Sumatriptan Injection, USP (Sterimax): Uses, Side Effects and Dosage

What Sumatriptan Injection, USP is used for:

Sumatriptan Injection, USP is used in adults to relieve migraine headaches. These migraine headaches may or may not be accompanied by an aura. This is when you may see black spots, flashes of light or shimmering spots or stars. Sumatriptan Injection, USP should not be used to prevent or reduce the number of headaches you experience. Use Sumatriptan Injection, USP only to treat an actual migraine headache attack.

How Sumatriptan Injection, USP works:

Migraine headache is believed to be caused by a widening of the blood vessels in the head. Sumatriptan Injection, USP narrows these vessels and relieves the symptoms of migraine headache.

The ingredients in Sumatriptan Injection, USP are:

Medicinal ingredient: sumatriptan succinate

Non-medicinal ingredients: sodium chloride and water for injection

Sumatriptan Injection, USP comes in the following dosage forms:

Sumatriptan Injection, USP (6 mg / 0.5mL) is available in a disposable single-dose autoinjector containing a pre-filled syringe. Supplied as 1-pack and 2-pack. The stopper is not made with natural rubber latex.

Do not use Sumatriptan Injection, USP if:

• you are allergic to sumatriptan, or to any of the ingredients in Sumatriptan Injection, USP (See “The ingredients in Sumatriptan Injection, USP are:”).
• if you have a heart problem such as heart failure or chest pains (angina), or have already had a heart attack.
• you have had a stroke or a mini-stroke (also called a transient ischemic attacks or TIA)
• you have a history, symptoms or signs of peripheral vascular disease. This is a reduced blood flow to the limbs and organs other than the heart and brain, such as ischemic bowel disease and Raynaud’s syndrome.
• you have uncontrolled or severe high blood pressure.
• you are taking or have taken within the past 2 weeks, a monoamine oxidase inhibitor (MAO), medication (such as phenelzine sulfate, tranylcypromine sulfate, moclobemide or selegiline).
• you are taking or have taken within the past 24 hours, medication containing ergotamine, dihydroergotamine, methysergide, or another triptan used to treat migraine headaches. If you are not sure if you have been prescribed these types of medications, ask your healthcare professional.
• you have severe liver problems.

• you have certain other types of migraine headaches including:

  • hemiplegic migraines. These are migraine headaches where you have weakness on one side of your body, or
  • basilar migraines. These are migraine headaches that start in the lower part of the brain, or
  • ophthalmoplegic migraines. These are migraine headaches where you have pain around the eyes.

If you are not sure if you have these types of migraines, ask your healthcare professional.

Sumatriptan Injection, USP should not be used for the treatment of other types of headaches that are different from migraine attacks.

Sumatriptan Injection, USP should not be given intravenously, but only into the tissues just below the skin (on the outside of the thigh or in the upper arm).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Sumatriptan Injection, USP. Talk about any health conditions or problems you may have, including if you:

• are pregnant, think you might be pregnant, or are trying to become pregnant

• are breastfeeding. The active ingredient in Sumatriptan Injection, USP, sumatriptan, will pass into your breast milk. Avoid breastfeeding for 24 hours after taking Sumatriptan Injection, USP. If you express any breast milk during this time, discard the milk and don’t give it to your baby.
• have risk factors for heart disease. This includes high blood pressure, high cholesterol, obesity, diabetes, smoking, strong family history of heart disease, or you are postmenopausal or a male over 40.
• have ever had to stop taking this or any other medication because of an allergy or other problems, or you are allergic to drugs containing sulphonamides.
• are under 18 years of age.
• are over 65 years of age.
• had or have any liver or kidney problems.
• had or have epilepsy or seizures.
• experience a headache that is different from your usual migraine attacks.

Other warnings you should know about:

Taking Sumatriptan Injection, USP can cause serious side effects, including:

• Serious heart problems
• Long term eye problems
• Raynaud’s Syndrome

See the Serious side effects and what to do about them table, below for more information on these and other serious side effects.

Serotonin toxicity (also known as Serotonin syndrome): Sumatriptan Injection, USP can cause serotonin toxicity, a rare but potentially life-threatening condition. It can cause serious changes in how your brain, muscles and digestive system work. You may develop serotonin toxicity if you take Sumatriptan Injection, USP with certain medication to treat depression.

Serotonin toxicity symptoms include:

• fever, sweating, shivering, diarrhea, nausea, vomiting;
• muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination;
• fast heartbeat, changes in blood pressure;
• confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma.

