Glatiramer Acetate Injection from Viatris is available in 2 dose strengths

20 mg/mL

For once-daily

Injection
40 mg/mL

For 3-times-a-week

Injection

Injecting Viatris’ Glatiramer Acetate Injection with WhisperJECT Autoinjector

Watch the video to see a demonstration of the WhisperJECT Autoinjector device, featuring a patient with relapsing multiple sclerosis and a nurse.

  • Video Transcript

    0:00-0:05
    Welcome
    In this video you’ll learn how to use the WhisperJECT Auto Injector device.

    0:09-0:26
    The WhisperJECT Auto-Injector is intended for use with FDA-approved drug products with non-viscous (aqueous) liquid formulations which are presented in a 1.0 milliliter BD®, pre-filled, glass syringe with staked needle, containing a fixed needle of 27G to 29G.

    0:31-0:40
    The WhisperJECT Auto-Injector is a reusable injection device for the subcutaneous injection of FDA-approved drugs.
    WhisperJECT is available by prescription only.

    0:43-0:50
    It is important that you read the full instructions for use for the WhisperJECT Auto-Injector device that are provided in the WhisperJECT packaging before use.

    0:58-1:18
    The WhisperJECT can be used to administer Viatris’ GLATIRAMER ACETATE INJECTION.
    GLATIRAMER ACETATE INJECTION is a prescription medicine used for the treatment of people with relapsing forms of multiple sclerosis (MS) to include clinically isolated syndrome, relapsing, remitting disease, and active secondary progressive disease in adults.

    1:22-1:28
    Do not take GLATIRAMER ACETATE INJECTION if you are allergic to glatiramer acetate or mannitol.

    1:31-2:05
    Serious side effects may happen right after or within minutes after you inject glatiramer acetate injection at any time during your course of treatment. Call your doctor right away if you have any of these immediate post-injection reaction symptoms, including redness to your cheeks or other parts of the body, flushing, chest pain, fast heartbeat, anxiety, breathing problems or tightness in your throat, or swelling, rash, hives, or itching. If you have symptoms of an immediate post-injection reaction, do not give yourself more injections until a doctor tells you to.

    2:09-2:35
    Additional Important Safety Information is provided later in this video.
    Before using GLATIRAMER ACETATE INJECTION, please read the Patient Information Leaflet and Instructions for Use found at the end of the Full prescribing information for GLATIRAMER ACETATE INJECTION. The Prescribing Information came with your prescription and your welcome pack. This information does not take the place of talking with your doctor about your medical condition or your treatment.

    2:38-3:00
    Viatris’ GLATIRAMER ACETATE INJECTION comes in individually wrapped pre-filled glass syringes. Keep your supply of syringes refrigerated at 36o to 46o Fahrenheit. If needed, you may store syringes at room temperature between 59o to 86o Fahrenheit for up to one month, but refrigeration is preferred.

    3:03-3:07
    Glatiramer Acetate is injected in the fatty layer under your skin.

    3:12-3:28
    You should receive your initial injection training and your first dose with your doctor or nurse present. Our patient support program, VIATRIS ADVOCATE, can schedule a follow-up, in-home injection training session with you with an MS experienced nurse should you need a refresher or have injection questions.

    3:33-3:48
    Before you inject gather your supplies, including your WhisperJECT Auto Injector device if your doctor has prescribed it, alcohol wipe, cotton ball, needle clipper or sharp disposal container, one pre-filled glass syringe, and a place to record your injections.

    3:51-3:58
    Remove the syringe from the refrigerator about 20 minutes before injection and make sure it still has the cap needle attached.

    4:00-4:19
    Wash your hands with soap and water and be careful not to touch your face or hair afterwards. Choose a well-lit area of your home with a clean flat surface. Check the prefilled glass syringe for cracks and check the solution for cloudiness or particles.

    4:22-4:27
    Do not try to remove any air bubbles from the syringe. This could cause you to lose some of your medicine.

    4:33-4:45
    Choose an injection area from the seven possible areas shown, including the back of both upper arms, the abdomen, the front of both thighs, and the back of both hips below the waist.

    4:47-5:01
    Choose a different injection area each time you inject. Each area has multiple injection sites. Do not inject in the same site more than once a week.
    Be sure to record the date and your injection site each time you inject.

    5:04-5:19
    Once you have chosen your injection site, you are ready to adjust the needle depth setting on the WhisperJECT device.
    To load the WhisperJECT twist the top and bottom of the device until the white arrows line up and pull the device apart.

