Zuellig Pharma
Concise Prescribing Info
Single disease modifying therapy in highly active relapsing remitting multiple sclerosis in adults w/ high active disease despite full & adequate course of treatment w/ at least 1 disease modifying therapy (DMT) or w/ rapidly evolving severe relapsing remitting multiple sclerosis defined by ≥2 disabling relapses in 1 yr & w/ ≥1 gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
Dosage/Direction for Use
IV 300 mg infusion over 1 hr once every 4 wk.
Hypersensitivity. Progressive multifocal leukoencephalopathy (PML). Patients w/ increased risk of opportunistic infection including immunocompromised & those receiving immunosuppressive therapies or those immunocompromised by prior therapies. Concomitant use w/ other DMTs. Known active malignancies, except for patients w/ cutaneous basal cell carcinoma.
Special Precautions
Do not administer as bolus inj. Increased risk of PML. Do not perform anti-JCV Ab testing w/in 2 wk of plasmapheresis/plasma exchange due to removal of Ab from the serum or w/in 6 mth of IVIg. Consider more frequent MRI (eg, 3-6 mthly basis) in patients who have all 3 risk factors for PML (anti-JCV Ab positive, 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 differential diagnosis in any patient w/ multiple sclerosis taking Tysabri, who presents w/ neurological symptoms &/or new brain lesions in MRI. Permanently discontinue treatment if PML develops. Monitor for development of immune reconstitution inflammatory syndrome. Discontinue use if infections including opportunistic infections (eg, encephalitis & meningitis) develops. Screen for acute retinal necrosis in patients presenting w/ eye symptoms eg, decreased visual acuity, redness & painful eye. Discontinue administration at the 1st symptoms or signs of hypersensitivity. Concurrent or prior treatment w/ immunosuppressants. Potential concomitant immune effects when switching patients from teriflunomide. Not recommended to initiate treatment after alemtuzumab therapy. Evaluate presence of Abs & discontinue treatment if these remain positive in a confirmatory test after at least 6 wk. Patients on controlled Na diet. Monitor for signs & symptoms of liver injury (eg, jaundice & vomiting). May affect ability to drive & use machines. Pregnancy. Discontinue use during lactation. Childn & adolescents ≤18 yr. Not recommended for use in elderly >65 yr.
Adverse Reactions
UTI, nasopharyngitis; headache, dizziness; nausea; arthralgia; fatigue. Urticaria; vomiting; rigors, pyrexia.
Drug Interactions
CI in combination w/ other DMTs. Slightly slower & reduced humoral immune response to a neoantigen. Live vaccines.
MIMS Class
ATC Classification
L04AA23 - natalizumab ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
Tysabri inj 300 mg/15 mL
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