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glatiramer (Copaxone)

Tradename: Copaxone. (glatiramer acetate) Indications: - multiple sclerosis (MS) - alternative agent for patients unable to tolerate or failure to respond to interferon-beta Dosage: - 20 mg SC QD - 40 mg SC 3X/week single use vials: - 20 mg + 40 mg mannitol with 1 mL sterile water - 40 mg/mL (generic available) [6] Monitor: - no monitoring recommended [2] Adverse effects: 1) immediate, post-injection site reaction 2) lipoatrophy of skin at injection site [2] 3) chest pain, palpitations 4) flushing (vasodilation) 5) anxiety 6) transient eosinophilia 7) dyspnea 8) diaphoresis 9) panic attack (rare) [2] Mechanism of action: 1) unknown 2) polymer of basic amino acids 3) reduces relapse rate in patients with relapsing-remitting form of MS 4) may delay progression of early multiple sclerosis [4] Notes: - one of 2 drugs accounting for 26% of total Medicare drug spending but just 1% of claims [5]

General

neurologic agent

Properties

MISC-INFO: elimination route PLASMA pregnancy-category B safety in lactation ?

Database Correlations

PUBCHEM cid=3081884

References

  1. The Pharmacological Basis of Therapeutics, 9th ed. Gilman et al, eds. Permagon Press/McGraw Hill, 1996
  2. Medical Knowledge Self Assessment Program (MKSAP) 11, 17. American College of Physicians, Philadelphia 1998, 2015
  3. Kaiser Permanente Northern California Regional Drug Formulary, 1998
  4. Comi G et al, Effect of glatiramer acetate on conversion to clinically definite multiple sclerosis in patients with clinically isolated syndrome (PreCISe study): a randomised, double- blind, placebo-controlled trial The Lancet, Early Online Publication, 7 October 2009 PMID: 19815268 doi:10.1016/S0140-6736(09)61259-9 http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2809%2961259-9/abstract
  5. Walker J Small Number of Drugs Drive Big Medicare Bill The Wall Street Journal. April 20, 2015 http://www.msn.com/en-us/money/insurance/small-number-of-drugs-drive-big-medicare-bill/ar-BBiZz23
  6. Fiore K NeuroBreak: First Copaxone Generic Okayed; Plus for Pain Tx News and commentary from the world of neurology and neuroscience. MedPage Today. October 10, 2017 https://www.medpagetoday.com/Neurology/GeneralNeurology/68443 - Sandoz announces US FDA approval and launch of Glatopa 40 mg/mL three times-a-week generic option for relapsing forms of multiple sclerosis. Sandoz. Feb 13, 2018 https://www.sandoz.com/news/media-releases/sandoz-announces-us-fda-approval-and-launch-glatopar-40-mgml-three-times-week
  7. Department of Veterans Affairs, VA National Formulary