travenous Infusion
Injection: 130 mg/26 mL (5 mg/mL) solution in a single-dose vial
4 CONTRAINDICATIONS
STELARA® is contraindicated in patients with clinically significant hypersensitivity to ustekinumab or to any of the excipients [see WARNINGS AND PRECAUTIONS (5.5)].
5 WARNINGS AND PRECAUTIONS
5.1 Infections
STELARA® may increase the risk of infections and reactivation of latent infections. Serious bacterial, fungal, and viral infections were observed in subjects receiving STELARA® [see ADVERSE REACTIONS (6.1)].
Serious infections requiring hospitalization occurred in patients with psoriasis, psoriatic arthritis and Crohn's disease in clinical studies. In patients with psoriasis, serious infections included diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis and urinary tract infections. In patients with psoriatic arthritis, serious infections included cholecystitis. In patients with Crohn's disease, serious or other clinically significant infections included anal abscess, gastroenteritis, ophthalmic herpes, pneumonia, and listeria meningitis.
Treatment with STELARA® should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of STELARA® in patients with a chronic infection or a history of recurrent infection.
Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur while on treatment with STELARA® and consider discontinuing STELARA® for serious or clinically significant infections until the infection resolves or is adequately treated.
5.2 Theoretical Risk for Vulnerability to Particular Infections
Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria (including nontuberculous, environmental mycobacteria), salmonella (including nontyphi strains), and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients.
It is not known whether patients with pharmacologic blockade of IL-12/IL-23 from treatment with STELARA® may be susceptible to these types of infections. Appropriate diagnostic testing should be considered, e.g., tissue culture, stool culture, as dictated by clinical circumstances.
5.3 Pre-treatment eva luation for Tuberculosis
eva luate patients for tuberculosis infection prior to initiating treatment with STELARA®.
Do not administer STELARA® to patients with active tuberculosis infection. Initiate treatment of latent tuberculosis prior to administering STELARA®. Consider anti-tuberculosis therapy prior to initiation of STELARA® in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed. Closely monitor patients receiving STELARA® for signs and symptoms of active tuberculosis during and after treatment.
5.4 Malignancies
STELARA® is an immunosuppressant and may increase the risk of malignancy. Malignancies were reported among subjects who received STELARA® in clinical studies [see ADVERSE REACTIONS (6.1)]. In rodent models, inhibition of IL-12/IL-23p40 increased the risk of malignancy [see NONCLINICAL T |
