Sumavel DosePro

Name: Sumavel DosePro

What should i avoid while using sumatriptan injection (alsuma, imitrex, imitrex statdose, imitrex statdose refill, sumavel dosepro)?

Do not use sumatriptan within 24 hours before or after using another migraine headache medicine, including:

  • sumatriptan tablets or nasal spray, almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt, Maxalt-MLT), or zolmitriptan (Zomig); or
  • ergot medicine such as dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine).

Sumatriptan may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Where can i get more information?

Your pharmacist can provide more information about sumatriptan.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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Side effects

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]
  • Arrhythmias [see WARNINGS AND PRECAUTIONS]
  • Chest, throat, neck, and/or jaw pain/tightness/pressure [see WARNINGS AND PRECAUTIONS]
  • Cerebrovascular events [see WARNINGS AND PRECAUTIONS]
  • Other vasospasm reactions [see WARNINGS AND PRECAUTIONS]
  • Medication overuse headache [see WARNINGS AND PRECAUTIONS]
  • Serotonin syndrome [see WARNINGS AND PRECAUTIONS]
  • Increase in blood pressure [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity reactions [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]
  • Seizures [see WARNINGS AND PRECAUTIONS]

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] 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.

Table 1. Adverse Reactions Reported by at Least 2% of Subjects and at a Greater Frequency Than Placebo in 2 Placebo-Controlled Migraine Clinical Trialsa

Adverse Reaction Percent of Subjects Reporting
Sumatriptan Injection
6 mg Subcutaneous
(n = 547)
Placebo
(n = 370)
Atypical sensations 42 9
  Tingling 14 3
  Warm/hot sensation 11 4
  Burning sensation 7 <1
  Feeling of heaviness 7 1
  Pressure sensation 7 2
  Feeling of tightness 5 <1
  Numbness 5 2
  Feeling strange 2 <1
  Tight feeling in head 2 <1
Cardiovascular    
  Flushing 7 2
  Chest discomfort 5 1
Tightness in chest 3 <1
Discomfort: nasal cavity/sinuses 2 <1
  Injection site reactionb 59 24
  Miscellaneous    
    Jaw discomfort 2 0
  Musculoskeletal    
  Weakness 5 <1
  Neck pain/stiffness 5 <1
  Myalgia 2 <1
  Neurological    
    Dizziness/vertigo 12 4
    Drowsiness/sedation 3 2
    Headache 2 <1
  Skin    
    Sweating 2 1
aThe sum of percentages cited is greater than 100% because subjects may have experienced more than 1 type of adverse reaction. Only reactions that occurred at a frequency of 2% or more in groups treated with sumatriptan injection and occurred at a frequency greater than that of the placebo group are included.
bIncludes injection site pain, stinging/burning, swelling, erythema, bruising, bleeding.

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], 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).

Read the entire FDA prescribing information for Sumavel DosePro (Sumatriptan Injection)

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Sumavel DosePro Overview

Sumatriptan is a prescription medication used to treat migraine headaches once they have started. Sumatriptan belongs to a group of drugs called serotonin receptor agonists or "triptans", which relieve pain by narrowing blood vessels around the brain.

This medication comes in tablet and nasal spray and is taken at the first sign of a migraine headache.

Sumatriptan is also available as an injectable form to be injected under the skin.

Sumatriptan injection is also used to treat cluster headaches in adults.

Common side effects of sumatriptan include tingling or numbness in fingers or toes, weakness, tiredness. Sumatriptan can cause drowsiness. Do not drive a car or operate machinery if you have these symptoms.

Sumavel DosePro Interactions

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

Sumatriptan and other medicines may affect each other, causing side effects.

Especially tell your healthcare provider if you take:

  • selective serotonin reuptake inhibitors (SSRIs) such as escitalopram (Lexapro), sertraline (Zoloft), citalopram (Celexa), paroxetine (Paxil), fluoxetine (Prozac, Sarafem), and fluvoxamine (Luvox)
  • serotonin-norepinephrine reuptake inhibitors (SNRIs) such as duloxetine (Cymbalta) venlafaxine (Effexor)
  • monoamine oxidase inhibitors (MAOIs) such as tranylcypromine (Parnate), phenelzine (Nardil), selegiline (Eldepryl, Zelapar), isocarboxazid (Marplan), and rasagiline (Azilect)
  • other ergot-containing medications such as dihydroergotamine (D.H.E. 45, MIGRANAL) or methysergide
  • other triptans such as sumatriptan (Imitrex, Treximet), eletriptan (Relpax), almotriptan (Axert), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), and zolmitriptan (Zomig)

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.

