say yes injection support

Injection Support

WhisperJECT® is a reusable device for subcutaneous injection.1

The WhisperJECT® Autoinjector is intended for use with the PrGlatiramer Acetate Injection pre-filled syringes.

WhisperJECT Autoinjector device
WhisperJECT Autoinjector device

Injecting PrGlatiramer Acetate Injection with WhisperJECT® Autoinjector

Watch the video to see a demonstration of the WhisperJECT® Autoinjector device and proper injection technique.

  • Video Transcript

    00:00 – 00:06
    Welcome. In this video, you’ll learn how to use the WhisperJECT® Autoinjector Device.

    00:07 – 00:18
    Viatris’ Glatiramer Acetate Injection comes in individually wrapped, prefilled glass syringes. Keep your supply of syringes refrigerated at 2°–8°C.

    00:19 – 00:39
    If needed, you may store syringes at room temperature, between 15° and 30°C, for up to one month, but refrigeration is preferred.
    Do not use if the medication is frozen. If Glatiramer Acetate Injection is frozen or has ever been frozen, discard the product.

    00:40 – 00:44
    Glatiramer Acetate is injected into the fatty layer under your skin.

    00:45 – 01:01
    If you would like to discuss any questions or concerns related to your Glatiramer Acetate Injection with a Registered Nurse, please contact your VIATRIS ADVOCATE patient support program at 1-888-223-0038.

    01:02 – 01:19
    Before you inject, gather your supplies, including your WhisperJECT® Autoinjector device, an alcohol wipe, a cotton ball, needle clipper and sharps disposal container, one prefilled glass syringe, and a place to record your injections.

    01:20 – 01:26
    Remove the syringe from the refrigerator about 20 minutes before injection, and make sure it still has the capped needle attached.

    01:27 – 01:32
    Wash your hands with soap and water and be careful not to touch your face or hair afterward.

    01:33 – 01:36
    Choose a well-lit area of your home with a clean, flat surface.

    01:37 – 01:44
    The WhisperJECT® Autoinjector is intended for use with the PrGlatiramer Acetate Injection pre-filled syringes.

    01:45 – 01:52
    Check the prefilled glass syringe for cracks and check the solution for cloudiness or particles.

    01:53 – 01:59
    Do not try to remove any air bubbles from the syringe; this could cause you to lose some of your medicine.

    02:00 – 02:03
    DO NOT remove the Prefilled Syringe Needle Cap.

    02:04 – 02:22
    Choose an injection area from the seven possible areas shown, including the back of both upper arms, the stomach 5 cm around the belly button, the front and upper part of both thighs 5 cm above the knee, and upper and rear quadrants of both buttocks below the waist.

    02:23 – 02:27
    Choose a different injection area each time you inject.

    02:28 – 02:34
    Each area has multiple injection sites. Do not inject in the same site more than once a week.

    02:35 – 02:39
    Be sure to record the date and your injection site each time you inject.

    02:40 – 02:47
    Once you have chosen your injection site, you are ready to adjust the needle depth setting on the WhisperJECT® Autoinjector.

    02:48 – 02:55
    To load the WhisperJECT® Autoinjector, twist the top and bottom of the device until the white arrows line up and pull the device apart.

    02:56 – 03:03
    Place the device, with the orange needle cap remover end up, on a flat surface and hold it with one hand for stability.

    03:04 – 03:19
    The WhisperJECT® Autoinjector 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.

    03:20 – 03:30
    To confirm the Autoinjector 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.

    03:31 – 03:38
    Also, the orange injection button will pop up.

    03:39 – 03:46
    Once the Autoinjector has been reset, turn the depth adjuster until the depth you want lines up with the blue semi-circle.

    03:47 – 03:51
    Check with your doctor or nurse to determine your appropriate needle depth settings.

    03:52 – 04:00
    Sites in areas with more fatty tissue require a deeper injection, and a higher depth setting, such as 8 or 10 millimeters.

    04:01 – 04:10
    In lean or muscular areas, you may need a lower depth setting, such as 4 or 6 millimeters.

    04:11 – 04:18
    Flip the syringe housing over so that the needle cap remover faces down.

    04:19 – 04:35
    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.

    04:36 – 04:40
    Align the white arrows and twist the two parts of the device together.

    04:41 – 04:49
    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.

    04:50 – 04:59
    Choose another injection site if the skin is scarred, dented, painful, discolored or where you feel firm knots or lumps.

    05:00 – 05:09
    To remove the needle cap, hold the WhisperJECT® Autoinjector with one hand, and firmly pull the orange needle cap remover away from the device with your other hand.

    05:10 – 05:24
    It will come out with the needle cap inside.

    05:25 – 05:33
    Grasping the device by the handle with the orange button comfortably within reach, place the Autoinjector straight on the injection site (not at an angle).

    05:34 – 05:47
    Firmly push the Autoinjector down against your skin and hold it in position. When the needle depth adjuster is fully depressed, your device will be unlocked so that the orange injection button can be pressed.

