-vell DOSE-pro)
(sumatriptan injection), for subcutaneous use
Needle-free Delivery System

Read these 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 doctor 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, 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.

Shaded areas show all possible areas of delivery.

1. Snap: In this step, you will learn how to correctly remove the snap-off tip.

Do not begin these steps until you are ready to take your dose.

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 lavender (4 mg) or green (6 mg) 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. Pinch and 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 click and feel a burst of air. Do not be alarmed. This means that the medicine has been delivered.

Steadily press Sumavel Dosepro straight down against your skin until you hear a click and feel a burst of air.  You will feel the dose being delivered.  There is no button to push. After you hear the click and feel the burst of air, 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, a small droplet of blood may be present. You can gently press a cotton ball or gauze over the injection site. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if needed.

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

Distributed by:
Endo Pharmaceuticals Inc.
Malvern, PA 19355

Manufactured by:
Patheon UK, Limited
Swindon, United Kingdom      

Sumavel® is a registered trademark of Endo Ventures Bermuda Limited.

DosePro® is a registered trademark of Zogenix, Inc.

©2016 Endo Pharmaceuticals Inc. All rights reserved.

Revised: June 2016

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