Observe patient during infusion & for 1 hr after completion of infusion; discontinue use & initiate appropriate therapy at the 1st symptoms or signs of hypersensitivity. Do not administer as bolus inj. Increased risk of PML. Recommended to perform serum anti-JVC Ab testing prior to therapy initiation or in patients receiving medicinal product w/ unknown Ab status; re-test of anti-JVC Ab -ve patients every 6 mth; re-test low index patients who have no history of prior immunosuppressant use every 6 mth once they reach 2 yr treatment point. Do not perform anti-JCV Ab testing w/in 2 wk of plasmapheresis/plasma exchange or w/in 6 mth of IVIg. Consider more frequent MRIs (eg, 3-6 mthly basis) using an abbreviated protocol in patients who have all 3 risk factors for PML (ie, anti-JCV Ab +ve, have received >2 yr of therapy & prior immunosuppressant therapy) or those w/ high anti-JCV Ab index who have received >2 yr of therapy & w/o prior history of immunosuppressant therapy. Frequently monitor patients switching from DMTs w/ an immunosuppressant effect. Consider PML as a differential diagnosis in any multiple sclerosis patient taking Tysabri presenting w/ neurological symptoms &/or new brain lesions in MRI. Suspend further dosing until PML has been excluded if PML or JCV granule cell neuronopathy is suspected; permanently discontinue treatment if PML develops. Monitor for development of immune reconstitution inflammatory syndrome. Discontinue use & administer appropriate treatment if herpes encephalitis or meningitis occurs. Permanently discontinue use if patient develops an opportunistic infection. Screen patients taking Tysabri presenting w/ eye symptoms (eg, decreased visual acuity, redness & painful eye) for acute retinal necrosis (ARN); discontinue use following clinical diagnosis of ARN. Concurrent treatment w/ immunosuppressants. CBC (including lymphocytes) is recommended prior to initiating Tysabri to ensure immune effects of previous therapy have resolved. Washout period should be sufficient for lymphocyte count to recover before treatment when switching from dimethyl fumarate. Potential concomitant immune effects when switching patients from teriflunomide. Prolonged immunosuppressive effects when initiating treatment after alemtuzumab therapy. Evaluate Abs presence & discontinue treatment if these remain +ve in a confirmatory test after at least 6 wk. Consider discontinuation of therapy if thrombocytopenia is identified. Possible thrombocytopenia including immune thrombocytopenic purpura; discontinue use if any signs of unusual or prolonged bleeding, petechiae or spontaneous bruising are observed. Natalizumab remains in the blood & has pharmacodynamic effects (eg, increased lymphocyte counts) for approx 12 wk following the last dose. Contains Na 52 mg/vial. Minor influence on the ability to drive & use machines; dizziness may occur. Renal & hepatic impairment. Monitor for impaired liver function & instruct patients to contact their physician in case signs & symptoms suggestive of liver injury occur (eg, jaundice & vomiting); discontinue use in cases of significant liver injury. Pregnancy; consider discontinuation if a woman becomes pregnant during treatment. Monitor platelet counts, Hb & haematocrit in neonates born to women exposed to natalizumab during pregnancy. Discontinue breast-feeding during treatment. Childn & adolescents ≤18 yr. Not recommended for use in elderly >65 yr.
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