Stelara Special Precautions

Infections: Ustekinumab (Stelara) is a selective immunosuppressant and may have the potential to increase the risk of infections and reactivate latent infections.
In clinical studies, serious bacterial, fungal, and viral infections have been observed in patients receiving Ustekinumab (Stelara).
Ustekinumab (Stelara) should not be given to patients with a clinically important, active infection. Caution should be exercised when considering the use of Ustekinumab (Stelara) in patients with a chronic infection or a history of recurrent infection.
Prior to initiating treatment with Ustekinumab (Stelara), patients should be evaluated for tuberculosis infection. Ustekinumab (Stelara) should not be given to patients with active tuberculosis. Treatment of latent tuberculosis infection should be initiated prior to administering Ustekinumab (Stelara). Anti-tuberculosis therapy should also be considered prior to initiation of Ustekinumab (Stelara) in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed. Patients receiving Ustekinumab (Stelara) should be monitored closely for signs and symptoms of active tuberculosis during and after treatment.
Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops a serious infection they should be closely monitored and Ustekinumab (Stelara) should not be administered until the infection resolves (see Adverse Reactions).
Malignancies: Ustekinumab (Stelara) is a selective immunosuppressant. Immunosuppressive agents have the potential to increase the risk of malignancy. Some patients who received Ustekinumab (Stelara) in clinical studies developed cutaneous and noncutaneous malignancies (see Adverse Reactions).
Ustekinumab (Stelara) has not been studied in patients with a history of malignancy. Caution should be exercised when considering the use of Ustekinumab (Stelara) in patients with a history of malignancy or when considering continuing treatment in patients who develop a malignancy.
All patients, in particular those greater than 60 years of age, patients with a medical history of prolonged immunosuppressant therapy or those with a history of PUVA treatment, should be monitored for the appearance of non-melanoma skin cancer (see Adverse Reactions).
Hypersensitivity reactions: In post-marketing experience, serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported. If an anaphylactic or other serious hypersensitivity reaction occurs, institute appropriate therapy and administration of Ustekinumab (Stelara) should be discontinued (see Adverse Reactions).
Immunizations: It is recommended that live viral or live bacterial vaccines not be given concurrently with Ustekinumab (Stelara).
No data are available on the secondary transmission of infection by live vaccines in patients receiving Ustekinumab (Stelara). Caution is advised when administering some live vaccines to household contacts of patients receiving Ustekinumab (Stelara) because of the potential risk for shedding from the household contact and transmission to the patient.
Patients receiving Ustekinumab (Stelara) may receive concurrent inactivated or nonlive vaccinations.
Long-term treatment with Ustekinumab (Stelara) does not suppress the humoral immune response to pneumococcal polysaccharide or tetanus vaccines (see Pharmacology: Pharmacodynamics under Actions).
Immunosuppression: In psoriasis studies, the safety and efficacy of Ustekinumab (Stelara) in combination with immunosuppressive agents or phototherapy have not been evaluated. In psoriatic arthritis studies, concomitant MTX use did not appear to influence the safety or efficacy of Ustekinumab (Stelara). In Crohn's disease and ulcerative colitis studies, concomitant use of immunomodulators (6-mercaptopurine (6-MP), azathioprine (AZA), MTX) or corticosteroids did not appear to influence the safety or efficacy of Ustekinumab (Stelara). Caution should be exercised when considering concomitant use of immunosuppressive agents and Ustekinumab (Stelara) or when transitioning from other biologic agents.
Immunotherapy: Ustekinumab (Stelara) has not been evaluated in patients who have undergone allergy immunotherapy. Ustekinumab (Stelara) may affect allergy immunotherapy. Caution should be exercised in patients receiving or who have received allergy immunotherapy particularly for anaphylaxis.
General: The needle cover on the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in individuals sensitive to latex.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed.