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ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS › IMMUNOSUPPRESSANTS › IMMUNOSUPPRESSANTS › Monoclonal antibodies
natalizumab
L04AG03
Forms & Strengths
- Intravenous infusion: 300 mg/15 mL single-dose vial
Adult Dosing
- Multiple Sclerosis: 300 mg intravenously every 4 weeks
- Crohn's Disease: 300 mg intravenously every 4 weeks
Pediatric Dosing
- Safety and efficacy in pediatric patients below 18 years have not been established
Indications
- Relapsing-remitting multiple sclerosis, monotherapy
- Moderately to severely active Crohn's disease with evidence of inflammation in patients who have had an inadequate response to or are unable to tolerate conventional TNF inhibitors
Mechanism of Action
- Recombinant humanized monoclonal antibody that binds to alpha-4 integrin, inhibiting leukocyte adhesion and migration across the blood-brain barrier and into inflamed intestinal tissue
Contraindications
- Hypersensitivity to natalizumab or any of its excipients
- Presence of current or history of progressive multifocal leukoencephalopathy (PML)
- Concomitant use of immunosuppressants or TNF inhibitors
Adverse Reactions
- Progressive multifocal leukoencephalopathy (PML)
- Infusion-related reactions
- Infections (including opportunistic infections)
- Hepatotoxicity
- Depression
- Fatigue, headache, arthralgia
Drug Interactions
- Increased risk of PML and severe infections with concomitant immunosuppressants
- Increased risk of serious infections with concomitant TNF inhibitors
- Live vaccines should be avoided during and for 6 months after discontinuation
Curated Content: Needs Vetting Before Put to Clinical Use