![]() ![]() Hepatic Injury: Cases of hepatic injury, some severe, including liver failure and hepatitis with jaundice, have been reported with COPAXONE ®. There is no evidence that COPAXONE ® does this, but there has not been a systematic evaluation of this risk. 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. ![]() Potential Effects on Immune Response: Because COPAXONE ® can modify immune response, it may interfere with immune functions. There is no known therapy for lipoatrophy. Lipoatrophy may occur at various times after treatment onset (sometimes after several months) and is thought to be permanent. Dimethyl fumarate copay assistance skin#Lipoatrophy and Skin Necrosis: At injection sites, localized lipoatrophy and, rarely, injection site skin necrosis may occur. Some patients experienced more than 1 such episode, and episodes usually began at least 1 month after the initiation of treatment. The pain was usually transient, often unassociated with other symptoms, and appeared to have no clinical sequelae. The temporal relationship of this chest pain to an injection was not always known. While some episodes of chest pain occurred in the context of the Immediate Post-Injection Reaction described above, many did not. 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.Ĭhest Pain: 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. 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. ![]() Immediate Post-Injection Reaction: 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 that may occur immediately (within seconds to minutes, with the majority of symptoms observed within 1 hour) after injection and included at least 2 of the following: flushing, chest pain, palpitations, tachycardia, anxiety, dyspnea, throat constriction, and urticaria. Important Safety InformationĬontraindication: COPAXONE ® is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol. COPAXONE ® is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |