| |
|
NOW AVAILABLE
|
|
|
| |
NEW dose: 3-times-a-week COPAXONE® (glatiramer acetate injection) 40 mg/mL
|
|
|
|
PACKAGING
|
Box is white with gray bar
|
Box is blue with white bar
|
|
NDC#
|
68546-0325-12
|
68546-0317-03
|
|
BOX DIMENSIONS
|
163 × 75 × 62 mm
|
162 × 118 × 95 mm
|
|
SYRINGE COUNT
|
12 prefilled syringes
|
30 prefilled syringes
|
|
SYRINGE PLUNGER
|
Blue
|
White
|
|
ACTIVE INGREDIENT
|
40 mg of glatiramer acetate per mL
of solution
|
20 mg of glatiramer acetate
per mL of solution
|
|
ADMINISTRATION
|
| |
• |
Administered 3 times per week |
| |
• |
Injections must be administered at least 48 hours apart |
|
|
|
DELIVERY
|
Can be administered manually or with autoject® 2 for glass syringe
|
|
STORAGE
|
| |
• |
Should be refrigerated (36°F to 46°F/2°C to 8°C)1 |
| |
• |
Can be stored at room temperature (59°F to 86°F/15°C to 30°C) for up to 1 month1 |
| |
• |
Should not be exposed to higher temperatures or intense light1 |
|
|
| |
• To place an order for COPAXONE® (glatiramer acetate injection) 40 mg/mL, please contact your wholesaler
|
|
| |
|
|
| |
3-times-a-week COPAXONE® 40 mg/mL—
A proven mix of efficacy, safety, and tolerability that you
and patients can count on1
|
|
|
| |
|
|
|
| |
Let patients know they can call Shared Solutions® at 1-800-887-8100 or contact their neurologist for help in transitioning to NEW 3-times-a-week COPAXONE® 40 mg/mL.
|
|
| |
COPAXONE® is indicated for the treatment of patients with relapsing forms of multiple sclerosis.
Important Safety Information about COPAXONE®
COPAXONE® is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol.
Approximately 16% of patients exposed to COPAXONE® 20 mg per mL compared to 4% of those on placebo, and approximately 2% of patients exposed to COPAXONE® 40 mg per mL compared to none on placebo experienced a constellation of symptoms immediately after injection that included at least 2 of the following: flushing, chest pain, palpitations, 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 noted in 13% of COPAXONE® 20 mg per mL patients compared to 6% of placebo patients, and approximately 2% of COPAXONE® 40 mg per mL patients compared to 1% on placebo. While some episodes of chest pain occurred in the context of the immediate postinjection reaction described above, 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 1 such episode, and episodes usually began at least 1 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 COPAXONE® can modify immune response, it may interfere with immune functions. For example, treatment with COPAXONE® 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 COPAXONE® does this, but there has not been a systematic evaluation of this risk.
In controlled studies of COPAXONE® 20 mg per mL, the most common adverse reactions with COPAXONE® vs placebo were injection site reactions (ISRs), such as erythema (43% vs 10%); vasodilatation (20% vs 5%); rash (19% vs 11%); dyspnea (14% vs 4%); and chest pain (13% vs 6%).
In a controlled study of COPAXONE® 40 mg per mL, the most common adverse reactions with COPAXONE® vs placebo were ISRs, such as erythema (22% vs 2%).
ISRs were one of the most common adverse reactions leading to discontinuation of COPAXONE®. ISRs, such as erythema, pain, pruritus, mass, edema, hypersensitivity, fibrosis, and atrophy, occurred at a higher rate with COPAXONE® than placebo.
Please see full Prescribing Information.
Reference: 1. COPAXONE® (glatiramer acetate injection) prescribing information. Teva Neuroscience, Inc.
|
|
| |
COPAXONE® is a registered trademark of Teva Pharmaceutical Industries Ltd.
Shared Solutions® is a registered service mark of Teva Neuroscience, Inc.
autoject® 2 for glass syringe is a registered trademark of Owen Mumford, Ltd.
Available by prescription only.
© 2014 Teva Neuroscience, Inc. COP-40933
|
|
|
|
|
|