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Information about Ustekinumab

stekinumab is human monoclonal antibody to a polypeptide found on interleukin-12 and -23 that is used to treat autoimmune conditions and is approved for use in severe psoriasis.

Liver safety of Ustekinumab

Ustekinumab is associated with a low rate of serum enzyme elevations during therapy, but has not been linked to cases of idiosyncratic, clinically apparent liver injury. Ustekinumab has immunomodulatory activity and may cause reactivation of hepatitis B in susceptible patients.

Mechanism of action of Ustekinumab

Ustekinumab (us” te kin’ ue mab) is a human monoclonal immunoglobulin G1 antibody to the p40 subunit polypeptide of both interleukin (IL)-12 and -23, cytokines that are important mediators of autoimmune reactions. IL-12 and IL-23 are found in the skin lesions of psoriasis and in the affected gastrointestinal mucosa of patients with inflammatory bowel disease.

FDA approval information for Ustekinumab

Ustekinumab was approved for use in psoriasis United States in 2010, and current indications include moderate-to-severe plaque psoriasis and active psoriatic arthritis. Ustekinumab has been evaluated in other autoimmune diseases including Crohn disease, but does not have official approval for use in other conditions. Ustekinumab is available in liquid solution in single use vials and prefilled syringes of 45 and 90 mg (90 mg/mL) under the brand name Stelara.

Dosage and administration for Ustekinumab

The typical dose regimen is 45 mg subcutaneously initially, 4 weeks later and then every 12 weeks, with higher doses recommended for patients with plaque psoriasis who weigh 100 kilograms or more.

Side effects of Ustekinumab

Side effects are uncommon and are usually mild, but may include infusion reactions, chills, fever, skin rash, fatigue, leukopenia and infections. Less common, but potentially severe side effects include serious infections, reactivation of tuberculosis, increased risk of malignancies and reversible posterior leukoencephalopathy syndrome (RPLS).

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