Sumavel DosePro Precautions

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
  • chest pain or chest discomfort that feels like heavy pressure, squeezing, or fullness
  • 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
  • are a female who has gone through menopause
  • are a male over age 40

Serotonin syndrome. Serotonin syndrome is a serious and life-threatening problem that can happen in people taking sumatriptan, especially if sumatriptan is used with anti-depressant medicines called selective serotonin reuptake inhibitors (SSRIs) or selective norepinephrine reuptake inhibitors (SNRIs). Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

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
  • nausea, vomiting, or diarrhea

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.

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.

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 kidney (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)
  • an allergy to sumatriptan or any of the ingredients in 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.

Sumavel DosePro 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.

Sumatriptan falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. 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.

Indications and Usage for 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.

Contraindications

Sumavel Dosepro is contraindicated in patients with:

  • Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal’s angina [see Warnings and Precautions (5.1)]
  • Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see Warnings and Precautions (5.2)] 
  • History of stroke or transient ischemic attack (TIA) because these patients are at a higher risk of stroke [see Warnings and Precautions (5.4)]
  • History of hemiplegic or basilar migraine
  • Peripheral vascular disease [see Warnings and Precautions (5.5)] 
  • Ischemic bowel disease [see Warnings and Precautions (5.5)]
  • Uncontrolled hypertension [see Warnings and Precautions (5.8)]
  • Recent (i.e., within 24 hours) use of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine1 (5-HT1) agonist [see Drug Interactions (7.1, 7.3)]
  • Concurrent administration of a monamine oxidase (MAO)-A inhibitor or recent (within 2 weeks) use of an MAO-A inhibitor [see Drug Interactions (7.2) and Clinical Pharmacology (12.3)]
  • Hypersensitivity to Sumavel Dosepro (angioedema and anaphylaxis seen) [see Warnings and Precautions (5.9) and Adverse Reactions (6)]

Nonclinical Toxicology

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis: In carcinogenicity studies, rats and mice were given sumatriptan by oral gavage. Mice were dosed for 78 weeks and rats were dosed for 104 weeks. Average exposures achieved in mice receiving the highest dose were approximately 110 times the exposure attained in humans after the maximum recommended single dose of 6 mg. The highest dose to rats was approximately 260 times the maximum single dose of 6 mg on a mg/m2 basis. There was no evidence of an increase in tumors in either species related to sumatriptan administration.

Mutagenesis: Sumatriptan was not mutagenic in the presence or absence of metabolic activation when tested in 2 gene mutation assays (the Ames test and the in vitro mammalian Chinese hamster V79/HGPRT assay). It was not clastogenic in 2 cytogenetics assays (the in vitro human lymphocyte assay and the in vivo rat micronucleus assay).

Impairment of Fertility: A fertility study (Segment I) by the subcutaneous route, during which male and female rats were dosed daily with sumatriptan prior to and throughout the mating period, has shown no evidence of impaired fertility at doses equivalent to approximately 100 times the maximum recommended single human dose of 6 mg on a mg/m2 basis. However, following oral administration, a treatment-related decrease in fertility, secondary to a decrease in mating, was seen for rats treated with 50 and 500 mg/kg/day. The no-effect dose for this finding was approximately 8 times the maximum recommended single human dose of 6 mg on a mg/m2 basis. It is not clear whether the problem is associated with the treatment of males or females or both.

13.2 Animal Toxicology and/or Pharmacology

Corneal Opacities: Dogs receiving oral sumatriptan developed corneal opacities and defects in the corneal epithelium. Corneal opacities were seen at the lowest dosage tested, 2 mg/kg/day, and were present after 1 month of treatment. Defects in the corneal epithelium were noted in a 60-week study. Earlier examinations for these toxicities were not conducted and no-effect doses were not established; however, the relative exposure at the lowest dose tested was approximately 5 times the human exposure after a 100 mg oral dose or 3 times the human exposure after a 6 mg subcutaneous dose.

Melanin Binding: In rats with a single subcutaneous dose (0.5 mg/kg) of radiolabeled sumatriptan, the elimination half-life of radioactivity from the eye was 15 days, suggesting that sumatriptan and its metabolites bind to the melanin of the eye. The clinical significance of this binding is unknown.

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