Names and pronunciation
(glah-tear′a-meer) Copaxone, Glatopa, Glatect
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Drug reference
(glah-tear′a-meer) Copaxone, Glatopa, Glatect
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Func. class.: Multiple sclerosis agent
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Chem. class.: Biologic response modifier
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ACTION: Unknown; may modify the immune responses responsible for multi- ple sclerosis (MS) by serving as a decoy to locally generated autoantibodies
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USES: Reduction of the frequency of relapses in patients with relapsing or remitting MS after first clinical episode with MRI results consistent with MS
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CONTRAINDICATIONS: Hyper- sensitivity to this product or mannitol, IV use Precautions: Pregnancy, breastfeeding, children <18 yr, immune disorders, renal disease, infection, vaccinations, geriatric patients
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SIDE EFFECTS CNS: Anxiety, hypertonia, tremor, ver- tigo, speech disorder, agitation, confu- sion, flushing CV: Migraine, palpitations, syncope, tachycardia, vasodilation, chest pain, hypertension EENT: Ear pain, blurred vision GI: Nausea, vomiting, diarrhea, anorexia, gastroenteritis GU: Urinary urgency, dysmenorrhea, vaginal moniliasis, vaginal hemorrhage HEMA: Ecchymosis, lymphadenopathy INTEG: Pruritus, rash, sweating, urti- caria, erythema, inj-site reaction META: Edema, weight gain MS: Arthralgia, back pain, neck pain, increased muscle tone RESP: Bronchitis, dyspnea, laryngis- mus, rhinitis, laryngospasm
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INTERACTIONS Increase: serious infection—denosumab, natalizumab, roflumilast; avoid using together Increase: hematologic toxicity (paneyto- penia, thrombocytopenia)—leflunomide • Avoid use with live virus vaccines Increase: neutropenia effect—trastu- zumab G Increase: immunosuppression—tofaci- tinib, avoid use Drug/Herb Decrease: glatiramer effect—echinacea, may need dosage change
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DOSAGE AND ROUTES • 20 mg/mL and 40 mg/mL are not inter- changeable • Adult: SUBCUT 20 mg/day or 40 mg 3 × per wk, give ≥48 hr apart
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Available forms: Inj premixed 20 mg/ mL in single-use syringe; sol for inj 40 mg/mL
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Administer: SUBCUT route • Refrigerate, allow to warm for 20 min; visually inspect for particulate or cloudi- ness; if present, discard; prefilled syringe contents are for single use; administer SUBCUT into hip, thigh, arm; discard unused portion; if refrigeration is un- available, may store ≤1 mo at room temperature • Use SUBCUT route only; do not give IM or IV, do not expel air bubble in prefilled syringe • Give 40-mg dose on same 3 days of the week, must be 48 hr apart
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Assess: • CNS symptoms: anxiety, confusion, vertigo • GI status: diarrhea, abdominal pain/ cramps, vomiting • CV status: B/P, pulse, HR; tachycardia, palpitations, vasodilation, and chest pain may occur • Postinjection reactions: Assess for chest pain, dyspnea, flushing, palpita- tions, usually resolve on their own, may occur quickly or several months after use; usually at least one episode of chest pain occurs 1 mo after start of therapy • Pregnancy/breastfeeding: use only if clearly needed; no well-controlled stud- ies; cautious use in breastfeeding
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Evaluate: • Therapeutic response: decreased symptoms of MS
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • With written, detailed instructions about product; provide initial and return demonstrations on inj procedure; give information about use and disposal of product, inj-site reaction (hives, rash, ir- ritation, severe pain, flushing, chest pain) • To notify prescribers of allergic reac- tions including itching, trouble breath- ing, chest pain, dizziness, sweating • That irregular menses, dysmenorrhea, metrorrhagia, breast pain may occur; to use contraception during treatment • To notify prescriber if pregnancy is suspected or if nursing • Not to change dosing or stop taking product without advice of prescriber • About immediate postinjection reaction: flushing, chest pain, palpitations, anxiety, dyspnea, laryngeal constriction, urticaria; does not usually require treatment, may occur months after beginning treatment • To take as directed; not to stop product or change schedule; teach on self- injection technique • That the 20 mg/mL and 40 mg/mL are not interchangeable
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PHARMACOKINETICS May be hydrolyzed locally, may reach regional lymph nodes
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• Adult: SUBCUT 20 mg/day or 40 mg 3 × per wk, give ≥48 hr apart
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