    05:48 – 05:55
    Press the orange Injection Button to start the injection. You will hear a “CLICK” when the injection has started.

    05:56 – 05:58
    Make sure you can see the viewing window.

    05:59 – 06:07
    Continue to hold the Autoinjector down against the injection site. You will see green hash marks in the Viewing Window as the medication is injected.

    06:08 – 06:15
    If you cannot see the Viewing Window slowly count to 10 seconds after pressing the Injection Button and hearing the first “CLICK”.

    06:16 – 06:18
    DO NOT lift up early.

    06:19 – 06:24
    When the injection is complete, a check mark will be fully visible in the window.

    06:25 – 06:32
    Pull the WhisperJECT® Autoinjector away from your skin and apply a cotton ball to the injection site with gentle pressure.

    06:33 – 06:39
    Record the date and injection site in your injection journal or use the Injection Site Rotation Plan available at our website,

    06:40 – 06:42
    GlatiramerAcetate.ca.

    06:43 – 06:55
    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.

    06:56 – 07:07
    Dispose of the used syringe in a sharps disposal container. Then replace the orange needle cap remover in its original location making sure the needle cap is out of the needle cap remover.

    07:08 – 07:18
    While not in use, store the WhisperJECT® Autoinjector in the Protective Case until required for your next dose. DO NOT store the Autoinjector in the refrigerator.

    07:19 – 07:35
    Your WhisperJECT® device must be replaced after 2 years from first day of use or if it has been dropped.2 Please contact VIATRIS ADVOCATE to receive a replacement device at 1-888-223-0038.

    07:36 – 07:49
    For more information on anything you've seen in this video, you can visit us at www.glatirameracetate.ca or call 1-888-223-0038.

    07:50 – 07:56
    Our nurses are MS-experienced and available to answer your injection questions or concerns.

    07:57 – 08:11
    Our nurses will also be more than happy to help you get started with your daily self-injections or provide support with questions that may arise. Please continue to watch for Important Safety Information about Glatiramer Acetate Injection.

    08:12 – 08:36
    PATIENT MEDICATION INFORMATION
    GLATIRAMER ACETATE INJECTION 20 mg per mL (once daily) is used to treat patients with Relapsing-Remitting Multiple Sclerosis (RRMS), including those who have experienced one episode of nervous system symptoms and who have abnormalities on their brain scan that may be the first signs of Multiple Sclerosis.

    08:37 – 08:46
    GLATIRAMER ACETATE INJECTION is not a cure. Patients treated with GLATIRAMER ACETATE INJECTION experience fewer relapses (flare-ups of the disease).

    08:47 – 09:07
    Do not use GLATIRAMER ACETATE INJECTION if: you are allergic to glatiramer or mannitol or if the solution in the prefilled syringe is cloudy, leaking, or contains any particles. To help avoid side effects and ensure proper use, talk to your healthcare professional before you take GLATIRAMER ACETATE INJECTION.

    09:08 – 09:32
    Talk with your doctor about any health conditions or problems you may have, including if you: have heart disease; have a history of developing severe allergic reactions; have chronic obstructive pulmonary disease (COPD); have asthma; have kidney and or liver problems; are pregnant, planning to become pregnant, or if you become pregnant while you are using this medication; are nursing; are under 18 years of age.

    09:33 – 09:42
    Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements, or alternative medicines.

    09:43 – 10:17
    These are not all the possible side effects you may feel when taking GLATIRAMER ACETATE INJECTION. If you experience any side effects not listed here, contact your healthcare professional. The most common side effects of GLATIRAMER ACETATE INJECTION are: skin reactions at the injection site, including redness, pain, inflammation, itching, swelling, lumps; permanent “dent” under the skin at the injection site, caused by damage to the fatty tissue at that site; rash; hives; headache; a feeling of worry, nervousness, unease (anxiety).

    10:18 – 10:47
    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 for information on how to report online, by mail, or by fax; or Calling toll-free at 1-866-234-2345.
    NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

    10:48 – 11:08
    If you want more information about GLATIRAMER ACETATE INJECTION, 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 website, the Viatris website, or by calling 1-888-223-0038.

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

    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 re-use the needle or syringe.

Disposal and Storage

Disposing of the Syringe

Disposal of syringe and needle in hard plastic box

  1. Put the used needles and syringes in a 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 a 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. Check with your doctor, pharmacist or nurse about proper disposal of needles and syringes.

  5. Do not dispose of your used sharps container in your household trash unless your community guidelines permit this. Check with your doctor, pharmacist or nurse about proper disposal of needles and syringes.

  6. The WhisperJECT® device should be replaced two years after first use. Please contact our VIATRIS ADVOCATE program to receive a replacement device within two years of date of receipt.

Storing PrGlatiramer Acetate Injection

Storage

  • Keep the carton of Pre-filled Syringes in the refrigerator at 2-8°C. Keep Glatiramer Acetate Injection out of the reach of children.

