Trade Names:Copaxone- Injection, solution 20 mg/mL
Unknown. May modify the immune processes that are thought to be responsible for multiple sclerosis (MS).
Pharmacokinetics have not been determined.
To reduce the frequency of relapses in patients with relapsing remitting MS.
Hypersensitivity to glatiramer acetate or mannitol.
Subcutaneous 20 mg every day.
Store prefilled syringes in refrigerator (36° to 46°F). Protect from freezing and exposure to light. Discard any syringes that have been frozen. If a refrigerator is not available, the syringes may be stored at room temperature (59° to 86°F) for up to 1 mo.
None well documented.
None well documented.
Vasodilatation (20%); palpitations (9%); tachycardia (5%); syncope (3%); hypertension (at least 1%); angina pectoris, arrhythmia, cardiomegaly, cardiomyopathy, CHF, coronary occlusion, deep thrombophlebitis, MI, pericardial effusion, peripheral vascular disease, thrombosis (postmarketing).
Asthenia (22%); anxiety (13%); pyrexia (6%); migraine, tremor (4%); nervousness, speech disorder (2%); emotional lability, stupor (at least 1%); abnormal dreams, aphasia, brain edema, cerebrovascular accident, CNS neoplasm, convulsions, meningitis, myelitis, neuralgia (postmarketing).
Rash (19%); hyperhidrosis (7%); pruritus (5%); skin disorder, urticaria (3%); benign skin neoplasm (2%); eczema, herpes zoster, pustular rash, skin atrophy, warts (at least 1%).
Rhinitis (7%); diplopia, eye disorder (3%); laryngospasm (2%); visual field defect (at least 1%); blindness, glaucoma (postmarketing).
Nausea (15%); vomiting (7%); gastroenteritis (6%); dysphagia (2%); bowel urgency, oral moniliasis, salivary gland enlargement, tooth caries, ulcerative stomatitis (at least 1%); enlarged abdomen, eructation, GI hemorrhage, stomach ulcer, tongue edema (postmarketing).
Micturition urgency (5%); vaginal candidiasis (4%); amenorrhea, hematuria, impotence, menorrhagia, suspicious papanicolaou smear, urinary frequency, vaginal hemorrhage (at least 1%); bladder carcinoma, breast carcinoma, kidney failure, nephrosis, ovarian carcinoma, urine abnormality, urogenital neoplasm (postmarketing).
Cholelithiasis, cirrhosis of the liver, hepatitis, liver damage, liver function abnormalities (postmarketing).
Lymphadenopathy (7%); acute leukemia, lymphoma-like reaction, thrombocytopenia (postmarketing).
Hypersensitivity (3%); allergic reaction, anaphylactic reaction (postmarketing).
Injection-site erythema (43%); injection-site pain (40%); injection-site pruritus (27%); injection-site mass (26%); injection-site edema (19%); injection-site inflammation (9%); injection-site reaction (8%); injection-site hypersensitivity (4%); local reaction (3%); injection-site atrophy, injection-site fibrosis (2%).
Increased weight (3%); hypercholesterolemia (postmarketing).
Back pain (12%); generalized spasm, rheumatoid arthritis (postmarketing).
Dyspnea (14%); bronchitis, cough (6%); hay fever, hyperventilation (at least 1%); carcinoma of the lung, pleural effusion, pulmonary embolus (postmarketing).
Infection (30%); pain (20%); influenza (14%); chest pain (13%); edema (8%); chills, face edema, peripheral edema (3%); abscess (at least 1%); hydrocephalus, sepsis, SLE syndrome (postmarketing).
Category B .
Safety and efficacy in children younger than 18 yr of age not established.
Has not been studied in elderly patients.
Approximately 16% of patients experience a constellation of symptoms immediately after injection. Symptoms may include flushing, chest pain, palpitations, anxiety, dyspnea, constriction of throat, or urticaria. These symptoms are usually transient and self-limited and generally occur several months after starting therapy.
Could possibly interfere with useful immune function (eg, decreased defense against infection or tumor surveillance).
At the injection sites, localized lipoatrophy and, rarely, skin necrosis have been reported during postmarketing experience.
Copyright © 2009 Wolters Kluwer Health.