Europe — EMA
Otulfi (Ustekinumab)
GNH USA supplies Otulfi (Ustekinumab), a interleukin‑12/23 inhibitor for plaque psoriasis, psoriatic arthritis and Crohn’s disease.
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What is Ustekinumab?
Ustekinumab, the active ingredient in Otulfi, is a interleukin‑12/23 inhibitor presented as a sterile solution for subcutaneous injection use. It is indicated for the treatment of moderate to severe plaque psoriasis, psoriatic arthritis, and Crohn’s disease in adult patients. GNH USA supplies Otulfi as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Ustekinumab used for?
Ustekinumab targets key cytokine pathways involved in inflammatory disorders, providing therapeutic benefit across several disease areas.
Plaque psoriasis: reduces skin lesions and improves quality of life. Psoriatic arthritis: alleviates joint inflammation and slows disease progression. Crohn’s disease: induces and maintains remission of intestinal inflammation.
What are the side effects of Ustekinumab?
Adverse reactions may occur with ustekinumab therapy and are categorized by frequency and severity.
Common Side Effects: - Injection site pain or erythema - Upper respiratory tract infection - Headache - Diarrhea - Nausea - Fatigue
Serious or Rare Side Effects: - Severe infections (e.g., tuberculosis, opportunistic infections) - Malignancies (e.g., lymphoma, skin cancer) - Hypersensitivity reactions including anaphylaxis - Cardiovascular events such as myocardial infarction - New onset or worsening of inflammatory bowel disease - Neurological disorders (e.g., demyelinating disease)
What precautions apply to Ustekinumab?
Before initiating therapy, clinicians should assess patient history and monitor for potential complications.
Screen for latent infections: evaluate for tuberculosis and hepatitis before starting. Monitor infection signs: promptly treat any emerging infections. Assess malignancy risk: consider patient’s cancer history and ongoing surveillance. Vaccination status: administer required vaccines prior to treatment. Pregnancy and lactation: weigh benefits against potential risks; limited data available. Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.
What does Ustekinumab interact with?
Ustekinumab may interact with other agents that modulate the immune system, requiring careful management.
Major Interactions (Avoid): - Live vaccines: concurrent use can cause severe infection. - Systemic immunosuppressants (e.g., high‑dose corticosteroids) when combined may increase infection risk.
Moderate Interactions (Monitor Closely): - Other biologics (e.g., TNF inhibitors) used sequentially; monitor for overlapping immunosuppression. - Antifungal agents (e.g., azoles) that may affect infection susceptibility. - Concomitant use of immunomodulators (e.g., methotrexate) may require dose adjustments.



