What blood tests are needed for Stelara?

• Baseline tests required before Stelara administration include a comprehensive metabolic panel, a complete blood count and a hepatitis panel; tuberculosis screening; and possibly antibody tests if vaccination status is unknown or uncertain.
• Ongoing monitoring tests depend on risk factors but may include a comprehensive metabolic panel and complete blood count every 3 to 6 months, and TB, hepatitis, or HIV screening in those with risk factors.

Stelara (ustekinumab) is a targeted treatment that reduces inflammation and may be used in the treatment of:

• Plaque psoriasis in adults and children who are at least 6 years old
• Psoriatic arthritis in adults, sometimes in combination with methotrexate
• Active psoriatic arthritis in children who are at least 6 years old
• Moderate-to-severe Crohn's disease in adults after other medicines have failed
• Moderate-to-severe ulcerative colitis in adults.

Stelara is administered by injection, under the skin (subcutaneous). The dosage and frequency of administration depend on the condition being treated. After appropriate training, people can be taught how to self-administer Stelara or caregivers shown how to give it to another person.

What initial blood tests are required before Stelara is given?

Because Stelara suppresses your immune system response, your physician should follow a diligent screening process before initiating it.

This is because Stelara can increase the risk of infection or precipitate symptoms of an infection that has been asymptomatic. It can also affect certain blood cells and organs in your body, although this has only happened rarely.

Baseline laboratory tests allow doctors to see any changes that occur due to starting a new treatment. Tests that should be performed include:

• A comprehensive metabolic panel that includes liver function tests
• A complete blood count
• A hepatitis panel
• Tuberculosis screening
• Antibody tests for certain vaccine-preventable conditions, if a person’s vaccination status is unknown.

Before starting treatment with Stelara, patients should have received all their appropriate immunizations for their age as recommended by National guidelines.

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What ongoing monitoring tests are required once Stelara has been initiated?

Ongoing monitoring tests that are suggested for biologics, such as Stelara include:

• Every 3 to 6 months: a comprehensive metabolic panel and complete blood count in people without risk factors for liver disease. More frequent monitoring is recommended for those with liver disease
• Regular hepatitis screening in patients with elevated liver tests or risk factors at baseline
• Regular HIV testing if risk factors are present
• Annual tuberculosis screening particularly in people at high risk of TB exposure (such as health care workers and those who have traveled to endemic areas).

How does Stelara work?

Stelara (ustekinumab) is a monoclonal antibody. Monoclonal antibodies are man-made proteins that act like human antibodies in the immune system. They are a type of “targeted” treatment. Targeted treatments attach only to specific proteins in the body.

Stelara binds to the p40 protein subunit that is used by two cytokines, IL-12 and IL-23. Cytokines are signaling substances that help control immunity, inflammation, and the manufacture of blood cells.

By binding to this protein, Stelara disrupts the interaction of these two cytokines which have been identified as being important contributors to chronic inflammation that is a hallmark of Crohn’s disease and ulcerative colitis. These cytokines are also present in skin lesions associated with psoriasis and in the joints of people with psoriatic arthritis.

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