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.
Dilute in 100 mL of NaCl 0.9% to a final concentration of 2.6 mg/mL.
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.
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.
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.
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.
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.
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.
Store between 2-8°C. Protect from light. Do not freeze.