    5:21-5:29
    Place the device with the orange needle cap remover end up on a flat surface and hold it with one hand for stability.

    5:33-5:45
    The WhisperJECT device is spring loaded. To set the spring, position the open end of the handle over the needle cap remover and push the handle down until you hear a click then lift the handle up and off.

    5:46-6:01
    To confirm the auto injector is reset, a white check mark inside a green box will no longer be visible and the plunger will occupy about half of the viewing window.
    Also, the orange injection button will pop up.

    6:05-6:17
    Once the auto injector has been reset. Turn the depth adjuster until the depth you want lines up with the blue semicircle.
    Check with your doctor or nurse to determine your appropriate needle depth settings.

    6:18-6:34
    Sites in areas with more fatty tissue require a deeper injection and a higher depth setting, such as 8 or 10 millimeters. In lean or muscular areas, you may need a lower depth setting, such as 4 or 6 millimeters.

    6:39-6:43
    Flip the syringe housing over so that the needle cap remover faces down.

    6:49-6:59
    Insert the glass syringe needle end first into the syringe housing. Firmly push down on the glass rim of the syringe until it clicks into place.

    7:04-7:18
    Align the white arrows and twist the two parts of the device together.
    Clean the injection site with an alcohol wipe and allow your skin to air dry. Be sure that your clothing is not blocking the injection site.

    7:20-7:23
    Choose another injection site if the skin is scarred or dented.

    7:25-7:38
    To remove the needle cap, hold the WhisperJECT device with one hand and firmly pull the orange needle cap remover away from the device with your other hand.
    It will come out with the needle cap inside.

    7:50-7:59
    Grasping the device by the handle with the orange button comfortably within reach, place the auto injector straight on the injection site, not at an angle.

    8:00-8:11
    Firmly push the auto injector down against your skin and hold in position when the needle depth adjusters fully depressed, your device will be unlocked so that the orange injection button can be pressed.

    8:15-8:23
    Press the orange injection button to start the injection, you will hear a click when the injection has started. Make sure you can see the viewing window.

    8:24-8:33
    Continue to hold the auto injector down against the injection site, you will see green hash marks in the viewing window as the medication is injected.

    8:34-8:44
    If you cannot see the viewing window, slowly count to 10 seconds after pressing the injection button and hearing the first click. Do not lift up early.

    8:46-8:57
    When the injection is complete, a check mark will be fully visible in the window. Pull the WhisperJECT away from your skin and apply a cotton ball to the injection site with gentle pressure.

    8:58-9:08
    Record the date and injection site in your injection journal or use the injection site Rotation plan available at our website glatirameracetate.com.

    9:10-9:21
    After injecting, carefully separate the two parts of your device. If you are using a needle clipper, clip the needle and dispose of the clipper following local regulations when it is full.

    9:23-9:32
    Dispose of the used syringe in a Sharps disposal container. Then replace the orange needle cap remover in its original location.

    9:35-9:47
    Your WhisperJECT device should be replaced after two years.
    Please contact VIATRIS ADVOCATE to receive a replacement device at 1.844.695.2667.

    9:48-10:03
    For directions on using only the pre-filled syringe to self-inject and for information on anything you've seen in this video, please see the Patient Information Leaflet and Instructions for Use at the end of the Full Prescribing Information for Glatiramer Acetate Injection.

    10:06-10:21
    Please see Full Prescribing Information at www.GlatiramerAcetate.com. You can also call VIATRIS ADVOCATE for instructions at 1-844-695-2667.

    10:23-10:30
    VIATRIS ADVOCATE Nurses are MS experienced and available to answer your injection questions or concerns.

    10:31-10:40
    You can also schedule an in-home visit for one-on-one refresher injection training with the pre-filled syringe or WhisperJECT device, if your doctor has prescribed it.

    10:41-10:57
    VIATRIS ADVOCATE nurses will also be more than happy to help you get started with your daily self-injections or to give you a refresher session if you've been on therapy for a while.
    Please continue to watch for Important Safety Information about Glatiramer Acetate Injection.

    11:01-11:17

    IMPORTANT SAFETY INFORMATION
    Do not take Glatiramer Acetate injection if you are allergic to glatiramer acetate or mannitol. Serious side effects may happen right after or within minutes after you inject glatiramer acetate injection at any time during your course of treatment.

    11:19-11:36
    Call your doctor right away if you have any of these immediate post injection reaction symptoms including redness to your cheeks or other parts of the body, flushing, chest pain, fast heartbeat, anxiety, breathing problems or tightness in your throat, or swelling, rash, hives, or itching.

