Cinnomer®

Description

Glatiramer Acetate consists of acetate salts of synthetic polypeptides (containing four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine). Cinnomer^® is the brand name of glatiramer acetate which is equipped with a disposable auto injector named Physioject^TM. Each pre-filled syringe of Cinnomer^® contains 40mg glatiramer acetate for subcutaneous injection.  

Indications

• Cinnomer^® (glatiramer acetate) is indicated for treatment of relapsing forms of multiple sclerosis.

Important safety information

• Chest pain: May or may not occur with the immediate postinjection reaction; described as a transient pain usually resolving in a few minutes; often unassociated with other symptoms. Episodes usually begin ≥1 month after initiation of treatment.
• Hypersensitivity reactions: Anaphylactic reactions (rare) have been reported.
• Immune response: Although there has not been a systematic evaluation of glatiramer’s potential to affect other immune functions, it may interfere with recognition of foreign antigens undermining the body’s tumor surveillance and defense system against infection. Risk of infection increases.
• Lipoatrophy: May occur locally at injection site at various times after treatment (sometimes after several months) and may not resolve; to possibly minimize occurrence, advise patients to follow proper injection technique and rotate site with each injection. Skin necrosis has also been observed.
• Systemic reactions: Postinjection systemic reactions may occur within minutes of injection and occur in a substantial percentage of patients (~16% [20 mg/mL] and ~2% [40 mg/mL] in studies). symptoms (anxiety, chest pain, constriction of the throat, dyspnea, flushing, palpitations, tachycardia, urticaria) are usually self-limited and transient. These symptoms generally occur several months after initiation of treatment. Also weakness, back pain, dyspnea and flu-like symptoms and can happen.