GLATIRAMER ACETATE
| GLATIRAMER ACETATE (gla-tir'a-mer) Copaxone, Copolymer-1 Classifications: immunomodulator; Therapeutic:immunomodulator Pregnancy Category: B |
Availability
20 mg injection
Action
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.
Therapeutic Effect
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 sclerosis.
Uses
Reduction of the frequency of relapses in patients with relapsing–remitting multiple sclerosis.
Contraindications
Hypersensitivity to glatiramer acetate or mannitol. Safety and effectiveness in children <18 y of age have not been established.
Cautious Use
Immunosuppression, history of asthma or other respiratory disorders; pregnancy (category B), lactation.
Route & Dosage
| Multiple Sclerosis Adult: SC 20 mg q.d. |
Administration
Subcutaneous- 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), ecchymoses, lymphadenopathy, ear pain, dysmenorrhea, urinary urgency.Nursing Implications
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 sec–30 min), require no treatment, and resolve spontaneously.
- Notify physician of a planned or suspected pregnancy.
- Report any distressing adverse drug effects.
Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; 
Canadian drug name; 
Prototype drug