STELARA ® is an immunosuppressant and may increase the risk of malignancy. Closely monitor patients receiving STELARA ® for signs and symptoms of active TB during and after treatment. Initiate treatment of latent TB before administering STELARA ®. Do not administer STELARA ® to patients with active tuberculosis infection. Pre-Treatment Evaluation of Tuberculosis (TB)Įvaluate patients for TB prior to initiating treatment with STELARA ®. Appropriate diagnostic testing should be considered (eg, tissue culture, stool culture) as dictated by clinical circumstances. 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. Serious infections and fatal outcomes have been reported in such patients. Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria, Salmonella, and Bacillus Calmette-Guerin (BCG) vaccinations. Theoretical Risk for Vulnerability to Particular Infections 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. 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. Treatment with STELARA ® should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. In patients with ulcerative colitis, these included gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeriosis. In patients with Crohn’s disease, these included anal abscess, gastroenteritis, ophthalmic herpes zoster, pneumonia, and Listeria meningitis. In patients with psoriatic arthritis, this included cholecystitis. In patients with psoriasis, these included diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis, and urinary tract infections. Serious bacterial, mycobacterial, fungal, and viral infections requiring hospitalization or otherwise clinically significant infections were reported. STELARA ® may increase the risk of infections and reactivation of latent infections. STELARA ® (ustekinumab) is contraindicated in patients with clinically significant hypersensitivity to ustekinumab or to any of the excipients. Void where prohibited, taxed, or limited by law. Program good only in the United States and its territories. Patient cannot submit the value of the free product as a claim for payment to any health plan. Prescriber cannot bill commercial insurance plan for any part of the prescribed subcutaneous treatment. Program covers the cost of therapy only-not associated administration cost. Program requires periodic verification of insurance coverage status to confirm continued eligibility. Patient is eligible until commercial insurance covers the medication. Prior authorization is denied due to missing information on coverage determination form, use for a non–FDA-approved indication, or invalid clinical rationale Examples of these programs are Medicare, Medicaid, TRICARE, Department of Defense, and Veterans Administration Patient uses any state or federal government funded healthcare program to cover medication costs. If coverage is denied, Prescriber must also submit a Letter of Formulary Exception, Letter of Medical Necessity or appeal within 90 days of patient becoming eligible for patient to stay in the program. a coverage determination form (i.e., prior authorization or prior authorization with exception) to the commercial insurance. In addition, for patient to be eligible, Prescriber must submit: a delay of more than 5 business days or a denial of treatment from their insurance commercial insurance with biologics coverage a subcutaneous STELARA ® prescription for an on-label, FDA-approved indication Janssen Link offers eligible patients subcutaneous STELARA ® (ustekinumab) at no cost until their commercial insurance covers the medication.
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