Stelara 90mg-IN (Ustekinumab PFS) 90mg/1ml

Stelara 90mg-IN acts on the interleukin-12 and interleukin-23 pathways, which are involved in inflammatory and autoimmune diseases. It is used to treat the following conditions:

• Moderate to severe plaque psoriasis: Reduces the severity and extent of skin lesions and improves overall skin condition.
• Psoriatic arthritis: Helps manage joint inflammation and pain associated with psoriatic arthritis.
• Crohn's disease: Reduces symptoms and induces clinical remission in patients with moderate to severe Crohn's disease.

• Ustekinumab, the active ingredient in Stelara 90mg-IN, is a fully human monoclonal antibody that binds to the p40 subunit of interleukin-12 and interleukin-23. By inhibiting these cytokines, ustekinumab prevents their interaction with cell surface receptors, thereby modulating inflammatory pathways involved in the pathogenesis of psoriasis, psoriatic arthritis, and Crohn's disease.

Stelara 90mg-IN may cause side effects, which can be categorized as common or serious.

Common Side Effects

• Injection site reactions: Redness, pain, or swelling at the injection site.
• Upper respiratory infections: Symptoms such as nasal congestion, runny nose, and sore throat.
• Headache: Mild to moderate headaches.
• Fatigue: General tiredness or lack of energy.
• Nausea: Feeling sick to the stomach.
• Diarrhea: Loose or watery stools.
• Back pain: Discomfort or pain in the back.
• Sinusitis: Inflammation of the sinuses.

Serious or Rare Side Effects

• Serious infections: Increased risk of infections, including tuberculosis and opportunistic infections.
• Allergic reactions: Severe allergic reactions, including anaphylaxis, angioedema, and urticaria.
• Lymphoma and other malignancies: Increased risk of certain cancers, including lymphoma and skin cancer.
• Reversible posterior leukoencephalopathy syndrome (RPLS): A rare but serious condition that can cause seizures, headaches, and vision problems.

Stelara 90mg-IN should be used with caution in certain patient populations and conditions. Precautions include:

• Infections: Patients with active infections should not receive Stelara 90mg-IN. It should be used with caution in patients with a history of chronic or recurrent infections.
• Tuberculosis: Patients should be tested for tuberculosis before starting treatment with Stelara 90mg-IN. If latent tuberculosis is detected, appropriate treatment should be initiated before starting Stelara 90mg-IN.
• Immunosuppression: Stelara 90mg-IN may increase the risk of infections and malignancies. It should be used with caution in patients with a history of immunosuppression or those receiving immunosuppressive therapy.
• Hypersensitivity: Patients with a history of hypersensitivity to ustekinumab or any of the excipients should not receive Stelara 90mg-IN.
• Pregnancy: The safety of Stelara 90mg-IN during pregnancy has not been established. It should be used during pregnancy only if the potential benefits outweigh the potential risks.
• Breastfeeding: It is not known whether ustekinumab is excreted in human milk. Caution should be exercised when administering Stelara 90mg-IN to breastfeeding women.
• Store at 2-8°C: Keep refrigerated, protect from light, do not freeze or shake.

Stelara 90mg-IN may interact with other medications, which can be categorized as major or moderate interactions.

Major Interactions (Avoid)

• Live vaccines: Avoid the use of live vaccines during treatment with Stelara 90mg-IN, as it may increase the risk of infections.
• Immunosuppressants: Avoid concomitant use of other immunosuppressants, as it may increase the risk of infections and malignancies.
• Biologics: Avoid concomitant use of other biologics, as it may increase the risk of infections and other adverse effects.

Moderate Interactions (Monitor Closely)

• Corticosteroids: Monitor patients closely for signs of infections and other adverse effects when used concomitantly with Stelara 90mg-IN.
• Methotrexate: Monitor patients closely for signs of infections and other adverse effects when used concomitantly with Stelara 90mg-IN.
• Azathioprine: Monitor patients closely for signs of infections and other adverse effects when used concomitantly with Stelara 90mg-IN.