What are the precautions for Ustekinumab?

In clinical studies of ustekinumab (Ustekinumab), warnings and precautions such as infection, malignant tumors, allergic reactions, posterior reversible encephalopathy syndrome, and non-infectious pneumonia have emerged. Before initiating ustekinumab treatment, assess the patient for tuberculosis infection and do not use ustekinumab in patients with active tuberculosis infection. Monitor patients receiving ustekinumab closely for signs and symptoms of active tuberculosis during and following treatment.

1. Infection: May increase the risk of infection and reactivation of latent infection. Serious bacterial, mycobacterial, fungal, and viral infections have occurred in patients receiving ustekinumab. Treatment with ustekinumab should not be initiated in patients with any clinically important active infection until the infection has resolved or been adequately treated. If a patient develops signs or symptoms suggestive of infection while receiving ustekinumab, patients should be instructed to seek medical advice and consider discontinuing ustekinumab due to serious or clinically significant infection until the infection resolves or is adequately treated.

2. Malignant tumors: Ustekinumab is an immunosuppressant and may increase the risk of malignant tumors. In rodent models, inhibition of IL-12/IL-23p40 increases the risk of malignancy. There have been postmarketing reports of the rapid development of multiple cutaneous squamous cell carcinomas in patients treated with ustekinumab who had preexisting risk factors for non-melanoma skin cancers. All patients treated with ustekinumab should be monitored for non-melanoma skin cancer. Patients older than 60 years of age, patients with a history of long-term immunosuppressive therapy, and patients with a history of PUVA therapy should be followed closely.

3. Anaphylaxis: Anaphylaxis, including anaphylaxis and angioedema, has been reported with ustekinumab. If anaphylaxis or other clinically significant hypersensitivity reactions occur, appropriate treatment should be instituted and ustekinumab should be discontinued.

4. Posterior reversible encephalopathy syndrome (PRES): Also known as reversible posterior leukoencephalopathy syndrome (RPLS). Cases have also been reported in postmarketing experience in patients with psoriasis, psoriatic arthritis, and Crohn's disease. Clinical manifestations include headache, seizures, confusion, visual disturbances, and radiographic changes in the days to months after initiation of ustekinumab treatment. A few cases have reported incubation periods of one year or longer. After ustekinumab was discontinued, the patient recovered with supportive care. Monitor all treated patients for signs and symptoms of PRES. If PRES is suspected, initiate appropriate treatment immediately and discontinue ustekinumab.

5. Non-infectious pneumonia: During post-approval use of ustekinumab, cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported. After one to three doses, clinical manifestations include cough, dyspnea, and interstitial infiltrates. Serious consequences include respiratory failure and prolonged hospitalization. Patients improved after discontinuation of treatment and, in some cases, administration of corticosteroids. If confirmed, discontinue ustekinumab and initiate appropriate treatment.

6. Immunizations: Before starting ustekinumab treatment, patients should receive all age-appropriate immunizations recommended by current immunization guidelines. Patients receiving treatment should not receive live vaccines. BCG vaccine should not be given during treatment with ustekinumab or one year before starting treatment or one year after stopping treatment. Caution is recommended when administering live vaccines to household contacts of patients receiving ustekinumab due to the potential risk of shedding from household contacts and transmission to the patient.