CONTRAINDICATIONS
YESINTEK is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients.
Infections
Ustekinumab products may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections were observed in patients receiving ustekinumab product.
Serious infections requiring hospitalization or otherwise clinically significant infections:
-
Plaque Psoriasis: diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis, and urinary tract infections.
- Psoriatic arthritis: cholecystitis.
-
Crohn’s disease: anal abscess, gastroenteritis, ophthalmic herpes
zoster, pneumonia, and Listeria meningitis.
-
Ulcerative colitis: gastroenteritis, ophthalmic herpes zoster,
pneumonia, and listeriosis.
Avoid initiating treatment with YESINTEK in patients with a clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of YESINTEK 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 YESINTEK and discontinue YESINTEK for serious or clinically significant infections until the infection resolves or is adequately treated.
Theoretical Risk for Vulnerability to Particular Infections:
Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria, salmonella, 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 ustekinumab may be susceptible to these types of infections. Consider appropriate diagnostic testing, e.g., tissue culture, stool culture, as dictated by clinical circumstances.
Pre-Treatment Evaluation of Tuberculosis (TB): Evaluate patients for TB prior to initiating treatment with YESINTEK.
Avoid administering YESINTEK to patients with active TB infection. Initiate treatment of latent TB before administering YESINTEK. Closely monitor patients receiving YESINTEK for signs and symptoms of active TB during and after treatment.
Malignancies: Ustekinumab products are immunosuppressants and may increase the risk of malignancy. Malignancies were reported among subjects who received ustekinumab in clinical trials.
The safety of ustekinumab products has not been evaluated in patients who have a history of malignancy or who have a known malignancy.
There have been reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving ustekinumab products who had risk factors for developing non-melanoma skin cancer (NMSC).
Monitor all patients receiving YESINTEK for the appearance of non-melanoma skin cancer. Closely follow patients greater than 60 years of age, those with a medical history of prolonged immunosuppressant therapy and those with a history of PUVA treatment.
Serious Hypersensitivity Reactions:
Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with ustekinumab products. Some serious hypersensitivity reactions have occurred during the first intravenous dose of ustekinumab products. If a severe or clinically significant hypersensitivity reaction occurs, discontinue YESINTEK immediately and initiate appropriate medical treatment.
Posterior Reversible Encephalopathy Syndrome (PRES):
Two cases of PRES, also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), were reported in clinical trials. Cases have also been reported in postmarketing experience in patients with psoriasis, psoriatic arthritis and Crohn’s disease. Clinical presentation included headaches, seizures, confusion, visual disturbances, and imaging changes consistent with PRES a few days to several months after ustekinumab product initiation. A few cases reported latency of a year or longer. Patients recovered with supportive care following withdrawal of ustekinumab products.
Monitor all patients treated with YESINTEK for signs and symptoms of PRES. If PRES is suspected, promptly administer appropriate treatment and discontinue YESINTEK.
Immunizations
Prior to initiating therapy with YESINTEK, patients should receive all age-appropriate immunizations as recommended by current immunization guidelines. Patients being treated with YESINTEK should avoid receiving live vaccines. Avoid administering BCG vaccines during treatment with YESINTEK or for one year prior to initiating treatment or one year following discontinuation of treatment. Caution is advised when administering live vaccines to household contacts of patients receiving YESINTEK because of the potential risk for shedding from the household contact and transmission to patient.
Non-live vaccinations received during a course of YESINTEK may not elicit an immune response sufficient to prevent disease.
Noninfectious Pneumonia
Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported during post-approval use of ustekinumab products. Clinical presentations included cough, dyspnea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalization. Patients improved with discontinuation of therapy and, in certain cases, administration of corticosteroids. If diagnosis is confirmed, discontinue YESINTEK and institute appropriate treatment.
Allergen Immunotherapy
Ustekinumab products may decrease the protective effect of allergen immunotherapy (decrease tolerance) which may increase the risk of an allergic reaction to a dose of allergen immunotherapy. Therefore, caution should be exercised in patients receiving or who have received allergen immunotherapy, particularly for anaphylaxis.
Most Common Adverse Reactions
-
Psoriasis and Psoriatic Arthritis: nasopharyngitis, upper respiratory tract infection, headache, and fatigue.
- Crohn’s Disease, induction: vomiting. .
- Crohn’s Disease, maintenance: nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis.
- Ulcerative colitis, induction: nasopharyngitis.
- Ulcerative colitis, maintenance: nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea.
