Watch the video to see a demonstration of the WhisperJECT Autoinjector device, featuring a patient with relapsing multiple sclerosis and a nurse.
Injecting Viatris’ Glatiramer Acetate Injection with WhisperJECT Autoinjector
Using the Prefilled Syringe
- Remove the syringe from its protective blister pack by peeling back the paper label.
- Choose an injection site on your body. Clean the injection site with a new alcohol wipe and let the site air-dry.
- Pick up the syringe with one hand and hold it like a pencil. Remove the needle cap with your other hand.
- Pinch about a 2-inch fold of skin between your thumb and index finger.
- 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.
- To inject the medicine, hold the syringe steady and slowly push down on the plunger.
- When you have injected all of the medicine, pull the needle straight out.
- 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
Put the used needles and syringes in an FDA-cleared sharps disposal container right away after use.
Do not dispose of loose needles and syringes in household trash.
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
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
Do not dispose of your used sharps container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
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
The WhisperJECT device should be replaced after two years. Please contact VIATRIS ADVOCATE to receive a replacement device within two years of date of receipt.
Storing Viatris’ Glatiramer Acetate Injection
Keep the carton of Prefilled Syringes in the refrigerator at 36-46°F (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 (59-86°F or 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.
GLATIRAMER ACETATE INJECTION is indicated for the treatment of patients with relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
IMPORTANT SAFETY INFORMATION
GLATIRAMER ACETATE INJECTION is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol.
Approximately 16% of patients exposed to GLATIRAMER ACETATE INJECTION 20 mg per mL compared to 4% of those on placebo, and approximately 2% of patients exposed to GLATIRAMER ACETATE INJECTION 40 mg per mL compared to none on placebo experienced a constellation of symptoms that may occur within seconds to minutes after injection and included at least 2 of the following: flushing, chest pain, palpitations, tachycardia, anxiety, dyspnea, throat constriction, and urticaria. In general, these symptoms have their onset several months after the initiation of treatment, although they may occur earlier, and a given patient may experience 1 or several episodes of these symptoms. Typically, the symptoms were transient and self-limited and did not require treatment; however, there have been reports of patients with similar symptoms who received emergency medical care.
Transient chest pain was experienced by 13% of GLATIRAMER ACETATE INJECTION 20 mg per mL patients compared to 6% of placebo patients, and approximately 2% of GLATIRAMER ACETATE INJECTION 40 mg per mL patients compared to 1% on placebo.
While some episodes of chest pain occurred in the context of the immediate post-injection reactions that are described, many did not. The temporal relationship of this chest pain to an injection was not always known. The pain was usually transient, often unassociated with other symptoms, and appeared to have no clinical sequelae. Some patients experienced more than one such episode, and episodes usually began at least one month after the initiation of treatment.
At injection sites, localized lipoatrophy and, rarely, injection site skin necrosis may occur. Lipoatrophy may occur at various times after treatment onset (sometimes after several months) and is thought to be permanent. There is no known therapy for lipoatrophy.
Because GLATIRAMER ACETATE INJECTION can modify immune response, it may interfere with immune functions. For example, treatment with GLATIRAMER ACETATE INJECTION may interfere with recognition of foreign antigens in a way that would undermine the body’s tumor surveillance and its defenses against infection. There is no evidence that GLATIRAMER ACETATE INJECTION does this, but there has not been a systematic evaluation of this risk.
Cases of hepatic injury, some severe, including liver failure and hepatitis with jaundice, have been reported with GLATIRAMER ACETATE INJECTION. Hepatic injury has occurred from days to years after initiating treatment with GLATIRAMER ACETATE INJECTION. If signs or symptoms of liver dysfunction occur, consider discontinuation of GLATIRAMER ACETATE INJECTION.
The most common adverse reactions observed in controlled studies of GLATIRAMER ACETATE INJECTION 20 mg per mL and 40 mg per mL, were injection site reactions (ISRs), vasodilatation, rash, dyspnea and chest pain; ISRs were one of the most common adverse reactions leading to discontinuation of GLATIRAMER ACETATE INJECTION. ISRs, such as erythema, pain, pruritus, mass, edema, hypersensitivity, fibrosis, and atrophy, occurred at a higher rate with GLATIRAMER ACETATE INJECTION than placebo.