Glatiramer acetate


Concise Prescribing Info
Indications/Uses
Relapsing-remitting multiple sclerosis.
Dosage/Direction for Use
Adult : SC 20 mg once daily. Alternatively, 40 mg 3 times/wk, administered at least 48 hr apart. Doses are not interchangeable.
Dosage Details
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.
Contraindications
Hypersensitivity to glatiramer acetate or mannitol.
Special Precautions
Patient w/ pre-existing cardiac disorder. Pregnancy and lactation. Not intended to be administered via IV/IM route.
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
MonitoringParameters
Monitor for post-inj reactions.
Drug Interactions
Increased incidence of inj site reactions w/ corticosteroids.
Action
Description: 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.
ATC Classification
L03AX13 - glatiramer acetate ; Belongs to the class of other immunostimulants.
Disclaimer: This information is independently developed by MIMS based on Glatiramer acetate from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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