What is Sumavel Dosepro?

QUICK LINKS

• Overview
• Proper Use
• Dosing
• Use & Storage
• Before Using
• Allergies
• Pediatric
• Geriatric
• Breast Feeding
• Drug Interactions
• Other Interactions
• Other Medical Problems
• Precautions

OverviewTOP

Sumatriptan injection is used to treat acute migraine attacks and cluster headaches in adults. Sumatriptan works in the brain to relieve the pain from migraine headaches. It belongs to the group of medicines called triptans.

Many people find that their headaches go away completely after they use sumatriptan. Other people find that their headaches are much less painful, and that they are able to go back to their normal activities even though their headaches are not completely gone. Sumatriptan often relieves other symptoms that occur together with a migraine headache, such as nausea, vomiting, sensitivity to light, and sensitivity to sound.

Sumatriptan is not an ordinary pain reliever. It will not relieve any kind of pain other than migraine headaches. This medicine is usually used for people whose headaches are not relieved by acetaminophen, aspirin, or other pain relievers.

Sumatriptan has caused serious side effects in some people, especially people who have heart or blood vessel disease. Be sure that you discuss with your doctor the risks of using this medicine as well as the benefits that it can do.

This medicine is available only with your doctor's prescription.

Proper UseTOP

Do not use this medicine for a migraine or cluster headache that is different from your usual headaches. Instead, check with your doctor.

To relieve your migraine as soon as possible, use this medicine as soon as the headache pain begins. Even if you get warning signals of a coming migraine (an aura), you should wait until the headache pain starts before using sumatriptan.

Ask your doctor ahead of time about any other medicine you might use if sumatriptan does not work. After you use the other medicine, check with your doctor as soon as possible. Headaches that are not relieved by sumatriptan are sometimes caused by conditions that need other treatment.

If you feel much better after a dose of sumatriptan, but your headache comes back or gets worse after a while, wait at least 1 hour before using another dose. However, use this medicine only as directed by your doctor. Do not use more of it, and do not use it more often, than directed. Using too much sumatriptan may increase the chance of side effects. Do not use more than 2 doses in 24 hours.

This medicine is given as a shot under your skin (usually on the abdomen or stomach or thighs or upper arms). Sumatriptan injection may sometimes be given at home to patients who do not need to be in a hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use the medicine.

If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems.

This medicine is available in 3 forms. You may use a single dose vial, prefilled syringe, or a prefilled autoinjector.

Do not use the medicine if it is dark colored or cloudy.

After you have finished injecting the medicine, be sure to follow the precautions in the patient directions about safely discarding the empty cartridge and the needle. Always return the empty cartridge and needle to their container before discarding them. Do not throw away the autoinjector unit, because refills are available.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

DosingTOP

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  • For migraine or cluster headaches:
    • Adults—
      • Alsuma™, Imitrex®, and Sumavel®: 4 or 6-milligram (mg) injected under the skin. If the headache comes back after being relieved, one more dose may be injected after 1 hour. Do not use more than 2 doses of 6-mg, or 3 doses of 4-mg in any 24-hour period.
      • Zembrace™ Symtouch™: 3 milligram (mg) injected under the skin. If the headache comes back after being relieved, one more dose may be injected after 1 hour. Do not use more than 4 doses of 3-mg in any 24-hour period.
    • Children—Use and dose must be determined by your doctor.

Use & StorageTOP

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away used syringes or autoinjectors in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Before UsingTOP

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

AllergiesTOP

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

PediatricTOP

Appropriate studies have not been performed on the relationship of age to the effects of sumatriptan injection in the pediatric population. Safety and efficacy have not been established.

GeriatricTOP

Use of sumatriptan injection is not recommended in elderly patients with kidney problems, heart or blood vessel disease, or high blood pressure, and should not be used by elderly patients with liver problems.

Breast FeedingTOP

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug InteractionsTOP

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Almotriptan
• Bromocriptine
• Dihydroergotamine
• Eletriptan
• Ergoloid Mesylates
• Ergonovine
• Ergotamine
• Frovatriptan
• Furazolidone
• Iproniazid
• Isocarboxazid
• Linezolid
• Methylene Blue
• Methylergonovine
• Methysergide
• Moclobemide
• Naratriptan
• Phenelzine
• Procarbazine
• Rasagiline
• Rizatriptan
• Selegiline
• Tranylcypromine
• Zolmitriptan

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfentanil
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amphetamine
• Benzhydrocodone
• Benzphetamine
• Buprenorphine
• Butorphanol
• Citalopram
• Clomipramine
• Codeine
• Dasabuvir
• Desipramine
• Desvenlafaxine
• Dexfenfluramine
• Dextroamphetamine
• Dibenzepin
• Dihydrocodeine
• Dolasetron
• Doxepin
• Duloxetine
• Escitalopram
• Fentanyl
• Fluoxetine
• Fluvoxamine
• Granisetron
• Hydrocodone
• Hydromorphone
• Imipramine
• Levomilnacipran
• Levorphanol
• Lisdexamfetamine
• Lofepramine
• Lorcaserin
• Melitracen
• Meperidine
• Metaxalone
• Methamphetamine
• Milnacipran
• Mirtazapine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nefazodone
• Nortriptyline
• Opipramol
• Oxycodone
• Oxymorphone
• Palonosetron
• Paroxetine
• Pentazocine
• Protriptyline
• Reboxetine
• Remifentanil
• Sertraline
• Sibutramine
• St John's Wort
• Sufentanil
• Tapentadol
• Tianeptine
• Tramadol
• Trazodone
• Trimipramine
• Venlafaxine
• Vilazodone
• Vortioxetine
• Ziprasidone

Other InteractionsTOP

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical ProblemsTOP

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Angina (chest pain) or
• Arrhythmia (heart rhythm problem) or
• Basilar migraine (migraine with vision and hearing problems), history of or
• Heart attack, history of or
• Heart or blood vessel disease or
• Hemiplegic migraine (migraine with some paralysis), history of or
• Hypertension (high blood pressure), uncontrolled or
• Ischemic bowel disease (bowels have low blood supply) or
• Liver disease, severe or
• Peripheral vascular disease (clogged arteries) or
• Stroke, history of or
• Transient ischemic attack (TIA), history of or
• Wolff-Parkinson-White Syndrome (heart rhythm problem)—Should not be used in patients with these conditions.

• Bleeding problems or
• Heart rhythm problems (eg, ventricular fibrillation, ventricular tachycardia) or
• Seizures or epilepsy, history of or
• Stomach or intestinal bleeding—Use with caution. May make these conditions worse.

• Coronary artery disease, history of or
• Diabetes or
• Hypercholesterolemia (high cholesterol in the blood) or
• Hypertension (high blood pressure) or
• Obesity or
• Raynaud's syndrome—Use with caution. May be at increased risk for more serious side effects.

PrecautionsTOP

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.