Sumatriptan: Package Insert and Label Information (Page 3 of 4)

14.2 Cluster Headache

The efficacy of sumatriptan injection in the acute treatment of cluster headache was demonstrated in 2 randomized, double-blind, placebo-controlled, 2-period crossover trials (Studies 4 and 5). Patients 21 to 65 years of age 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 patients receiving 6 mg of sumatriptan injection compared with those who received placebo (see Table 4).

Table 4. Proportion of Patients with Cluster Headache Relief by Time in Studies 4 and 5

a P <0.05.

(n = Number of headaches treated.)

Study 4 Study 5
Placebo (n = 39) Sumatriptan Injection 6 mg (n = 39) Placebo (n = 88) Sumatriptan Injection 6 mg (n = 92)
Patients with pain relief (no/mild) 5 Minutes post-injection 10 Minutes post-injection 15 Minutes post-injection 8% 10% 26% 21% 49% a 74% a 7% 25% 35% 23% a 49% a 75% a

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

Figure 1. Time to Relief of Cluster Headache from Time of Injection a

Figure 1
(click image for full-size original)

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

The plot was constructed with data from patients 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).

16 HOW SUPPLIED/STORAGE AND HANDLING

Sumatriptan injection contains sumatriptan (base) as the succinate salt and is supplied as a clear, colorless to pale yellow, sterile, nonpyrogenic solution as follows:

Prefilled Syringe Autoinjector: Each carton contains a Patient Information leaflet and Patient Instructions for Use leaflet.

  • Sumatriptan Injection, USP, containing 6 mg sumatriptan (base) in each of 2 prefilled single-dose syringe autoinjectors
    • (NDC 60429-994-02).

Store between 2° and 30°C (36° and 86°F). Protect from light.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling ( Patient Information and Instructions for Use).

Risk of Myocardial Ischemia and/or Infarction, Prinzmetal’s Angina, Other Vasospasm-Related Events, Arrhythmias, and Cerebrovascular Events

Inform patients that sumatriptan injection 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 if any indicative sign or symptoms are observed. Apprise patients 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 sumatriptan injection. 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 Contraindications ( 4), Warnings and Precautions ( 5.9)].

Concomitant Use with Other Triptans or Ergot Medications

Inform patients that use of sumatriptan injection within 24 hours of another triptan or an ergot-type medication (including dihydroergotamine or methysergide) is contraindicated [see Contraindications ( 4), Drug Interactions ( 7.1, 7.3)] .

Serotonin Syndrome

Caution patients about the risk of serotonin syndrome with the use of sumatriptan or other triptans, particularly during combined use with SSRIs, SNRIs, TCAs, and TCAs and MAO inhibitors [see Warnings and Precautions ( 5.7), 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 sumatriptan injection 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

Treatment with sumatriptan injection may cause somnolence and dizziness; instruct patients to evaluate their ability to perform complex tasks after administration of sumatriptan injection.

How to Use Sumatriptan Injection

Provide patients instruction on the proper use of sumatriptan injection if they are able to self-administer sumatriptan injection in medically unsupervised situations.

Inform patients that the needle in the autoinjector penetrates approximately 1/4 of an inch (5 to 6 mm). Inform patients that the injection is intended to be given subcutaneously and intramuscular or intravascular delivery should be avoided. Instruct patients to use injection sites with an adequate skin and subcutaneous thickness to accommodate the length of the needle.

Manufactured In Israel For:
Antares Pharma, Inc.
Ewing, NJ 08628

Distributed by: TEVA PHARMACEUTICALS USA, INC.
North Wales, PA 19454

©2018, Antares Pharma, Inc. All rights reserved.

Marketed/Packaged by:

GSMS, Inc.

Camarillo, CA USA 93012

Patient Information

Sumatriptan
Injection, USP
(SOO-ma-TRIP-tan)

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 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 injection?

Do not take sumatriptan injection 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 injection?

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.

Using sumatriptan 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 Sumatriptan Injection?

  • Certain people should take their first dose of sumatriptan injection 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 injection 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 injection 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 injection so you can talk with your healthcare provider about how sumatriptan injection is working for you.

What should I avoid while taking sumatriptan injection?

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 injection?

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

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 injection especially if sumatriptan injection 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 injection who have never had seizures before. Talk with your healthcare provider about your chance of having seizures while you take sumatriptan injection.

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 injection. 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 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 injection and all medicines out of the reach of children.

General information about the safe and effective use of sumatriptan injection

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

For more information, go to www.antarespharma.com or call 1-855-287-7476.

What are the ingredients in sumatriptan injection?

Active ingredient: sumatriptan succinate

Inactive ingredients: sodium chloride, water for injection

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

*The following are registered trademarks of their respective manufacturers: AXERT®/ Janssen Pharmaceuticals, Inc; RELPAX®/ Roerig, a Division of Pfizer Inc.; FROVA® / Endo Pharmaceuticals Inc.; MAXALT®, MAXALT-MLT®/ Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.; CAFERGOT®/ Sandoz, Inc.; ERGOMAR®/ Rosedale Therapeutics; MIGERGOT®/ Crealta Pharmaceuticals LLC; D.H.E. 45® and MIGRANAL®/ Valeant Pharmaceuticals North America LLC; and AMERGE®, IMITREX®, and TREXIMET®/ GlaxoSmithKline. The brands listed are trademarks of their respective owners and are not trademarks of the Antares Pharma, Inc. The makers of these brands are not affiliated with and do not endorse Antares Pharma, Inc. or its products.

Manufactured In Israel For:
Antares Pharma, Inc.
Ewing, NJ 08628

Distributed by: TEVA PHARMACEUTICALS USA, INC.
North Wales, PA 19454 ©2018, Antares Pharma, Inc. All rights reserved.

Marketed/Packaged by:

GSMS, Inc.

Camarillo, CA USA 93012

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