Stelara

About Ustekinumab or Stelara

Ustekinumab or Stelara, Interleukin (IL) 12 – IL 23 antagonist prescribed to treat patients with cases including:

• Moderate to severe plaque psoriasis for candidates undergoing phototherapy.
• Adults with active psoriatic arthritis, with or without the use of the drug methotrexate.
• Individuals with moderately to severely active Crohn’s disease who have tried other medications without results.
• Individuals with moderately to extremely active ulcerative colitis who have tried various medications without results.

Strength: 

• 130 mg/26 mL (5 mg/mL) solution in a single-dose vial for intravenous infusion.
• 45 mg/0.5 mL in a single-dose vial and  45 mg/0.5 mL or 90 mg/mL in a single-dose prefilled syringe for subcutaneous infusion. 

Recommended Dosage 

The dosage of Ustekinumab may vary based on the patient’s weight. 

Psoriasis Adult

• In adult Psoriasis with weight under 100 kgs, initial subcutaneous administration of 45 mg, followed by subcutaneous administration of 45 mg every 4 weeks for the next 12 weeks.
• In adult Psoriasis with weight greater than 100 kgs, Initial subcutaneous administration of 90 mg, followed by subcutaneous administration of 90 mg every 4 weeks for the next 12 weeks.

Psoriasis Adolescent

It is advised to administer medications for Psoriasis Adolescent (12 years and older) depending on weight at the first dose, 4 weeks later, and then every 12 weeks after that.

• 0.75 mg/kg for weight less than 60 kgs, 45 mg for weight between 60-100 kgs, and 90 mg for greater than 100 kgs with subcutaneous administration. 

Adult Psoriatic Arthritis

• The recommended dosage is 45 mg delivered subcutaneously initially, followed by 4 weeks later, and then every 12 weeks after that. 
• The suggested dosage is 90 mg taken subcutaneously initially and 4 weeks later, followed by 90 mg administered subcutaneously every 12 weeks, for patients with co-existing moderate-to-severe plaque psoriasis who weigh more than 100 kg.

Crohn’s Disease

• The recommended intravenous dosage recommendation for Crohn’s disease is 260 mg (2 vials) for patients with weight up to 55 kg
• 390 mg (3 vials) for patients with weight between 55-85 kg
• 520 mg (4 vials) for patients with weight greater than 85 kg. 

Important: In case of severe effects of the medication, kindly connect with your doctor. 

Warnings & Precautions

• ustekinumab should not be used to treat any clinically significant active infection. Discontinue the use of ustekinumab if a major infection or clinically significant infection appears until the infection clears itself. 
• Mycobacteria, salmonella, and Bacillus Calmette-Guerin (BCG) immunizations have all been linked to serious illnesses in people who are genetically weak in IL-12/IL-23. Consider diagnostic tests for these infections when warranted by the clinical situation. 
• Check for TB in patients before starting ustekinumab medication. Start latent TB treatment before taking ustekinumab. 
• There might be higher risks of cancer. It has not been determined whether ustekinumab is safe for use in patients with a history of or known cancer.
• It’s possible to experience anaphylaxis or other clinically serious hypersensitivity events after taking ustekinumab. 
• In the case of Leukoencephalopathy Syndrome, the patient must discontinue the use of ustekinumab and treat it immediately. 
• During the post-approval usage of ustekinumab, cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been recorded. Discontinue the use of ustekinumab if the diagnosis is confirmed, and start the recommended treatments.

Common ustekinumab Side Effects

• Nasopharyngitis
• Upper respiratory tract infection
• Headache
• Fatigue
• Vomiting

Severe Reactions of ustekinumab

• There might be a high risk of certain infections.
• Patients may also experience decreased immune system activity and a high risk of certain cancer types. 

Storage & Handling 

The diluted infusion solution may be kept at room temperature up to 25°C (77°F) for up to 4 hours. Avoid freezing. Any unused infusion solution should be thrown away.