    11:38-11:44
    If you have symptoms of an immediate post injection reaction, do not give yourself more injections until a doctor tells you to.

    11:46-12:04
    Chest pain may occur either as part of the immediate post injection reaction or on its own. This pain usually only lasts a few minutes or can begin around one month after you start using glatiramer acetate injection.
    Call your doctor right away if you experience chest pain.

    12:05-12:17
    A permanent indentation under the skin, lipoatrophy, and rarely, death of your skin tissue, also referred to as necrosis at the injection site, may occur due to local destruction of fat tissue.

    12:18-12:31
    In order to reduce your chance of developing these problems, be sure to follow your doctor's instruction on how to use glatiramer acetate injection and be sure to choose a different injection site each time you use glatiramer acetate injection.

    12:33-12:54
    Liver problems, including liver failure, can occur with glatiramer acetate injection.
    Call your healthcare provider right away if you have symptoms such as nausea, loss of appetite, tiredness, dark colored urine, and pale stools, yellowing of your skin or the white part of your eye, bleeding more easily than normal confusion or sleepiness.

    12:55-13:11
    The most common side effects in studies of glatiramer acetate injection are redness, pain, swelling, itching or a lump at the side of injection, rash, shortness of breath, and flushing.
    These are not all the possible side effects of glatiramer acetate injection.

    13:12-13:21
    For a complete list, ask your doctor or pharmacist. Tell your doctor about any side effects that you have while taking Glatiramer Acetate Injection.

    13:22-13:35
    You are encouraged to report negative side effects of prescription drugs to the FDA.
    Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

    13:36-13:43
    Please see full Prescribing Information, Patient Information Leaflet, and Instructions for Use for Glatiramer Acetate Injection.

    13:45-13:55
    We hope you found this video helpful.
    For more information about Viatris’ Glatiramer Acetate Injection, visit our website GlatiramerAcetate.com.

    13:56-14:13
    Carefully read the Patient Information Leaflet and Instructions for Use sections in the full Prescribing Information for Glatiramer Acetate Injection.
    It is important that you read the Instructions for use included with your WhisperJECT Auto Injector for complete instructions and important safety information before use.

Gather the supplies you will need.

  • 1 blister pack with a Glatiramer Acetate Injection prefilled syringe with needle attached.
  • Alcohol wipe (not supplied).
  • Dry cotton ball (not supplied).
  • A place to record your injections, like the downloadable Rotation Planner or a notebook.
  • Sharps disposal container (not supplied) or needle clipper (from your Welcome Pack).

Remove one blister pack from the Glatiramer Acetate Injection pre-filled syringe carton.

  • Keep all unused syringes in the carton and store them in the refrigerator.
  • Place the supplies you will need on a clean, flat surface in a well-lit area.
  • Let the blister pack with the syringe inside warm up to room temperature for about 20 minutes.
  • Wash your hands. Be careful not to touch your face or hair after washing your hands.

Look closely at your Glatiramer Acetate Injection pre-filled syringe.

  • There may be small air bubbles in the syringe. Do not try to push the air bubbles from the syringe before giving your injection so you do not lose any medicine.
  • Check the liquid medicine in the syringe before you give your injection. It should look clear and colorless or slightly yellow. If it is cloudy or contains any particles, do not use the syringe. Throw it away in a sharps disposal container.

Choose your injection area. Talk with your doctor about the injection areas that are best for you.

  • The possible injection areas on your body include:
Human body with injection sites marked
  • For each dose, pick a different injection area from one of the areas listed above.
  • Glatiramer Acetate Injection is for under the skin (subcutaneous) injection only; do not inject into your veins (intravenously).
  • Do not stick the needle in the same place (site) more than once a week. Each injection area contains multiple injection sites for you to choose from. Avoid injecting in the same site over and over again.
  • Keep a record of your injection sites, so you know where you have injected. Use the downloadable Rotation Planner or a notebook.
  •  * Stomach area; avoid 2 inches around the belly button.
  • ** 2 inches above knee and 2 inches below groin.

Prepare to give your injection.

  • There are some injection areas on your body that are hard to reach (like the back of your arm). You may need help from someone who has been instructed on how to give your injection in these areas.
  • Do not inject in sites where the skin has scarring or “dents,” because it may make your skin worse.

Clean the injection site.

  • Clean the injection site using the alcohol wipe and allow your skin to air-dry.

How to Use

Using the pre-filled Syringe.

  • Prefilled syringe

    Remove the syringe from its protective blister pack by peeling back the paper label.