Continuous use of Sumatriptan Injection, USP: Sumatriptan Injection, USP should not be used continuously to prevent or reduce the number of attacks you experience. Use Sumatriptan Injection, USP only to treat an actual migraine headache attack. If you use Sumatriptan Injection, USP too often, it may make your migraine headaches worse. If this happens, your healthcare professional may tell you to stop taking Sumatriptan Injection, USP.

Driving and Operating Machines: Sumatriptan Injection, USP can cause dizziness which may affect your ability to drive or use machines. Wait to see how you respond to Sumatriptan Injection, USP before you drive or use machines.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Sumatriptan Injection, USP:

• Medicines used to treat depression such as MAO Inhibitors, selective serotonin reuptake inhibitors (SSRIs), and serotonin noradrenaline reuptake inhibitors (SNRIs).
• Other medicines used to treat migraine headaches such as triptans, 5-HT1 agonists, ergotamine, dihydroergotamine, and methysergide.

How to use Sumatriptan Injection, USP:

• Sumatriptan Injection, USP (6 mg / 0.5mL) is available in a pre-filled syringe packaged in a carton with one disposable autoinjector.
• Before using the Sumatriptan Injection, USP autoinjector, see the instructions below for information.
• Sumatriptan Injection, USP is given as a single injection into the tissues just below the skin on the outside of the thigh or the upper arm.
• Sumatriptan Injection, USP can be taken at any time during your migraine headache.
• It may take up to 15 minutes for Sumatriptan Injection, USP to start working.
• If after taking Sumatriptan Injection, USP you need more pain relief, you can take another pain medication. This medication should not contain ergotamine. If you are not sure which medications you can use talk to your healthcare professional.

Remember, this medicine has been prescribed only for you. Do not give it to anybody else, as they may experience undesirable effects, which may be serious.

INSTRUCTIONS FOR USE OF DISPOSABLE SUMATRIPTAN AUTOINJECTOR SYSTEM

This section explains how to use Sumatriptan Injection, USP. Read it several times to make sure you understand it, before using the autoinjector. If you have any questions, ask your healthcare professional.

Keep the cap on the Sumatriptan Autoinjector until you are ready to give an injection. Keep the Sumatriptan Autoinjector System out of the reach and sight of children.

Important things that you need to know

This device is called a Sumatriptan autoinjector. Here the shorter name ‘autoinjector’ is used.

1. 1. Follow these step-by-step instructions every time you use the autoinjector.
2. 2. Only use each autoinjector once - do not try to use more than once.
3. 3. Always keep the autoinjector in its box until you are ready to use it.

About the Autoinjector

The parts of the Autoinjector are shown in this picture

Gray Cap

The Autoinjector will not work until the cap is taken off

Getting Ready

Getting ready for the Injection

1. 1. Wash your hands.
2. 2. Choose an area with an adequate fatty tissue layer. For example, on the outside of the thigh or in the upper arm (see Figure A). Do not inject into areas where the skin is tender, bruised, red or hard.
3. 3.

   Clean the skin area to be injected with alcohol or a new sterile swab and allow your skin to dry. Do not touch this area again before giving the injection.

4. 4. It is recommended to alternate injection sites (the outside of the thigh and the upper arm).

Getting the Autoinjector Ready

1. 5. Take the autoinjector out of the package. Check the expiration date on the autoinjector label.
2. 6.

   Look in the medicine window on the autoinjector.

   1. • Before using, make sure the liquid is clear (see Figure B). Do not use if the liquid looks discoloured, cloudy, contains lumps, flakes, or particles, or if there are any signs of leakage
   2. • If it is difficult to see what is in the window, hold the autoinjector up to the light and check. After use, the blue plunger rod completely fills the medicine window (see Figure C).
   3. •

      When you see the blue plunger rod through the window, the device is empty and

      Medicine Window

      Use the window to make sure the liquid is clear

      Blue Injection Button

      The button must be pressed firmly down for the injection to start. Do not release the button until all the medicine has been injected.

      • cannot be used again.

1. 7.

   Pull the gray cap off the autoinjector.

   1. • Do not twist the cap.
   2. • Pull it straight off (see Figure D)

1. 8.

   Look inside the cap and check the gray needle cover is inside (see symbol ✓ in Figure E).

   Do not use the autoinjector if the gray needle cover is not inside the cap (see symbol X in Figure E).

