Relapsing remitting multiple sclerosis
Adult: 20 mg once daily. Alternatively, 40 mg 3 times wkly, administered at least 48 hr apart. Doses are not interchangeable.
Indications and Dosage
Subcutaneous
Relapsing remitting multiple sclerosis Adult: 20 mg once daily. Alternatively, 40 mg 3 times wkly, administered at least 48 hr apart. Doses are not interchangeable.
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Contraindications
Hypersensitivity to glatiramer acetate or mannitol.
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Special Precautions
Patient w/ pre-existing cardiac disorder. Pregnancy and lactation. Not intended to be administered via IV/IM route.
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Adverse Reactions
Significant: Immediate post-inj reactions (e.g. chest pain, flushing/vasodilation, palpitations, anxiety, dyspnoea, throat constriction, tachycardia, urticaria), localised lipoatrophy, potential effects on immune response (e.g. undermining of body’s tumour surveillance and defense system against infection). Rarely, convulsions, anaphylactoid reactions, skin necrosis.
Nervous: Dizziness, depression, syncope, migraine, nervousness, speech disturbance, abnormal dreams, stupor, tremors, asthenia, hypertonia. CV: HTN, peripheral oedema. GI: Nausea, vomiting, gastroenteritis, dysphagia, bowel urgency, dental carries, constipation. Resp: Rhinitis, bronchitis, cough, laryngospasm. Genitourinary: Urinary urgency, vulvovaginal candidiasis. Endocrine: Wt gain. Haematologic: Lymphadenopathy, benign skin neoplasm. Musculoskeletal: Back pain, neck pain, arthralgia. Ophthalmologic: Diplopia, visual field defect. Dermatologic: Rash, hyperhidrosis, diaphoresis, facial oedema, skin atrophy. Immunologic: Infections (e.g. influenza). |
Parenteral/SC: B
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Monitoring Parameters
Monitor for post-inj reactions.
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Drug Interactions
Increased incidence of inj site reactions w/ corticosteroids.
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Action
Description:
Mechanism of Action: Glatiramer acetate is an immunomodulating drug composed of a mixt of random polymers of L-alanine, L-glutamic acid, L-lysine, and L-tyrosine. The exact mechanism of action is still unknown, but it is thought to induce and activate T-cells that migrate into the CNS, suppressing immune response to myelin antigens resulting in downregulation of inflammation. Pharmacokinetics: Distribution: Small amounts of drug enter lymphatic circulation either intact or partially hydrolysed. Metabolism: Rapidily metabolised via hydrolysis by subcutaneous and muscle tissues. |
Storage
Store between 2-8°C. Do not freeze.
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MIMS Class
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References
Anon. Glatiramer Acetate. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 02/06/2017. Buckingham R (ed). Glatiramer Acetate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/06/2017. Copaxone 20 mg/mL, Solution for Injection, Pre-Filled Syringe (Teva Pharmaceuticals Ltd.). eMC. https://www.medicines.org.uk/emc/. Accessed 02/06/2017. Copaxone 20mg/mL, 40mg/mL Pre-Filled Syringe (Teva Pharma Australia Pty Ltd). TGA eBusiness Services Product and Consumer Medicine Information. https://www.ebs.tga.gov.au. Accessed 02/06/2017. Copaxone 40 mg/mL Solution for Injection, Pre-Filled Syringe (Teva Pharma B.V.). eMC. https://www.medicines.org.uk/emc/. Accessed 02/06/2017. Copaxone Injection, Solution (Teva Neuroscience, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 02/06/2017. Glatopa Injection, Solution (Sandoz Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 02/06/2017. Joint Formulary Committee. Glatiramer Acetate. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/06/2017. McEvoy GK, Snow EK, Miller J et al (eds). Glatiramer Acetate. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 02/06/2017. Rossi S (ed). Glatiramer. Australian Medicines Handbook [online]. Adelaide. Australian Medicines Handbook Pty Ltd. https://amhonline.amh.net.au. Accessed 02/06/2017.
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