ustekinumab, Stelara

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Pharmacy Author:

Omudhome Ogbru, PharmD

Omudhome Ogbru, PharmD

Dr. Ogbru received his Doctorate in Pharmacy from the University of the Pacific School of Pharmacy in 1995. He completed a Pharmacy Practice Residency at the University of Arizona/University Medical Center in 1996. He was a Professor of Pharmacy Practice and a Regional Clerkship Coordinator for the University of the Pacific School of Pharmacy from 1996-99.

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Medical and Pharmacy Editor:

Jay W. Marks, MD

Jay W. Marks, MD

Jay W. Marks, MD, is a board-certified internist and gastroenterologist. He graduated from Yale University School of Medicine and trained in internal medicine and gastroenterology at UCLA/Cedars-Sinai Medical Center in Los Angeles.

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GENERIC NAME: ustekinumab

BRAND NAME: Stelara

DRUG CLASS AND MECHANISM: Ustekinumab is an injectable biologic drug that suppresses the immune system and is used for the treatment of psoriasis. It is an antibody that binds to interleukin (IL)-12 and IL-23, two chemicals produced by cells in the body that stimulate immune reactions. Scientists believe that psoriasis is caused by an increase in the production of T-lymphocytes in response to the attachment of a stimulant, such as interleukin, to the lymphocyte. Stimulated T-lymphocytes cause skin cells to grow rapidly, and the rapid growth of the skin cells produces the skin plaques of psoriasis. Ustekinumab reduces symptoms of psoriasis (inflammation and excessive production of skin cells) by attaching to IL-12 and IL-23, preventing them from binding and activating T-lymphocytes. In scientific studies, 59% to 73% of patients received an assessment of cleared or minimal psoriasis after 12 weeks of treatment. Ustekinumab was approved by the FDA in September 2009.

PRESCRIPTION: Yes

GENERIC AVAILABLE: No

PREPARATIONS: Single use vials: 45 mg/0.5 ml and 90 mg /1 ml.

STORAGE: Ustekinumab should be refrigerated between 2 and 8 C (36 and 46 F). It should not be frozen and should be kept in its original carton to protect it from light until the time of administration.

PRESCRIBED FOR: Ustekinumab is used for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or medications that are absorbed into the blood stream (systemic therapy).

DOSING: Ustekinumab is injected under the skin.

• Patients weighing <100 kg (220 lbs) should receive 45 mg initially, 45 mg 4 weeks later then 45 mg every 12 weeks.
• Patients weighing >100 kg (220 lbs) should receive 90 mg initially, 90 mg 4 weeks later then 90 mg every 12 weeks.

DRUG INTERACTIONS: Drug interaction studies have not been conducted with ustekinumab; however, since ustekinumab suppresses the immune system, it should not be used with other drugs that also suppress the immune system.

Live vaccines should not be administered to patients treated with ustekinumab because they may develop active disease from the live viruses contained in the vaccine because of their weakened immune system. Vaccine containing killed virus may not generate an adequate immune response because ustekinumab suppresses the immune system.

PREGNANCY: Use of ustekinumab during pregnancy has not been evaluated.

NURSING MOTHERS: Use of ustekinumab by nursing mothers has not been adequately evaluated. Other proteins similar to ustekinumab are excreted in human milk. Therefore, ustekinumab may be excreted in human milk.

SIDE EFFECTS: The most common side effects of ustekinumab are tiredness, upper respiratory tract infections, and headaches. Ustekinumab may reduce the ability the immune system to fight infections, increasing the risk of infections such as tuberculosis (TB), and infections caused by bacteria, fungi, or viruses. Ustekinumab also may increase the risk of certain types of cancer and cause posterior leukoencephalopathy syndrome (RPLS). RPLS is a rare condition that affects the brain and can cause death. The cause is unknown but if detected early and treated, most people recover. Symptoms may include headache, seizures, confusion, and vision problems.

REFERENCE: Stelara Prescribing Information, September 2009

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