| GLATIRAMER ACETATE
Classifications: immunomodulator; Therapeutic:immunomodulator
Pregnancy Category: B
20 mg injection
Glatiramer is a random synthetic copolymer of L-alanine, L-glutamic acid, L-lysine, and L-tyrosine. It modifies immune processes that are responsible for the pathogenesis of multiple sclerosis.
Its function is to reduce the relapse rate of multiple sclerosis (MS), a demyelinating disease of the CNS of unknown origin.
During an autoimmune response, glatiramer is thought to divert immune cells away from their myelin target as occurs in multiple
Reduction of the frequency of relapses in patients with relapsingremitting multiple sclerosis.
Hypersensitivity to glatiramer acetate or mannitol. Safety and effectiveness in children <18 y of age have not been established.
Immunosuppression, history of asthma or other respiratory disorders; pregnancy (category B), lactation.
Route & Dosage
Adult: SC 20 mg q.d.
- Use recommended SC injection sites: Arms, abdomen, hips, and thighs.
- Reconstitute with supplied diluent, swirl gently, let stand at room temperature until completely dissolved, then use immediately.
- Do not store reconstituted drug. Before reconstitution, store vials at 20° to 10° C (4°
to 14° F).
Adverse Effects (≥1%)Body as a Whole: Asthenia, back pain,
chills, facial edema, fever, flu-like syndrome, infection, pain, arthralgia. CNS:
Migraine, agitation, anxiety, hypotonia
. CV: Chest pain, palpitations,
syncope, tachycardia, vasodilation
. GI: Diarrhea, nausea,
anorexia, gastroenteritis, vomiting. Respiratory: Dyspnea, rhinitis, bronchitis
. Skin: Rash, pruritus, sweating. Other: Postinjection reaction (flushing, chest pain, palpitations, anxiety, dyspnea, constriction of throat, urticaria), injection
site reactions (erythema, hemorrhage, pain, pruritus, urticaria, swelling),
ear pain, dysmenorrhea, urinary urgency.
Assessment & Drug Effects
- Monitor for therapeutic effectiveness: Indicated by longer remission periods and reduced frequency of attacks.
- Assess for systemic postinjection reactions (see PATIENT & FAMILY EDUCATION). Assure patient that reaction is self-limiting. Assess for local reactions at injection sites including erythema, itching,
induration, and soreness.
- Monitor for S&S of compromised immune response (e.g., increasing frequency of infections).
Patient & Family Education
- Note: Systemic postinjection reaction with chest pain, palpitations, flushing, urticaria, anxiety, dyspnea, and laryngeal constriction
may occur immediately after injection. These symptoms are transient (lasting from 30 sec30 min), require no treatment,
and resolve spontaneously.
- Notify physician of a planned or suspected pregnancy.
- Report any distressing adverse drug effects.