Natalizumab
TYSABRI
What it isAlpha-4 integrin antibody blocking lymphocyte entry into the CNS; relapsing MS and Crohn disease.
Why this oneIt produces rapid, high-efficacy MS control by blocking immune-cell trafficking rather than broadly depleting lymphocytes.
What limits it⚑ Progressive multifocal leukoencephalopathy risk depends on JC virus antibody, prior immunosuppression, and duration; monitoring is mandatory.
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Relapsing forms of multiple sclerosis (monotherapy) | Adults | 300 mg IV over 1 hour q4wk | 300 mg IV q4wk | 300 mg IV q4wk |
| Moderately to severely active Crohn's disease (inadequate response/intolerance to conventional therapy and TNF-α inhibitors) | Adults | 300 mg IV over 1 hour q4wk | 300 mg IV q4wk | 300 mg IV q4wk |
Renal Undefined (pharmacokinetics not studied in renal insufficiency)
Hepatic Undefined (pharmacokinetics not studied in hepatic insufficiency)
Instructions
- 300 mg IV infusion over ~1 hour every 4 weeks; do not give as IV push or bolus
- Dilute in 100 mL 0.9% Sodium Chloride only; administer within 8 hours of preparation (use within 48 h if refrigerated)
- Observe during all infusions; observe 1 hour post-infusion for first 12 infusions
- In Crohn's disease, do not use with immunosuppressants or TNF-α inhibitors; discontinue if no benefit by 12 weeks
Contraindications
- Patients who have or have had progressive multifocal leukoencephalopathy (PML)
Cautions
- PML and JCV granule cell neuronopathy (see Boxed Warning)
- Herpes encephalitis, meningitis, and acute retinal necrosis — can be fatal or cause blindness
- Hepatotoxicity, including liver failure — discontinue if liver injury
- Serious hypersensitivity reactions including anaphylaxis — permanently discontinue
- Immunosuppression/increased infection risk
- Thrombocytopenia (including ITP); neonatal thrombocytopenia and anemia — obtain CBC in exposed neonates
- Immune reconstitution inflammatory syndrome (IRIS)
Adverse reactions
- Headache
- Fatigue
- Arthralgia
- Urinary tract infection
- Lower respiratory tract infection
- Gastroenteritis
- Depression
- Rash
- Nausea (Crohn's)
- Upper respiratory tract infection (Crohn's)
Pregnancy No adequate data; neonatal thrombocytopenia and anemia reported with 3rd-trimester exposure (obtain CBC in exposed neonates); animal studies show fetal hematologic/immunologic effects and increased abortions
Lactation Natalizumab detected in human milk; no data on effects on breastfed infant or milk production; weigh benefits vs. risk
⚠ BOXED WARNING
- Progressive multifocal leukoencephalopathy
Classes and tags
Clinical profile
Mechanism of action: Natalizumab ballicule
