Alsuma

Name: Alsuma

Patient information

ALSUMA™
(Awl-SOO'-mah)
(sumatriptan injection) Auto-Injector

Read this Patient Information before you start taking ALSUMA 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 ALSUMA?

ALSUMA can cause serious side effects, including:

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

Stop taking ALSUMA 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

ALSUMA 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 ALSUMA?

ALSUMA Auto-Injector 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.

ALSUMA 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.

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

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

Who should not take ALSUMA?

Do not take ALSUMA 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®)
    • sumatriptan (IMITREX®)
    • 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 ALSUMA. See the end of this leaflet for a complete list of ingredients in ALSUMA.

What should I tell my healthcare provider before taking ALSUMA?

Before you take ALSUMA, 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 ALSUMA
  • are breastfeeding or plan to breastfeed. ALSUMA 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 ALSUMA.

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

Using ALSUMA 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 ALSUMA?

  • Read the Instructions for Use that come with ALSUMA.
  • Certain people should take their first dose of ALSUMA 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 ALSUMA 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.
  • Do not give ALSUMA into a vein.
  • Give the injection in the side of your thigh, or the upper arm just below the skin (subcutaneous). Check with your healthcare provider if you are not sure where to inject yourself.
  • 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 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.
  • You can take a second injection 1 hour after the first injection, but not sooner, if your headache came back after your first injection.

Do not take more than 2 doses of ALSUMA in 24 hours.

If you use too much ALSUMA, 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 ALSUMA so you can talk with your healthcare provider about how ALSUMA is working for you.

What should I avoid while taking ALSUMA?

ALSUMA 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 ALSUMA?

ALSUMA can cause serious side effects. See “What is the most important information I should know about ALSUMA?”

These serious side effects include:

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

The most common side effects of ALSUMA include:

  • bleeding, swelling, redness, bruising and pain at the 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 ALSUMA. 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 1800-FDA-1088.

How should I store ALSUMA?

  • Store ALSUMA between 59°F to 86°F (15°C to 30°C).
  • Store your medicine away from light.
  • Do not put ALSUMA in the refrigerator.
  • Keep each ALSUMA Auto-Injector in its storage and disposal case.
  • Remove the ALSUMA Auto-Injector from the storage and disposal case only when you need to give yourself an injection.

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

General information about the safe and effective use of ALSUMA

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use ALSUMA for a condition for which it was not prescribed. Do not give ALSUMA 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 ALSUMA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ALSUMA that is written for healthcare professionals.

For more information, go to www.alsuma.com or call 1-877-770-8796.

What are the ingredients in ALSUMA?

Active ingredient: sumatriptan succinate

Inactive ingredients: sodium chloride, water for injection

PATIENT INSTRUCTIONS FOR USE

ALSUMA™
(Awl-SOO´-mah)
(sumatriptan injection) Auto-Injector

Read the Patient Instructions for Use that come with the ALSUMA™ Auto-Injector before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment.

Before you use ALSUMA for the first time, make sure your healthcare provider teaches you the right way to use it.

Follow these instructions each time you use ALSUMA.

ALSUMA is a disposable one time use, prefilled auto-injector used for the treatment of acute migraine or cluster headaches.

Each ALSUMA Auto-Injector is filled with medicine and ready to use. No assembly is required.

ALSUMA is packaged with two doses to a box, with each ALSUMA dose stored in a separate storage and disposal case. (see Figure 1)

Figure 1

ALSUMA Important Tips

  • Do not remove the Blue Safety Release until you are ready to inject yourself.
  • Do not place your fingers on the top or the bottom end of the ALSUMA Auto-Injector.
  • Do not touch the orange needle end.
  • Always point the orange needle end down.
  • Do not take apart the ALSUMA Auto-Injector.
  • Keep out of the reach of children.

The Storage and Disposal Case (see Figure 2)

  • Always store and carry ALSUMA in the storage and disposal case.
  • Do not remove ALSUMA from the storage and disposal case until you are ready to use it.
  • Always keep the orange needle end facing the bottom of the storage and disposal case.
  • The purple cap should be screwed tightly onto the storage and disposal case before use.
  • After your injection, the ALSUMA Auto-Injector should be placed back into the storage and disposal case. Throw away the case the way your healthcare provider told you.

Figure 2

The ALSUMA Auto-Injector

  • Locked : When the Blue Safety Release is in place, ALSUMA is locked and will not inject. (see Figure  3 )

Figure 3

  • Unlocked : When the Blue Safety Release is taken off, ALSUMA is unlocked and ready to use. (see Figure  4 )

Figure 4

Holding the ALSUMA Auto-Injector

Always hold the ALSUMA Auto-Injector in the middle with the orange needle end pointing down. (see Figure 5)

  • Never hold the injector upside down. (see Figure 6)
  • Never put your thumb on either end of the injector. (see Figures 7 and 8)
  • Never touch the orange needle end. (see Figure 8)

Figure  5, 6, 7 and 8

How to Use ALSUMA

1. Choose an injection site.

  • Ask your doctor about where you should inject yourself (usually the side of your thigh or your upper arm). (see Figures 9 and 10)
  • Do not inject through your clothes.

