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|Glatiramer Acetate

Glatiramer Acetate

Trade Names:
Copaxone
- Injection 20 mg

Mechanism of Action

Pharmacology

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

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 q 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 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 7 days.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Vasodilation (27%); palpitation (17%); syncope, tachycardia (5%); hypertension (at least 1%); thrombosis, peripheral vascular disease, pericardial effusion, MI, deep thrombophlebitis, coronary occlusion, CHF, cardiomyopathy, cardiomegaly, arrhythmia, angina pectoris (postmarketing).

CNS

Asthenia (41%); anxiety (23%); hypertonia (22%); tremor (7%); vertigo (6%); migraine (5%); agitation (4%); foot drop (3%); confusion, nervousness, nystagmus, speech disorder (2%); abnormal dreams, emotional lability, stupor (at least 1%); meningitis, CNS neoplasm, cerebrovascular accident, brain edema, abnormal dreams, aphasia, convulsion, neuralgia, myelitis (postmarketing).

Dermatologic

Pruritus, rash (18%); sweating (15%); erythema, herpes simplex, urticaria (4%); skin nodule (2%); eczema, herpes zoster, pustular rash, skin atrophy, warts (at least 1%).

EENT

Rhinitis (14%); eye pain (7%); eye disorder (4%); visual field changes (at least 1%); glaucoma, blindness, visual field defect (postmarketing).

GI

Nausea (22%); diarrhea (12%); anorexia (8%); vomiting (6%); GI disorder (5%); gastroenteritis (3%); bowel urgency, oral moniliasis, salivary gland enlargement, tooth caries and ulcerations (at least 1%); tongue edema, stomach ulcer, GI hemorrhage, eructation (postmarketing).

Genitourinary

Urinary urgency (10%); vaginal moniliasis (8%); dysmenorrhea (6%); amenorrhea, hematuria, impotence, menorrhagia, suspicious papanicolaou smear, urinary frequency, vaginal hemorrhage (at least 1%); urogenital neoplasm, urine abnormality, ovarian carcinoma, nephrosis, kidney failure, breast carcinoma, bladder carcinoma, urinary frequency (postmarketing).

Hematologic-Lymphatic

Lymphadenopathy (12%); ecchymosis (8%); thrombocytopenia, lymphoma-like reaction, acute leukemia (postmarketing).

Hepatic

Abnormal liver function, liver damage, hepatitis, liver cirrhosis, cholelithiasis (postmarketing).

Local

Injection site pain (73%); injection site erythema (66%); injection site Inflammation (49%); injection site pruritus (40%); injection site mass (27%); injection site induration (13%); injection site welt (11%); injection site hemorrhage, injection site urticaria (5%); injection site edema, atrophy, abscess or hypersensitivity (at least 1%).

Metabolic-Nutritional

Weight gain (3%); hypercholesterolemia (postmarketing).

Musculoskeletal

Arthralgia (24%); back pain (16%); neck pain (8%); rheumatoid arthritis, generalized spasm (postmarketing).

Respiratory

Dyspnea (19%); bronchitis (9%); Laryngismus (5%); hyperventilation; hay fever (at least 1%); pulmonary embolus, pleural effusion, lung carcinoma, (postmarketing).

Miscellaneous

infection (50%); pain (28%); chest pain (21%); flu syndrome (19%); peripheral edema (7%); fever (8%); face edema (6%); bacterial infection (5%); chills (4%); edema (3%); cyst (2%); sepsis, lupus erythematosus syndrome, hydrocephalus, enlarged abdomen, allergic reaction, anaphylactoid reaction (postmarketing).

Precautions

Pregnancy

Category B .

Lactation

Undetermined.

Children

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

Immunity

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

Immediate postinjection reaction

Approximately 10% of patients experience a constellation of symptoms immediately after injection. Symptoms may include the following: flushing, chest pain, palpitations, anxiety, dyspnea, constriction of throat, urticaria. These symptoms are usually transient and self-limited and generally occur several months after starting therapy.

Patient Information

• Explain name, dose, action, and potential side effects of drug.
• Advise patient, family, or caregiver that medication is not a cure for MS, but it may decrease the number of flare-ups and slow the development of some of the physical disabilities caused by MS.
• Advise patient or caregiver to review the Patient Information sheet before using the 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 the 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.
• Advise patient not to change the dose or stop taking unless advised by health care provider.
• 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 the glatiramer (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 (redness, pain, swelling, itching, or lump at injection site) are the most common side effects and to inform health care provider if they occur and are bothersome.
• Advise patient to contact health care provider if experiencing bothersome side effects or experience 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.
• Advise women to notify health care provider if pregnant, planning to become pregnant, or breastfeeding.
• Instruct patient not to take any prescription or OTC medications, herbal preparations, or dietary supplements unless advised by health care provider.
• Remind patient that office visits will be required to monitor therapy and to keep appointments.
• Instruct patient on proper self-injection techniques to ensure safe administration.