NOW AVAILABLE COPAXONE (glatiramer acetate injection)
   
NEW dose: 3-times-a-week COPAXONE® (glatiramer acetate injection) 40 mg/mL
 
Product Information COPAXONE 40mg/1ml COPAXONE 20mg/1ml
  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
 

  Administered daily
  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.  
 
 
TEVA Neuroscience
 
 
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
COPAXONE