2. Preparing your ALSUMA Auto-Injector.

Figure 9 and 10

An Inside Look

Figure 11 and 12

  • Twist off the purple cap from the storage and disposal case. (see Figure 13)

Figure 13

  • Slide the ALSUMA Auto-Injector out into your hand. (see Figure 14)

Figure 14

  • Hold the ALSUMA Auto-Injector in the middle. (see Figure 15)

Figure 15

  • Pull off the Blue Safety Release to unlock the ALSUMA Auto-Injector. (see Figure 16)

Figure 16

3. Giving your injection.

Give yourself the injection exactly the way your healthcare provider showed you.

  • Place the orange needle end on your skin where you will give the injection. (see Figures 17 and 18)
  • Push the ALSUMA Auto-Injector hard into your skin until you feel a jolt. (see Figures 17 and 18)

Figure 17 and 18

  • Hold the ALSUMA Auto-Injector in place for 5 seconds to deliver the medicine. (see Figures 17 and 18)

4. After your injection, throw away (dispose of) the ALSUMA Auto-Injector.

  • Place the uncapped, empty storage and disposal case onto a flat surface. (see Figure 19)
  • Slowly insert the orange needle end of the used injector into the open end of the storage and disposal case. Slide the entire used injector into the case. (see Figure 19)
  • Tilt up the open end of the storage and disposal case and screw on the purple cap. (see Figure 20)

Figure 19 and 20

Check with your healthcare provider about the right way to throw away your used ALSUMA Auto-Injector. Each ALSUMA Auto-Injector can be used only one time.

Important Tips on Storing and Using Your Auto-Injector

  • Store the ALSUMA Auto-Injector between 59°F to 86°F (15°C-30°C).
  • Keep the ALSUMA Auto-Injector out of the light.
  • Do not put the ALSUMA Auto-Injector in the refrigerator.
  • Keep each ALSUMA Auto-Injector in its storage and disposal case.
  • Remove the ALSUMA Auto-Injector from the storage and disposal case only when you need to give yourself an injection.

Alsuma and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Alsuma falls into category C. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Precautions While Using Alsuma

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.

Check with your doctor if you have used this medicine and have not had good relief. Also, check with your doctor if your migraine or cluster headaches are worse, or if they are occurring more often, than before you started receiving this medicine.

You should not receive this medicine if you have used an MAO inhibitor (MAOI) such as phenelzine (Nardil®) or tranylcypromine (Parnate®) within the past 2 weeks. Do not use this medicine if you have used other triptan migraine medicines. Some examples of triptan medicines are almotriptan (Axert®), eletriptan (Relpax®), naratriptan (Amerge®), or zolmitriptan (Zomig®). Some examples of ergot-type medicines are dihydroergotamine (D.H.E. 45®, Migranal®), ergotamine (Bellergal®, Cafergot®, Ergomar®, Wigraine®), or methysergide (Sansert®).

Check with your doctor if you have used sumatriptan and your migraine got worse or started occurring more often.

This medicine may increase your risk of having abnormal heart rhythm, heart attack, angina, or stroke. This is more likely to occur if you or a family member already has heart disease, if you have diabetes, high blood pressure, or if you smoke. Call your doctor right away if you have any symptoms of a heart problem, such as chest pain or discomfort, an uneven heartbeat, nausea or vomiting, pain or discomfort in the shoulders, arms, jaw, back, or neck, shortness of breath, or sweating. Call your doctor right away if you have any symptoms of a stroke, such as confusion, difficulty with speaking, double vision, headaches, an inability to move the arms, legs, or facial muscles, an inability to speak, or slow speech.

Check with your doctor right away if you have chest discomfort, jaw or neck tightness after using this medicine. Also, tell your doctor if you have sudden or severe abdominal or stomach pain or bloody diarrhea after using this medicine.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Using sumatriptan alone or in combination with other migraine medicines for 10 or more days per month may lead to worsening of headache. You may keep a headache diary to record the headache frequency and drug use.

Make sure your doctor knows about all the other medicines you are using. Sumatriptan may cause a serious condition called serotonin syndrome when used with some medicines. This especially includes medicines used to treat depression, such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, olanzapine, paroxetine, sertraline, venlafaxine, Celexa®, Cymbalta®, Effexor®, Lexapro®, Luvox®, Paxil®, Prozac®, Sarafem®, Symbyax®, or Zoloft®. Check with your doctor right away if you have agitation, confusion, diarrhea, excitement while talking that is not normal, fever, overactive reflexes, poor coordination, restlessness, shivering, sweating, trembling or shaking that you cannot control, or twitching. These could be symptoms of serotonin syndrome.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, or fainting. Other signs may include changes in color of the skin of the face, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once.

