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 BRAND NAMES
 MECHANISM OF ACTION
Ustekinumab is a monoclonal antibody that has been designed to attach to two cytokines (messenger molecules) in the immune system called interleukin 12 and interleukin 23. These cytokines are involved in the inflammation and other processes that cause psoriasis and psoriatic arthritis. By blocking their activity, ustekinumab reduces the activity of the immune system and the symptoms of the disease.
Ustekinumab is indicated for the treatment of adult patients (18 years or older) with
- Moderate to severe plaque psoriasis (Ps) that involves large areas or many areas of their body, who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills). In a medical study, 7 out of 10 people taking STELARA® saw at least 75% clearer skin at 12 weeks and 6 out of 10 people had their plaque psoriasis rated as cleared or minimal at 12 weeks. The European label recommends its use in patients who have not responded to or cannot use other systemic treatments for psoriasis, such as ciclosporin, methotrexate or PUVA (psoralen ultraviolet A). PUVA is a type of treatment where the patient receives a medicine containing a compound called a ‘psoralen’ before being exposed to ultraviolet light.
- Active psoriatic arthritis (PsA), alone or in combination with methotrexate. the European label recommends its use when the condition has not responded well enough to other treatments called disease-modifying antirheumatic drugs (DMARDs).
Ustekinumab (STELARA®) is a 45 mg or 90 mg injection given under the skin, at weeks 0, 4, and every 12 weeks thereafter. It is administered by a healthcare provider or self-injected only after proper training.
- For patients weighing ≤100 kg (220 lbs), the recommended dose is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks.
- For patients weighing >100 kg (220 lbs), the recommended dose is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.
- The recommended dose is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks.
- For patients with co-existent moderate-to-severe plaque psoriasis weighing >100 kg (220 lbs), the recommended dose is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks
Clinically significant hypersensitivity to ustekinumab or to any of the excipients.
 WARNINGS AND PRECAUTIONS
- Infections: Serious infections have occurred, which may require hospitalization, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses. Do not start STELARA® during any clinically important active infection. If a serious infection develops, stop STELARA® until the infection resolves.
- Theoretical Risk for Particular Infections: Serious infections from mycobacteria, salmonella and Bacillus Calmette-Guerin (BCG) vaccinations have been reported in patients genetically deficient in IL-12/IL-23. Diagnostic tests for these infections should be considered as dictated by clinical circumstances.
- Tuberculosis (TB): Evaluate patients for TB prior to initiating treatment with STELARA®. Initiate treatment of latent TB before administering STELARA®.
- Cancers: STELARA® may increase risk of malignancy. The safety of STELARA® in patients with a history of or a known malignancy has not been evaluated.
- Anaphylaxis or other clinically significant hypersensitivity reactions may occur.
- Reversible Posterior Leukoencephalopathy Syndrome (RPLS): One case was reported. If suspected, treat promptly and discontinue STELARA. RPLS is a rare condition that affects the brain and can cause death. The cause of RPLS is not known. If RPLS is found early and treated, most people recover. Tell your doctor right away if you have any new or worsening medical problems including: headache, seizures, confusion, and vision problems.
- Live vaccines: Live vaccines should not be given with STELARA®.
- Concomitant therapy: In psoriasis studies, the safety of concomitant use of STELARA® with immunosuppressants or phototherapy has not been evaluated.
 PREGNANCY AND LACTATION
 SIDE EFFECTS
Most common adverse reactions (incidence ≥3% and greater than with placebo): upper respiratory infections, headache, tiredness, joint pain and nausea.