Glatiramer Acetate

Trade Names:Copaxone- Injection, solution 20 mg/mL

Pharmacology

Unknown. May modify the immune processes that are thought to be responsible for multiple sclerosis (MS).

Pharmacokinetics

Special Populations

Pharmacokinetics have not been determined.

Indications and Usage

To reduce the frequency of relapses in patients with relapsing remitting MS.

Contraindications

Hypersensitivity to glatiramer acetate or mannitol.

Dosage and Administration

Subcutaneous 20 mg every day.

General Advice

• For subcutaneous administration only. Not for intradermal, IM, IV, or intra-arterial administration.
• Allow syringe to warm to room temperature before administering. This may take up to 20 min.
• Rotate injection sites (hips, thighs, abdomen, back of arms). Use a different area than where the last injection was administered. Do not inject into areas that are tender, bruised, red, or hard.
• Do not administer if particulate matter, cloudiness, or discoloration is noted.
• Discard any unused solution. Do not save for future use.

Storage/Stability

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.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

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).

CNS

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).

Dermatologic

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%).

EENT

Rhinitis (7%); diplopia, eye disorder (3%); laryngospasm (2%); visual field defect (at least 1%); blindness, glaucoma (postmarketing).

GI

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).

Genitourinary

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).

Hepatic

Cholelithiasis, cirrhosis of the liver, hepatitis, liver damage, liver function abnormalities (postmarketing).

Hematologic-Lymphatic

Lymphadenopathy (7%); acute leukemia, lymphoma-like reaction, thrombocytopenia (postmarketing).

Hypersensitivity

Hypersensitivity (3%); allergic reaction, anaphylactic reaction (postmarketing).

Local

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%).

Metabolic-Nutritional

Increased weight (3%); hypercholesterolemia (postmarketing).

Musculoskeletal

Back pain (12%); generalized spasm, rheumatoid arthritis (postmarketing).

Respiratory

Dyspnea (14%); bronchitis, cough (6%); hay fever, hyperventilation (at least 1%); carcinoma of the lung, pleural effusion, pulmonary embolus (postmarketing).

Miscellaneous

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).

Precautions

Pregnancy

Category B .

Lactation

Undetermined.

Children

Safety and efficacy in children younger than 18 yr of age not established.

Elderly

Has not been studied in elderly patients.

Immediate postinjection reaction

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.

Immunity

Could possibly interfere with useful immune function (eg, decreased defense against infection or tumor surveillance).

Lipoatrophy and necrosis

At the injection sites, localized lipoatrophy and, rarely, skin necrosis have been reported during postmarketing experience.

Patient Information

• Advise patient, family, or caregiver that medication is not a cure for MS, but it may decrease the number of flare-ups and slow development of some physical disabilities caused by MS.
• Advise patient or caregiver to review the patient information leaflet before using first time and with each refill.
• If patient or caregiver will be administering at home, ensure that the patient or caregiver has reviewed the patient information leaflet for self-injection procedure and understands how to store, prepare, and administer dose, and dispose of used equipment and supplies. The first injection should be performed under supervision of a qualified health care provider.
• Instruct patient to rotate injection sites as described in the patient information leaflet to reduce likelihood of severe injection-site reactions developing.
• Instruct patient to notify health care provider immediately if any of the following occur: hives, skin rash with irritation, dizziness, sweating, chest pain, trouble breathing, or severe pain at injection site. Caution patient not to administer any more injections unless advised by health care provider.
• Patient may experience a short-term reaction right after injecting glatiramer (eg, flushing, chest pain tightness with heart palpitations, anxiety, trouble breathing). Advise patient that these symptoms appear a few minutes after an injection, last a few minutes, and go away by themselves without further problems. Instruct patient to discontinue use and immediately seek medical care if symptoms become severe, and not to administer any more injections unless advised by health care provider.
• Advise patient that injection-site reactions (eg, redness, pain, swelling, itching, or lump at injection site) are the most common adverse reactions and to inform health care provider if they occur and are bothersome.
• Advise patient to contact health care provider if experiencing bothersome adverse reactions or any unusual problems.
• Caution patient that drug may cause dizziness, and to use caution while driving or performing other tasks requiring mental alertness or coordination until tolerance is determined.
• Instruct patient on proper self-injection techniques to ensure safe administration.

Copyright © 2009 Wolters Kluwer Health.