glatiramer acetate


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glatiramer acetate

Copaxone

Pharmacologic class: Immunomodulator

Therapeutic class: Multiple sclerosis agent

Pregnancy risk category B

Action

Unknown. Thought to alter immune processes believed to be responsible for pathogenesis of multiple sclerosis.

Availability

Injection: 20 mg lyophilized glatiramer acetate and 40 mg mannitol in single-use 2-ml vial (1-ml vial of sterile water for injection included for reconstitution)

Indications and dosages

To reduce frequency of relapses in relapsing-remitting multiple sclerosis

Adults: 20 mg/day subcutaneously

Contraindications

• Hypersensitivity to drug

Precautions

Use cautiously in:
• pregnant or breastfeeding patients
• children (safety and efficacy not established).

Administration

• Give only by subcutaneous injection into arms, abdomen, hips, or thighs.
• Administer immediately after preparing. Discard unused portion.

Adverse reactions

CNS: abnormal dreams, agitation, anxiety, confusion, emotional lability, migraine, nervousness, speech disorder, stupor, tremor, weakness, vertigo

CV: chest pain, hypertension, palpitations, tachycardia, peripheral edema

EENT: eye disorder, nystagmus, ear pain, rhinitis

GI: nausea, vomiting, diarrhea, anorexia, gastroenteritis, other GI disorder, oral candidiasis, salivary gland enlargement, ulcerative stomatitis

GU: urinary urgency, hematuria, erectile dysfunction, amenorrhea, dysmenorrhea, menorrhagia, abnormal Papanicolaou smear, vaginal candidiasis, vaginal hemorrhage

Hematologic: ecchymosis, lymphadenopathy

Musculoskeletal: joint, back, or neck pain; foot drop; hypertonia

Respiratory: bronchitis, dyspnea, hyperventilation

Skin: eczema, erythema, diaphoresis, pruritus, rash, skin atrophy, skin nodules, urticaria, warts

Other: dental caries, facial edema, weight gain, herpes simplex, herpes zoster, cysts, chills, flulike symptoms, pain at injection site

Interactions

None reported

Patient monitoring

Assess for immediate postinjection reaction, including flushing, chest pain, anxiety, breathing problems, and hives.
• Watch for transient chest pain, but be aware that this problem doesn't seem to be clinically significant.
• Check for vaginal bleeding.
• Watch for signs and symptoms of infection.

Patient teaching

• Teach patient how to prepare and self-administer drug. Supervise him the first time he does so.

Teach patient to recognize and immediately report signs and symptoms of postinjection reaction. Tell him this reaction may occur right away or up to several months after first dose.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.

Instruct patient to report signs or symptoms of infection or vaginal hemorrhage.
• Provide dietary counseling. Refer patient to dietitian if adverse GI effects significantly affect food intake.
• As appropriate, review all other significant and life-threatening adverse reactions.

glatiramer acetate (glahtear´a-meer as´ətāt),

n a medication used to decrease or stop a relapse of multiple sclerosis. It is typically used to treat individuals resistant to the effects of interferon-β.
References in periodicals archive ?
The FAS Russia Commission considered the complaint of ZAO Biocad against the actions of the Ministry of Health of the Russian Federation when purchasing the Glatiramer acetate drug used for the treatment of multiple sclerosis with a contract price of about 650 million rubles.
The Food and Drug Administration approved Mylan's Abbreviated New Drug Applications (ANDAs) for glatiramer acetate injection 40 mg/ml for three-times-a-week injection, a substitutable generic version of Teva's Copaxone 40 mg/ml, and glatiramer acetate injection 20 mg/ml for once-daily injection, a substitutable generic version of Teva's Copaxone 20 mg/ml.
BANKING AND CREDIT NEWS-May 28, 2014-Mapi Pharma receives extension for Glatiramer Acetate Depot
Prescribing interferon-beta or glatiramer acetate (Copaxone) for patients with progressive, nonrelapsing forms of multiple sclerosis (MS): These costly drugs often have troublesome side effects, and do not prevent the development of permanent disability in progressive MS.
On quality of life measures, monotherapy and combination therapy proved largely equal--and equally well tolerated--in the "CombiRx" study, in which half of the patients got the combination and a quarter got either glatiramer acetate (Copaxone) or interferon beta-la (Avonex) alone plus a placebo.
SAN DIEGO -- Glatiramer acetate and interferon beta-la used in combination were no more effective for patients with relapsing-remitting multiple sclerosis than were either agent alone in a 3-year, randomized trial.
The drug can be given to patients whose condition is not being controlled by self-administered injections of beta interferon or glatiramer acetate.
Khoury, of Brigham and Women's Hospital and Harvard Medical School, Boston, and colleagues assessed the effects of albuterol treatment as an add-on therapy for patients starting treatment with glatiramer acetate, currently approved as a therapy for relapsing-remitting MS.
Glatiramer acetate significantly delayed the conversion of clinically isolated syndrome to clinically definite multiple sclerosis, according to a randomized, double-blind, placebo-controlled trial published in the Lancet.
New data demonstrating remyelination of damaged axons in mice treated with glatiramer acetate (COPAXONE") were published in the October 6, 2009, Proceedings of the National Academy of Sciences.
Patients with multiple sclerosis often use injectable medication such as glatiramer acetate or interferons to treat their disease.