Natalizumab


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IV Relapsing-remitting multiple sclerosis; Crohn’s disease 300 mg once every 4 weeks.
Dosage Details
Intravenous
Relapsing-remitting multiple sclerosis
Adult: As monotherapy: 300 mg via infusion over 1 hour once every 4 weeks. Discontinue use if no progress is shown after 6 months of treatment.

Intravenous
Crohn's disease
Adult: Moderate to severe, refractory cases: 300 mg via infusion over 1 hour once every 4 weeks. Discontinue use if no progress is shown within 12 weeks upon initiation of treatment.
Reconstitution
Dilute in 100 mL of NaCl 0.9% to a final concentration of 2.6 mg/mL.
Contraindications
Patient with or with history of progressive multifocal leukoencephalopathy (PML), active malignancies (except cutaneous basal cell carcinoma), active infection. Immunocompromised patients. Concomitant use of immunosuppressants, immunomodulator, antineoplastics, and TNF-α inhibitors.
Special Precautions
Patient with chronic infections, history of recurring infections and/or underlying conditions that may predispose them to develop infections, presence of anti-JCV antibodies. Hepatic impairment. Pregnancy and lactation.
Adverse Reactions
Significant: Hypersensitivity/antibody formation, immune reconstitution inflammatory syndrome (IRIS).
Blood and lymphatic system disorders: Anaemia, hyperbilirubinaemia.
GI disorders: Nausea, vomiting,
General disorders and admin site conditions: Fatigue. Fever, chills.
Immune system disorders: Urticaria.
Investigations: Increased ALT/AST.
Musculoskeletal and connective tissue disorders: Arthralgia, limb and back pain.
Nervous system disorders: Headache, dizziness.
Psychiatric disorders: Depression.
Renal and urinary disorders: UTI.
Resp, thoracic and mediastinal disorders: Upper and lower resp tract infection, nasopharyngitis.
Skin and subcutaneous tissue disorders: Rash.
Potentially Fatal: Anaphylaxis, hepatotoxicity, herpes infections (e.g. herpes encephalitis and meningitis, acute retinal necrosis; progressive multifocal leukoencephalopathy.
Patient Counseling Information
This drug may cause dizziness, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor LFT, eye examination results, and radiographic signs of PML periodically. Perform CBC and anti-JCV antibody testing prior to initiation and periodically during therapy. Monitor for any signs/symptoms of PML during treatment and 6 months after discontinuation and hypersensitivity reactions during and 1 hour after infusion.
Drug Interactions
Potentially Fatal: Increased risk of opportunistic infections with immunosuppressants (e.g. 6-mercaptopurine, azathioprine, ciclosporin, methotrexate), immunomodulators (e.g. interferon beta or glatiramer), antineoplastics, and TNF-α inhibitors.
Action
Description: Natalizumab is a recombinant humanised monoclonal antibody that selectively binds to the α-4 integrin molecules. It prevents the migration of leucocytes into the CNS and the gut, thus reducing frequency of relapse, inflammation, and demyelination.
Pharmacokinetics:
Distribution: Crosses the placenta and enters breast milk. Volume of distribution: Multiple sclerosis: 3.8-7.6 L; Crohn’s disease: 2.4-8 L.
Excretion: Elimination half-life: Multiple sclerosis: 7-15 days; Crohn’s disease: 3-17 days.
Chemical Structure

Click on icon to see table/diagram/image
Storage
Store between 2-8°C. Protect from light. Do not freeze.
MIMS Class
ATC Classification
L04AA23 - natalizumab ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
Disclaimer: This information is independently developed by MIMS based on Natalizumab from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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