Glatiramer acetate

Hypersensitivity (including history of anaphylaxis) to glatiramer acetate or mannitol.

Patient with pre-existing cardiac disorders. Available dosage strengths (20 mg/mL and 40 mg/mL) are not interchangeable. Avoid administration of live-attenuated vaccine. Renal and hepatic impairment. Pregnancy and lactation.

Significant: Immediate post-inj reactions (e.g. chest pain, dyspnoea, throat constriction, flushing or vasodilatation, urticaria, palpitations, tachycardia, and anxiety); potential effects on immune response (e.g. undermining of body's tumour surveillance and defense system against infection); localised lipoatrophy; severe liver injury (including hepatitis with jaundice and liv er failure). Rarely, skin necrosis.
Blood and lymphatic system disorders: Lymphadenopathy.
Ear and labyrinth disorders: Otitis media.
Eye disorders: Diplopia.
Gastrointestinal disorders: Nausea, vomiting, gastroenteritis, constipation, dyspepsia, dysphagia, dysgeusia.
General disorders and administration site conditions: Asthenia, pain, fever, chills, inj site reactions (e.g. erythema, pruritus, pain, swelling).
Infections and infestations: Infection, influenza, tooth abscess
Investigations: Increased weight, abnormal LFTs.
Metabolism and nutrition disorders: Anorexia, peripheral oedema.
Musculoskeletal and connective tissue disorders: Back pain, arthralgia, neck pain, hypertonia.
Neoplasms benign, malignant and unspecified: Benign neoplasm of skin, neoplasm.
Nervous system disorders: Headache, syncope, tremor, migraine. Rarely, convulsions.
Psychiatric disorders: Depression, nervousness.
Renal and urinary disorders: Urinary urgency, urinary retention.
Reproductive system and breast disorders: Vaginal candidiasis.
Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, bronchitis, cough, rhinitis.
Skin and subcutaneous tissue disorders: Rash, hyperhidrosis, pruritus.
Potentially Fatal: Rarely, serious allergic reaction (e.g. anaphylaxis) which may occur shortly following administration, any time during treatment, or even months or years after treatment initiation.

Parenteral/SC: B

Serious and potentially life-threatening allergic reactions may rarely occur at any time after starting treatment; discontinue use and seek immediate help when symptoms (e.g. dyspnoea, flushing, tachycardia, urticaria, palpitation, chest pain, constriction of the throat) occur.

Perform baseline screening for latent infections (e.g. hepatitis, tuberculosis) in high-risk populations or regions with a high tuberculosis burden. Monitor for signs and symptoms anaphylactic reactions following administration, during treatment, and months up to years after treatment initiation.

Description:
Mechanism of Action: Glatiramer acetate, an immunomodulating drug is a mixture of synthetic polypeptides containing fixed molar ratio of L-alanine, L-glutamic acid, L-lysine, and L-tyrosine. The exact mechanism of action is still unknown; however, studies suggest that it induces and activates drug-specific suppressor T-cells specific for a myelin antigen in the periphery and downregulates immune response such as inflammation.
Pharmacokinetics:
Distribution: Small amount of the injected dose (either intact or partially hydrolysed) is presumed to enter the lymphatic and systemic circulation.
Metabolism: Rapidly hydrolysed locally in the subcutaneous tissues.

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 168311709, Glatiramer (acetate). https://pubchem.ncbi.nlm.nih.gov/compound/168311709. Accessed Mar. 26, 2025.

Store between 2-8°C. Do not freeze. If necessary, may store between 15-30°C for up to 1 month. Protect from intense light or high temperatures.

Neuromuscular Disorder Drugs

L03AX13 - glatiramer acetate ; Belongs to the class of other immunostimulants.

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Copaxone, Glatopa (Glatiramer Acetate): Drug Safety Communication - FDA Adds Boxed Warning About a Rare but Serious Allergic Reaction Called Anaphylaxis. U.S. FDA. https://www.fda.gov. Accessed 04/02/2025.

FDA adds Boxed Warning about a Rare but Serious Allergic Reaction called Anaphylaxis with the Multiple Sclerosis Medicine Glatiramer Acetate (Copaxone, Glatopa). U.S. FDA. https://www.fda.gov. Accessed 04/02/2025.

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