Description
Drug Info: ApoThera Drug Disease Clinical Support App
IV Administration
– If stored under refrigeration, allow solution to warm to room temperature prior to administration.
– Diluted solution should be infused over 1 hour; do not administer by IV bolus or push.
– Patients should be closely monitored for signs and symptoms of hypersensitivity during the infusion and for at least 1 hour after the infusion is complete.
– The infusion should be discontinued if a reaction occurs, and treatment of the reaction should be instituted.
– Following infusion, flush line with NS
IV Reconstitution
– Dilute natalizumab 300 mg in NS 100 mL to a final concentration of 2.6 mg/mL
– Gently invert to mix; do not shake
Storage
– Store concentrated solution under refrigeration between 2°C to 8°C (36°F to 46°F)
– Do not freeze
– Protect from light
– Do not shake
– Following dilution, may store refrigerated for use within 8 hours.
Monitoring
– Symptoms of hepatotoxicity (elevated serum transaminases, bilirubin)
– Hypersensitivity reactions during, and for 1 hour after, infusion
– Symptoms of persistent antibody-positivity (anxiety, dizziness, dyspnea, feeling cold, flushing, headache, hypertension, myalgia, nausea, pruritus, pyrexia, rigors, tachycardia, tremor, urticaria or, vomiting)
– Signs/symptoms of meningitis and encephalitis
– Signs/symptoms of acute retinal necrosis
– Radiographic signs of PML periodically
– Antibody testing is recommended if persistent antibodies are suspected and repeated in 3 months in all patients with documented positivity on initial test
– Consider antibody testing in patients that resume therapy following a period of dosage interruption
– Baseline brain MRI scan; if PML is suspected, obtain gadolinium-enhanced brain MRI scan and CSF analysis for JC viral DNA. Evaluate for signs or symptoms of progressive multifocal leukoencephalopathy during treatment and for 6 months after discontinuation
– Transient and reversible leukocytosis (excluding neutrophils) and mildly reduced hemoglobin may occur with treatment and may require ~4 months for return to baseline values after the last dose; anti-JCV antibody (prior to therapy and periodically during therapy).
