Sumavel DosePro Subcutaneous

Generic Name: sumatriptan (Subcutaneous route)

soo-ma-TRIP-tan

Commonly used brand name(s)

In the U.S.

• Alsuma


• Imitrex


• Imitrex Stat Dose Refill


• Sumavel DosePro

Available Dosage Forms:

• Kit


• Solution

Therapeutic Class: Antimigraine

Pharmacologic Class: Serotonin Receptor Agonist, 5-HT1

Uses For Sumavel DosePro

Sumatriptan injection is used to treat acute migraine attacks and cluster headaches in adults. It does not prevent migraine attacks nor treat certain types of migraine headaches (e.g., hemiplegic or basilar type).

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 good that it can do.

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

Before Using Sumavel DosePro

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:

Allergies

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.

Pediatric

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.

Geriatric

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.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

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


• Dihydroergotamine


• Eletriptan


• Ergoloid Mesylates


• Ergonovine


• Ergotamine


• Frovatriptan


• Methylergonovine


• Methysergide


• Naratriptan


• Rizatriptan


• 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.

• Citalopram


• Desvenlafaxine


• Dexfenfluramine


• Duloxetine


• Escitalopram


• Fluoxetine


• Fluvoxamine


• Milnacipran


• Paroxetine


• Reboxetine


• Sertraline


• Sibutramine


• St John's Wort


• Tapentadol


• Venlafaxine


• Vilazodone

Interactions with Food/Tobacco/Alcohol

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 Problems

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:

• Bleeding problems or


• Blurred vision or


• CNS disorders or


• Kidney disease or


• Liver disease or


• Seizures or epilepsy, history of or


• Stomach or intestinal bleeding—Use with caution. May make these conditions worse.

• Cerebrovascular disease (e.g., stroke, transient ischemic attack), or history of or


• Heart attack, history of or


• Heart disease (e.g., angina) or


• Hemiplegic or basilar types of migraine or


• Hypertension (high blood pressure), uncontrolled or


• Ischemic bowel disease or


• Liver disease, severe—Should not be used in patients with these conditions.

• Coronary artery disease, history of or


• Diabetes or


• Hypercholesterolemia (high cholesterol in the blood) or


• Hypertension (high blood pressure), controlled or


• Obesity or


• Raynaud's syndrome—Use with caution. The chance of side effects may be increased. Heart or blood vessel disease sometimes do not cause any symptoms, so some people do not know that they have these problems. Before deciding whether you should use this medicine, your doctor may need to do some tests to make sure that you do not have any of these conditions.

Proper Use of sumatriptan

This section provides information on the proper use of a number of products that contain sumatriptan. It may not be specific to Sumavel DosePro. Please read with care.

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. Using sumatriptan during the aura probably will not prevent the headache from occurring. However, even if you do not use sumatriptan until your migraine has been present for several hours, the medicine will still work.

Lying down in a quiet, dark room for a while after you use this medicine may help relieve your migraine.

If you feel much better after a dose of sumatriptan, but your headache comes back or gets worse after a while, wait at least 2 hours 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 two doses in 24 hours.

This medicine is given as a shot under your skin (usually on the abdomen or stomach, 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.

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.

Dosing

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—One 6-milligrams (mg) injected under the skin. One more 6-mg dose may be injected, if necessary, if the migraine comes back after being relieved. However, the second injection should not be given any sooner than 1 hour after the first one. Do not use more than two 6-mg injections in a 24-hour period (one day). However, some people may be directed to use no more than two 6-mg doses in a 48-hour period (two days).
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Storage

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.

Precautions While Using Sumavel DosePro

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.

Make sure your doctor knows if you are pregnant. Your doctor may want you to join a pregnancy registry for patients using this medicine.

This medicine may increase your risk of having a heart attack or stroke. This is more likely to occur if you already have a heart disease, if you smoke, if you are over 40, or if you have gone through menopause. People who use this medicine for a long time might also have a higher risk.

You should not receive this medicine if you have used an MAO inhibitor (MAOI) such as isocarboxacid (Marplan®), phenelzine (Nardil®), selegiline (Eldepryl®), or tranylcypromine (Parnate®) within the past two weeks. Do not use this medicine if you have taken other migraine medicines (e.g., almotriptan, frovatriptan, naratriptan, rizatriptan, zolmitriptan, Axert™, Frova®, Amerge®, Maxalt®, or Zomig®) or an ergotamine medicine (e.g., methysergide, D.H.E. 45®, or Migranal®) within the past 24 hours.

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 first before taking any other medicines.

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, wheezing, 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.

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).

