Drug information of Natalizumab

Natalizumab

Drug group:

Natalizumab is a monoclonal antibody that affects the actions of the body's immunesystem. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage. Natalizumab is used to treat relapsing forms of multiple sclerosis

Mechanism of effect

: Exact mechanism of action is unknown; may inhibit interaction of alpha-4–expressing leukocytes with their ligands in the extracellular matrix and on parenchymal cells, thereby inhibiting further recruitment and inflammatory activity of activated immune cells

Pharmacodynamic

Binds to the α4-subunit of α4b 1 and α4b 7 integrins expressed on the surface of all leukocytes except neutrophils, and inhibits the α4-mediated adhesion of leukocytes to their counter-receptor(s).

Pharmacokinetics

Mean C max is approximately 101 mcg/mL (Crohn disease) and 110 mcg/mL (multiple sclerosis). After every 4 wk dosing, the time to steady state is approximately 16 to 24 wk. Vd is 5.2 to 5.7 L. The mean half-life is approximately 10 to 11 days; Cl is 16 to 22 mL/h.

Dosage

Adults IV 300 mg infused over 1 h every 4 wk

Alerts

1-Natalizumab therapy increases the risk of PML, an opportunistic viral infection of the brain that usually leads to death or severe disability. 2- Natalizumab is available only through a special restricted distribution program, and only prescribers, infusion centers, and pharmacies associated with registered infusion centers are able to prescribe, distribute, or infuse the product. 3-The product must only be administered to patients who are enrolled in and meet the conditions of the prescribing program. 4-Monitor patients for any new signs or symptoms suggestive of PML. Withhold natalizumab immediately at the first sign or symptom suggestive of PML

Points of recommendation

• For IV infusion only. Do not administer as an IV push or bolus injection. • Observe patient during infusion and for 1 h after infusion is complete. Promptly discontinue infusion upon the first signs or symptoms of a hypersensitivity reaction. • Each vial is intended for single use only. • Inspect vial for particulate material prior to dilution and administration. If particulates are observed or the liquid is discolored, do not use the vial. • Dilute in 100 mL of sodium chloride 0.9% injection. Upon dilution, gently invert solution to mixcompletely. Do not shake. • Instruct patient to immediately report any symptoms consistent with hypersensitivity during or following an infusion. • Inform patients that medication may lower the ability of their immune system to fight infections and to contact their health care provider if symptoms of infection develop. • Inform patients that medication may cause liver injury and to contact their health care provider if they develop symptoms of hepatotoxicity

Pregnancy level

C

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