Drug reference

Natalizumab

Monoclonal Antibody · Multiple Sclerosis and Inflammatory Bowel Disease Agent

Also known as TYSABRI

Monoclonal AntibodyMultiple Sclerosis and Inflammatory Bowel Disease Agent

CDSCO approvedSchedule H

EXCRETION

—

not curated

INTERACTIONS

12 major

SEVERE in our sources

PREGNANCY

—

not curated

Top interactionssee all 12 →

AbataceptSevereDatabaseDDInter
AbemaciclibSevereDatabaseDDInter
AcalabrutinibSevereDatabaseDDInter
AdalimumabSevereDatabaseDDInter

Mechanism

Natalizumab is a humanized IgG4 monoclonal antibody that binds to the α4-subunit of α4β1 and α4β7 integrins expressed on activated lymphocytes and monocytes. It inhibits α4-mediated adhesion of leukocytes to their cognate receptors. This action interferes with T-cell adhesion to the endothelium, blocking T-cell trafficking into the CNS and reducing inflammation.

Indications

Moderate to severe active ulcerative colitis in patients who have had an inadequate response with, lost response to, or are intolerant to either conventional therapy or a tumour necrosis factor alpha inhibitorModerate to severe active Crohn’s disease in patients who have had an inadequate response with, lost response to, or are intolerant to either conventional therapy or a tumour necrosis factor alpha inhibitorRelapsing-remitting multiple sclerosis (RRMS)Multiple sclerosis in patients who have not tolerated or had inadequate responses to conventional treatmentsCrohn’s disease in patients who have not tolerated or had inadequate responses to conventional treatmentslimiting new neuroinflammatory lesion formation in relapsing-remitting multiple sclerosisMultiple sclerosisCrohn's diseaserelapsing-remitting msactive, secondary progressive msmoderate to severe crohn’s disease that does not adequately respond to conventional therapies or tnfα inhibitorsinduction and maintenance of remission in moderate-to-severe Crohn’s disease in adults with inadequate response to TNF-α antagonists or other traditional therapies

Dosing

Adult: By intravenous infusion: Initially 300 mg, then 300 mg after 2 weeks, followed by 300 mg after 4 weeks, followed by 300 mg every 8 weeks. Each dose should be given over 30 minutes. For Crohn's disease, if no response is observed, an additional dose of 300 mg may be given 10 weeks after the initial dose. If treatment is interrupted or response decreases, dosing frequency may be increased.

Contraindications

Severe active infection
Controlled chronic severe infection
History of recurring severe infection
Previous treatment with rituximab
Concomitant use with anti-TNF-α drugs
patients who have or have had pml
immunodeficiency
immunosuppressed patients (due to possible increased risk of progressive multifocal leukoencephalopathy)

Side effects

Common

ArthralgiaConstipationCoughFatigueFeverGastrointestinal discomfortGastrointestinal disordersHeadacheHypertensionIncreased risk of infectionMuscle spasmsMuscle weaknessNasal congestionNauseaNight sweatsOropharyngeal painPainParaesthesiaSkin reactionsChillsFeeling coldhepatotoxicity

Serious

Progressive multifocal leukoencephalopathy (PML)
Hypersensitivity reactions
Infusion related reaction
significant increase the risk of progressive multifocal leukoencephalopathy (pml)
increased risk of developing herpes encephalitis and meningitis
progressive multifocal leukoencephalopathy (PML, an often lethal viral infection)