Drinking alcoholic beverages can make headaches worse or cause new headaches to occur. People who suffer from severe headaches should probably avoid alcoholic beverages, especially during a headache.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. If any of these side effects occur, do not drive, use machines, or do anything else that could be dangerous until you know how this medicine affects you.

Indications and Usage for Alsuma

Alsuma™ (sumatriptan injection) is indicated in adults for the acute treatment of migraine, with or without aura, and 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 Alsuma, reconsider the diagnosis of migraine before Alsuma is administrated to treat any subsequent attacks.
  • Alsuma is not indicated for the prevention of migraine attacks.

Drug Interactions

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 Alsuma within 24 hours of each other is contraindicated.

Monoamine Oxidase-A Inhibitors

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

Other 5-HT1 Agonists

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

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)].

Use in specific populations

Pregnancy

Pregnancy Category C. There are no adequate and well-controlled trials of sumatriptan injection in pregnant women. In developmental toxicity studies in rats and rabbits, oral administration of sumatriptan to pregnant animals was associated with embryolethality, fetal abnormalities, and pup mortality. When administered by the intravenous route to pregnant rabbits, sumatriptan was embryolethal. Alsuma should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Oral administration of sumatriptan to pregnant rats during the period of organogenesis resulted in an increased incidence of fetal blood vessel (cervicothoracic and umbilical) abnormalities. The highest no-effect dose for embryofetal developmental toxicity in rats was 60 mg/kg/day. Oral administration of sumatriptan to pregnant rabbits during the period of organogenesis resulted in increased incidences of embryolethality and fetal cervicothoracic vascular and skeletal abnormalities. Intravenous administration of sumatriptan to pregnant rabbits during the period of organogenesis resulted in an increased incidence of embryolethality. The highest oral and intravenous no-effect doses for developmental toxicity in rabbits were 15 and 0.75 mg/kg/day, respectively.

Oral administration of sumatriptan to rats prior to and throughout gestation resulted in embryofetal toxicity (decreased body weight, decreased ossification, increased incidence of skeletal abnormalities). The highest no-effect dose was 50 mg/kg/day. In offspring of pregnant rats treated orally with sumatriptan during organogenesis, there was a decrease in pup survival. The highest no-effect dose for this effect was 60 mg/kg/day. Oral treatment of pregnant rats with sumatriptan during the latter part of gestation and throughout lactation resulted in a decrease in pup survival. The highest no-effect dose for this effect was 100 mg/kg/day.

Nursing Mothers

Sumatriptan is excreted in human milk following subcutaneous administration. Infant exposure to sumatriptan can be minimized by avoiding breastfeeding for 12 hours after treatment with Alsuma.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Alsuma is not recommended for use in patients younger than 18 years of age.

Two controlled clinical trials evaluated sumatriptan nasal spray (5 to 20 mg) in 1,248 adolescent migraineurs aged 12 to 17 years who treated a single attack. The trials did not establish the efficacy of sumatriptan nasal spray compared with placebo in the treatment of migraine in adolescents. Adverse reactions observed in these clinical trials were similar in nature to those reported in clinical trials in adults.

Five controlled clinical trials (2 single-attack trials, 3 multiple-attack trials) evaluating oral sumatriptan (25 to 100 mg) in pediatric subjects aged 12 to 17 years enrolled a total of 701 adolescent migraineurs. These trials did not establish the efficacy of oral sumatriptan compared with placebo in the treatment of migraine in adolescents. Adverse reactions observed in these clinical trials were similar in nature to those reported in clinical trials in adults. The frequency of all adverse reactions in these subjects appeared to be both dose- and age-dependent, with younger subjects reporting reactions more commonly than older adolescents.

Postmarketing experience documents that serious adverse reactions have occurred in the pediatric population after use of subcutaneous, oral, and/or intranasal sumatriptan. These reports include reactions similar in nature to those reported rarely in adults, including stroke, visual loss, and death. A myocardial infarction has been reported in a 14-year-old male following the use of oral sumatriptan; clinical signs occurred within 1 day of drug administration. Clinical data to determine the frequency of serious adverse reactions in pediatric patients who might receive subcutaneous, oral, or intranasal sumatriptan are not presently available.

Geriatric Use

Clinical trials of sumatriptan injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.

A cardiovascular evaluation is recommended for geriatric patients who have other cardiovascular risk factors (e.g., diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving Alsuma [see Warnings and Precautions (5.1)].

Alsuma Description

Alsuma 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 C14H21N3O2S • 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.

Alsuma is a clear, colorless to pale yellow, sterile, nonpyrogenic solution for subcutaneous injection. Each 0.5 mL of Alsuma 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 the solution is approximately 4.2 to 5.3.

What is sumatriptan injection (alsuma, imitrex, imitrex statdose, imitrex statdose refill, sumavel dosepro)?

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. 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, a headache that causes loss of movement on one side of your body, or any headache that seems to be different from your usual migraine headaches. Use this medication 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.

What should i discuss with my health care provider before using sumatriptan injection (alsuma, imitrex, imitrex statdose, imitrex statdose refill, sumavel dosepro)?

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.

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