glatiramer acetate


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

See 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.

See 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.

See 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.