Natalizumab
- Atc Codes:L04AA23
- CAS Codes:189261-10-7
- PHARMGKB ID:189261-10-7
Table of contents
- Brand Names
- Chemistry
- Pharmacologic Category
- Mechanism of Action
- Therapeutic Use
- Pregnancy and Lactation Implications
- Contraindications
- Warnings and Precautions
- Adverse Reactions
- Genes that may be involved
- Drug Interactions
- Dosage
- Pharmacokinetics and Pharmacodynamics
- Special Considerations
Brand Names
Europe
Austria: Tysabri; Belgium: Tysabri; Bulgaria: Tysabri; Cyprus: Tysabri; Czech Republic: Tysabri; Denmark: Tysabri; Estonia: Tysabri; Finland: Tysabri; France: Tysabri; Germany: Tysabri; Greece: Tysabri; Hungary: Tysabri; Ireland: Tysabri; Italy: Tysabri; Latvia: Tysabri; Lithuania: Tysabri; Luxembourg: Tysabri; Malta: Tysabri; Netherlands: Tysabri; Poland: Tysabri; Portugal: Tysabri; Romania: Tysabri; Slovakia: Tysabri; Slovenia: Tysabri; Sweden: Tysabri; UK: Tysabri.
North America
Canada: Tysabri; USA: Tysabri.
Drug combinations
Chemistry
Natalizumab: Immunoglobulin G~4~ (human-mouse monoclonal AN100226 4-chain anti-human integrin 4), disulfide with human-mouse monoclonal AN100226 light chain, dimer. CAS-189261-10-7.
Pharmacologic Category
Biologic Response Modifiers; Selective Adhesion-Molecule Inhibitor; Monoclonal Antibody. Gastrointestinal Agent (Miscellaneous). (ATC-Code: L04AA23).
Mechanism of action
A monoclonal antibody against α~4~ subunit of integrin molecules. Blocks integrin association with vascular receptors, limiting adhesion and transmigration of leukocytes. In multiple sclerosis, efficacy may be related to blockade of T-lymphocyte migration into CNS. In Crohn’s disease, natalizumab decreases inflammation by binding to α~4~ integrin, blocking adhesion and migration of leukocytes in gut.
Therapeutic use
Treatment of relapsing forms of multiple sclerosis. Treatment of moderately- to severely-active Crohn’s disease.
Pregnancy and lactiation implications
Teratogenic effects not reported in animal studies; however, decrease in fetus survival noted. Crosses placenta in animals. Mild anemia, decreased platelet counts, and other effects noted in offspring. There are no adequate, well-controlled studies in pregnant women. Use only if clearly needed. Not recommended in nursing women.
Unlabeled use
Contraindications
Hypersensitivity to natalizumab, murine proteins, or any component of the formulation. History of progressive multifocal leukoencephalopathy. Immune-compromised patients as result of immunosuppressants, antineoplastic therapy or immunodeficiencies.
Warnings and precautions
Hepatotoxicity, including transaminase and bilirubin elevation, reported. Severe reactions, including anaphylaxis, occur rarely. Infusion-related reactions may occur more frequently in patients with antibody to natalizumab. Use may be associated with increased risk of infections, including opportunistic infections (concurrent use of antineoplastic, immunosuppressant (including short course corticosteroids), or immunomodulating agents may increase this risk). Increased risk of developing fatal or disabling progressive multifocal leukoencephalopathy (concurrent immunomodulator therapy or immunosuppression may be risk factors). Natalizumab should not be used in combination with immunosuppressants or tumor necrosis factor inhibitors in Crohn’s disease. Aminosalicylates may be used concurrently with natalizumab. Use with caution in history of depression.