  • alcohol wipe

    Choose an injection site on your body. Clean the injection site with a new alcohol wipe and let the site air-dry.

  • Needle cap

    Pick up the syringe with one hand and hold it like a pencil. Remove the needle cap with your other hand.

  • Skin pinch

    Pinch about a 2-inch fold of skin between your thumb and index finger.

  • Inserting needle

    Rest the heel of your hand holding the syringe against your skin at the injection site. Insert the needle at a 90-degree angle straight into your skin. When the needle is all the way in, release the fold of skin.

  • Injecting syringe

    To inject the medicine, hold the syringe steady and slowly push down on the plunger.

  • Pulling out needle

    When you have injected all of the medicine, pull the needle straight out.

  • Press cotton ball

    Press a dry cotton ball on the injection site for a few seconds. Do not rub the injection site or reuse the needle or syringe.

Disposal & Storage

Disposing of the Syringe.

Disposal of syringe and needle in hard plastic box
  1. Put the used needles and syringes in an FDA-cleared sharps disposal container right away after use.

  2. Do not dispose of loose needles and syringes in household trash.

  3. If you do not have an FDA-cleared sharps disposal container, you may use a household container that:

    • Is made of heavy-duty plastic
    • Can be closed with a tight-fitting, puncture-resistant lid
    • Is upright and stable during use
    • Is leak-resistant
    • Is properly labeled to warn of hazardous waste inside
  4. When the sharps container is almost full, follow the community guidelines and dispose of the container properly. For more information about regulations, visit the FDA website.

  5. Do not dispose off your used sharps container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

  6. The needle can also be clipped with the Needle Clipper provided in the Welcome Pack from VIATRIS ADVOCATE. This Needle Clipper stores up to 1,500 needles; dispose of it, following local regulations, when it is full.1

  7. The WhisperJECT device should be replaced after two years. Please contact VIATRIS ADVOCATE to receive a replacement device within two years off date of receipt.

Storing Viatris' Glatiramer Acetate Injection.

Storage
  1. Keep the carton of pre-filled syringes in the refrigerator at 36-46°F (2-8°C).
    Keep Glatiramer Acetate Injection out of the reach of children.

  2. When you are not able to refrigerate Glatiramer Acetate Injection, you may store it for up to 1 month at room temperature (59-86°F or 15-30°C).

  3. Protect Glatiramer Acetate Injection from light and high temperatures.

  4. Do not freeze Glatiramer Acetate Injection. If a syringe freezes, throw it away in a sharps disposal container.

IMPORTANT SAFETY INFORMATION

MORE LESS

USE

GLATIRAMER ACETATE INJECTION is a prescription medicine used for the treatment of people with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

IMPORTANT SAFETY INFORMATION

Do not take GLATIRAMER ACETATE INJECTION if you are allergic to glatiramer acetate or mannitol.

Serious side effects may happen right after or within minutes after you inject glatiramer acetate injection at any time during your course of treatment. Call your doctor right away if you have any of these immediate post-injection reaction symptoms including: redness to your cheeks or other parts of the body (flushing); chest pain; fast heart beat; anxiety; breathing problems or tightness in your throat; or swelling, rash, hives, or itching. If you have symptoms of an immediate post-injection reaction, do not give yourself more injections until a doctor tells you to.

Chest pain may occur either as part of the immediate post-injection reaction or on its own. This pain usually only lasts a few minutes or can begin around 1 month after you start using glatiramer acetate injection. Call your doctor right away if you experience chest pain.

A permanent indentation under the skin (lipoatrophy and, rarely, death of your skin tissue also referred to as necrosis) at the injection site may occur due to local destruction of fat tissue. In order to reduce your chance of developing these problems, be sure to follow your doctor’s instruction on how to use glatiramer acetate injection and be sure to choose a different injection site each time you use glatiramer acetate injection.

Liver problems, including liver failure, can occur with GLATIRAMER ACETATE INJECTION. Call your healthcare provider right away if you have symptoms, such as nausea, loss of appetite, tiredness, dark colored urine and pale stools, yellowing of your skin or the white part of your eye, bleeding more easily than normal, confusion, or sleepiness.

The most common side effects in studies of GLATIRAMER ACETATE INJECTION are redness, pain, swelling, itching, or a lump at the site of injection, rash, shortness of breath, and flushing. These are not all the possible side effects of GLATIRAMER ACETATE INJECTION. For a complete list, ask your doctor or pharmacist. Tell your doctor about any side effects that you have while taking GLATIRAMER ACETATE INJECTION.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.