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

  • Protect Glatiramer Acetate Injection from light and high temperatures.

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

Indications and Clinical Use

Glatiramer Acetate Injection (glatiramer acetate) 20 mg/mL once daily is indicated for:

  • Treatment of ambulatory patients with Relapsing-Remitting Multiple Sclerosis (RRMS), including patients who have experienced a single demyelinating event and have lesions typical of multiple sclerosis on brain MRI:
    • To decrease the frequency of clinical exacerbations.
    • To reduce the number and volume of active brain lesions identified on Magnetic Resonance Imaging (MRI) scans.

The safety and efficacy in chronic progressive MS have not been established.

Contraindications

  • Hypersensitivity to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

Most Serious Warnings and Precaution

Route of administration: the only recommended route of administration is the subcutaneous route; it should not be administered intravenously or intramuscularly.

General: Patients should be instructed on aseptic self-injection techniques for safe administration including part III Patient Medication Information; first injection should be performed under the supervision of an appropriately qualified healthcare professional; patient understanding and use of aseptic self-injection techniques and procedures periodically re-evaluated; patients cautioned against the re-use of needles, syringes or pens and instructed in safe disposal procedures, puncture-resistant container for disposal of used needles, syringes and pens should be used; patients instructed on safe disposal of containers.

Localized Adverse Reactions Associated with Subcutaneous Use: At injection sites, localized lipoatrophy and, rarely, injection site skin necrosis; lipoatrophy may occur after treatment onset (sometimes several months) and may be permanent; to assist in possibly minimizing these events the patient should be advised to follow proper injection technique, rotate injection areas/sites on a regular basis.

Cardiovascular: Symptoms of potentially cardiac origin, transient chest pain; immediate post-injection reaction including at least two of the following: flushing, chest pain, palpitations, anxiety, dyspnea, constriction of the throat and urticaria.

Hepatic: Very rare severe liver injury, including liver failure, hepatitis with jaundice, and extremely rare cases of fulminant hepatitis leading to liver transplant, in patients with and without relevant risk factors in their medical history, occurred from days to years after initiating treatment, some cases suggestive of autoimmune hepatitis, most events resolved with discontinuation of treatment. Caution is recommended when considering treatment in patients who have pre-existing liver disease or who have experienced liver injury previously during treatment with other drugs, including other disease modifying therapies (DMTs) for treatment of multiple sclerosis or with concomitant (DILI) risk drugs. Prior to initiating treatment, serum aminotransferase, alkaline phosphate and total bilirubin levels should be obtained (within 6 months) for all patients. Patients should be monitored during treatment for signs of hepatic injury. Evaluation of transaminases is recommended during treatment, as clinically relevant. Patients should be advised to immediately report any signs or symptoms of hepatotoxicity. Discontinue treatment if clinically significant liver injury is suspected.

Immune: considerations involving the use of a product capable of modifying immune responses, antigenic substance and thus it is possible that detrimental host responses can occur with its use. Whether it can alter normal human immune responses, such as the recognition of foreign antigens is unknown. It is possible that treatment may undermine the body’s defenses against infections and tumor surveillance. Continued alteration of cellular immunity due to chronic treatment might result in untoward effects. Anaphylaxis can be associated with the administration of almost any foreign substance and, therefore, this risk cannot be excluded. Particular caution is advised in patients with a history of severe anaphylactoid reactions, obstructive pulmonary disease or asthma, nor in patients under treatment for either of these two latter conditions.

Monitoring and laboratory tests: patients with renal impairment should be monitored for their renal function while treated; liver transaminases should be checked within 6 months before initiating treatment and evaluation recommended during treatment as clinically relevant.

Pregnancy: should be used during pregnancy only when, in the judgment of the physician, the potential benefits outweigh the possible hazards.

Breast-feeding: caution should be exercised when administered to a nursing woman.

Other Relevant Warnings and Precautions:

  • Post-injection reaction: Flushing, dizziness, skin eruptions with irritation, sweating, chest pain, chest tightness, irregular heartbeat, anxiety, difficulty in breathing, tightness in the throat, hives appearing immediately after injection
  • Low blood pressure: dizziness, fatigue, nausea
  • High blood pressure: headache, dizziness, blurred vision, or shortness of breath
  • Breathing problems: shortness of breath, difficulty breathing
  • Heartbeat: fast heartbeat or skipping a beat
  • Pain: pressure or tightness in the chest, back, neck or joint
  • Angioedema: swelling of the arms, legs or face
  • Depression: change in weight, difficulty sleeping, lack of interest in regular activities
  • Vision: changes of vision

For More Information:

Consult the Product Monograph at https://health-products.canada.ca/dpd-bdpp/index-eng.jsp for more information about conditions of clinical use, contraindications, warnings, precautions, adverse reactions, interactions, and dosing. The Product Monograph is also available by calling 1-844-596-9526.