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Pharmacologic class: Immunomodulator
Therapeutic class: Multiple sclerosis agent
Pregnancy risk category B
Unknown. Thought to alter immune processes believed to be responsible for pathogenesis of multiple sclerosis.
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
• Hypersensitivity to drug
Use cautiously in:
• pregnant or breastfeeding patients
• children (safety and efficacy not established).
• Give only by subcutaneous injection into arms, abdomen, hips, or thighs.
• Administer immediately after preparing. Discard unused portion.
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
☞ 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.
• 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.