1. 9.

   Do not try to put the cap back on.

   If you try to put the cap back, it will will damage the needle inside the autoinjector. You are now ready to inject the medicine, go to step 9.

Injecting the Medicine

1. 10.

   Without pressing the blue button, push the autoinjector firmly against your skin at a right angle (90 degrees) (see Figure F).

   1. • Push down until you feel the stop point. This will unlock the blue button. Do NOT push the blue button until you are ready to inject.
   2. • As long as the autoinjector is firmly pressed against the skin, the safety lock is turned off. The autoinjector could fire by mistake if the blue button is pressed by accident.
   3. • Do not attempt to re-engage the safety lock at any time.
   4. • Keep the autoinjector pressed tightly against your skin for the next steps.

1. 11.

   Keep pushing the autoinjector against your skin. Then firmly press down on the blue button found on the top of the autoinjector until it will not go further (see Figure G).

   1. • You will hear a click. This means the injection has started (see Figure G).
   2. • If you do not hear a click, the injection did not start. Let go of the blue button. Make sure the autoinjector is pushed firmly against the skin and push down harder on the blue button.

1. 12.

   Do not take the autoinjector off your skin.

   1. • Watch the injection through the medicine window to make sure the whole amount of medicine is given. The blue plunger will move down the window and completely fill it. The blue plunger will stop moving when the injection is done (see Figure H).
   2. • When the injection is done, keep holding the autoinjector against the skin for 5 seconds (see Figure I). If you take the autoinjector off the skin too soon, not all of the medicine will be released.

1. 13. Carefully take the autoinjector off your skin (see Figure J).
2. • The protective sleeve will cover the needle on its own. It is then locked and the needle is

Blue plunger moves down and fills the window

• protected.

What to do After the Injection

1. 14. If you notice a spot of blood at the injection site, dab away with a cotton ball or tissue paper. Do not rub the injection site. If needed, you may cover the injection site with a bandage.
2. 15.

   Visually check that there is no liquid left at the bottom of the medicine window. If there is liquid, consult your healthcare professional. If you think you have not received the full dose:

   1. • Do not try to use the autoinjector again. NEVER ATTEMPT TO REUSE AN AUTOINJECTOR.
   2. • Do not repeat the injection using a new autoinjector.

Dispose the Autoinjector

1. 16. Dispose the Autoinjector and cap as instructed by your healthcare professional or return to the pharmacy. Do not discard in regular home waste.

Usual dose:

• The usual adult dose is 6 mg / 0.5 mL. Do not exceed the usual adult dose.
• If you do not respond to the first dose of Sumatriptan Injection, USP, do not take a second dose for the same attack.
• If your symptoms come back, and it has been 1 or more hour since your first injection, you may take a second injection.
• DO NOT take more than 12 mg (two 6 mg injections) in any 24 hour period.

Overdose:

If you think you, or a person you are caring for, have taken too much Sumatriptan Injection, USP, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Possible side effects from using Sumatriptan Injection, USP:

These are not all the possible side effects you may feel when taking Sumatriptan Injection, USP. If you experience any side effects not listed here, contact your healthcare professional.

The most commonly reported side effects of sumatriptan injection are:

• flushing (redness of the face lasting for a short time)
• feeling sick or vomiting
• dizziness
• drowsiness
• tiredness
• weakness
• temporary increase in blood pressure
• temporary pain at the site of injection
• stinging or burning, redness, swelling, bruising and bleeding at the site of injection

Other side effects include:

• trouble with eyesight, such as blind spots, flashes of light, and seeing two images of a single object.
• shaking, tremors or uncontrolled movements.
• loss of normal colour in the fingers and toes.
• sweating.
• breast pain.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Keep your syringes away from heat and light. Always keep Sumatriptan Injection, USP in the case provided and store between 15°C and 30°C. Handle the device as instructed. This will keep the syringe and medicine sterile.

Medicines should not be disposed of via wastewater or household waste. Your healthcare professional will throw away any medicines that are no longer being used. These measures will help protect the environment.

Needles and syringes may be hazardous and should be disposed of safely and hygienically.

Keep out of reach and sight of children.

If you want more information about Sumatriptan Injection, USP:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html), the manufacturer’s website (www.sterimaxinc.com), or by calling 1-800-881-3550

SteriMax Inc.

2770 Portland Drive

Oakville, ON, L6H 6R4

Date of Authorization:

2026-04-01