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 ?
Detailed analysis of the data from the 20 interviews revealed seven recurrent themes: choosing glatiramer acetate, self-managing care, injecting, healthy lifestyle, side effects, support, and advice to others.
LONDON, Ontario, November 1 /PRNewswire/ -- In this week's issue of the Lancet Neurology, glatiramer acetate, known as Copaxone(R), was subjected to an independent review.
Hundreds of people will gather in London on Thursday to hand in the petition calling for Beta Interferon and Glatiramer Acetate to be available on the NHS.
Glatiramer acetate (GA) 40 mg/1 ml three times weekly significantly reduced annualized relapse rates (ARR) - Significant reductions in new/enlarging T2 and gadolinium-enhancing (GdE) lesions in RRMS patients also observed - New data being presented at late-breaking news session at the 28(th) ECTRIMS congress
Tenders are invited for Medicinal Products - Glatiramer Acetate - National Program for the Treatment of Neurological Diseases - Multiple Sclerosis
Teva) announced the presentation of the Gene Expression Analysis data at the 2014: Joint ACTRIMS-ECTRIMS Meeting, which demonstrated differences between gene expression profiles of Teva's COPAXONE (glatiramer acetate injection) and other glatiramer acetate products.
A convenience sample included 108 individuals with multiple sclerosis who initiated therapy with glatiramer acetate (Copaxone), plus or minus 21 days, and completed instruments online that included the Multiple Sclerosis Self-Efficacy Scale (MSSE), the Herth Hope Index, Performance Scales, and a sociodemographic data sheet that included questions about previous use of immunomodulators and individuals considered most supportive of glatiramer acetate therapy.
The multinational randomized, double-blind placebo-controlled Phase III Glatiramer Acetate Low-frequency Administration (GALA) study examined the efficacy, safety and tolerability of an investigational formulation of glatiramer acetate 40 mg/1 ml administered three times a week compared to placebo in a randomized, double-blind placebo-controlled design in patients with RRMS.
For over a decade now, we have had the benefit of FDA-approved disease-modifying drugs: the beta interferons (Betaseron, Avonex, and Rebif), glatiramer acetate (Copaxone), and, more recently, mitoxantrone (Novantrone) All are injected under the skin, into muscle, or into a vein.
Abstract: The purpose of this study was to evaluate psychological, biophysical, and sociodemographic variables as predictors of adherence to glatiramer acetate (Copaxone) therapy in individuals with self-reported progressive forms of multiple sclerosis (MS).
Mapi" or the "Company"), a developer of high-barrier to entry and high value-added generic drugs, announced today that its US patent for the company's Glatiramer Acetate Depot has been extended until December 2030.