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

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 if you are dizzy or are not alert while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Sumavel DosePro Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Blurred vision


• chest pain or discomfort


• chills


• confusion


• difficult or labored breathing


• dizziness


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• fainting


• fast, pounding, or irregular heartbeat or pulse


• headache


• nervousness


• pounding in the ears


• shakiness in the legs, arms, hands, or feet


• shortness of breath


• slow or fast heartbeat


• sweating


• tight feeling in the head


• tightness or pressure in the chest


• trembling or shaking of the hands or feet


• unusual tiredness or weakness


• wheezing

Rare

• Black, tarry stools


• blood in the urine


• blood in the vomit


• burning while urinating


• cough


• decreased urination


• depression of the skin


• diarrhea


• dry mouth


• feeling of warmth or heat


• fever


• flushing or redness of the skin, especially on the face and neck


• general feeling of discomfort or illness


• inability to move the eyes


• inability to move the legs or arms


• increase in heart rate


• increased blinking or spasms of the eyelid


• increased sensitivity to pain


• increased sensitivity to touch


• indentation of the skin


• joint pain


• loss of appetite


• muscle aches and pains


• nausea and vomiting


• pain in the groin or genitals


• paleness of the skin


• paleness or cold feeling in the fingertips and toes


• paralysis of one side of the body


• rapid breathing


• runny nose


• severe or continuing stomach pain


• sharp back pain just below the ribs


• shivering


• sore throat


• sticking out of the tongue


• sunken eyes


• thirst


• tingling in the hands and feet


• tingling or pain in the fingers or toes when exposed to cold


• trouble with breathing, speaking, or swallowing


• trouble with sleeping


• uncontrolled twisting movements of the neck, trunk, arms, or legs


• unusual facial expressions


• wrinkled skin

Incidence not known

• Abdominal or stomach pain and tenderness


• agitation


• back, leg, or stomach pains


• bleeding gums


• blood in the stools


• bluish color of the fingernails, lips, skin, palms, or nail beds


• changes in skin color


• changes in vision


• coma


• depression


• difficulty with swallowing


• double vision


• general body swelling


• headache, sudden, severe, and continuing


• high fever


• hives


• hostility


• inability to speak


• irritability


• itching


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• lethargy


• loss of ability to use or understand speech or language


• loss of appetite


• loss of vision


• migraine headache


• muscle twitching


• noisy breathing


• nosebleeds


• overactive reflexes


• pain, tenderness, or swelling of the foot or leg


• pinpoint red spots on the skin


• poor coordination


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• rapid weight gain


• rectal bleeding


• redness, soreness, or itching skin


• restlessness


• seizures


• severe or sudden headache


• slurred speech


• sores, ulcers, or white spots on the lips or in the mouth


• sores, welting, or blisters


• stupor


• swelling of the face, ankles, hands, feet, or lower legs


• swollen glands


• talking or acting with excitement you cannot control


• temporary blindness


• trembling or shaking


• twitching


• unexplained bleeding or bruising


• unusual bleeding or bruising


• unusually warm skin


• weakness in the arm or leg on one side of the body, sudden and severe


• weight loss


• yellowing of the eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site


• burning or tingling sensation


• drowsiness


• feeling of constant movement of self or surroundings


• feeling of warmth


• redness of the face, neck, arms, and occasionally, upper chest


• relaxed and calm


• sensation of spinning


• sleepiness

Less common

• Abdominal or stomach discomfort


• anxiety


• bad, unusual, or unpleasant (after) taste


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• change in color vision


• change in taste


• difficulty seeing at night


• difficulty with moving


• discomfort in the jaw, nasal cavity, or throat


• false or unusual sense of well-being


• feeling strange


• heartburn


• increased sensitivity of the eyes to sunlight


• joint pain, stiffness, or swelling


• mental confusion


• muscle aching or cramping


• neck pain or stiffness


• red, sore eyes


• swollen joints


• tearing of the eyes


• thirst


• weakness

Rare

• Backache


• belching


• bloated or full feeling


• changes in patterns and rhythms of speech


• cramps


• dry heaves


• excess air or gas in the stomach or intestines


• extreme thirst


• heavy bleeding


• hiccups


• hunger


• increased thirst


• muscle tiredness


• muscle twitching or jerking


• pain


• passing gas


• reduced appetite


• rhythmic movement of muscles


• severe stomach pain with nausea and vomiting


• tenderness of the skin


• trouble with speaking

Incidence not known

• Deafness


• panic


• severe sunburn

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Sumavel DosePro Subcutaneous side effects (in more detail)

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More Sumavel DosePro Subcutaneous resources

• Sumavel DosePro Subcutaneous Side Effects (in more detail)
• Sumavel DosePro Subcutaneous Use in Pregnancy & Breastfeeding
• Sumavel DosePro Subcutaneous Drug Interactions
• 14 Reviews for Sumavel DosePro Subcutaneous - Add your own review/rating

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