Article

FDA Approves First Generic MS Drug

Glatiramer acetate injection for relapsing forms of MS


 

References

Indications: Glatiramer acetate injections (Glatopa) is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS).

Dosing: This medication comes in a single-dose 20mg/mL prefilled syringe, which is the daily dose. It is not interchangeable with glatiramer acetate 40 mg/mL.

Pharmacokinetics: The mechanism of action of glatiramer acetate is unknown, but is believed to act by modifying immune processes responsible for the pathogenesis of MS. Studies suggest it activates specific T-cells.

Side Effects/Risks: The most common adverse reactions were injection site reactions, vasodilation, rash, dyspnea, and chest pain. Immediate post-injection reactions, including flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, and/or urticaria, are generally transient and self-limiting. Lipoatrophy and skin necrosis may occur. Injection site rotation is recommended.

More Information: Glatopa, the generic form of Copaxone, is the first generic disease modifying therapy approved for the treatment of multiple sclerosis.

Source: Highlights of prescribing information: Glatopa. Glatopa website. http://www.glatopa.com/pdf/Glatopa-Package-Insert-03-2014.pdf. Revised March 2014. Accessed April 24, 2015.

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